Der Pharmacia Lettre
Abstract
Author(s): Hiren P. Patel, Jayvadan K. Patel, Ravikumar R. Patel and Manish P. Patel
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.
