Development of Prussian Blue formulations under GMP Facility
The instant project requirement comprises Development of Prussian Blue insoluble formulations under GMP Facility for Nuclear Warfare. Prussian blue formulations have been developed and evaluated at laboratory scale. The formula of Prussian blue formulations and method of preparation has been developed and evaluated at laboratory level and validated with batches of upto 100 gm. The formulations developed at Laboratory level comprise Prussian blue along with pharmaceutical excipients. The analytical method based on UV spectroscopy has been developed and validated at Laboratory level. To develop these formulations further, various parameter needs to be performed & evaluated which include scaling up of the production under GMP facility, taking process validation batches, generating stability data of the batches prepared under GMP, conducting in vitro efficacy studies or bioequivalence studies and/or generating any other additional data required for regulatory approval from competent authority i.e CDSCO. This part for the formulation development is technology oriented and scale-up technology can be developed under GMP facility of a Pharmaceutical Industry only.