15. March 2018
Excipient-induced salt disproportionation (conversion from salt form to free form) in the solid state during storage or manufacturing is a severe formulation issue that can negatively influence product performance. However, the role of excipient properties on salt disproportionation and mechanisms of proton transfer between salt and excipients are still unclear.
13. February 2017
Abstract Poloxamer 188, a commonly used emulsifying and solubilizing agent, was found to be the cause of crystallization of an investigational drug, AMG 579, from its amorphous solid dispersion at accelerated storage conditions. Investigation of this physical stability issue included thorough characterization of poloxamer 188 at non-ambient conditions. At 40 °C, poloxamer 188 becomes deliquescent above relative humidity of 75%. Upon returning to ambient conditions, the deliquescent poloxamer...
20. December 2016
Abstract Salt disproportionation (a conversion from the ionized to the neutral state) in solid formulations is a potential concern during manufacturing or storage of products containing a salt of the active pharmaceutical ingredient (API) due to the negative ramifications on product performance. However, it is challenging to find an effective approach to prevent or mitigate this undesirable reaction in formulations. Hence, the overall objective of this study is to explore novel formulation...
22. November 2016
Abstract The surface of hydrophilic silica particles was modified with different concentrations (2, 4, 6, 8 and 10%) of γ-methacryloxypropyltrimethoxysilane (MPTS). The hydrophobicity and hygroscopicity of unmodified and modified silica were investigated through water contact angle (WCA) tests and dynamic vapor sorption (DVS) method, respectively. The results showed that the surface properties of silica were closely related with the MPTS concentration. Within the range of MPTS concentration...
17. June 2016
Abstract Three granulation processing methods; Hot melt extrusion (HME), Roller compaction Dry granulation (RCDG) and Moisture assisted dry granulation (MADG) are assessed to evaluate different polymeric binders for preparation of a high dose immediate release tablet of acetaminophen drug. Different characterization techniques were used to enumerate poor physical property characteristic for drug (paracetamol) including hygroscopicity, low solubility and bulk density, and poor powder...