Formulation and bioequivalence of two Valsartan/Amlodipine Immediate release tablets after a single oral administration
Journal Title: Pakistan Journal of Pharmaceutical Sciences - Year 2014, Vol 27, Issue 4
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.
Authors and Affiliations
Abdel Naser Zaid , Salam Natur , Aiman Qaddomi , Murad Abualhasan , Rowa Al- Ramahi , Naser Shraim , Saed Khammash , Nidal Jaradat
Keywords
Related Articles
- EP ID EP136872
- DOI -
- Views 109
- Downloads 0
Studies on bioactivity and secondary metabolites of crude extracts of Bidens pilosa L. (Asteraceae): A medicinal plant used in the Transkei region of South Africa
Whole plant-parts of Bidens pilosa were powdered and extracted in concentrated hexane, acetone, ethanol, methanol and water. The extracts were tested for antimicrobial activity against Escherichia coli (25922), Bac...
Phenolic contents and antimicrobial activity of squirting cucumber (Ecballium elaterium) extracts against food-borne pathogens
Squirting cucumber (Ecballium elaterium), is an indigenous species of the south of Europe and the Mediterranean basin, sometimes cultivated for its use as a medicinal plant. This study compared phenolic contents in...
Protection of DNA during oxidative stress and cytotoxic potential of Artemisia absinthium
Medicinal plants are rich in secondary metabolites (alkoloids, glycosides, coumarins, flavonides, steroids, etc.) and considered to be more effective and a safer alternative source to manage a variety of diseases...
Biodistribution and kinetic studies of technetium-99m labeled Naja naja karachiensis venom via gamma scintigraphic and SPECT images
Naja naja karachiensis have been responsible for plentiful deaths in Pakistan. To investigate bio distribution and blood kinetics, venom was labeled with the radiotracer (technetium-99m) by following the method of...
Antitumor activity of a novel survivin siRNA
Breast cancer resistance to therapy can result from expression of antiapoptotic genes. Survivin is an antiapoptotic gene that is over expressed in most human tumors. RNA interference using short interfering RNA (si...