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Title: Novel and Sustainable Processes for Amorphous Solid Dispersions of Drugs to Enhance their Dissolution and Bioavailability
Researcher: Nair Rashmi
Guide(s): Raviraj Pillai
Keywords: Clinical Pre Clinical and Health
Pharmacology and Pharmacy
Pharmacology and Toxicology
University: Birla Institute of Technology and Science
Completed Date: 2018
Abstract: This research is an attempt to understand alternatives to conventional methods of product design for amorphous solid dispersions considering environmental sustainability. Various scientific aspects like amorphization, polymer supported stabilization, drug-polymer miscibility, advanced analytical characterizations etc., have been researched, however, studies on sustainable manufacturing methods and green processes has been scant. This is an important gap that needs to be addressed because as a process amorphous solid dispersions are either solvent intensive (spray drying) or energy intensive (hot melt extrusion) and both of these are threats to the concept of sustainability. newlineIn this work two case scenarios were evaluated, one each for solvent based amorphous solid dispersion and thermal energy based amorphous solid dispersion. For first case scenario, a poorly water soluble drug, Itraconazole, was selected as model drug. This class of drugs, triazole antifungals, have been a subject of research because they are not amenable to most solubility and bioavailability enhancement techniques. Conventionally hazardous solvents like dichloromethane have been used for production of amorphous Itraconazole. In this research, a retrospective analysis of drug in discovery stage was done. What would have been the stages for a first formulation? A salt screening exercise that selects crystalline salts, automatically eliminates non-crystalline or amorphous salts/drug-counter ion mixtures. With this as a starting point, literature was analysed to see reasons for no major salts of Itraconazole. Avoiding salt isolation and stabilization of amorphous form with polymer(s) was considered as a approach. In salt screening, aqueous content (water) is known to cause drug crystallization, therefore, a non-aqueous solvent system that would also be as per the recommendations for a green solvents was researched. newlineAcidified methanol was found to be a suitable solvent that could be utilised to design a benign process. With evidence of good physico-chemi
Pagination: 155p.
Appears in Departments:Pharmacy

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