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2015, Number 4

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Rev Cubana Farm 2015; 49 (4)

Stability of 50mg-Beeswax alcohols tablets (Abexol®) packed in high-density polyethylene flasks

González-Canavaciolo VL, Sierra-Pérez RC, Morales-Rico CL, Vicente-Murillo R, Rodríguez-Leyes EA, Marrero-Delange D

Language: English
References: 12
Page: 700-707
PDF size: 167.99 Kb.


ABSTRACT

Introduction: beeswax alcohols, consisting in a reproducible mixture of six primary fatty alcohols from 24 to 34 carbon atoms purified from Apis mellifera beeswax, has been shown to produce antioxidant and gastroprotective effects.
This substance is used to manufacture Abexol® 50 mg tablets, the finished form used in clinical studies and in routine practice.
Objective: to determine the stability of 50 mg‒Beeswax alcohols tablets (Abexol®) packed in high‒density polyethylene flasks.
Methods: samples from three batches of Abexol® 50 mg tablets packed in white high density polyethylene flasks (Rainbow & Nature, Sydney, Australia) were put into cardboard boxes and kept under climatic conditions of the zone IV (30 ± 2 ºC, 70 ± 5% of relative humidity) for five years.
Results: all parameters tested were within specifications throughout the whole study: appearance (white round tablets with intact surfaces), average weight (initial average weight ± 7,5%), total content of the six fatty alcohols (50 ± 3.75 mg), disintegration time ( ‹ 15 min), hardness ( › 3 kg/cm2) and microbiological content ( ≤ 1 000 bacteria/g and ≤ 100 fungi/g, absence of E. coli,S. aureus, Pseudomonas, Salmonella and C. albicans). This result is consistent with the data of a previous stability study of Abexol® 50 mg tablets manufactured in Cuba and packed in blisters of polyvinyl chloride and aluminum.
Conclusions: the results of the present study support that Abexol® 50mg tablets packed in white high density polyethylene flasks and stored at the conditions of the climatic zone IV have a shelf life of 5 years.


REFERENCES

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