Shah Shefaat Ullah, Shah Kifayat Ullah, Rehman Asimur, Khan Gul Majid
Drug Delivery Research center, Department of Pharmaceutics, Faculty of Pharmacy, Gomal University, Dera Ismail Khan (KPK), Pakistan.
Pak J Pharm Sci. 2011 Apr;24(2):183-92.
The objective of the study was to formulate and evaluate controlled release polymeric tablets of Diclofenac Potassium for the release rate, release patterns and the mechanism involved in the release process of the drug. Formulations with different types and grades of Ethyl Cellulose Ether derivatives in several drug-to-polymer ratios (D:P) were compressed into tablets using the direct compression method. In vitro drug release studies were performed in phosphate buffer (pH 7.4) as dissolution medium by using USP Method-1 (Rotating Basket Method). Similarity factor f2 and dissimilarity factor f1 were applied for checking the similarities and dissimilarities of the release profiles of different formulations. For the determination of the release mechanism and drug release kinetics various mathematical/kinetic models were employed. It was found that all of the Ethocel polymers could significantly slow down the drug release rate with Ethocel FP polymers being the most efficient, especially at D:P ratios of 10:03 which lead towards the achievement of zero or near zero order release kinetics.
本研究的目的是制备并评估双氯芬酸钾控释聚合物片,以研究其释放速率、释放模式以及药物释放过程中涉及的机制。将几种不同类型和等级的乙基纤维素醚衍生物按不同药物与聚合物比例(D:P)制成的制剂,采用直接压片法压制成片。以磷酸盐缓冲液(pH 7.4)为溶出介质,采用美国药典方法1(转篮法)进行体外药物释放研究。应用相似因子f2和差异因子f1来检验不同制剂释放曲线的相似性和差异性。为了确定释放机制和药物释放动力学,采用了各种数学/动力学模型。结果发现,所有乙基纤维素聚合物都能显著减缓药物释放速率,其中乙基纤维素FP聚合物最为有效,尤其是在D:P比例为10:03时,可实现零级或接近零级释放动力学。