Estudio de estabilidad a largo plazo de tabletas de Abexol® envasadas en frascos de polietileno de elevada densidad

Abstract

The mixture of fatty alcohols extracted and purified from the Apis mellifera beeswax, composes the active ingredient of the Abexol® tablets, which show antioxidant and gastroprotective effects. Samples from three batches of Abexol® tablets with doses of 50 mg fatty alcohols (Rainbow & Nature, LIPA Pharmaceuticals LTD, Sydney, Australia), packed in high density polyetylene flasks, were put in cardboard boxes, as secondary packaging, and were kept in the ambient conditions of the climatic zone IV: (30 ± 2) °C and (70 ± 5) % of relative humidity for three years. During all the study, the assayed parameters fulfilled the quality specifications of these tablets: appearance (white tablets), average weight (initial average weight ± 10 %), fatty alcohols content (50 mg ± 5 mg), hardness (> 3 kgf), disintegration time (< 30 min) and microbiological content (≤ 1000 bacteria/g and ≤ 100 fungi/g, absence of Escherichia coli, Staphylococcus aureus, Pseudomonas, Salmonella and Candida albicans). The results of the study support a shelf live of at least three years for this dosage form in climatic zone IV conditions, which is consistent with the results of a previous stability study of Abexol® tablets manufactured in Cuba and packed in blisters of polyvinyl chloride and aluminum.