Resumo

GONZALEZ CHAVEZ, Lissette et al. Diseño y evaluación de nuevas formulaciones de tabletas de acetato de cortisona (25 mg). Rev Cubana Farm [online]. 2002, vol.36, n.1, pp. 7-14. ISSN 1561-2988.

Three different formulations of cortisone acetate tablets (25 mg) were produced at laboratory scale aimed at obtaining a formulation that fulfills the parameters established by the British Pharmacopoeia (2000), specifically the dissolution parameter that is not fulfilled by the current formulation. In the 3 studied formulations the agglutinant solution of the present formulation (gelatin-starch) was substituted by polyvynilpyrrolidone in alcoholic solution and extragranular disintegrator (acdisol) was added, among other variations. The tablets were analyzed taking into account the technological and analytical characteristics according to the quality specifications of the official pharmacopoeias. The content uniformity trial was also carried out by using a spectrophotometric method previously validated. The physical and chemical stability of the 3 assayed formulations was studied during 3 years. All the formulations met the quality parameters established when they were newly manufactured and during the studied period of useful life, which supports the feasibility for their production at a pilot scale.

Palavras-chave : CHEMISTRY, PHARMACEUTICAL; QUALITY CONTROL; DRUG STABILITY; CORTISONE [administration & dosage]; CORTISONE [analysis]; ADRENAL CORTEX HORMONES [analysis]; TABLETS [analysis]; TECHNOLOGY, PHARMACEUTICAL..

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