CA2927334C — Water soluble pharmaceutical film with enhanced stability

USPTO Abstract

This invention comprises an Oral Thin Film that is instantly wettable, rapid dissolving, non-sticky, non-tacky and non-curving, the said Film capable of carrying an active ingredient for oral delivery being a moisture stabilized film that remains non-sticky and non-curving when exposed to 70±5 % RH (Relative Humidity) at 25°C for at least 2 minutes up to 2 hours in open conditions without packaging.; and a process/method of making them. The active ingredient may comprise, without limitation, an active pharmaceutical, nutraceutical or cosmaceutical ingredient. The processes/method comprising (a) drying a casted film in two or more stages, (b) drying of the film after casting is done alternately both the sides, (c) coating the dried film with synthetic water insoluble moisture resistant/moisture repellant hydrophobic polymers that does not melt at high temperature, (d) adding a synthetic water insoluble moisture resistant/moisture repellant hydrophobic polymer that does not melt at high temperature to the solution to be casted as a film.