Patent ID: 11872306
Assignee: ETHYPHARM
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. A method for producing granules of active ingredient with double taste masking, the method comprising performing (a) and (b) as two successive steps:
(a) thermally granulating an active ingredient with a first compound to form first granules at at least a melting temperature of the first compound; and then
(b) thermally granulating the first granules with a second compound at a temperature below (a) and at at least the glass thermoplastic temperature of the second compound to form granules of the active ingredient with double taste masking provided by the combination of the first compound and the second compound,, wherein:
the first compound comprises a hot-melt compound selected from waxes, hydrogenated vegetable oils, fatty acids, monoesters of fatty acids, diesters of fatty acids, triesters of fatty acids, monoesters of glycerol, diesters of glycerol, triesters of glycerol, triglycerides, glycerides, polyoxylglycerides, fatty acids, or mixtures of any of the foregoing hot-melt compounds and the second compound comprises a thermoplastic polymer that is soluble at a gastric pH less than or equal to 5, wherein the thermoplastic polymer is a cationic copolymer based on alkyl methacrylate and alkylamine methacrylate;
and
each thermal granulation step (a) and (b) is divided into three phases, the three phases comprising:
mixing at constant paddle and lump breaker speeds while increasing temperature;
granulating at stable temperature while increasing paddle and lump breaker speeds relative to the mixing step; and
cooling by decreasing temperature while decreasing paddle and lump breaker speeds relative to the granulating step.