Rodríguez CJE, Díaz PI, Gil AJM, Fuste MV

Language: Spanish
References: 6
Page:
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ABSTRACT

Introduction: Albendazole is a medication whose pharmacological action defines it as wide-spectrum anti-helminthic. As part of the process of the Cuban pharmaceutical industry development, a new technology for the production of 200 mg Albendazole tablets was researched and implemented.
Objective: to evaluate the chemical and microbiological stability of the drug.
Methods: three batches of 5 kg each were prepared according to the previously developed technological process. They were divided into two parts. One half was packed in high density plastic polyethylene reservoirs (format number 8) containing 10 tablets, with threaded cap and tamper-proof seal, whereas the other half was placed in 10-tablet thermoformed PVC and aluminum packets. Chemical stability and shelf-life studies were conducted on the basis of the high performance liquid chromatography method described in the US Pharmacopea, the specificity of which was previously determined. The samples were collected at 0, 1, 2, 3 and 6 months for the accelerated stability study whereas they were gathered at 0, 6, 12, 18 and 24 months for the shelf-life stability study.
Results: it was confirmed that the batches met at the beginning the set quality parameters for the product as per the analysis technique. The studies of accelerated stability at 40° and of the product's behavior on light and on humidity showed that Albendazole did not suffer sizeable variations under these conditions.
Conclusions: the stability studies proved that the technology developed in Cuba for Albendazole tablet manufacture is optimal, which assures the chemical and microbiological quality of the drug for 24 months.

REFERENCES

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