Shear-induced APAP de-agglomeration

Drug Development and Industrial Pharmacy
Marcos LlusaFernando J Muzzio

Abstract

Active pharmaceutical ingredient agglomerates can generate many solid product regulatory compliance issues. To study the effects of shear rate, strain, type of excipient, and grade of acetaminophen (APAP) on the process of APAP de-agglomeration. A shear-controlled environment is used to expose six different blends that consist of one of three APAP grades and one of two possible types of excipient to 10 different combinations of shear rate and strain. APAP agglomerates are sifted and weighed. Finer APAP grades lead to blends with more APAP agglomerates and type of excipient only affects the de-agglomeration process for the finest APAP grade. De-agglomeration proceeds mainly as a function of strain with a minor contribution toward further de-agglomeration when larger shear rates are used. When mechanical stress (which us proportional to shear rate) overcomes interparticle forces, de-agglomeration occurs. Higher shear rates (and stress) contribute slightly to further APAP de-agglomeration. Extended exposure to stress (strain) reduces the size and the number of agglomerates. Blends with finer APAP present more agglomerates, particularly after low strain exposure. This article presents a useful method for formulation and process dev...Continue Reading

References

Feb 1, 1982·The Journal of Pharmacy and Pharmacology·J N Staniforth, J E Rees
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Nov 30, 2004·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·B H J DickhoffH W Frijlink
Jan 22, 2005·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Peter J Stewart, Feng-Ying Zhao
May 23, 2006·Pharmaceutical Research·Emilie Desrosiers LachiverJean-Sébastien Simard
Jun 27, 2006·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Emilie DesRosiers LachiverJean-Sébastien Simard
Apr 7, 2009·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Kamakshi KalePeter Stewart

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Citations

Jan 24, 2012·Molecular Pharmaceutics·Manoj K MishraRangaramanujam M Kannan
Apr 13, 2012·Drug Development and Industrial Pharmacy·Marcos LlusáFernando J Muzzio
Aug 21, 2016·International Journal of Pharmaceutics·Andrés D Román-OspinoRodolfo J Romañach
Mar 13, 2016·Applied Spectroscopy·Eduardo HernándezRodolfo J Romañach

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