Development of modified release dosage form of midodrine hydrochloride using quality by design approach

Abstract

quotMidodrine Hydrochloride is mainly used in to treat orthostatic hypotension. Problem associated with current immediate release tablet of Midodrine Hydrochloride is it requires three or four dosing per day for symptomatic relief from orthostatic hypotension. (Half Life is 3-4 hrs). Therefore, there is a need to reduce the variability of such type of molecule / product by preparation of Modified release dosage form by using different concentration of polymers. newlineMidodrine Hydrochloride is mainly used for treatment of orthostatic hypotension. The purpose of the development of modified release dosage form is to minimizing the frequency of dosing while maintaining therapeutic concentration. The objective of the present research work is to formulate and evaluate modified release capsules and bilayer tablets of Midodrine Hydrochloride by applying QbD approaches using various tooling for optimization of drug products. For capsule dosage form: MCC sphere were drug layered, Polymer coated and again drug layered using fluid bed processor to achieve desired drug release over extended period of time. For Bilayer tablets: Immediate release and extended release layer compressed and % drug release was measured. Central composite design (CCD) was employed for both the formulation and % of drug release was measured at 2, 4, 8 and 12 hrs. Stability study carried out for final formulation and there is no any major changes observed for % drug release over 12 hours. newlinequot newline