Evaluation of in Vitro Dissolution Profile Comparison Methods of Immediate Release Gliclazide Tablet Formulations

Esra DEMİRTÜRK; Levent ÖNER

Article Details

Evaluation of in Vitro Dissolution Profile Comparison Methods of Immediate Release Gliclazide Tablet Formulations

Authors:

Esra DEMİRTÜRK | Levent ÖNER

Publisher:

Hacettepe University

Journal:

Hacettepe University Journal of the Faculty of Pharmacy 2005 Issue 1, pp.1-10

Document Type:

Article

Publication Date:

12/2004

Document Language:

English

Document ID (Org No.):

2000454460

Frequency:

Quarterly

eISSN:

2458-8806

Abstract:

 

In vitro dissolution has been recognized as an important test in drug  development process to find an in vitro characteristic of the formulation  that reflects its in vivo performance. Immediate release solid dosage  forms are routinely subjected to tests which shows the pharmaceutical  quality such as content, uniformity of content, weight, hardness, friability,  disintegration and dissolution test. The dissolution test is the most  important one that exhibits the biopharmaceutical quality.  The immediate release gliclazide tablet formulation was prepared by  direct compression method and the dissolution profile of this formulation  was compared with reference formulation  Diamicron® lot no:8A0799 . In  this study, three general approaches to compare dissolution profiles were  examined, they were statistical methods, model dependent and model  independent approaches.

 

İn vitro çözünme testi, ilaç geliştirme sürecinde formülasyonun in vivo  performansını yansıtacak bir in vitro özelliğinin bulunmasında önemli  bir test olarak bilinmektedir. Hemen salım sağlayan dozaj şekilleri rutin  olarak miktar tayini, içerik tekdüzeliği, ağırlık, sertlik, ufalanma aşınma,  dağılma ve çözünme testi gibi farmasötik ürün kalitesini gösteren testlere  tabi tutulmaktadırlar. Çözünme testi biyofarmasötik kaliteyi gösteren en  önemli testtir.  Hemen salım sağlayan gliklazid tablet formülasyonu direkt basım  yöntemi ile hazırlandı ve bu formülasyonun çözünme profili referans  formülasyon ile karşılaştırıldı  Diamicron® lot no:8A0799 . Çalışmada  çözünme profillerinin karşılaştırılmasında kullanılan üç genel yöntem  araştırıldı, bunlar istatistiksel yöntemler, modele bağımlı yöntemler ve  modelden bağımsız yöntemlerdir.

Article Details

Evaluation of in Vitro Dissolution Profile Comparison Methods of Immediate Release Gliclazide Tablet Formulations

Authors: Esra DEMİRTÜRK | Levent ÖNER

Publisher: Hacettepe University

Journal: Hacettepe University Journal of the Faculty of Pharmacy 2005 Issue 1, pp.1-10

Document Type: Article

Publication Date: 12/2004

Document Language: English

Document ID (Org No.): 2000454460

Frequency: Quarterly

eISSN: 2458-8806

Issues

Authors:

Esra DEMİRTÜRK | Levent ÖNER

Publisher:

Hacettepe University

Journal:

Hacettepe University Journal of the Faculty of Pharmacy 2005 Issue 1, pp.1-10

Document Type:

Article

Publication Date:

12/2004

Document Language:

English

Document ID (Org No.):

2000454460

Frequency:

Quarterly

eISSN:

2458-8806