Compressed nitroglycerin tablet and its method of manufacture

Details Compressed nitroglycerin tablet and its method of manufacture Compressed nitroglycerin tablet and its method of manufacture

A - Human Necessities

61

K

A61K 31/21 (2006.01) A61K 9/00 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2299231

The present invention is directed to a stable nitroglycerin containing pharmaceutical composition, preferably a tablet which is prepared by direct compression technology. The formulation closely replicates the properties of nitroglycerin molded sublingual tablets (e.g. adequate disintegration and sublingual absorption), while reducing the problems experienced with compressed tablets (e.g. friability and weight variations). The stable tablets are characterized by a decreased migration of nitroglycerin, decreased potency loss, excellent content uniformity when stored. The preferred combination of components are: nitroglycerin/lactose dilution, hydrous lactose, glyceril monostearate, fumed silica, pregelatinized starch and calcium stearate. The preferred process employs direct compression technology to yield composition showing adequate disintegration, bioavailability and improved stability.

L'invention concerne une composition pharmaceutique stable contenant de la nitroglycérine, de préférence une tablette préparée par compression pure. La formule présente pratiquement toutes les propriétés des tablettes sublinguales moulées de nitroglycérine (ex. désintégration et absorption sublinguale adéquates), et ne pose pas le problème des tablettes comprimées (ex. friabilité et changement de poids). Les tablettes stables se caractérisent par une migration réduite de la nitroglycérine, par une perte de puissance réduite et par une uniformité de contenu excellente au stockage. La combinaison de composants préférée est la suivante: dilution nitroglycérine/lactose, lactose hydraté, monostéarate de glycéryle, silice sublimée, amidon pré-gélatinisé et stéarate de calcium. Dans le procédé préféré, on utilise la compression pure pour produire une composition présentant une désintégration et une biodisponibilité adéquates ainsi qu'une stabilité accrue.

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