Formulation design and characterization of osmotically controlled tablet of Ramipril

Abstract

Objective: Ramipril is a long-acting angiotensin-converting enzyme inhibitor. The study aimed to design, formulate and evaluate the oral osmotic drug delivery dosage form of an anti-hypertensive drug, ramipril. Methods: The tablet was formulated using ramipril and different polymers like PVP- K30 and Ethyl cellulose. The microcrystalline cellulose (MCC - diluent), Potassium chloride, Mannitol (osmogen) and Magnesium stearate (lubricant) were used in all the formulations. All the tablets were manufactured by wet granulation method followed by film coating. Compatibility of the drug with excipients was determined by FT-IR spectral analysis. The granules were evaluated for bulk density, Carr’s index and Hausner’s ration to determine flow properties. The prepared compressed and coated tablets were evaluated for weight variation, thickness, hardness, friability, and drug content and in vitro drug release and release kinetic studies. Results: The FT-IR study revealed that drug was compatible with excipients.  The flow properties of granules of most formulation were excellent. All osmotic tablet formulations had good tablet physiochemical properties as per Pharmacopeia. The drug content of all tablet batches was satisfactory. The in vitro drug release study revealed that the formulation F7 containing 100 mg of ethyl cellulose release 100% of drug in 24 h with zero order release kinetics. Conclusions: Ramipril osmotic tablet could be used for safe management of hypertension with greater novelty.