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 97
- Downloads 0
Adrenaline improves endurance of rabbit gastrocnemius: A study with continuous high frequency stimulation
Beta adrenoceptor agonists are well known for their potentiating effects on peak twitch and tetanic tension and defatiguing effects on skeletal muscles. Adrenaline (ADR) is one of these agonist which is known for i...
Borneol inhibits TRPA1, a proinflammatory and noxious pain-sensing cation channel
Borneol, a natural product isolated from several species of Artemisia, Blumea and Kaempferia, has a widespread use in traditional medicine. TRP ion channels are a class of nonselective cation channel proteins invol...
Prevalence of zinc deficiency among rural women during childbearing age in Peshawar, Pakistan
Zinc deficiency is a commonly reported health problem throughout the world. This cross sectional survey was conducted in rural Peshawar with an aim to estimate the prevalence of zinc deficiency in women of child be...
Preliminary screening of 44 plant extracts for anti-tyrosinase and antioxidant activities
In order to find new tyrosinase inhibitors and antioxidant materials, we investigated 44 plants, which were evaluated for the anti-tyrosinase and antioxidant activities. The mushroom tyrosinase inhibition assay and...
Exploiting the interaction of polymethacrylates with iron oxide for the enhancement of mucoadhesive strength
Abstract: The present investigation was aimed at preparation of polymethacrylate(s)- iron oxide conjugates and to evaluate mucoadhesive performance using texture analyzer. Eudragit RL-iron oxide or Eudragit RS-ir...