AusPAR Attachment 1 Extract from the Clinical Evaluation Report for Diltiazem hydrochloride Proprietary Product Name: Ano-Cream Sponsor: AFT Pharmaceuticals Pty Ltd

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Tenofovir disoproxil fumarate/Emtricitabine/Elvitegravir/Cobicistat

The Release Behavior and Kinetic Evaluation of Diltiazem HCl from Various Hydrophilic and Plastic Based Matrices

In this study, the effects of various hydrophilic (HPMC and Carbopol 971) and plastic (Ethylcellulose and Eudragit RL100) polymers on the release profile of diltiazem HCl from matrix tablets were evaluated in-vitro. For this purpose, tablets containing 60 mg of diltiazem HCl along with various amounts of the aforementioned polymers were prepared using the wet granulation technique. Tablets prep...

In vitro Release Kinetics Study of Diltiazem Hydrochloride from Wax and Kollidon SR Based Matrix Tablets

Extended-release matrix tablets of diltiazem hydrochloride (DTZ) were prepared using waxy materials alone or in combination with Kollidon SR. Matrix waxy materials were carnauba wax (CW), bees wax (BW), cetyl alcohol (CA) and glyceryl monostearate (GMS). Dissolution studies were carried out by using a six stations USP XXII type 1 apparatus. The in vitro drug release study was done in 1000 ml ph...

In vitro Release Kinetics Study of Diltiazem Hydrochloride from Wax and Kollidon SR Based Matrix Tablets

Extended-release matrix tablets of diltiazem hydrochloride (DTZ) were prepared using waxy materials alone or in combination with Kollidon SR. Matrix waxy materials were carnauba wax (CW), bees wax (BW), cetyl alcohol (CA) and glyceryl monostearate (GMS). Dissolution studies were carried out by using a six stations USP XXII type 1 apparatus. The in vitro drug release study was done in 1000 ml ph...

The Release Behavior and Kinetic Evaluation of Diltiazem HCl from Various Hydrophilic and Plastic Based Matrices

In this study, the effects of various hydrophilic (HPMC and Carbopol 971) and plastic (Ethylcellulose and Eudragit RL100) polymers on the release profile of diltiazem HCl from matrix tablets were evaluated in-vitro. For this purpose, tablets containing 60 mg of diltiazem HCl along with various amounts of the aforementioned polymers were prepared using the wet granulation technique. Tablets prep...