ORAL SOLID PREPARATION OF COMPOUND ANTITUBERCULOSIS DRUG AND PREPARATION METHOD THEREOF Russian patent published in 2016 - IPC A61K31/496 A61K31/133 A61K31/4965 A61K31/4409 A61K47/00 A61K9/30 A61K9/24 A61P31/06 

FIELD: medicine.

SUBSTANCE: oral solid preparation of a compound anti-tubercular drug is disclosed, wherein the active ingredients are rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride in weight ratio of 150:75:400:275, respectively. Compound oral solid preparation is a coated tablet with coated core or a coated three-layer tablet, wherein the two active ingredients rifampicin and isoniazid do not come to contact with each other directly. In the coated tablet with coated core in the inner core contains isoniazid or rifampicin and polymer, which is quickly destroyed and is quickly increased in volume during absorption of water, or rifampicin in the inner core is in the form of enteric solid dispersion. In the coated three-layer tablet the top layer and bottom layer separately and independently comprise a layer of rifampicin, including polymer which is quickly destroyed and is quickly increased in volume during absorption of water, and a layer of isoniazid/pyrazinamide, and a central layer is a layer of ethambutol hydrochloride including an inhibitor, which retains fast disintegration or release of ethambutol hydrochloride, or in the layer containing rifampicin, rifampicin is in form of enteric solid dispersion, where the weight ratio of rifampicin and enteric solid carrier is from 2:1 to 1:3.

EFFECT: compound oral solid preparation according to the invention is characterized by high stability, higher bioavailability of rifampicin, that enhances treatment efficacy and reduces a probability of drug resistance.

19 cl, 11 dwg, 11 tbl, 11 ex