Hate, Siddhi Santosh. Investigation of physico-chemical properties of lipid-based excipients in a hot-melt fluid bed coating process. Retrieved from https://doi.org/doi:10.7282/T3D220GJ
DescriptionFluidized bed coating process is widely used in the pharmaceutical industry. In the case of lipid-based excipients as a coating material, the coating process requires an additional operation of melting the coating material prior to its application. Thus the process is said to be a hot melt fluid bed coating process. The objective of this study is to understand the hot-melt fluid bed coating process for coating of lipid-based excipients onto drug crystals to produce orally disintegrating granules. Orally disintegrating granules are a ‘direct to mouth’ dosage form and offers better patient compliance by making it easier to swallow the medication in the form of granules. However, for such dosage form, it is imperative to have a drug product with an immediate release profile and a good taste masking to mask the unpleasant taste of the active ingredient. In this work, a parametric study using a fractional factorial design of experiments was carried out to understand the influence of process parameters on thickness of the coating layer, dissolution rate of the API and taste masking ability of the coating material. With the help of analysis of the factorial design, an optimal design space to achieve desired quality of the drug product was found. In this work, in addition to the parametric study, an experimental study to understand polymorphism of the coating layer was also performed. Lipids tend to exhibit polymorphism. The presence of an unstable crystal form in the product may result in storage instabilities and in turn affect the dissolution rate of the drug. Therefore, the influence of fluidization air temperature and emulsifier content on polymorphism of the coating layer was studied in detail. Thermal analysis of the coated granules helped understand the melting and crystallization behavior of different polymorphs exhibited by the coating layer. The results of this work suggests that a more detailed investigation of kinetics of crystallization and phase transformation of lipids is required for its application as a coating material for pharmaceutical products.