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Towards the Importance of a Roller Mill in Compounding Practice: An Experimental Approach

Author(s):  Polonini Hudson, Loures da Silva Sharlene, Batista Patrício Fernando, Fernandes Brandão Marcos Antônio, de Oliveira Ferreira Anderson

Issue:  Mar/Apr 2019 - Volume 23, Number 2
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Abstract:  There are a substantial amount of suppliers for roller mills in the market, but there is a lack of scientific evidence of a roller mill’s capacity to improve particle size reduction/distribution or homogenization. In this concise paper, we evaluate the use a roller mill in the final steps of compounding semisolid dosage forms. We performed three simple tests to verify these claims: 1) particle size evaluation through dynamic light scattering and scanning electron microscopy techniques, 2) content uniformity through high-performance liquid chromatography technique, and 3) cross contamination through a cleaning validation method. Dynamic light scattering and scanning electron microscopy techniques of benzoyl peroxide 5% (gel) and testosterone 1% (cream) showed a significant reduction on particle diameter. Content uniformity testing of creams containing progesterone 5%, estradiol 0.1%, and estriol 0.4% showed better homogeneity when using the roller mill. Finally, the proposed cleaning procedure decreased the presence of the compounded preparation to a “none-detection” level after the procedure. This suggests that the roller mill used does, in fact, play a role in the final aspect and quality of pharmaceutical semisolid dosage forms.

Related Keywords: Hudson Polonini, BPharm, MSc, PhD, Sharlene Loures da Silva, BBiomed, Fernando Batista Patrício, BChem, Marcos Antônio Fernandes Brandão, BPharm, PhD, Anderson de Oliveira Ferreira, BPharm, MSc, PhD, roller mills, compounding equipment, particle size, content uniformity, homogenization, particle diameter, semisolid dosage forms

Related Categories: PEER-REVIEWED, TECHNOLOGY, QUALITY CONTROL

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