Klinische Pharmakologie und Biopharmazeutik

Abstrakt

Kinetic Studies of Ranitidine Hydrochloride Film Coated Tablets Available in Bangladesh: In vitro Study Reflection on in vivo

Md Kamrul Islam, Md Didaruzzaman Sohel, Redwan Hossain, Tania Sultana and Md Hassan Kawsar

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.