ABSTRACT
Aim:Some generics were reported to be counterfeit and inferior quality than the innovators. This study was aimed to make sure about the compliance with standard specifications and evaluation of the quality of different selected brands (generic and innovator),after performing different pharmacopeial quality control tests, of Candesartan cilexetil tablets (16 mg) commercially available in Saudi Arabia for hypertensive patients Study Design:In vitrostudy of tablets.Place and Duration of Study: Collegeof Pharmacy, Jazan University, Jazan, KSA, between September 2018 and May 2019.Methodology:The different generic brands of Candesartan cilexetil (CC) and innovator brand (16 mg) were subjected to weight variation, hardness, friability, assay, and disintegration tests following the established protocols. The purity of active ingredient was authenticated by comparative analysis of FT-IR spectra with pure drug. In vitro bioequivalence was studied after analyzing the results of dissolution summaries in phosphate buffer (pH 6.5) mixed with polysorbate 20 (0.35% v/v).Results:The results of the tests conducted for evaluation of the tablets were found to be in acceptable limits for all the selected brands. After comparative analysis of FT-IR spectra with pure drug, it was inferred that correct active ingredient was used for the preparation of tablets. The drug release profile exhibited 96.89 –101.97% of release of CC from all generic brands, in comparison to 99.4% for innovator brand after 60 min of study. The assessment of difference factor (f1<15) and similarity factor (f2>50) revealed the resemblance of generic brands with that of innovator brand. Furthermore, the dissolution efficiency (DE = ±10% of the innovator value) of all generic brands (73.12 –73.25%) exhibited equivalency with that of innovator brand (70.45%). Conclusion:The selected generics were considered to be biopharmaceutically equivalent to the innovator and maintained their efficacy. As a consequence, these brands can be used interchangeably by the hypertensive patients in Saudi Arabia
ABSTRACT
Psoriasis is a chronic T lymphocyte mediated autoimmune inflammatory disorder that affects the skin, joints, and tendons. Betamethasone dipropionate (BD) has anti-inflammatory, immunosuppressive,and antiproliferative activity. The aim of this study was to investigate and evaluate a nanoemulsion topical gel of betamethasone dipropionate. For the preparation of nanoemulsion eucalyptus oil and babchi oil was taken. Nanomulsions were prepared by aqueous phase-titration method. Pseudoternary phase diagrams were constructed for the identification of nanoemulsion existence zones. Prepared nanoemulsions were subjected to different thermodynamic stability tests and characterized for droplet size, viscosity and refractive index. In vitro skin permeation of betamethasone dipropionate through rat abdominal skin was determined by the Franz diffusion cell. The prepared nanoemulsion gel is a potential vehicle for improved topical delivery of BD for better treatment of psoriasis.
ABSTRACT
Tablets containing zidovudine and lamivudine (ZILA) were prepared by direct compression method. Optimization studies were done for the selection of glidant, lubricant and coating materials. Evaluation of granuleswere done on the basis of preformulation studies. The prepared tablets were evaluated for physicochemical properties. The in- vitro release studies were performed as per USP and compared with marketed product. The release of zidovudine and lamivudine were analysed by high performance liquid chromatography (HPLC). The ZILA tablets exhibited better release characteristics than the marketed product. Stabilities studies were performed in both blister as well as cold form blister packings. Stabilities studies revealed the suitability of blister package in comparison to the cold form blister packing. From the study it was concluded that the selected composition can be used for the preparation of tablets that can be used for the treatment of HIV-1 and Hepatitis-B after performing studies on animals for its suitability and efficacy.