Preparation and Evaluation of Fixed Combination of Ketoprofen Enteric Coated and Famotidine Floating Mini Tablets by Single Unit Encapsulation System

Abstract

Ketoprofen is a non steroidal anti inflammatory drug and famotidine is a H2 receptor antagonist. The patients with immune mediated diseases like rheumatoid and osteo arthritis treated with ketoprofen, which induces ulcers in the stomach by the stimulation of H2 receptor and inhibition of COX-I enzyme. Upon the addition of famotidine suppress the acid secretion in the stomach, this mechanism was implemented by the delivery system at different time periods with different site specificity in the GIT and drug release was programmed according to the pH dependent solubility and also includes reducing the cost. Hence, the content of this investigation was to prepare and evaluate the famotidine floating and ketoprofen enteric coated mini tablets capsulated in a single unit dosage form. The tablets were prepared by wet granulation method using HPMC K100M and HPMC K15M as release controlling polymers. Pre compression and post compression parameters of prepared tablets were evaluated as per pharmacopeial methods. From the in vitro release studies, optimized formulation of famotidine floating and ketoprofen enteric coated tablets has shown 98.02 ± 2.79% and 97.5 ± 2.08% release in 12 h, respectively. Floating lag time of optimized famotidine formulation was 13 sec with total floating time of >12 h and ex vivo retention time was found to be 12 h. SEM studies were conducted to the optimized ketoprofen enteric coating tablet and found to be smooth surface. In vivo imaging studies revealed that tablets remained in the stomach for 8h for famotidine and 12 h in intestinal region for ketoprofen tablet. DSC studies revealed that there was no interaction between the drug and excipients used for the formulation development.