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Formulations of Ramipril

a technology of ramipril and stable pharmaceutical formulation, which is applied in the field can solve the problems of complicated preparation of stable pharmaceutical formulation of ramipril

Inactive Publication Date: 2008-09-25
ACTAVIS GRP PTC EHF
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The formulation significantly reduces the formation of ramipril diketopiperazine, a degradation product, maintaining stability over time, even under storage conditions of 40°C and 75% relative humidity, thus meeting permissible limits of degradation.

Problems solved by technology

The preparation of stable pharmaceutical formulations of ramipril is complicated since it is susceptible to certain types of degradation.

Method used

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  • Formulations of Ramipril

Examples

Experimental program
Comparison scheme
Effect test

example 1

Formulation for 1.25 mg Ramipril Tablets

[0028]

Ramipril 0.96%Compactrol87.08% w / wSodium hydrogen carbonate 0.96% w / wStarch pregelatinised10.00% w / wSodium stearyl fumarate 1.00% w / w

example 2

Formulation for 2.5 mg, 5 mg and 10 mg Ramipril Tablets

[0029]

Ramipril1.9% w / wCompactrol85.2% w / w Sodium hydrogen carbonate1.9% w / wStarch pregelatinised10.0% w / w Sodium stearyl fumarate1.0% w / w

example 3

Formulation for 2.5 / 12.5 mg and 5 / 25 mg Ramipril Hydrochlorothiazide (HCT) Tablets

[0030]

Ramipril1.9% w / wHydrochlorothiazide9.6% w / wCompactrol70.5% w / w Sodium hydrogen carbonate1.9% w / wStarch pregelatinised15.0% w / w Sodium stearyl fumarate1.0% w / w

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Abstract

The present invention relates to stable tablet formulations of ramipril, optionally in combination with a diuretic.

Description

FIELD OF THE INVENTION[0001]The present invention relates to stable pharmaceutical formulations of ramipril, optionally in combination with a diuretic.TECHNICAL BACKGROUND AND PRIOR ART[0002]Ramipril, (2S,3aS,6aS)-1[(S)—N—[(S)-1-carboxy-3-phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid, 1-ethyl ester is an angiotensin converting enzyme (ACE) inhibitor. Ramipril is used for the treatment of hypertension, heart failure, stroke, myocardial infarction, diabetes and cardiovascular disease.[0003]Ramipril and the acid form, ramiprilat, is described in EP 0 097 022 B1.[0004]The preparation of stable pharmaceutical formulations of ramipril is complicated since it is susceptible to certain types of degradation. Ramipril can undergo cyclization via internal nucleophilic attack to form substituted diketopiperazines and also degrade via hydrolysis and oxidation.[0005]EP 1 501 546 A1 describes stable pharmaceutical formulation for combinations of a statin and an ACE inhibitor....

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/403A61K9/20A61K31/401A61K31/549
CPCA61K9/2009A61K9/2059A61K31/00A61K31/407A61K31/549A61K2300/00
Inventor EYJOLFSSON, REYNIR
Owner ACTAVIS GRP PTC EHF
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