盐酸雷尼替丁薄膜包衣片在孟加拉国的动力学研究:体外研究和体内反思

K. Islam, D. Sohel, Redwan Hossain, T. Sultana, H. Kawsar
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引用次数: 0

摘要

背景:本研究比较了孟加拉国最常见的盐酸雷尼替丁不同品牌薄膜包衣片的体外溶出度和体外崩解特性,反映了体内研究情况。本研究的目的是评价盐酸雷尼替丁薄膜包衣片在孟加拉国的体外动力学研究。盐酸雷尼替丁是一种有效的H2阻滞剂,推荐用于高酸性相关疾病,是世界上最常见的非处方药,也是普通人经常使用的药物。方法:采用分光光度法对孟加拉国药品市场上销售的21个品牌盐酸雷尼替丁薄膜包衣片进行测定,并对其进行零级、一级、Higuchi和Hixson-Crowell动力学研究,预测其体内分析结果。结果:对孟加拉国市售的21个品牌盐酸雷尼替丁薄膜包衣片进行了研究。为了确定盐酸雷尼替丁的完全感官特性,本研究的介质为蒸馏水(pH为7.5)。9个品牌(RH-3、RH-5、RH-6、RH-10、RH-11、RH-12、RH-13、RH-14和RH-17)的崩解时间是延迟的,而不是这些制造商经常声称的快速释放配方。其余12个牌号(RH-1、RH-2、RH-4、RH-7、RH-8、RH-9、RH-15、RH-16、RH-18、RH-19、RH-20和RH-21)的崩解时间适中。采用USP标准溶出度仪对其在蒸馏水中1 h的体外溶出度进行了研究。13个药牌(RH-1、RH-2、RH-4、RH- 7、RH-8、RH-9、RH-13、RH-15、RH-16、RH-18、RH-19、RH-20和RH-21)的体外溶出度符合45 min内释药80%的USP体外溶出度标准,但有5个药牌(RH-3、RH-5、RH-10、RH-12和RH-17)不符合USP体外溶出度标准。其余3个品牌(RH-6、RH-11和RH-14)的释药规律很差,1h后释药率分别为23%、11%和19%。本研究确定了药物效力、多重系数(从零阶、一阶、Higuchi和Hixson-Crowell立方根定律)、相似因子和不相似因子。利用稳态血药浓度测定的叠加原理,通过对比参比品牌(赞替他)的体内药动学数据,预测稳态血药浓度。结论:大多数品牌符合官方要求,这是预测口服给药体内释放的重要参数。因此,患者在使用这些品牌的盐酸雷尼替丁薄膜包衣片时,会得到适当的治疗效果,以对抗高酸性问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Kinetic Studies of Ranitidine Hydrochloride Film Coated Tablets Available in Bangladesh: In vitro Study Reflection on in vivo
Background: This study deals with the comparative in vitro dissolution and in vitro disintegration characteristics of different brands of ranitidine hydrochloride film coated tablets most commonly available in Bangladesh which reflects the in vivo study. The objective of this present study was to evaluate the in vitro kinetic studies of ranitidine hydrochloride film coated tablets available in Bangladesh. Ranitidine hydrochloride is a potent H2 blocker recommended for hyperacidity related disorders and most common OTC drugs that frequently used by the common people in the world. Methods: Twenty one brands of ranitidine hydrochloride film coated tablets available in Bangladesh drug market were assayed spectrophotometrically and their various kinetics (Zero Order, First Order, Higuchi and Hixson-Crowell) studies were performed to predict in vivo analysis. Results: In Bangladesh, commercially available twenty one brands of ranitidine hydrochloride film coated tablets were studied. The media of the study was distilled water (pH 7.5) due to identify complete organoleptic properties of Ranitidine Hydrochloride. Nine brands (RH-3, RH-5, RH-6, RH-10, RH-11, RH-12, RH-13, RH-14 and RH-17) showed delayed disintegration time instead of quick release formulation, which often claimed by those manufacturer. Other twelve brands (RH-1, RH-2, RH-4, RH-7, RH-8, RH-9, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) showed the moderate disintegration time. The tablets were studied for in vitro dissolution behavior for 1 h in distilled water using USP reference dissolution apparatus. The in vitro dissolution profiles of the thirteen brands (RH-1, RH-2, RH-4, RH- 7, RH-8, RH-9, RH-13, RH-15, RH-16, RH-18, RH-19, RH-20 and RH-21) were fulfilled the USP in vitro dissolution specification of 80% drug release within 45 min. On the other hand, five of the total selected brands (RH-3, RH-5, RH-10, RH-12 and RH-17) were failed to fulfill the USP in vitro dissolution specification. Rest three brands (RH-6, RH-11 and RH-14) exhibited very poor release pattern among the selected brands and their drug release rate were 23%, 11% and 19% respectively after one hour study. The drug potency, multiple coefficient (from zero order, first order, Higuchi and Hixson-Crowell cube root law), similarity and dissimilarity factors were determined in this study. The predicted steady state plasma concentration determined by comparing the in vivo pharmacokinetic data of reference brand (Zantac) using superposition principle of steady state plasma levels determination. Conclusion: Most of the brands meet the official requirements, which are very essential parameters for the prediction of in vivo drug release by oral route. As a result the patients will get the proper therapeutic effect to combat against hyperacidity problems while they use those brands of ranitidine hydrochloride film coated tablets.
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