Related Experiment Video
Updated: Apr 27, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
Published on: July 27, 2022
Formulation and bioequivalence of two Valsartan/Amlodipine immediate release tablets after a single oral
Abdel Naser Zaid1, Salam Natur2, Aiman Qaddomi2
1Pharmaceutics & Pharmacokinetics Units, Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, P.O. Box 7. Nablus, Palestine.
Abstract:
The aim of this study was to formulate a film-coated Valsartan/Amlodipine (VS/AM) immediate release tablets and to evaluate their in vivo release profile. VS/AM core tablets were manufactured using dry granulation method. Opadry aqueous coating dispersion was used as film coating material. Dissolution of the film coated tablets was tested in 900 ml of 0.5% SLS media, bioequivalence of tablets was tested by comparisons against the reference brand product. The ICH guidelines were used to evaluate the stability of the obtained tablets. The coated tablets were subjected to gastric pH, and drug release was analyzed using HPLC system to evaluate the efficiency of the film coat. The coated tablets had no defects. VS/AM release met the FDA guidelines for bioequivalence studies. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. These findings suggest that aqueous film coating with Opadry system is an easy and economical approach for preparing stable film coated VS/AM tablets without compromising their in vivo drugs release.
Related Concept Videos
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Bioequivalence studies: Biowaivers
Bioequivalence: Overview
Modified-Release Drug Delivery Systems: Bioavailability
Bioequivalence of Drugs: Drugs with Multiple Indications
Bioavailability Study Design: Single Versus Multiple Dose Studies

