STABILISED DOSAGE FORMS OF AMLODIPINE BESYLATE

STABILISED DOSAGE FORMS OF AMLODIPINE BESYLATE

The present invention relates to a stable solid dosage form comprising 2-20% by weight of amlodipine besylate, 10-70% by weight polyols, and at least a known pharmaceutical excipient having levels of impurity D ({3-ethyl-5-methyl-2-[ (2-aminoethoxy) methyl] 4- (2-chlorophenyl)-6-methylpyridine-3, 5...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: DATARKAR, SANDEEP, G, PRASAD, MAVULETI, KRISHNA, SINGH, SAMPRADA, NARAYANA, VEMULA, SATHYA
Format: Patent
Sprache:eng ; fre
Schlagworte:
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:The present invention relates to a stable solid dosage form comprising 2-20% by weight of amlodipine besylate, 10-70% by weight polyols, and at least a known pharmaceutical excipient having levels of impurity D ({3-ethyl-5-methyl-2-[ (2-aminoethoxy) methyl] 4- (2-chlorophenyl)-6-methylpyridine-3, 5 dicarboxylate}) less than 0.5%. La présente invention concerne une forme galénique solide stable comprenant de 2 à 20 % en poids de bésylate d'amlodipine, de 10 à 70 % en poids de polyols et au moins un excipient pharmaceutique connu ayant des niveaux d'impureté D ({3-éthyl-5-méthyl-2-[(2-aminoéthoxy)-méthyl]-4-(2-chlorophényl)-6-méthylpyridine-3,5-dicarboxylate}) inférieurs à 0,5 %.