COMPARISON BETWEEN HOMOGENIZATION METHODS FOR COMPOUNDED SODIUM ALENDRONATE CAPSULES: PLASTIC BAG x MORTAR AND PESTLE

Authors

  • Mayara Myuki Wada Centro Universitário FIEO
  • Ana Ferreira Ribeiro Instituto Federal de Educação Ciência e Tecnologia do Rio de Janeiro – IFRJ

DOI:

https://doi.org/10.14450/2318-9312.v26.e1.a2014.pp27-34

Keywords:

sodium alendronate, powder mixture, content uniformity

Abstract

Homogenization using mortar and pestle is a traditional method for powder mixing of drugs formulations. Compounding pharmacies have used a method of homogenization using plastic bags inflated with air in order to improve the production of capsules. In this work the efficiency of this method compared to the mortar and pestle one, for the production of sodium alendronate capsules, was evaluated. Batches of capsules containing 70 mg of alendronic acid (equivalent to 91.42 mg of sodium alendronate trihydrate) were produced using, for the homogenization of powder blend, the mortar and pestle technique (ALE-MP) and the plastic bag method with or without the previous sieving of the bulk materials (ALE-PB-S and ALE -PB, respectively). Acid-base titration method was used for the quantitative determination of alendronate in the capsules. Each batch was evaluated with respect to drug content, uniformity of mass and content uniformity and presented results according to the pharmacopeial specifications. However, after analysis of the content uniformity data, we found a statistically significant difference in the variance of the ALE-PB batch compared to the other batches, mainly the ALE-MP batch (P < 0.0001, for α = 0.05). This result suggests poor homogenization efficiency for the plastic bag method without sieving.

Author Biographies

Mayara Myuki Wada, Centro Universitário FIEO

Farmacêutica graduada pela UNIFIEO

Ana Ferreira Ribeiro, Instituto Federal de Educação Ciência e Tecnologia do Rio de Janeiro – IFRJ

Graduada em Farmácia pela UFJF e mestre em Ciências Farmacêuticas pela UFRJ. Atualmente é doutoranda em Ciências Farmacêuticas pela UFRJ e docente do curso de graduação em Farmácia do IFRJ.

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Published

2014-03-31

How to Cite

Myuki Wada, M., & Ferreira Ribeiro, A. (2014). COMPARISON BETWEEN HOMOGENIZATION METHODS FOR COMPOUNDED SODIUM ALENDRONATE CAPSULES: PLASTIC BAG x MORTAR AND PESTLE. Infarma - Pharmaceutical Sciences, 26(1), 27–34. https://doi.org/10.14450/2318-9312.v26.e1.a2014.pp27-34

Issue

Vol. 26 No. 1 (2014)

Section

Original article

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