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

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.