FIELD: medicine; pharmaceutics.
SUBSTANCE: group of inventions relates to pharmaceutical industry, namely to an orally disintegrating pharmaceutical composition containing nefopam, and a method for preparing it. Orally disintegrating pharmaceutical composition in the form of a tablet for rapid relief of acute pain contains nefopam and pharmaceutically acceptable inert excipients, wherein composition contains: pellets or granules having a taste-masking coating, wherein the pellets or granules contain 8.57 wt.% of nefopam hydrochloride, 27.71 wt.% of nonparelle seed crystals and 2.29 wt.% of hydroxypropyl methylcellulose, and wherein the taste-masking coating contains 2.19 wt.% of hydroxypropyl methylcellulose, 1.93 wt.% of colloidal silicon dioxide and 8.74 wt.% of poly(meth)acrylate polymer; 30.0 wt.% of microcrystalline cellulose; 10.0 wt.% of polyvinylpyrrolidone; 1.0 wt.% of colloidal silicon dioxide; 1.0 wt.% of magnesium stearate; 3.71 wt.% of mannitol; 2.00 wt.% of sweetener and 0.86 wt.% of flavoring agent, where % is given relative to total weight of composition. Method of producing said orally disintegrating pharmaceutical composition includes the following steps: obtaining pellets or granules of nefopam; taste masking of said pellets or granules; obtaining a mixture containing pharmaceutically acceptable inert excipients; mixing the mixture with pellets or granules of nefopam and its lubrication; and compressing the lubricated mixture to produce a tablet.
EFFECT: use of the group of inventions provides the creation of a composition characterized by rapid disintegration in the oral cavity and rapid relief of acute pain, wherein the time for complete disintegration of the composition is no more than 3 minutes at 37 ± 2 °C.
7 cl, 2 tbl, 2 ex
