Abstract
Aim: the objective of the present paper was to design and formulate Ranitidine hydrochloride (RH) floating microspheres by the emulsion solvent evaporation technique using different polymers: [Ethyl cellulose (EC) and Eudragit E100 (E E100)] with different drug: polymer ratio and at different speeds of rotation. Methodology: the emulsion solvent- evaporation technique was used for the preparation of Ranitidine floating microspheres. The prepared microspheres were examined for their production yield, entrapment efficiency, micromeritic properties, in- vitro buoyancy and in-vitro drug release. Results and discussion: Evaluation of micromeretics properties of the prepared microspheres showed that all formulae have good flow properties. The production yield of the microspheres ranging from 60.7% to 98.7% [the best one was (RH-EC/E E100 (1:2.5)400 rpm)] and encapsulation efficiencies ranging from 47.5% to 79.7% [the best one was (RH-EC (1:4)400 rpm)].Microspheres showed excellent buoyancy ranging from72% to 92% over 12hr [the best one was (RH-E E100 (1:1)400 rpm)] as RH microspheres with low density showed excellent floatation behavior than others with high density. In vitro release of the drug showing a biphasic pattern with controlled release during 12 hours. The release of RH increased as the concentration of polymer decreased. By combining the production yield, micromeretics parameters, entrapment efficiency and the in vitro release of RH from capsules, it was found that RH-EC/E E100 (1:2.5) 400 rpm was superior to all of the prepared formulae.
Highlights
Drug absorption from oral controlled release (CR) dosage forms is often limited by the short gastrointestinal retention time, available for absorption
The range of the production yield of the prepared Ranitidine hydrochloride (RH) microspheres found to be between 60.66% and 98.68% as shown in table (2).The highest value appeared in the formula R H - Ethyl cellulose (EC)/E E 100 (1:2.5) 400 rpm (98.68%) while the lowest value appeared in formula R H - E E 100 (1:1) 400 rpm (60.66%)
The RH microspheres can be arranged in descending order concerning their production yield above 90 % as follows: RH - EC/E E 100 (1:2.5) 400 rpm> RH - EC/Eudragit E100 (E E100) (1:4) 500 rpm >RH - EC/E E100 (1:4) 300 rpm >RH - EC (1:2.5) 500 rpm >RH - E E 100 (1:2.5) 300 rpm
Summary
Drug absorption from oral controlled release (CR) dosage forms is often limited by the short gastrointestinal retention time, available for absorption. Floating drug delivery systems are among the several approaches that have been developed in order to increase the gastric residence time of the dosage forms Singh et al, (2011) .The multiple unit system has been developed to identify the merit over a single unit dosage form because the single unit. The synthetic polymer has been used to prepare floating microspheres. The present study was based on floating microspheres of both hydrophilic and acrylic polymers using Ranitidine hydrochloride (RH) as a model drug. It is an anti ulcer drug that has been widely used in treating gastric and duodenal ulceration and in Zollinger Ellison syndrome. It is poorly absorbed from the lower GIT and has a short elimination half life of 2-3 hours and a bioavailability of 50% Mastiholimath et al, (2008)
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