Process for preparation of a drug-polymer composition
OwnerKirit Patelinventor
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Abstract
The present invention relates to an improved active or inactive pharmaceutical ingredient-polymer composition and process of preparation thereof. In particular, the present invention relates to an improved active or inactive pharmaceutical ingredient-polymer composition and process of preparation thereof wherein the monomer encapsulates particles of active or inactive pharmaceutical ingredient at molecular level and with controlled polymerization process the monomer turns into the said polymer coat over the said active or inactive pharmaceutical ingredient that facilitates the disclosed invention to be completed a single step process.
Claims23
An improved process for preparation of a drug-polymer composition based on monomer and pharmaceutically active or inactive ingredient which produces composite sensitive to pH for the purpose of use in masking taste of bitter drugs, sustained release of API, enteric coating, multiple coating, film coating, pH sensitive coating, protection from outer atmosphere, stability of light sensitive material, stability of moisture sensitive material, smell masking, stability from UV radiation, prevent leaching of the coated material into the vehicle and increasing bioavailability of the API etc. comprising the steps of:
- (a) Preparing a uniform blend of the vehicle (water) saturated with salt and surfactants as part A;
- (b) Preparing a blend of the desired amount of active drug and thickner and adding it to part A with constant stirring keeping the suspension over a desired period of time in desired temperature as part B;
- (c) Preparing a catalyst content with desired amount of DM water as part C;
- (d) Adding part C to part B with constant stirring and maintaining the desired temperature as part D;
- (e) Separately preparing a homogeneously blend containing desired monomers, from which polymer is formed, and a catalyst and pouring the entire content to the uniformly dispersed part D;
- (f) Initiating the reaction in an inert atmosphere for complete polymerization of the monomer, over the subject molecules, in the contents of step (e) by maintaining the desired pH, temperature, pressure and time;
- (g) Recovering the polymerized product by filtration and washing repeatedly;
- (h) Feeding the contents of step (g) to a spray drier for drying the final product.
An improved process for preparation of a drug-polymer composition as claimed in 1 wherein the said process is carried out at a temperature in the range of 20-95° C. and for a period of 1-24 hours.
Dependencies are inferred from the claim text.