Milling and comilling Praziquantel at cryogenic and room temperatures: Assessment of the process-induced effects on drug properties

Journal of Pharmaceutical and Biomedical Analysis
Debora ZanollaBeatrice Albertini

Abstract

This study is a comprehensive evaluation of praziquantel (PZQ) behavior upon grinding considering the influence of milling temperature (cryogenic vs room temperature), frequency and time and presence of polymers (milled raw PZQ vs comilled PZQ/povidone and PZQ/crospovidone at 50:50 w/w) on two experimental responses (residual crystallinity and PZQ recovery). To this aim a full factorial design was set up and the responses of the experimental design were statistically assessed. The powder temperature, measured in different milling conditions, was found to increase with increasing milling frequency and time, up to a maximum recorded value of 46.9 °C (after 90 min at R.T.), for all the three powder systems. When PZQ was ground in RT environment, the recovery was 100%, independently from frequency and time of milling. Its residual crystallinity remained pronounced (>70%) upon milling, even if treated at the most severe conditions. Conversely, when the drug was milled in presence of the polymers, it showed a higher tendency to degradation and amorphysation, independently from the choice of the polymer. The use of cryogenic conditions, operating at temperatures lower than PZQ glass transition, permitted to dramatically reduce PZQ res...Continue Reading

Citations

Mar 16, 2019·International Journal of Molecular Sciences·Beatrice AlbertiniNadia Passerini
Sep 29, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Serena BertoniNadia Passerini
Oct 19, 2019·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Debora ZanollaDario Voinovich
Aug 4, 2020·Journal of Pharmaceutical and Biomedical Analysis·Alessio GaggeroMario Jug
Jul 20, 2021·Crystal Growth & Design·Jan-Joris DevogelaerRené de Gelder

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