12. September 2018
The amorphous solid dispersion (ASD) technique has been employed to formulate poorly-soluble drugs, however, development of solid dosage forms with ASD is challenging due to the high propensity of amorphous drug to precipitate upon dissolution. Thus this work aimed to explore the potential of controlled release amorphous solid dispersion (CRASD) systems using polyvinyl acetate (PVAc) as a release-retarding excipient to mitigate the drug precipitation during dissolution of poorly water-soluble...
01. March 2018
Form changes during drug product processing can be a risk to the final product quality in terms of chemical stability and bioavailability. In this study, online Raman spectroscopy was used to monitor the form changes in real time during high shear wet granulation of Compound A, a highly soluble drug present at a high drug load in an extended release formulation. The effect of water content, temperature, wet massing time and drying technique on the degree of drug transformation were examined.
22. February 2017
Abstract Mannitol is a commonly used bulking agent in lyophilized formulations. It can crystallize into multiple solid forms during lyophilization thereby exhibiting phase heterogeneity and variability in product performance. In this manuscript, we studied the effect of cyclophosphamide (CPA), an anticancer drug, on the solid form of mannitol during lyophilization from aqueous solutions. Freeze-concentration studies were performed in the DSC while lyophilization was performed in a lab scale...
16. February 2016
In the pharmaceutical field, solid-state transitions that may occur during manufacturing of pharmaceuticals are of great importance. The phase transition of a model API, caffeine Form I (CFI), was studied during direct compression process by analysing the impacts of the operating conditions (process and formulation). This work is focused on two formulation parameters: nature of the diluent and impact of the caffeine dilution, and one process parameter: the compression pressure that may impact...