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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