Influence of small amorphous amounts in hydrophilic and hydrophobic APIs on storage stability of dry powder inhalation products

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V
Thorsten MüllerHartwig Steckel

Abstract

The effects of different manufacturing methods to induce formation of amorphous content, changes of physico-chemical characteristics of powder blends and changes of aerodynamic properties over storage time (6months) analyzed with the Next Generation Impactor (NGI) are investigated. Earlier studies have shown that standard pharmaceutical operations lead to structural disorders which may influence drug delivery and product stability. In this investigation, fully amorphous drug samples produced by spray-drying (SD) and ball-milling (BM) as well as semi-crystalline samples (produced by blending and micronization) are studied and compared to fully crystalline starting material. The amorphous content of these hydrophilic and hydrophobic active pharmaceutical ingredients (APIs) was determined using a validated one-step DVS-method. For the conducted blending and micronization tests, amorphous amounts up to a maximum of 5.1% for salbutamol sulfate (SBS) and 17.0% for ciclesonide (CS) were measured. In order to investigate the impact of small amorphous amounts, inhalable homogenous powder mixtures with very high and low amorphous content and a defined particle size were prepared with a Turbula blender for each API. These blends were stor...Continue Reading

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Citations

Jan 19, 2016·Advanced Drug Delivery Reviews·Lan ChenHak-Kim Chan
Jun 17, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Thorsten MüllerHartwig Steckel
Aug 20, 2020·Expert Opinion on Drug Delivery·Rachel Yoon Kyung ChangHak-Kim Chan
Jun 15, 2017·Pharmaceutical Development and Technology·Kyeong Soo KimHan-Gon Choi
Mar 7, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Noor Ul Saba BagwanArvind Kumar Bansal

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