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Development and Evaluation of Ramipril Pellets
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The objective of this study was to develop Ramipril pellets. Ramipril is a prodrug and is converted to the active metabolite Ramiprilat by liver esterase enzymes, is an angiotensin-converting enzyme (ACE) inhibitor, used to treat hypertension and congestive heart failure. Its long biological Half life (3-16 hours) and its dose (2.5 mg / day) and long elimination phase (9-18 hours) suggest the its immediate action for treating hypertension. As Ramipril needs special care when formulating into pharmaceutical preparations due the physical stress associated with formulating processes which can increase the rate the decomposition of ramipril into degradant products. Indeed, factors that influence the stability of ramipril formulations are mechanical stress, compression, manufacturing processes, excipients, storage conditions, heat and moisture. So, special formulation for ramipril is required, which gives more stability to Ramipril from compression and other stress condition during formulation and storage conditions. So, pellets formulation of Ramipril with film coating is protect the drug from the light, moisture, and elasticity of film coating will protect the drug from stress condition during compression. Our final formulation is tablet because we have to make formulation which is bioequivalent with the innovator product.
Keywords
Pellets, Ramipril, ACE Inhibitor.
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