Stability studies of film-coated tablets containing 5 mg of D-003 as active ingredient

Abstract

D-003 is a new under research drug with potential use for preventing or treating atherothrombotic diseases. This product is made up of a mixture of very high molecular weight aliphatic acids (C24:0 to C36:0) purified from sugar cane (Saccharum officinarum, L.) wax. The aim of this study was to determine the stability of the proposed formulation of D-003 5 mg film-coated tablets, following International Harmonization Conference guidelines for knowing their possible specifications change on storage conditions and for predicting their expiration date. Specifications such as D-003 content, color, tablet weight, hardness, disintegration time, and microbial content were assessed. Stress testing included acid hydrolysis, thermolysis, oxidation and photolysis. In addition, accelerated studies under drastic conditions: 40 oC and 75 % of relative humidity (RH) as well as long-term studies (48 months) at conditions of Climatic Zones IV (30 oC and 70 % RH) and II (25 oC and 60 % RH) were also conducted using three batches. Tablets were crushed to a fine powder and the active ingredient with chloroform was extracted in a hot way. The acids were converted to methyl esters and in a BP-5 wide-bore capillary column by gas chromatography were analyzed. Quantification by the internal standard method, using 1-nonacosanoic acid was carried out and peaks purity by gas chromatography - mass spectrometry was confirmed. No significant changes or trends either on the content of D-003 or on other specifications were found in any study.