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

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

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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, 15-eg2373cl 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 jolly rancher filled gummies 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.