{"id":1022,"date":"2025-12-12T00:51:42","date_gmt":"2025-12-12T00:51:42","guid":{"rendered":"https:\/\/www.materialstests.com\/?p=1022"},"modified":"2025-12-12T00:52:10","modified_gmt":"2025-12-12T00:52:10","slug":"10-essential-benefits-of-a-reliable-softgel-capsule-hardness-tester","status":"publish","type":"post","link":"https:\/\/www.materialstests.com\/tr\/resources\/10-essential-benefits-of-a-reliable-softgel-capsule-hardness-tester.html","title":{"rendered":"10 G\u00fcvenilir Softgel Kaps\u00fcl Sertlik Test Cihaz\u0131n\u0131n Temel Faydalar\u0131"},"content":{"rendered":"

Softgel nedir kaps\u00fcl sertli\u011fi<\/a> test cihaz\u0131? Yumu\u015fak jelatin kaps\u00fcllerin paketlenmeden \u00f6nce elastikiyet testinden ge\u00e7mesi gerekir. Test cihaz\u0131n\u0131n gerekli oldu\u011fu yer buras\u0131d\u0131r ve s\u0131radan bir test cihaz\u0131 de\u011fildir.<\/p>\n\n\n\n

Kaps\u00fcl \u00fcreticileri, \u00fcr\u00fcnlerini t\u00fcketici halka sunmadan \u00f6nce \u00fcr\u00fcnlerinin belirlenen end\u00fcstri standard\u0131 kaliteyi ge\u00e7ti\u011finden emin olmak i\u00e7in g\u00fcvenilir bir yumu\u015fak jel kaps\u00fcl sertlik test cihaz\u0131na ihtiya\u00e7 duyarlar.<\/p>\n\n\n\n

Sonu\u00e7, kaps\u00fcl\u00fcn paketlenmeye haz\u0131r olup olmad\u0131\u011f\u0131n\u0131 g\u00f6sterecektir. Bu \u015fekilde, paketleme s\u0131ras\u0131nda \u00fcreticiye ek maliyet anlam\u0131na gelebilecek tekrarlanan ar\u0131zalar \u00f6nlenebilir.<\/p>\n\n\n\n

Gelomat, jelatin kaps\u00fcllerin test edilmesinde en y\u00fcksek kalite standartlar\u0131n\u0131 elde etmeyi ama\u00e7lamaktad\u0131r<\/p>\n\n\n\n

Yumu\u015fak Jel Kaps\u00fcller hakk\u0131nda daha fazla bilgi<\/h2>\n\n\n\n

Kaps\u00fcl \u00fcr\u00fcnlerde agelatine sertlik test cihaz\u0131n\u0131n kullan\u0131m\u0131na ili\u015fkin belirlenmi\u015f kurallar vard\u0131r. Tipik olarak, gerekli test say\u0131s\u0131 kaps\u00fcllerin birim dozuna ba\u011fl\u0131d\u0131r. Bununla birlikte, bu makalenin inceleyece\u011fi bir\u00e7ok ba\u015fka fayda sunar.<\/p>\n\n\n\n

Ama \u00f6nce, yumu\u015fak jel kaps\u00fcller hakk\u0131nda bilmeniz gerekenler. Bu \u00fcr\u00fcnler yayg\u0131n olarak ila\u00e7larda, mineral takviyelerinde ve vitaminlerde kullan\u0131l\u0131r. Kaps\u00fcl veya mikrokaps\u00fcller, \u00fcr\u00fcn\u00fc \u00e7e\u015fitli fakt\u00f6rlerden korumak i\u00e7in i\u00e7inde aktif bile\u015fenlerle paketlenmi\u015ftir.<\/p>\n\n\n\n

Bu aktif bile\u015fenler, ki\u015fi kaps\u00fcl\u00fc a\u011fz\u0131na yerle\u015ftirdi\u011finde dif\u00fczyon, erime, \u00e7\u00f6z\u00fcnme veya y\u0131rt\u0131lma yoluyla sal\u0131n\u0131r. Aktif bile\u015fenlerin ne kadar yava\u015f veya h\u0131zl\u0131 sal\u0131naca\u011f\u0131 kaps\u00fcl duvar\u0131n\u0131n g\u00fcc\u00fcne ba\u011fl\u0131d\u0131r.<\/p>\n\n\n\n

Jel kaps\u00fcller veya jelatin kaps\u00fcller olarak da adland\u0131r\u0131lan yumu\u015fak jel kaps\u00fcller, jelatin yapmak i\u00e7in \u00fcretilen hayvan kemi\u011fi ve deri kolajeninden yap\u0131l\u0131r. Ana bile\u015fen olarak HPMC veya hidroksipropil metilsel\u00fcloz kullanan sel\u00fclozdan yap\u0131lm\u0131\u015f vejetaryen veya bitkisel kaps\u00fcller de vard\u0131r. Ancak, jel kaps\u00fcllerin \u00fcretimi daha uygun maliyetlidir, bu nedenle di\u011fer t\u00fcre g\u00f6re daha yayg\u0131n olarak kullan\u0131lmaktad\u0131r.<\/p>\n\n\n\n

Yumu\u015fak kabuklu ve sert kabuklu olmak \u00fczere iki \u00e7e\u015fit jelatin kaps\u00fcl vard\u0131r.<\/p>\n\n\n\n

Yumu\u015fak kabuklu kaps\u00fcller<\/strong> ya\u011flara sahiptir veya ya\u011fda s\u00fcspanse edilmi\u015f veya \u00e7\u00f6z\u00fcnm\u00fc\u015f aktif bile\u015fenler kullan\u0131r.<\/p>\n\n\n\n

Sert kabuklu kaps\u00fcller<\/strong> minyat\u00fcr peletler veya kuru, toz halindeki i\u00e7eriklere sahiptir. \u0130ki yar\u0131dan olu\u015furlar: Yar\u0131mlardan biri ilac\u0131 i\u00e7erir ve di\u011fer yar\u0131m daha b\u00fcy\u00fck bir \u00e7apa sahiptir ve kaps\u00fcl\u00fc kapatmak i\u00e7in bir kapak olarak kullan\u0131l\u0131r.<\/p>\n\n\n\n

Gelomat Kaps\u00fcl hakk\u0131nda her \u015fey Sertlik Test Cihaz\u0131<\/a><\/h2>\n\n\n\n

Gelomat, kaps\u00fcl sertli\u011fini otomatik olarak test etmek i\u00e7in kullan\u0131lan bir cihazd\u0131r. Hem yumu\u015fak hem de normal kaps\u00fcller i\u00e7in \u00e7al\u0131\u015f\u0131r. Yenilebilir jelatin, hamuru, jelatin kaps\u00fcller ve di\u011fer malzemeler \u00fczerinde sertlik testi yapabilir. Standart bir test ba\u015fl\u0131\u011f\u0131 ile birlikte gelir, ancak cihaz\u0131 y\u00fckseltmek ve verimlili\u011fini art\u0131rmak i\u00e7in ba\u015fka aksesuarlar da eklenebilir.<\/p>\n\n\n\n

Gelomat, jelatin kaps\u00fcllerin test edilmesinde en y\u00fcksek kalite standartlar\u0131n\u0131 elde etmeyi ama\u00e7lamaktad\u0131r. En son Ar-Ge teknolojisi ve son teknoloji \u00fcr\u00fcn\u00fc bir sistem kullan\u0131larak geli\u015ftirilmi\u015ftir. Cihaz, y\u00fck kapasitelerine g\u00f6re de\u011fi\u015fen test ba\u015fl\u0131klar\u0131 ile donat\u0131labilir: 0-2N ve 0-20N. Operat\u00f6r, ba\u015fl\u0131klar aras\u0131ndan se\u00e7im yapabilir ve gereksinimlere g\u00f6re bunlar\u0131 de\u011fi\u015ftirebilir.<\/p>\n\n\n\n

G\u00fcvenilir Bir Softgel Kaps\u00fcl Sertlik Test Cihaz\u0131n\u0131n En \u00d6nemli Faydalar\u0131<\/h2>\n\n\n\n

1. Tahribats\u0131z \u00e7\u00f6z\u00fcm<\/strong><\/h3>\n\n\n\n

Gelomat, yumu\u015fak jel kaps\u00fcllerin sertli\u011fini test etmek i\u00e7in tahribats\u0131z bir \u00e7\u00f6z\u00fcm sunar. Yumu\u015fak jel kaps\u00fcller ve jelatinin yan\u0131 s\u0131ra, agar, paintball, oyun hamuru ve daha fazlas\u0131n\u0131n direncini ve sertli\u011fini de \u00f6l\u00e7ebilir. Dijital \u00f6l\u00e7\u00fcm sistemleri ve cihaz\u0131n benzersiz tasar\u0131m\u0131, en g\u00fcvenilir ve en y\u00fcksek d\u00fczeyde \u00f6l\u00e7\u00fcm hassasiyeti sa\u011flar.<\/p>\n\n\n\n

Operat\u00f6r, 0-2N veya 0-20N standart \u00f6l\u00e7\u00fcm ba\u015fl\u0131\u011f\u0131n\u0131 kullanman\u0131n yan\u0131 s\u0131ra Centrofix veya Rotofix takmay\u0131 da tercih edebilir. Centrofix, manuel olarak \u00e7al\u0131\u015ft\u0131r\u0131lan bir numune fikst\u00fcr\u00fcd\u00fcr. Rotofix ise otomatik olarak \u00e7al\u0131\u015fan bir konumland\u0131rma cihaz\u0131d\u0131r. Kullan\u0131c\u0131, toplu klas\u00f6rler olu\u015fturma, histogramlar\u0131 g\u00f6r\u00fcnt\u00fcleme, verileri saklama, sonu\u00e7lar\u0131 analiz etme ve daha fazlas\u0131 dahil olmak \u00fczere yaz\u0131l\u0131m yard\u0131m\u0131yla i\u015flevleri ger\u00e7ekle\u015ftirebilir.<\/p>\n\n\n\n

Yumu\u015fak jel kaps\u00fcllerin test edilmesindeki t\u00fcm bu tela\u015f neden? Kaps\u00fclleme s\u00fcreci titizdir, ancak forma odaklan\u0131r. Kaps\u00fcl\u00fcn \u015fekillendirildi\u011finden ve dolguyu tutabildi\u011finden emin olunur. Kaps\u00fcller nihai formlar\u0131na ula\u015fmak i\u00e7in gerekli t\u00fcm ad\u0131mlardan ge\u00e7tikten sonra test yap\u0131l\u0131r.<\/p>\n\n\n\n

\u0130\u015fte yumu\u015fak jel kaps\u00fcllerin nas\u0131l yap\u0131laca\u011f\u0131na dair ad\u0131mlara bir g\u00f6z at\u0131n:<\/p>\n\n\n\n

S\u0131cak s\u0131v\u0131 jelatin d\u00f6k\u00fcl\u00fcrken 24 in\u00e7 \u00e7ap\u0131nda paslanmaz \u00e7elik bir tambur yava\u015f\u00e7a d\u00f6ner.<\/p>\n\n\n\n

Tambur, kompres\u00f6r\u00fcn dakikada 400 fit k\u00fcp ak\u0131\u015f h\u0131z\u0131na ve y\u00fczde 20 ba\u011f\u0131l nemde 590F'ye kadar hava s\u0131cakl\u0131\u011f\u0131na maruz kal\u0131r.<\/p>\n\n\n\n

Tambur d\u00f6nmeye devam ettik\u00e7e jelatin, elastik ve yap\u0131\u015fkan bir bant di\u011fer u\u00e7tan yuvarlanana kadar so\u011fuk ve kuru hava ile birle\u015fir.<\/p>\n\n\n\n

\u0130nce bant kaps\u00fclleri olu\u015fturan \u015feydir. \u0130\u015flem otomatik olarak yap\u0131l\u0131r.<\/p>\n\n\n\n

Kaps\u00fcller, \u00fcreticinin vitamin, ila\u00e7, takviye ve daha fazlas\u0131 gibi \u00fcr\u00fcnleriyle doldurulur.<\/p>\n\n\n\n

Doldurulan kaps\u00fcller kapat\u0131l\u0131r ve bir tepsiye b\u0131rak\u0131l\u0131r.<\/p>\n\n\n\n

Doldurulan kaps\u00fcller hala nemli ve yumu\u015fakt\u0131r, bu nedenle odalara veya kurutma tamburlar\u0131na aktar\u0131l\u0131rlar.<\/p>\n\n\n\n

Kurutma s\u00fcresi, nemi gidermek i\u00e7in gereken s\u00fcre, kaps\u00fcl say\u0131s\u0131 ve kaps\u00fcllerin boyutu dahil olmak \u00fczere bir\u00e7ok fakt\u00f6re g\u00f6re de\u011fi\u015fir.<\/p>\n\n\n\n

Bu, yumu\u015fak jel kaps\u00fclleri olu\u015fturman\u0131n ne kadar titiz oldu\u011funu g\u00f6sterir. D\u00f6kme i\u015flemi s\u0131ras\u0131nda tamburun maruz kald\u0131\u011f\u0131 havan\u0131n s\u0131cakl\u0131\u011f\u0131 \u00e7ok \u00f6nemlidir, \u00e7\u00fcnk\u00fc jellerin \u00e7ok k\u0131r\u0131lgan olmas\u0131na veya \u00e7ok h\u0131zl\u0131 sertle\u015fmesine neden olabilir. Her iki sonu\u00e7 da \u00fcretimi durdurabilir ve s\u00fcreci ba\u015ftan tekrarlayabilir.<\/p>\n\n\n\n

Hava h\u0131z\u0131 \u00e7ok y\u00fcksek oldu\u011funda, jel kaps\u00fcllerin kal\u0131nl\u0131\u011f\u0131 veya inceli\u011fi tutarl\u0131 olmayacakt\u0131r. \u00d6te yandan, \u00e7ok d\u00fc\u015f\u00fck oldu\u011funda ve nem ile hava s\u0131cakl\u0131\u011f\u0131 \u00e7ok y\u00fcksek oldu\u011funda, jelatin kat\u0131la\u015fmakta zorlanacakt\u0131r.<\/p>\n\n\n\n

Kurutma s\u00fcresi boyunca ortam\u0131n s\u0131cakl\u0131\u011f\u0131n\u0131n s\u00fcrekli olarak kontrol edilmesi gerekir. \u0130deal nem seviyesi, havan\u0131n her bir kilosu i\u00e7in 20 tane ve 25\u00b0 F \u00e7i\u011flenme noktas\u0131d\u0131r.<\/p>\n\n\n\n

Kaps\u00fcller tamamen kurudu\u011funda, Gelomat gibi bir yumu\u015fak jel kaps\u00fcl sertlik test cihaz\u0131 kullan\u0131larak test edilir. O zaman bile, sonunda piyasaya sat\u0131lacak kaps\u00fcllerin say\u0131s\u0131 test sonu\u00e7lar\u0131na ba\u011fl\u0131 olacakt\u0131r. Bu, korunan envanterin de\u011ferli olmas\u0131n\u0131 ve \u00fcreticinin ad\u0131na g\u00f6lge d\u00fc\u015f\u00fcrmemesini sa\u011flar.<\/p>\n\n\n\n

Cihaz\u0131n y\u00fcksek oranda tekrarlanabilir olmas\u0131 neden \u00f6nemlidir? Kaps\u00fcller partiler halinde test edilir ve partideki her bir kaps\u00fcl\u00fcn di\u011ferleriyle benzer \u00f6zellikler ve sertlik g\u00f6stermesi gerekir.<\/p>\n\n\n\n

2. Test cihaz\u0131 dayan\u0131kl\u0131l\u0131k ve do\u011fruluk i\u00e7in \u00fcretilmi\u015ftir<\/strong><\/h3>\n\n\n\n

Bu jelatin sertlik test cihaz\u0131, Alman \u00fcretimi bir cihaz i\u00e7in mevcut olan en y\u00fcksek standart do\u011frulukla geli\u015ftirilmi\u015ftir. Ayr\u0131ca y\u00fcksek oranda tekrarlanabilir.<\/p>\n\n\n\n

Cihaz\u0131n y\u00fcksek oranda tekrarlanabilir olmas\u0131 neden \u00f6nemlidir? Kaps\u00fcller partiler halinde test edilir ve partideki her bir kaps\u00fcl\u00fcn di\u011ferleriyle benzer \u00f6zellikler ve sertlik g\u00f6stermesi gerekir.<\/p>\n\n\n\n

T\u00fcketicinin farkl\u0131l\u0131klar\u0131 g\u00f6zlemlemesini ve daha yumu\u015fak olanlar\u0131n son kullanma tarihinin ge\u00e7ti\u011fi veya kendilerine orijinal olmayan \u00fcr\u00fcnler verildi\u011fi sonucuna varmas\u0131n\u0131 istemezsiniz. Sadece kaps\u00fcller y\u00fcksek oranda \u00e7o\u011falt\u0131ld\u0131\u011f\u0131nda en y\u00fcksek g\u00fcvenilirlik derecesine ula\u015f\u0131labilir.<\/p>\n\n\n\n

Bilimde tekrar \u00fcretilebilirlik, hassasiyet testinin son ve \u00fc\u00e7\u00fcnc\u00fc a\u015famas\u0131d\u0131r. Kararl\u0131l\u0131k elde etmek i\u00e7in, test edilen \u00fcr\u00fcne ba\u011fl\u0131 olarak bir i\u015faret sistemi se\u00e7ilir. Jelatin kaps\u00fcllerin test edilmesinde, kuru plastikle\u015ftirici uygun a\u011f\u0131rl\u0131k oran\u0131d\u0131r.<\/p>\n\n\n\n

Kuru jelatinin suya oran\u0131 1:1'dir ve kuru jelatin 0.4-0.6:1.0'a e\u015fittir. Elde edilen a\u011f\u0131rl\u0131k oran\u0131 1,8:1 oldu\u011funda, bu kabu\u011fun yumu\u015fak oldu\u011fu anlam\u0131na gelir. Kaps\u00fcl\u00fcn en sert formda olmas\u0131 i\u00e7in plastikle\u015ftirici ve jelatin aras\u0131ndaki a\u011f\u0131rl\u0131k oran\u0131n\u0131n 0,3:1,0 olmas\u0131 gerekir.<\/p>\n\n\n\n

3. Farkl\u0131 end\u00fcstriler i\u00e7in uygundur - ila\u00e7 end\u00fcstrisi<\/strong><\/h3>\n\n\n\n

Bir tablet sertlik test cihaz\u0131 \u00f6ncelikle ila\u00e7 end\u00fcstrisinde kullan\u0131l\u0131r. Bu laboratuvar testi, bir tabletin yap\u0131sal b\u00fct\u00fcnl\u00fc\u011f\u00fcn\u00fc ve k\u0131r\u0131lma noktas\u0131n\u0131 belirler. Ta\u015f\u0131ma, paketleme, nakliye ve depolama s\u0131ras\u0131nda nas\u0131l de\u011fi\u015fti\u011fini belirler. \u015eekil, bir tabletin k\u0131r\u0131lma noktas\u0131n\u0131 belirler.<\/p>\n\n\n\n

Bu t\u00fcr bir test cihaz\u0131 1930'lardan beri kullan\u0131lmaktad\u0131r. Ancak patenti 1953 y\u0131l\u0131nda Robert Albrecht taraf\u0131ndan al\u0131nm\u0131\u015f ve Strong-Cobb test cihaz\u0131 olarak adland\u0131r\u0131lm\u0131\u015ft\u0131r. O zamanlar hava pompas\u0131 olarak kullan\u0131l\u0131yordu.<\/p>\n\n\n\n

Test cihazlar\u0131n\u0131n eski modellerindeki sorun, sonu\u00e7lardaki tutars\u0131zl\u0131kt\u0131. Gelomat gibi daha yeni modeller bu sorunu a\u015fm\u0131\u015ft\u0131r.<\/p>\n\n\n\n

Bu, bu iyi bilinen cihaza a\u015fa\u011f\u0131daki \u00f6zelliklerin dahil edilmesiyle m\u00fcmk\u00fcn olmaktad\u0131r:<\/p>\n\n\n\n

Otomatik \u00f6l\u00e7\u00fcm s\u00fcrecinin tam entegrasyonu<\/p>\n\n\n\n

Histerezis fonksiyonu<\/p>\n\n\n\n

Y\u00fcksek oranda test verimlili\u011fi ve en y\u00fcksek d\u00fczeyde do\u011fruluk sa\u011flar<\/p>\n\n\n\n

\u00d6zelle\u015ftirilmi\u015f tutma armat\u00fcrleri<\/p>\n\n\n\n

USB portu \u00fczerinden rahat ve h\u0131zl\u0131 veri aktar\u0131m\u0131<\/p>\n\n\n\n

Tekrarlanabilirlik ve en y\u00fcksek do\u011fruluk standartlar\u0131n\u0131 kar\u015f\u0131lamak \u00fczere tasarlanm\u0131\u015f kullan\u0131c\u0131 dostu sistem<\/p>\n\n\n\n

Otomatik d\u00fczeltme \u00f6zelli\u011fi<\/p>\n\n\n\n

Dijital ekran, elde edilen de\u011ferlerin s\u0131n\u0131r de\u011ferin alt\u0131nda veya \u00fcst\u00fcnde oldu\u011funu g\u00f6sterir<\/p>\n\n\n\n

Dijital g\u00f6sterge \u00fcnitesi, zaman ve aral\u0131k \u00f6l\u00e7\u00fcm\u00fc de dahil olmak \u00fczere \u00e7e\u015fitli i\u015flevlere sahiptir<\/p>\n\n\n\n

4. Farkl\u0131 end\u00fcstriler i\u00e7in uygundur - paintball end\u00fcstrisi<\/strong><\/h3>\n\n\n\n

Paintball end\u00fcstrisinde sertlik test cihaz\u0131 ne i\u015fe yarar? Kaps\u00fcllerde elde edilmesi gerekene benzer \u015fekilde, paintball toplar\u0131 da top tutucular\u0131, namlular\u0131 ve i\u015faretleyicileri test etmek i\u00e7in tekrarlanabilir ve g\u00fcvenilir bir y\u00f6ntem gerektirir. Test sisteminin do\u011fruluk, tekrarlanabilirlik ve basitlik sa\u011flamas\u0131 gerekir.<\/p>\n\n\n\n

Bu sekt\u00f6rde, bir paintball'un y\u00f6r\u00fcngesini etkileyen ba\u011f\u0131ms\u0131z ve ba\u011f\u0131ml\u0131 de\u011fi\u015fkenleri izole etmek ve tan\u0131mlamak \u00e7ok \u00f6nemlidir. Topun isabetlili\u011fi b\u00fcy\u00fck \u00f6l\u00e7\u00fcde kalitesine ba\u011fl\u0131d\u0131r. Topu ancak \u015fi\u015fik, diki\u015fli veya \u00e7ukurlu de\u011filse d\u00fcz vurabilirsiniz - test uzman\u0131n\u0131n not ald\u0131\u011f\u0131 ve ortadan kald\u0131rd\u0131\u011f\u0131 fakt\u00f6rler.<\/p>\n\n\n\n

Top kalitesinin yan\u0131 s\u0131ra, namlunun sertli\u011fi de i\u00e7 kaplaman\u0131n uzun \u00f6m\u00fcrl\u00fcl\u00fc\u011f\u00fcn\u00fc belirler. Namlu deliklerinin de yeterli a\u00e7\u0131 ve boyuta sahip olmas\u0131 gerekir. Dolum i\u00e7in bir\u00e7ok \u00fcretici bas\u0131n\u00e7l\u0131 hava kullanmaktad\u0131r, \u00e7\u00fcnk\u00fc bunu daha g\u00fcvenilir bulmakta ve CO2'den daha y\u00fcksek bir do\u011fruluk oran\u0131 sunmaktad\u0131r.<\/p>\n\n\n\n

5. Farkl\u0131 end\u00fcstriler i\u00e7in uygundur - kozmetik end\u00fcstrisi<\/strong><\/h3>\n\n\n\n

Kozmetik sekt\u00f6r\u00fcnde sertlik testinden ge\u00e7irilmesinden fayda sa\u011flayacak bir\u00e7ok \u00fcr\u00fcn vard\u0131r. Birincisi, bir kozmetik fond\u00f6ten, bas\u0131ld\u0131\u011f\u0131nda yeterince sert oldu\u011fundan ve belirlenen Ar-Ge ve kalite kontrol standartlar\u0131n\u0131 kar\u015f\u0131lad\u0131\u011f\u0131ndan emin olmak i\u00e7in testten ge\u00e7er. Bu genellikle yaz\u0131l\u0131m, kablo, test stand\u0131 ve kuvvet \u00f6l\u00e7er \u00f6l\u00e7\u00fcmleri kullanan bir test cihaz\u0131 kullan\u0131larak yap\u0131l\u0131r. Test cihaz\u0131, soyulma kuvveti, s\u0131k\u0131\u015ft\u0131rma ve gerilim dahil olmak \u00fczere mekanik \u00f6zelliklere sahiptir.<\/p>\n\n\n\n

Sertlik test cihaz\u0131 ayr\u0131ca ruj, ka\u015f veya dudak kalemi ve balmumu ve krem \u00fcr\u00fcnleri dahil olmak \u00fczere kozmetik \u00fcr\u00fcnlerin kalitesini sa\u011flamak i\u00e7in de kullan\u0131labilir. End\u00fcstri, sertlikten daha \u00e7ok \u00fcr\u00fcnlerin doku testinin sonu\u00e7lar\u0131na g\u00fcvenmektedir. Kozmetik \u00fcr\u00fcnleri piyasaya s\u00fcrmeden \u00f6nce ciltte iyi bir his b\u0131rakt\u0131\u011f\u0131ndan emin olmak zorundad\u0131rlar.<\/p>\n\n\n\n

6. Malzemeleri \u00e7ekme ve s\u0131k\u0131\u015ft\u0131rma i\u00e7in test eder<\/strong><\/h3>\n\n\n\n

Yumu\u015fak jeller teste tabi tutuldu\u011funda, kopma noktas\u0131n\u0131 belirlemek i\u00e7in kaps\u00fcl\u00fcn duvar mukavemeti \u00f6l\u00e7\u00fcl\u00fcr. Ayr\u0131ca jelatinin contas\u0131n\u0131n veya filminin zay\u0131fl\u0131\u011f\u0131 da belirlenir. Test, kaps\u00fcl\u00fcn t\u00fcketiciye ula\u015fmadan \u00f6nce patlamas\u0131na neden olabilecek fakt\u00f6rleri sim\u00fcle etmek i\u00e7in yap\u0131l\u0131r.<\/p>\n\n\n\n

Gelomat, kalite kontrol\u00fcnden ge\u00e7ip ge\u00e7medikleri hakk\u0131nda veri toplamak i\u00e7in kaps\u00fcllere bas\u0131n\u00e7 kuvveti uygular. Cihaz, kaps\u00fcllerin duvar mukavemetini, d\u0131\u015f kuvvetlere maruz kald\u0131ktan sonra bile kaps\u00fcl\u00fcn formunu ta\u015f\u0131maya yeterli olup olmad\u0131\u011f\u0131n\u0131 test eder.<\/p>\n\n\n\n

Cihaz\u0131n amac\u0131, s\u0131z\u0131nt\u0131 yapan kaps\u00fcllerin t\u00fcketicilerin eline ge\u00e7memesini sa\u011flamakt\u0131r. Bu da t\u00fcketicilerin \u00fcreticilere daha fazla g\u00fcven duymas\u0131na ve tekrar sat\u0131n alma oranlar\u0131n\u0131n artmas\u0131na neden olur.<\/p>\n\n\n\n

Sertlik testi, kaps\u00fcller gibi \u00fcr\u00fcnlerin kalite kontrol\u00fcn\u00fc uygulamak i\u00e7in ge\u00e7ti\u011fi bir\u00e7ok testten yaln\u0131zca biridir. Ayn\u0131 durum boya toplar\u0131 ve kozmetik \u00fcr\u00fcnler i\u00e7in de ge\u00e7erlidir. T\u00fcketiciler taraf\u0131ndan sat\u0131n al\u0131nmas\u0131 veya t\u00fcketilmesi ama\u00e7lanan t\u00fcm bu \u00fcr\u00fcnler paketlenip sat\u0131lmadan \u00f6nce bir dizi testten ge\u00e7irilir.<\/p>\n\n\n\n

Yumu\u015fak jel kaps\u00fcller i\u00e7in, her parti, reklamlar\u0131n\u0131n yap\u0131lma \u015fekline g\u00f6re standartlar\u0131 kar\u015f\u0131lad\u0131klar\u0131n\u0131 ve t\u00fcketim i\u00e7in kabul edilebilir olduklar\u0131n\u0131 belirlemek i\u00e7in bir dizi teste tabi tutulur.<\/p>\n\n\n\n

7. En son teknolojiyi kullan\u0131r<\/strong><\/h3>\n\n\n\n

Eski modellerin aksine, Alman \u00fcretimi Gelomat gibi yeni geli\u015ftirilen sertlik test cihazlar\u0131 entegre de\u011fer, verimlilik ve en son patentli teknolojiyi sunar. Gelomat et sertlik test cihaz\u0131, krema sertlik test cihaz\u0131, tereya\u011f\u0131 sertlik test cihaz\u0131 ve daha fazlas\u0131 olarak kullan\u0131labilir. Bu, \u00fcreticilerin m\u00fc\u015fterilerinin en iyi \u00fcr\u00fcnleri almalar\u0131n\u0131 sa\u011flama konusunda ne kadar ciddi olduklar\u0131n\u0131 g\u00f6stermektedir.<\/p>\n\n\n\n

Gelomat, test sonu\u00e7lar\u0131ndan \u00f6d\u00fcn vermeden s\u00fcreci daha kolay hale getirmek i\u00e7in hassas dijital \u00f6l\u00e7\u00fcm sistemleri ve benzersiz tasar\u0131m kullan\u0131r. Jelatin kaps\u00fcller, optimum tekrarlanabilirlik ve do\u011fruluk elde etmek i\u00e7in g\u00fcvenilebilecek bir sistem arac\u0131l\u0131\u011f\u0131yla sertlikleri i\u00e7in otomatik bir \u00f6l\u00e7\u00fcme tabi tutulur.<\/p>\n\n\n\n

Gelomat sistemi, m\u00fc\u015fterilerin benzersiz test gereksinimlerini kar\u015f\u0131lamak i\u00e7in \u00f6zel fikst\u00fcrlerin ve \u00f6rslerin geli\u015ftirilmesi yoluyla en \u00fcst d\u00fczeyde esneklik sa\u011flayabilen d\u00fcnyadaki tek sistemlerden biridir. Bu da Gelomat sistemini t\u00fcr\u00fcn\u00fcn tek \u00f6rne\u011fi bir \u00e7\u00f6z\u00fcm paketi haline getirmektedir.<\/p>\n\n\n\n

8. Tabletlerde sertli\u011fin \u00f6l\u00e7\u00fclmesini kolayla\u015ft\u0131rmak<\/strong><\/h3>\n\n\n\n

Kat\u0131 tabletler, farmas\u00f6tiklerde kullan\u0131lan en yayg\u0131n dozaj \u015feklidir. Tabletlerin sertli\u011fi, \u00fcr\u00fcn\u00fcn kalite kontrol spesifikasyonlar\u0131n\u0131 ve \u00fcr\u00fcn geli\u015ftirme kriterlerini olu\u015fturur.<\/p>\n\n\n\n

Tablet sertlik test cihaz\u0131n\u0131n \u00fcr\u00fcnden kaliteli sonu\u00e7lar elde etmesi gerekir, yani her tabletin \u00e7ok yumu\u015fak veya \u00e7ok sert olmamas\u0131 gerekir.<\/p>\n\n\n\n

Bir tablet \u00e7ok yumu\u015fak oldu\u011funda, hasta taraf\u0131ndan al\u0131nd\u0131\u011f\u0131nda erken par\u00e7alanmaya yol a\u00e7abilir. Bu, zay\u0131f ba\u011flanma sonucu meydana gelebilir. Ayr\u0131ca, \u00e7ok yumu\u015fak bir tablet paketleme, kaplama ve di\u011fer \u00fcretim a\u015famalar\u0131nda k\u0131r\u0131labilir veya par\u00e7alanabilir.<\/p>\n\n\n\n

\u00d6te yandan, tablet a\u015f\u0131r\u0131 sert oldu\u011funda, hasta ald\u0131\u011f\u0131nda uygun dozaj\u0131n uygunsuz \u015fekilde \u00e7\u00f6z\u00fcnmesine yol a\u00e7abilir. Sorun, yard\u0131mc\u0131 maddeler ve aktif bile\u015fenler aras\u0131nda \u00e7ok fazla ba\u011flanma potansiyeli olmas\u0131ndan kaynaklan\u0131yor olabilir.<\/p>\n\n\n\n

Tabletin sertli\u011finin test edilmesi, \u00fcr\u00fcn\u00fcn t\u00fcketilebilir olup olmad\u0131\u011f\u0131n\u0131 ve en y\u00fcksek kalite standartlar\u0131n\u0131 ge\u00e7ip ge\u00e7medi\u011fini \u00f6l\u00e7ecektir. Bununla birlikte, optimize edilmi\u015f sonu\u00e7lar i\u00e7in gereken t\u00fcm mekanik \u00f6zellikleri de i\u00e7ermelidir. \u00dcreticinin, \u00fcr\u00fcn\u00fcn do\u011fru bile\u015fen bile\u015fimini, aktif bile\u015fenlerin yap\u0131s\u0131n\u0131 ve kullan\u0131lan ba\u011flay\u0131c\u0131lar\u0131 kulland\u0131\u011f\u0131n\u0131 g\u00f6rmesi gerekir. Nihai tabletlerin sertlik testini ge\u00e7me \u015fans\u0131n\u0131 art\u0131rmak i\u00e7in bu fakt\u00f6rleri hen\u00fcz \u00fcretim a\u015famas\u0131ndayken kontrol etmeleri gerekir.<\/p>\n\n\n\n

9. En son end\u00fcstri standartlar\u0131na s\u0131k\u0131 bir \u015fekilde uyulmas\u0131n\u0131 sa\u011flar<\/strong><\/h3>\n\n\n\n

Jelatin kaps\u00fcller s\u00f6z konusu oldu\u011funda, bitmi\u015f \u00fcr\u00fcnlerin testlerden ge\u00e7mesi gerekir. Kaps\u00fcl sertlik test cihaz\u0131 veya jelatin sertlik test cihaz\u0131 gibi terimleri zaten duymu\u015f olabilirsiniz.<\/p>\n\n\n\n

Kaps\u00fcller, yasal gerekliliklere ve standartlara uymak i\u00e7in bir dizi testten ge\u00e7irilir. Testlerin sonu\u00e7lar\u0131, partinin ama\u00e7lanan kullan\u0131m ve pazarlama i\u00e7in ge\u00e7ip ge\u00e7medi\u011fini belirleyecektir.<\/p>\n\n\n\n

10. Halk\u0131n g\u00fcvenini kazanmak<\/strong><\/h3>\n\n\n\n

Bu testler neden gereklidir? Bu \u00fcr\u00fcnler b\u00fcy\u00fck \u00f6l\u00e7\u00fcde t\u00fcketicilerin g\u00fcvenine dayanmaktad\u0131r. S\u0131zd\u0131ran kaps\u00fcller, insanlar\u0131n \u00fcr\u00fcne ve ayn\u0131 \u00fcreticinin di\u011fer t\u00fcm \u00fcr\u00fcnlerine bak\u0131\u015f\u0131n\u0131 olumsuz etkileyebilir.<\/p>\n\n\n\n

Bu nedenle kusurlu kaps\u00fcllerin piyasaya ula\u015fmamas\u0131 \u00e7ok \u00f6nemlidir; bu nedenle \u00fcreticiler, piyasaya s\u00fcrecekleri t\u00fcm \u00fcr\u00fcnlerin adlar\u0131ndan \u00f6d\u00fcn vermemesini sa\u011flamak i\u00e7in bir softgel kaps\u00fcl sertlik test cihaz\u0131 kullan\u0131rlar.<\/p>\n\n\n\n

Son D\u00fc\u015f\u00fcnceler<\/h2>\n\n\n\n

Kalite kontrol tesisiniz softgel sertlik test cihaz\u0131n\u0131 kullanarak bir\u00e7ok fayda elde edecektir, ancak test edilmi\u015f ve kaliteli cihazlara g\u00fcvenmeniz gerekir. Bareiss, 1954 y\u0131l\u0131nda kuruldu\u011fundan bu yana kendini teknolojiye ve yeniliklere adam\u0131\u015f bir \u015firket olarak bilinmektedir.<\/p>\n\n\n\n

Test: Kaps\u00fclleriniz Ne Kadar S\u0131zd\u0131rmaz?<\/h2>\n\n\n\n

S\u0131zd\u0131ran jelatin kaps\u00fcller t\u00fcketicinin \u00fcr\u00fcne ve \u00fcreticiye olan g\u00fcvenini azalt\u0131r. Kusurlu kaps\u00fcllerin pazara ula\u015fmas\u0131n\u0131 \u00f6nlemek i\u00e7in bunlar\u0131 tan\u0131mlayacak testler geli\u015ftirmelisiniz. Yakla\u015f\u0131mlardan biri, jelatin kaps\u00fcllere \u00e7ekme ve basma kuvvetleri uygulayarak \u00fcretim, depolama, paketleme ve nakliye s\u0131ras\u0131nda d\u0131\u015f kuvvetlere dayanacak yeterli duvar mukavemetine sahip olduklar\u0131n\u0131 do\u011frulayan bir doku analiz cihaz\u0131 kullanmakt\u0131r. <\/p>\n\n\n\n

Bir kaps\u00fcl ila\u00e7 \u00fcr\u00fcn\u00fcn\u00fc form\u00fcle ederken, dolgunun (hem API hem de yard\u0131mc\u0131 maddeler) suda \u00e7\u00f6z\u00fcnen proteinlerin bir kar\u0131\u015f\u0131m\u0131ndan olu\u015fan jelatin kabukla uyumlu olup olmad\u0131\u011f\u0131n\u0131 bilmek \u00f6nemlidir. Aldehit i\u00e7eren herhangi bir madde (\u00f6rn. formaldehit) jelatinin \u00e7apraz ba\u011flanmas\u0131na, jelatin ipliklerinin i\u00e7inde ve aras\u0131nda lizin kal\u0131nt\u0131s\u0131na neden olabilir. Bu, jelatin yap\u0131s\u0131n\u0131 sertle\u015ftirir ve par\u00e7alanmas\u0131n\u0131 yava\u015flat\u0131r. Bir dolgunun jelatin kabu\u011fun su i\u00e7eri\u011fiyle nas\u0131l etkile\u015fime girece\u011fini \u00f6\u011frenmek de \u00f6nemlidir. \u00d6rne\u011fin y\u00fcksek higroskopik bir dolgu, kabuktan su emebilir ve kabu\u011fun k\u0131r\u0131lganla\u015fmas\u0131na ve k\u0131r\u0131lmaya daha yatk\u0131n hale gelmesine neden olabilir. <\/p>\n\n\n\n

Bir doku analiz\u00f6r\u00fc sert malzemelerin mekanik mukavemetini \u00f6l\u00e7er jelatin kaps\u00fcl<\/a> B\u00f6ylece farkl\u0131 dolgular\u0131n kaps\u00fcl mukavemetini ve stabilitesini nas\u0131l etkiledi\u011fini de\u011ferlendirebilirsiniz. Bunu, bir numuneye kontroll\u00fc mekanik ko\u015fullar uygulayarak ve ard\u0131ndan ortaya \u00e7\u0131kan davran\u0131\u015f\u0131 \u00f6l\u00e7erek yapar. Numunelerin nas\u0131l tepki verdi\u011fi do\u011frudan fiziksel \u00f6zellikleriyle ilgilidir ve i\u00e7 yap\u0131lar\u0131n\u0131n ger\u00e7ek hayattaki bir g\u00f6stergesini sa\u011flar. <\/p>\n\n\n\n

Bir doku analiz\u00f6r\u00fc gerilim veya s\u0131k\u0131\u015ft\u0131rma modunda \u00e7al\u0131\u015f\u0131r ve birden fazla kez deformasyon eylemi uygulad\u0131\u011f\u0131 d\u00f6ng\u00fcsel testler ger\u00e7ekle\u015ftirebilir. Cihaz, genellikle gram cinsinden y\u00fck kuvvetini \u00f6l\u00e7er ve bunu kaps\u00fcl deformasyonu ile ili\u015fkilendirir. Sonu\u00e7lar daha sonra zamana kar\u015f\u0131 kuvvet veya mesafeye kar\u015f\u0131 kuvvet olarak grafik bi\u00e7iminde sunulur. Deformasyon s\u0131ras\u0131nda \u00e7e\u015fitli dokusal parametreler i\u015f ba\u015f\u0131nda olabilir ve bunlar\u0131 testin olu\u015fturdu\u011fu kuvvet-deformasyon e\u011frisinde g\u00f6zlemlemek m\u00fcmk\u00fcnd\u00fcr. Son 40 y\u0131lda, doku analizini kullanan bir\u00e7ok akademik \u00e7al\u0131\u015fma, bu davran\u0131\u015flar\u0131 duyusal \u00f6zellikleriyle ili\u015fkilendirmi\u015ftir. <\/p>\n\n\n\n

Kaps\u00fcl-D\u00f6ng\u00fc \u00c7ekme Testi <\/h2>\n\n\n\n

Doku analiz cihaz\u0131n\u0131 yukar\u0131daki foto\u011frafta g\u00f6sterildi\u011fi gibi bir kaps\u00fcl d\u00f6ng\u00fcs\u00fc \u00e7ekme fikst\u00fcr\u00fc ile donatmak, bo\u015f kaps\u00fcl kabuklar\u0131n\u0131n mekanik mukavemetini kar\u015f\u0131la\u015ft\u0131rman\u0131za olanak tan\u0131r. Uygulamada, fikst\u00fcr\u00fcn iki ince \u00e7ubu\u011fu kaps\u00fcl kabu\u011funun bir yar\u0131s\u0131na, genellikle kapa\u011fa yerle\u015ftirilir. Alt \u00e7ubuk daha sonra cihaz taban\u0131na sabitlenirken, \u00fcst \u00e7ubuk analiz\u00f6r\u00fcn tahrik mekanizmas\u0131na ba\u011flan\u0131r. Tahrik, \u00fcst \u00e7ubu\u011fu sabit bir h\u0131zda, tipik olarak saniyede 0,1 ila 1,0 milimetre aras\u0131nda kald\u0131r\u0131r ve kaps\u00fcl kabu\u011funu belirli bir mesafe uzat\u0131r. Baz\u0131 durumlarda, test kabu\u011fun y\u0131rt\u0131lmas\u0131na neden olur. <\/p>\n\n\n\n

S\u0131k\u0131\u015ft\u0131rma Testi <\/h2>\n\n\n\n

Bir doku analiz\u00f6r\u00fc ayr\u0131ca iki test y\u00f6ntemi kullanarak yumu\u015fak jelatin kaps\u00fcl\u00fcn (softgel) bas\u0131n\u00e7 dayan\u0131m\u0131n\u0131 \u00f6l\u00e7ebilir. \u0130lkinde, 36 milimetre \u00e7ap\u0131nda bir sonda s\u0131zd\u0131rmazl\u0131k mukavemetini \u00f6l\u00e7mek i\u00e7in kullan\u0131l\u0131r (\u015eekil 2) ve ikincisinde - penetrasyon testi - 2 milimetrelik silindirik bir sonda yumu\u015fak jelin kopma noktas\u0131n\u0131 belirler. Bu iki test sadece yumu\u015fak jelin mukavemetindeki zay\u0131fl\u0131klar\u0131 belirlemekle kalmaz, ayn\u0131 zamanda yumu\u015fak jelin paketleme veya ta\u015f\u0131ma s\u0131ras\u0131nda patlayabilece\u011fi ko\u015fullar\u0131 da sim\u00fcle eder. Sert veya yumu\u015fak herhangi bir kaps\u00fcl\u00fcn s\u0131zd\u0131rmazl\u0131k mukavemetini \u00f6l\u00e7erken, \u00e7ap\u0131 kaps\u00fclden daha b\u00fcy\u00fck olan bir s\u0131k\u0131\u015ft\u0131rma probu kullan\u0131n ve s\u0131zd\u0131rmazl\u0131\u011f\u0131 hem proba hem de uygulanan kuvvete dik olarak y\u00f6nlendirin. A\u015fa\u011f\u0131daki foto\u011frafa bak\u0131n. Tablo 2 yumu\u015fak jel sertlik testlerinin sonu\u00e7lar\u0131n\u0131 listelemektedir.<\/p>\n\n\n\n

Jel Mukavemet Testi <\/h2>\n\n\n\n

Jelatin bir\u00e7ok end\u00fcstride ve bir\u00e7ok farkl\u0131 uygulamada kullan\u0131lmaktad\u0131r ve neredeyse t\u00fcm durumlarda hem jelatin \u00fcreticisi hem de son kullan\u0131c\u0131 jelin etkinli\u011fini g\u00f6steren jel g\u00fcc\u00fcn\u00fc \u00f6l\u00e7mektedir. Jel g\u00fcc\u00fc b\u00fcy\u00fck \u00f6l\u00e7\u00fcde \u00e7i\u00e7eklenme g\u00fcc\u00fcne ba\u011fl\u0131d\u0131r. Bir sonraki sayfadaki foto\u011fraf, test edilmeye haz\u0131r jelatin numunesi i\u00e7eren bir bloom kavanozunu g\u00f6stermektedir. <\/p>\n\n\n\n

Standart bir \u00e7i\u00e7eklenme probu, \u00e7i\u00e7eklenme \u015fi\u015feleri ve jelatin banyosu ile donat\u0131lm\u0131\u015f bir doku analiz\u00f6r\u00fc kullanarak basit testler yapabilir ve jeli belirli bir mesafe boyunca deforme etmek i\u00e7in gereken kuvvet olarak \u00f6l\u00e7\u00fclen jel g\u00fcc\u00fcn\u00fc h\u0131zl\u0131 ve do\u011fru bir \u015fekilde belirleyebilirsiniz.<\/p>\n\n\n\n

Bir doku analiz\u00f6r\u00fc, \u0130ngiliz Standart Metodu, \u201cJelatinden numune alma ve test etme\u201d (BS757: 1975) uyar\u0131nca veya 1998 y\u0131l\u0131nda GMIA standard\u0131n\u0131 benimseyen Amerika Jelatin \u00dcreticileri Enstit\u00fcs\u00fc (GMIA) veya Avrupa Jelatin \u00dcreticileri standartlar\u0131n\u0131 kullanarak jelatinin jel g\u00fcc\u00fcn\u00fc \u00f6l\u00e7mek i\u00e7in kullan\u0131labilir. Sonu\u00e7 olarak, mevcut t\u00fcm y\u00f6ntemler 12,7 milimetre \u00e7ap\u0131nda, keskin kenarl\u0131, d\u00fcz y\u00fczl\u00fc silindirik bir probun kullan\u0131lmas\u0131n\u0131 \u00f6ng\u00f6rmektedir. (Avrupa metodunda keskin kenar yerine k\u00fc\u00e7\u00fck yar\u0131\u00e7apl\u0131 bir prob belirtilmi\u015ftir). <\/p>\n\n\n\n

Bu y\u00f6ntem HPMC gibi di\u011fer kaps\u00fcl kabu\u011fu malzemeleriyle de kullan\u0131labilir. Y\u00fcksek mekanik mukavemete sahip numuneleri test ederken, daha b\u00fcy\u00fck kapasiteli bir y\u00fck h\u00fccresi kullanmay\u0131 d\u00fc\u015f\u00fcn\u00fcn. Ayn\u0131 \u015fekilde, y\u00fcksek elastik bile\u015fene sahip numuneler i\u00e7in test mesafesini uzatman\u0131z gerekebilir. <\/p>\n\n\n\n

Sonu\u00e7 <\/h2>\n\n\n\n

Tekst\u00fcr analizi, bitmi\u015f \u00fcr\u00fcn\u00fc etkileyen temel \u00f6zellikleri belirleyerek Ar-Ge, proses optimizasyonu ve \u00fcretimin ayr\u0131lmaz bir par\u00e7as\u0131d\u0131r. Geli\u015ftirmenin ilk a\u015famalar\u0131nda se\u00e7imlerinizi y\u00f6nlendirmenize yard\u0131mc\u0131 olur ve hat \u00fczerinde proses kontrol\u00fc sa\u011flar. Doku analizi, y\u00fcksek ve d\u00fc\u015f\u00fck kabul s\u0131n\u0131rlar\u0131n\u0131 belirleyerek \u00fcretimi optimize etmenizi ve israf\u0131 azaltman\u0131z\u0131 sa\u011flar. <\/p>\n\n\n\n

Challenges of Dissolution Methods Development for Soft Gelatin Capsules<\/h2>\n\n\n\n

Noyes and Whitney first documented the study of the dissolution process in 1897 as a field of physical chemistry, which later was mimicked in pharmacy due to its importance in drug administration [74]. The dissolution of solid dosage forms attracted attention as the realization of the importance of drug dissolution concerning bioavailability was identified in the 1950s with the understanding that only dissolved drugs can diffuse through the human body [74,75,76,77,78]. Poor drug solubility and low dissolution rates potentially lead to insufficient availability of the drug at the site of action and subsequent failure of the in vivo therapeutic performance. This is independent of the fact that the drug could be an ideal structure for the target site. Essentially, if the drug is too insoluble, it can never reach its target site, and it will be of no therapeutic relevance. Characterization of the dissolution of a drug from a given dosage form is critical for the successful development of a drug product. This section discusses the current state-of-the-art of SGCs dissolution and various practical concepts of developing dissolution methods for SGCs.<\/p>\n\n\n\n

Dissolution testing is an official test used for evaluating the rate of drug release from a dosage form into the dissolution medium or solvent under standardized conditions of liquid\/solid interface, temperature, paddle speed, or solvent composition. Dissolution testing has become important in measuring the in vitro rate and extent of API release from different dosage forms, including SGCs. Dissolution can be described as a process by which molecules of a solute (e.g., API) are dissolved in a solvent to form a solution. The in vivo effectiveness of a dosage form depends on its ability to release the drug for systemic absorption. SGCs dissolution goes through three main steps, the first one being swelling and rupture of the gelatin shell, followed by release and dispersion of the fill material, and finally, the dissolution of the active ingredient(s) in the dissolution medium ( ). These processes occur in series, and thus the slowest step determines dissolution rate of the SGCs. The slowest step in this case controls the overall rate and extent of drug absorption. However, this varies from drug to drug. For poorly soluble drugs, especially BCS II and IV, their dissolution will be a rate-limiting step in the absorption process. On the other hand, for drugs that have high solubility, their dissolution will be rapid, and rate and extent of absorption can be affected by other factors, e.g., membrane permeability, enzymes degradation in the GIT, or first pass metabolism.<\/p>\n\n\n\n

A critical requirement for drug products is that they release the APIs in vivo at a predictable rate [ 9 , 82 , 83 ]. The kinetics of drug release follows the release mechanism of the system, such as diffusion through the inert matrix, diffusion across the gel, osmotic release, ion-exchange, or pH-sensitive delivery systems. Among the various mechanisms involved in API release, diffusion is the principal release mechanism, and it takes place at varying degrees in every system. Solute release models in physical chemistry preceded the development of drug delivery systems by many years [ 77 , 78 ]. In 1961, Higuchi introduced a mathematical model of drug release for diffusion-controlled systems [ 84 ]. The author analyzed the release kinetics of an ointment, assuming that it is homogeneously dispersed and is released in the planar matrix and the medium. According to the model, the release mechanism is proportional to the square root of time [ 85 ]. This model is recommended for the initial 60% of the release curve due to its approximate nature. In late 1969, Wang published an article considering the two independent mechanisms of transport, Fick\u2019s law, and polymer relaxation on the molecules\u2019 movement in the matrix [ 86 ]. Then, Peppas, in 1985, introduced a semi-empirical equation, power law, to describe drug release from polymeric devices in a generalized way [ 87 , 88 ].<\/p>\n\n\n\n

Another concept that needs to be introduced here is the drug release phenomenon. Drug dissolution rates and drug release rates are quite different. Drug release refers to the process by which the drug in a drug product is released in the dissolution medium or at the site of absorption by diffusion or dissolution of a drug product. Depending on the physical form of the API in the drug product, the release of API may be slow or immediate. As described in the previous section, dissolution is a process by which molecules of a solute are dissolved in solvent vehicles as a function of time. On the other hand, the term \u201crelease\u201d most often refers to a much more complex phenomenon. Release encompasses capsule dissolution as one of its several steps. Upon contact with the aqueous medium, water penetrates the soft gelatin shell and at least partially dissolves the API [ 81 ]. Then, the dissolved API diffuses out through the capsule shell due to concentration gradients. Furthermore, the gelatin shell might undergo significant swelling as soon as the critical water content is reached, which will result in the rupture of the shell, followed by dispersion and eventual dissolution in the release medium. Hence, several steps are involved in the process of releasing the API from SGCs drug products, with only one of them being drug dissolution.<\/p>\n\n\n\n

The dissolution rate of a drug product in each solvent is defined as the rate of transfer of individual drug molecules from the solid particles into the solution as individual molecules, and it can be expressed as the concentration of dissolved API for a given time interval. The rate of dissolution can vary depending on the form of API, e.g., the amorphous form usually has rapid dissolution compared to crystalline forms of API [ 79 , 80 ].<\/p>\n\n\n\n

Another important thermodynamic property in a discussion of dissolution processes is solubility, which may be expressed in several ways, including but not limited to molarity, molality, mole fraction, mole ratio, and parts per million. As an illustration, for the case of a drug molecule, consider an excess amount of solid that is exposed to the solvent phase at a defined temperature and pressure. In the equilibrium state, the number of drug molecules going into the solution equals the number of drug molecules which re-precipitate. Under these conditions, the solution is saturated with drug molecules and the concentration of dissolved drug under these conditions is defined as the \u201cequilibrium drug solubility\u201d (specific to the given temperature and pressure) [ 89 ]. It is important to assure that the solid phase present at the beginning of the experiment remains unaltered after reaching thermodynamic equilibrium during any solubility experiment. It is worth mentioning that, when particle size or the presence of additives, or the pH modifies the intrinsic solubility, this is usually reported as \u201capparent solubility\u201d to distinguish it from the equilibrium value. In order to avoid the inconsistency in solubility data reporting, the size of filters used in the separation of dissolved drug particles must be stated.<\/p>\n\n\n\n

However, the USP General Chapter , Disintegration and dissolution of dietary supplements, accepts a rupture test as a performance test of SGCs if the capsule content is semi-solid or liquid [ 92 ]. The rupture test is performed using apparatus 2, as described under General Chapter Dissolution , at a rotation speed of 50 rpm in 500 mL of immersion medium for a duration of 15 min. As per USP , the requirements are met if all of the SGCs tested rupture in not more than 15 min\u201d. If 1 or 2 of the SGCs rupture in more than 15 min but not more than 30 min, the test is repeated on 12 additional SGCs: not more than 2 of the total of 18 capsules tested rupture in more than 15 but not more than 30 min. For SGCs that do not conform to the above rupture test acceptance criteria, the test is repeated with the addition of papain to the medium in the amount that results in an activity of not more than 550,000 units\/L of medium or with the addition of bromelain in the amount that results in an activity of not more than 30 gelatin-digesting units\/L of medium [ 92 ]. Almukainzi et al. [ 93 ] compared the rupture and disintegration tests of SGCs of amantadine, ginseng, flaxseed oil, pseudoephedrine hydrochloride, and soybean oil. Their data showed that neither rupture test nor disintegration test was advantageous over the other. However, rupture test reached the endpoint quicker compared to the disintegration test. In another study, Bachour et al. [ 94 ] evaluated the suitability of the rupture test for stability studies of SGCs containing oil-based oral multivitamins. Their study showed that the rupture test was sensitive to stability conditions, and that the commercial drug products passed the rupture test. However, all long-term stability samples failed the rupture test using tier 2 conditions. This indicates that the rupture test may be suitable for assessing the performance of some drug products, but this will depend on the properties of fill components.<\/p>\n\n\n\n

The disintegration test is considered as one of the performance tests for the immediate release dosage forms [ 90 ]. As per the USP , disintegration is defined as \u201cthe state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core\u201d [ 91 ]. The requirements of disintegration are met if all test units have completely disintegrated or if not fewer than 16 of a total of 18 units tested are disintegrated within a predetermined time period. This does not imply complete solution of the API or the drug product.<\/p>\n\n\n\n

6.5. Practical Concepts of Developing a Dissolution Method<\/h3>\n\n\n\n

Dissolution testing is used throughout drug product development as an indicator of drug product performance. During formulation development, dissolution testing is used to demonstrate the release and uniformity of a dosage form in a simulated environment. Once the performance is established for the product, this information is used periodically during stability to determine if the characteristics of the product are changing in such a way that the product continues to or stops performing as required. Often, the performance of a drug product in dissolution shows physical behavior; however, it does not necessarily indicate performance in vivo. Therefore, correlation between dissolution and pharmacokinetic data can be used to demonstrate if dissolution testing has the ability to predict drug performance. This is referred to as establishing in vitro\u2013in vivo correlation (IVIVC) [95].<\/p>\n\n\n\n

The purpose of this section is to give an overview of the practical concepts of developing dissolution test methods for SGCs. It is important to understand that the dissolution of a product requires a number of physical changes to take place. Unlike other typical solid dose forms, SGCs must first reach the point where the integrity of the gelatin is compromised and the outer shell ruptures to allow release of the fill material. Following this, the fill components must disperse within the media to allow the active ingredients to either enter solution or distribute evenly throughout the media ( ). The challenge is that the capsule shell is very sensitive to its environment and can change relative to hardness, cross-linking, and seam integrity, which can all play a role in perceived dissolution changes when in fact they are changes in rupture time. Therefore, it is essential to develop a dissolution strategy that accounts for differences in the integrity of the capsule shell as well as changes in the fill material.<\/p>\n\n\n\n

Dissolution methods development are labor-intensive processes even with careful technique and practice. It is important to invest time in developing a procedure that can be efficiently executed on a routine basis and repeated robustly. Dissolution tests are required by the Pharmacopeias to determine the release of the drug from the dosage form in an environment with a pH from 1.2 to 7.4. For example, USP [96] requires a two-step dissolution method for enteric-coated solid oral dosage forms that demonstrates coating integrity in an acidic environment, usually 0.1 N HCl, followed by exposure to a neutral pH environment, preferably with a phosphate buffer, where the first step of dissolution method provides information about the coating quality and the potential for coating failure. The United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA) provide guidelines on the development and validation of dissolution procedures [96,97]. Most of these guidelines are for solid oral dosage forms like tablets and hard gelatin capsules; however, one cannot extrapolate these methods to SGCs without proper assessment. The choice of dissolution method should be based on the dosage form and the fill characteristics of SGCs. shows the common USP dissolution apparatus used in dissolution testing.<\/p>\n\n\n\n

 <\/h3>\n\n\n\n

Developing a discriminating dissolution test for SGCs requires special considerations and knowledge of gelatin and fill material properties and factors influencing them. Several factors affect the dissolution behavior of SGCs and subsequently affect the development of dissolution procedures. These factors include physical properties of the gelatin shell, physical and chemical properties of the fill material, chemical interaction between the gelatin shell and fill components, and moisture exchange between the shell and the fill material. In particular, moisture exchange can potentially result in brittleness of the gelatin shell, and chemical interactions between the shell and fill could result in gelatin cross-linking.<\/p>\n\n\n\n

Two key considerations in the design and development of dissolution methods are the solubility of the active ingredient and solution stability of the SGCs. To establish a suitable medium, several dissolution media should be evaluated to identify the one that achieves appropriate sink conditions. Sink conditions can be defined as the volume of medium that is at least three times the saturated solubility of the API, with the lowest quantity of designated surfactant. These studies allow optimization and observing the amount of surfactant that is needed to solvate the fill material within a time that is relevant to the dissolution test. It is more reasonable that a dissolution result reflects the properties of the API under the sink conditions; however, a medium that fails to provide sink conditions may be acceptable by the USP if it is appropriately justified. Likewise, when choosing the medium, the effect of additives such as acid and salt concentration, buffer counter-ions and co-solvents, and types of enzymes and their activity must also be evaluated and justified, if used. The solubility improvement of the API depends on various factors, including the nature of the surfactant and the fill material, temperature, pH, and ionic strength. This relationship should be understood for different surfactants and compounds before executing the dissolution experiment.<\/p>\n\n\n\n

Typical media for dissolution studies include: dilute hydrochloric acid (0.1 N), buffers in the physiologic pH range of 1 to 7.5 (i.e., phosphate, acetate, or citrate), simulated gastric or intestinal fluid (with or without enzymes), water, and surfactants such as Tween, Brij 35, Triton, polysorbate 80, cetyl trimethyl ammonium bromide (CTAB), sodium lauryl sulfate (SLS), and bile salts [100]. Some SGC formulations may contain a matrix or API that is not soluble in water or acidic environment and consequently, does not meet sink conditions in aqueous solution. In these instances, surfactants with a justified concentration may be added to the dissolution medium. The choice of surfactant and its concentration in relation to solubility and physical stability of the API is critical and must be optimized, understood, and justified. The addition of surfactant should reflect changes in the formulation and interactions among fill components and may shed light on the in vivo behavior of the SGCs.<\/p>\n\n\n\n

Surfactants play a role in dissolution by replacing water molecules on the particle surface, which reduces interfacial tension between the solution and the surface [101]. Amidon et al. has proposed that the use of media containing surfactants is a suitable method for solubilizing such drugs because various surfactants are present in the GI fluid, e.g., bile salts, lecithin, cholesterol and its esters [102]. They consist of two distinct components, hydrophilic and hydrophobic, and are categorized into four groups according to the charge on the hydrophilic group: anionic (e.g., sodium lauryl sulfate (SLS)), cationic (e.g., cetyl trimethyl ammonium bromide (CTAB), zwitterionic (e.g., alkyl betaine) [101], and non-ionic (e.g., Tween and Triton) [103,104]. Dissolution media containing cationic surfactants are better able to discriminate dissolution rates of acidic fill materials, while anionic surfactants differentiate better for basic fill materials. SLS has been reported to be the most commonly used surfactant in dissolution studies [100]. Solubility and dissolution rate enhancement by the surfactants are a function of surfactant concentration and the size of a micelle, and its stability, all of which can be related to the critical micelle concentration (CMC) [105]. The CMC is defined as the minimum concentration of a surfactant\u2019s monomer at which it aggregates to micelles and is characteristic for each surfactant. A lower CMC value for a given surfactant means the micelles are more stable [106]. Furthermore, the knowledge of the molecular structure of the surfactant can provide information on the size of the micelles.<\/p>\n\n\n\n

It is important to note that the addition of surfactant to dissolution media can sometimes cause a decrease in the dissolution rates of some drug products, and in some instances can also distort drug peaks during high-performance liquid chromatography (HPLC) analysis ( ). In a previous study [63], it was found that an immediate-release SGC, containing a poorly soluble drug, loratadine, showed peaks distortion in the presence of SLS. A similar observation of a decrease in the dissolution of gelatin capsules with SLS at lower pH has also been reported by other research groups [107,108].<\/p>\n\n\n\n

The development of simulated fluids for dissolution testing requires understanding of the physiological conditions of the GIT. It is important to note that the GIT is complex and has a regional dependence drug absorption [109]. Several physiological factors that can affect the dissolution process in vivo include: surfactants in gastric juice and bile, viscosity of the GI contents, GI mobility patterns, GI secretions, pH, buffer capacity, and co-administration of fluids or food [110]. Vertzoni et al. [111] developed a fasted-state simulated gastric fluid (FaSSGF) containing sodium taurocholate, lecithin, and pepsin at pH of 6.5 in order to assess its importance for the in vivo dissolution of lipophilic compounds. The authors concluded that simulation of the gastric content was essential in order to assess the absorption profile of lipophilic weak bases. An overview of the composition of the common in vitro bio-relevant dissolution media is provided by Klein [112] and Galia et al. [113]. Likewise, simulated dissolution media must take into account the developmental changes in gastrointestinal fluid composition because these can result in variations in luminal drug solubility between children and adults. Therefore, evaluating age-specific changes in GI fluid parameters (i.e., pepsin concentration, bile acids, luminal viscosity, pH, osmolality, etc.) is very important in order to define the composition of bio-relevant dissolution media in pediatrics [114]. Furthermore, aged population with medical conditions such as hypochlorhydria and achlorhydria have elevated gastric pH [115]. Therefore, simulated dissolution media in this population may need to be adjusted to reflect this increased pH.<\/p>\n\n\n\n

The selection of dissolution apparatus is another critical step in the dissolution evaluation of SGCs, as the mixing efficiency of fill material contents with media is very much influenced by the agitation hydrodynamics, particularly to variables such as paddle rotation speed. The two commonly used methods for evaluating the dissolution properties of SGCs are the paddle and basket methods.<\/p>\n\n\n\n

A basket apparatus has the advantage of enclosing SGCs. This method may be selected if SGCs are filled with a material that has a specific gravity less than that of water, where baskets prevent the SGC and its components from floating in the medium. One common problem observed using the basket is that during the dissolution experiment, the soft gel shell may disintegrate into a soft and sticky mass that can clog the basket\u2019s mesh, generating high variability in the results. Additionally, if the fill material is hydrophobic, i.e., an oil-based fill, dispersion into fine droplets that can pass through the basket\u2019s mesh may not take place, giving rise to a delay in dissolution that is not representative of the true properties of the SGCs. To mitigate this problem, an alternative would be using a basket with larger pores, i.e., 20 or 10 mesh sizes [116]. Pillay and Fassihi used a rotating basket method to evaluate the dissolution of lipid-based SGCs of nifedipine. Their data showed that, after six hours of dissolution test, most of the viscous oily fill formulation was still entangled within the baskets and this led to the dissolution failure [55]. This was attributed to using the standard dissolution basket with pores size of 40 mesh, combined with inappropriate hydrodynamic conditions within the basket. However, when the dissolution test was repeated using a re-designed dissolution apparatus, in this case, nifedipine SGCs showed the best dissolution profiles.<\/p>\n\n\n\n

The paddle method constitutes about 70% of the dissolution methods used by FDA-approved commercial drug products [100]. This method does not use a mesh basket to contain the capsules, and so a common initial problem observed in this method is the floating of the SGCs to the surface of the dissolution medium once it breaks. In these instances, wire coils, also known as sinkers, can be used to enclose the soft gels and hold them on the bottom of the vessel [117]. This allows the fill to be better exposed to the medium (upon shell rupture) and helps to prevent the capsule from sticking to the vessel walls. The shape and size of the sinker should be selected carefully as it can impact the dissolution process, especially in cases where SGCs swell when they encounter the dissolution medium. In previous study, it was shown that the dissolution rate obtained using the paddle method was faster, highly variable at lower time points than those obtained using the basket. In contrast, the data collected using the basket dissolution apparatus showed that the method was more selective and had less variation in terms of API release profile [63]. shows examples of SGCs that are commercially available and their dissolution methods. Other research groups have evaluated the feasibility of using the USP III in evaluating the dissolution of SGCs. Monterroza and Ponce De Le\u00f3n [118] developed a discriminating dissolution method of SGCs containing an oily suspension of micronized progesterone. They compared the dissolution profiles generated using USP 1, 2, and 3. After preliminary tests, USP 1 and USP 2 methods did not reach the target of releasing more than 85% of the API in less than 90 min. However, USP 3 showed promising prospect of releasing more than 85% of the API in less than 90 min in the presence of 250 mL of 4% of SLS in pH 6.8 phosphate.<\/p>\n\n\n\n

 <\/h3>\n\n\n\n

In some cases, such as coated SGCs, a two-step or two-tier dissolution technique must be developed [120,121,122]. The purpose of this method is to assess the integrity of the coating in the acidic conditions of the stomach and measure the drug release in lower parts of the GIT, which have near-neutral pH conditions. Manually performing the two-step dissolution test is labor-intensive and requires well-trained analysts. For example, it requires pre-heating the second medium solution, adjusting the medium by adding the second part of the solution as well as adjusting and confirming pH for six vessels within 5 min. Typically, there are two approaches towards medium modification known as medium-addition or medium-exchange. For example, both approaches may start with an acidic step, such as 0.1 N hydrochloric acid, for a certain period, followed with a buffer step, such as phosphate buffer at pH 6.8. The specific time is chosen as needed for the individual drug product. While using either approach, the pH adjustment must be accomplished in a controlled and reproducible manner via pre-heated media. The operation of adding and adjusting the pH must be done within 5 min [123]. Zhao and co-workers described a two-step dissolution method using medium addition and paddle apparatus, in which the surfactant Tween 80 was included in the media to enhance the solubility of the API in the first stage [124]. The developed dissolution method was able to discriminate against the changes in composition, manufacturing process, and stability of the drug product. When developing a two-step dissolution procedure, several factors must be carefully examined to establish a suitable medium. The most critical step is to carefully evaluate different media to identify the one that achieves the sink conditions. The fill material may have a pH-dependent solubility, so an evaluation of the solubility of the compound in both the acidic and neutral media must be made. For instance, 0.1 N HCl and 50 mM pH 6.8 phosphate buffers are commonly used media.<\/p>\n\n\n\n

The medium-addition technique, which is used for a two-step dissolution for enteric-coated capsules or two-tier dissolution testing, uses paddle or basket apparatus. This approach requires the addition of a relatively small amount of medium to each vessel in a short time. Generally, the common dissolution volumes used are in the range of 500 to 1000 mL, with 900 mL being the most commonly used in the FDA-approved drug products [100]. However, the dissolution volumes should be defined by the sink conditions. To develop a robust two-step dissolution method which can be transferred to quality control, a medium addition method is preferred where a volume of, e.g., 200 mL, can be added to 700 mL initial volume to adjust pH, and then add the surfactant, or enzyme, depending on the soft gelatin capsule drug product [124]. Furthermore, an accurate volume of the medium must be added to ensure that a volumetric error does not occur. Likewise, media addition must consider the final desired pH of the final volume. This technique is less invasive for the SGCs and is easier to conduct in a short time when running multiple batches. This approach is also less labor-intensive and allows for higher sampling throughput during the experiment run. For use in enteric-coated drug products, the API should be soluble up to the specification level in the medium of the first step to be able to detect a failure in the coating. For example, if the specification level for the first step is not more than 10% released, then this medium must be able to dissolve at least 10% of the active ingredient in the soft-gelatin capsule drug product. If the fill material is not soluble in the first-step medium, a surfactant may be added to solubilize at least 10% of the API in the fill material [124]. For use in two-tier dissolution, the fill material would require the surfactant to be present to meet solubility requirements, but also needs the enzyme to overcome the cross-linking.<\/p>\n\n\n\n

For the medium-exchange approach used for enteric-coated capsules, the acid medium is drained after the first step, and a full amount of pH 6.8 buffer that has been equilibrated at similar conditions is added to the same vessel for the buffer stage. The dosage form should be undisturbed during the medium change. The complete medium replacement method resembles the medium-addition approach in that the capsules are first introduced to an acidic medium. At the end of the first step, a sample for analysis is taken, and then the dosage form is removed from the acidic conditions. Removing technique of dosage form depends on the type of dissolution apparatus. The dosage forms may be manually moved from one vessel to another. Alternatively, the entire vessel containing the acid could be removed and replaced with another vessel containing the buffer, and the dosage form is transferred to the new vessel. The quality of the SGCs dosage form is ensured by meeting the USP acceptance criteria for the acid stage, i.e., less than 10% of the API is released from the drug product during the first step of the developed dissolution technique, and therefore, the coating is considered to have passed the acid-step test. If each unit release is not less than Q + 5% for the buffer stage, then the soft gel dosage form has passed the second step of dissolution [125]. Q represents the amount of an active ingredient dissolved in the dissolution medium, expressed as a percentage of the labelled content. To overcome the challenges of manual manipulations of adding the buffer solutions and adjusting the pH during the two-step dissolution testing, other research groups have developed semi-automated dissolution systems for these measurements [125]. The media exchange technique is challenging for SGCs, especially if the capsules have softened due to the liquid exposure, soaking alone will cause some softening but may not cause the rupture of the capsule. Therefore, the transfer of the capsule or media removal without disturbing the shell may be difficult due to mechanical stress.<\/p>\n\n\n\n

The European Medicines Agency (EMA) has developed its own guidance on in vitro dissolution tests for immediate-release drug products [126]. In dissolution guidance, EMA describes specifications for the quantity of active substance dissolved in a specified time, which is expressed as a percentage of API on the product label. The goal of the guidance is to set specifications to ensure batch-to-batch consistency and highlight possible problems with in vivo bioavailability. The guidance for solid immediate-release (IR) drug products from the European Pharmacopoeia (Ph. Eur. 5.17.1) has some differences compared with the FDA specifications. From a pharmaceutical perspective, the European Pharmacopoeia (Ph. Eur.) states that IR formulations should normally achieve in vitro dissolution of at least 80% of the drug substance within not more than 45 min. However, based on the USP guidance, in general, 85% or more of the drug substance should be released within 30 to 45 min.<\/p>\n\n\n\n

Dissolution methods for SGCs must also consider the aspect of age-related gelatin cross-linking influencing the dissolution performance. The USP permits the use of a two-tier assessment of hard and SGCs when evidence of cross-linking is present. Evidence of cross-linking usually occurs based on visual observations during the performance of the dissolution testing. This is based on the fact that the USP general chapters on dissolution as well as disintegration and dissolution of dietary supplements , allow the addition of various enzymes based on pH of the dissolution medium when hard or SGCs and gelatin-coated tablets do not conform to the dissolution or to resolve potential cross-linking issues specifications [127]. Cross-linking evidence can come in the form of poorly dissolving gelatin shell or pellicle formation, which appears as a sac surrounding and containing the fill material after the shell is dissolved (see Section 8). To overcome cross-linking, the two-tier dissolution test would involve the addition of proteolytic enzymes such as pepsin, papain, bromelain, or pancreatin to the dissolution media and repeating the dissolution [128]. These enzymes effectively digest the peptide bonds between the amino acids making up the gelatin strands in the shell. The use of enzymes for dissolution must be done with care, as the enzymes require significant mechanical mixing to get into solution, are minimally stable in solution, and can be impacted by other components of the media, such as surfactants. If a protein denaturing surfactant [129] is used in the media, a two-step tier 2 method must be performed. The first step involves the dissolution of the capsule shell using media containing an enzyme and no surfactant as a pre-treatment step. After the capsule shell is dissolved, media containing surfactant is added to complete the dissolution and solubilization of the fill and active pharmaceutical ingredient. It was observed that using the digestive enzyme while conducting the dissolution study and afterward using the surfactant showed a better effect in the two-tier method [130].<\/p>\n\n\n\n

Another important aspect that is worth discussing regarding dissolution of SGCs is the concept of an in vitro\u2013in vivo correlation (IVIVC). This is normally used to establish a relationship between an in vivo response (e.g., amount of drug absorbed) and an in vitro physicochemical property of a dosage form. The main objective of this concept is to make sure that the in vitro properties of two or more batches of the same drug product are performing similarly under in vivo conditions. Hence, this relationship is essentially important in guiding drug development and drug approval processes that are designed to mimic the in vivo drug release. There have been various studies on IVIVC of SGCs and some have shown good correlations. Meyer et al. [53] assessed whether the changes in the in vitro dissolution of hard and soft gelatin acetaminophen capsules, as a result of gelatin cross-linking, are predictive of changes in the bioavailability of the capsules under in vivo conditions. Their data showed that the in vitro rate of dissolution of hard and SGCs decreased due to cross-linking. On the other hand, the bioequivalence studies showed that both hard and SGCs, which failed to meet the USP dissolution specification in water, but complied when tested in SGF containing pepsin, were bioequivalent to the unstressed control capsules. Based on the plasma concentration parameters, the capsules that were cross-linked to the greatest extent were not bioequivalent with the unstressed control capsules. In another study, Nishimura et al. [131] attempted to predict the human plasma drug concentrations of SGCs containing a poorly soluble drug, arundic acid. SGCs were stored at short- and long-term conditions, i.e., 15 \u00b0C for 3 months and 25 \u00b0C (60% relative humidity (RH)) for 30 months, respectively. The authors showed that the in vitro dissolution data obtained with the dissolution medium containing surfactant (i.e., 2% SLS, pH 6.8) were more effective in predicting the drug plasma concentrations following oral administrations of the SGCs under both storage conditions. Likewise, Rossi et al. [132] developed and validated a dissolution test for ritonavir SGCs based on human in vivo pharmacokinetic data. The authors used a USP II method with 900 mL of dissolution medium containing water with 0.3%, 0.5%, 0.7%, or 1% (w\/v) of SLS at rotation speed of 25 rpm. Their data showed strong level A correlation between the percent of the drug dissolved versus percent absorbed. Significant in vitro\u2013in vivo correlation was achieved using dissolution medium containing water with 0.7% SLS. In another similar study, Donato et al. [133] reported similar results on the development and validation of a dissolution test for lopinavir, a poorly water-soluble drug, in soft gel capsules, based on in vivo data. In this work, a new formulation of lopinavir was developed and its dissolution tests validated using in vivo data. All formulations were evaluated for in vitro dissolution containing 2.3% SLS at pH 6.0 and USP 1 at 25 rpm. At these conditions, the authors showed strong level A correlations for the fraction dissolved versus fraction absorbed.<\/p>\n\n\n\n

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<\/p>","protected":false},"excerpt":{"rendered":"

Yumu\u015fak jel kaps\u00fcl sertlik test cihaz\u0131 nedir? Yumu\u015fak jelatin kaps\u00fcllerin paketlenmeden \u00f6nce elastikiyet testinden ge\u00e7mesi gerekir. Test cihaz\u0131n\u0131n gerekli oldu\u011fu yer buras\u0131d\u0131r ve s\u0131radan bir test cihaz\u0131 de\u011fildir. Kaps\u00fcl \u00fcreticileri, \u00fcr\u00fcnleri t\u00fcketiciye sunmadan \u00f6nce \u00fcr\u00fcnlerinin belirlenen end\u00fcstri standard\u0131 kaliteyi ge\u00e7ti\u011finden emin olmak i\u00e7in g\u00fcvenilir bir yumu\u015fak jel kaps\u00fcl sertlik test cihaz\u0131na ihtiya\u00e7 duyar [...]<\/p>","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1022","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/posts\/1022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/comments?post=1022"}],"version-history":[{"count":0,"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/posts\/1022\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/media?parent=1022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/categories?post=1022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.materialstests.com\/tr\/wp-json\/wp\/v2\/tags?post=1022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}