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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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Page(s):  154-156

Towards the Importance of a Roller Mill in Compounding Practice: An Experimental Approach Page 1
Towards the Importance of a Roller Mill in Compounding Practice: An Experimental Approach Page 2
Towards the Importance of a Roller Mill in Compounding Practice: An Experimental Approach Page 3

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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: 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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