Caracterização, análise físico-química e estabilidade térmica do complexo de inclusão ciclodextrina-17-valerato de betametasona / Physicochemical characterization and thermal stability evaluation of betamethasone 17-valerate cyclodextrincomplex

AUTOR(ES)
FONTE

IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia

DATA DE PUBLICAÇÃO

11/11/2010

RESUMO

Preparation of formulations containing the active ingredient betamethasone 17-valerate (VB) is widely defunded within pharmaceutical industry, once it concerns an anti-inflammatory drug and an option, in the treatment of conditions in which corticosteroids therapy is indicated. Often employed in topical treatment of eye, ear and nose allergic and inflammatory conditions, inhalation for asthma prophylaxes, and also in veterinary. This because its high anti-inflammatory activity, when compared to others corticosteroids, and its virtual lack of mineralocorticoids properties, causing a low sodium retention and, subsequently, of water. As described in the United States pharmacopeia USP 32 NF 27, the active ingredient betamethasone 17-valerate hydrolyses into its isomer betamethasone 21- valerate, its main degradation product, that has a low anti-inflammatory activity . Additionally, the Brazilian legislation for drug products stability study, RE n°1, July 29th 2005, introduce long therm stability study stressing conditions (30°C/75%RH), accelerating the reactive hydrolysis (degradation) for the active ingredient. Well known, previous studies show that topical formulations containing VB (lotion, cream, solution and ointment) presents a short stability. Complexation (inclusion) with cyclodextrin (CD) compounds shows a reasonable way to improve the VB stability. The project objective is to establish procedures for the obtainment, physicochemical characterization and solid complex (cited above) thermal stability evaluation. In order to achieve this objective thermal analysis techniques (differential scanning calorimetry and thermogravimetry), Fourier transformation middle infrared, nuclear magnetic resonance and high performance liquid chromatography, were needed.

ASSUNTO(S)

17-valerato de betametasona análise térmica anti-inflammatory antiinflamatórios betamethasone-17-valerate ciclodextrina cyclodextrin estabilidade térmica nuclear magnetic resonance ressonância magnética nuclear thermal analysis thermal stability

ACESSO AO ARTIGO

Documentos Relacionados