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Int J Pharm Compd ; 23(2): 154-156, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31085780

RESUMEN

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.


Asunto(s)
Composición de Medicamentos , Estriol , Farmacia , Progesterona/química , Cromatografía Líquida de Alta Presión , Estriol/química , Tamaño de la Partícula
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