Development and evaluation of controlled porosity osmotic pump for Nifedipine and Metoprolol combination

Rajagopal Kumaravelrajan,Venkatesan Suba,Nallaperumal Narayanan

doi:10.1186/1476-511x-10-51

Abstract

BackgroundA system that can deliver multi-drug at a prolonged rate is very important for the treatment of various chronic diseases such as diabetes, asthma and heart disease. Controlled porosity osmotic pump tablet (CPOP) system was designed to deliver Nifedipine (NP) and Metoprolol (MP) in a controlled manner up to 12 h. It was prepared by incorporating drugs in the core and coated with various types (PVP, PEG-400 and HPMC) and levels (30, 40 and 50% w/w of polymer) of pore former at a weight gain of 8, 12 & 15%.ResultsFormulation variables like type and level of pore former and percent weight gain of membrane was found to affect the drug release from the developed formulations. Drug release was inversely proportional to the membrane weight but directly related to the level of pore former. Burst strength of the exhausted shell was inversely proportional to the level of pore former, but directly affected by the membrane weight. Results of scanning electron microscopy (SEM) studies showed the formation of pores in the membrane from where the drug release occurred. Dissolution models were applied to drug release data in order to establish the mechanism of drug release kinetics. In vitro release kinetics was subjected to superposition method to predict in vivo performance of the developed formulation.ConclusionThe developed osmotic system is effective in the multi-drug therapy of hypertension by delivering both drugs in a controlled manner.

Highlights

A system that can deliver multi-drug at a prolonged rate is very important for the treatment of various chronic diseases such as diabetes, asthma and heart disease
We have recently developed controlled release formulation of NP and MP based on sandwiched osmotic delivery system [8]
Osmotic drug delivery was attempted since, though a number of design options are available to control the drug release from a dosage form, majority of the oral dosage form fall in the category of matrix, reservoir or osmotic systems

Summary

Introduction

A system that can deliver multi-drug at a prolonged rate is very important for the treatment of various chronic diseases such as diabetes, asthma and heart disease. One quarter of the total global population is affected by at least any one of the cardiovascular disease (CVD) [1] It caused 2.3 million deaths in India in 1990, which may double by year 2020, where hypertension alone contribute 57% of all stroke death and 24% of all coronary heart disease [2]. Management of cardiovascular disease reported that smooth plasma profile of NP by modified release dosage forms decreased morbidity and mortality, prevents myocardial infarction in diabetes mellitus patients and reduces atherosclerosis in carotid and coronary arteries [7]. These facts justify our interest in controlled release dosage form. The development of oral osmotic systems has a strong market potential, as evident from the marketed products and number of patents granted in the last few years [10]

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