Development of Platform Technology for Oral Controlled Delivery of Highly Water Soluble Drugs Using Milnacipran HCl as a Model Drug

The present study was aimed towards development of porosity controlled osmotic pump as a platform technology for delivering highly water soluble drugs using Milnacipran HCl as a model drug. Theoretical zero order drug release profile (5 mg/hr) was targeted to achieve for fulfilling desired plasma concentration up to 24 hrs. Novel ethyl cellulose based coating system, Aquarius EKX 19102 SRX-2, was employed in the development of osmotic pump. Influences of media pH, agitation intensity and osmotic pressure on drug release rate were investigated. Statistical approaches including mean dissolution time, dissolution efficiency, similarity factor and SeDeM diagram were applied to translate dissolution profile in to a single value. The Aquarius EKX 19102 SRX-2 coating system at 7% weight gain exhibited zero order drug release. Scanning electron microscopy confirmed the microporous structure of the film. The results obtained from stability study, Fourier Transform Infra Red spectra and Differential Scanning Calorimetry study of optimized formulation confirmed stable characteristics. This platform technology was further validated using Diltiazem HCl and satisfactory results were obtained. FORTRAN language based software was applied to assess drug release kinetics and it was found to be zero order.