Formulation development and optimization of multiple unit particles system (MUPS) containing Ramipril and Hydrochlorothiazide

By Hiren P. Patel, Jayvadan K. Patel, Ravikumar R. Patel and Manish P. Patel

Abstract

Conventional immediate release drug delivery system are based on single or multiple-unit reservoir or matrix system, which are designed to provide immediate drug levels in short period of time. Immediate release drug delivery is desirable for drugs having long biological half life, high bioavailability, lower clearance and lower elimination half life. But main criterion for immediate release dosage form is poor solubility of the drug and need the immediate action of drug to treat any unwanted defect or disease. The present invention relates to produce Multiple Unit Particle System (MUPS) of stabilized Ramipril pellets, Hydrochlorothiazide, diluents, superdisintegrants and lubricants which produce better dissolution of the System for better bioavailability with improving stability and bioavailability of Ramipril. More particularly, the present invention is directed for stabilized Ramipril against decomposition into degradation products, namely, Ramipril-DKP and Ramipril-diacid, during formulation and storage conditions. Simple Ramipril formulation shows 15.15 % Related impurities after 3 month accelerated stability study which was minimized to the 2.07% related impurities in Ramipril pellets after 6 month accelerated stability study. By making MUPS of Ramipril pellets, Hydrochlorothiazide and other excipients shows better dissolution (100.4 % of Ramipril and 97.9 % of Hydrochlorothiazide within 60 minutes) to produce better bioavailability. So, by making MUPS containing Ramipril pellets with polymer coating and Hydrochlorothiazide and other excipients shown better stability of Ramipril along degradation and synergistic effect amongst hypertension in immediate delivery.

 

Key Words : Multiple Unit Particle System, bioavailability, Hydrochlorothiazide, Ramipril pellets, polymer coating.

 

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