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Revista Cubana de Farmacia

On-line version ISSN 1561-2988

Abstract

GONZALEZ CANAVACIOLO, Víctor Luis; MARTINEZ ALVAREZ, Luis; MARRERO DELANGE, David  and  SIERRA PEREZ, Roxana Caridad. Organoleptic, physicochemical and microbiological studies and its interaction with pharmaceutical excipients of a purified extract from Apis mellifera wax. Rev Cubana Farm [online]. 2010, vol.44, n.3, pp. 354-359. ISSN 1561-2988.

The D002, an antioxidant active ingredient extracted from the Apis mellifera bees wax was characterized from the physicochemical point of view analyzing its interaction with excipients of pharmaceutical interest. The D-002 is a creamy white odourless fluid powder with losses by £ 1 % dry; it is water and ethanol insoluble and very slightly soluble in other organic solvents. Its composition, determined by gas chromatography was: 1-tetracosanol (6-15 %), 1-hexacosanol (7-20 %), 1-octacosanol (12-20 %), 1-triacontanol (25-35 %, 1-dotriacontanol (18-25 %) and 1-tetratriacontaol (£ 7,5 %) for ³ 85 % of purity. It remained stable during 5 years in the IV climatic zone and its analysis by differential scanning calorimetry showed 2 fusion transitions at 59.0 and 81.1 °C. without decomposition, a high thermal stability up to 200 °C, as well as a lack of interactions with lactose, starch, sodium croscarmelosa, polyvinylpyrrolidone, microcrystalline cellulose, and magnesium stearate allowing the use of these excipients in tablets formula.

Keywords : Scanning differential calorimetry; thermogravimetry analysis; Apis mellifera; fatty alcohols.

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