ANTITUBERCULAR COMPOSITION COMPRISING RIFAMPICIN, ISONIAZID, ETHAMBUTOL AND PYRAZINAMIDE AND PROCESS FOR PREPARATION THEREOF Russian patent published in 2018 - IPC A61K31/133 A61K31/4409 A61K31/496 A61K31/4965 A61K47/00 A61K9/20 A61P31/06 

Abstract RU 2672879 C2

FIELD: medicine; pharmaceuticals.

SUBSTANCE: present invention relates to a single layer tablet for use in the treatment of tuberculosis. Tablet contains a mixture of granules containing isoniazid, pyrazinamide, ethambutol or a pharmaceutically acceptable salt thereof and a granulation binder, rifampicin in powder form, extragranular excipients in an amount of 10 to 17 wt. %. Granulating agent is selected from povidone, polyvinyl alcohol, maize starch, pregelatinised starch, or mixtures thereof. Extragranular excipients contain a disintegrant selected from croscarmellose sodium, crospovidone, maize starch, low substitution hydroxypropylcellulose, alginic acid, or mixtures thereof. All granules have a particle size less than 0.422 mm. Method of producing a single-layer tablet is also described. Amount of impurity – 3-formyl-rifampicin-isoniazid adduct is negligible.

EFFECT: single-layer tablet of the invention provides rifampicin bioavailability and is stable.

16 cl, 9 tbl, 1 ex

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RU 2 672 879 C2

Authors

Amitkh Kumar

Bindu Madavan

Kum Prasad

Pravin Kkhullar

Dates

2018-11-20Published

2014-07-22Filed