METHOD FOR PREPARING SOLID FORM OF DRUG TAMERON IN FORM OF ENTERIC CAPSULES Russian patent published in 2024 - IPC A61K9/52 A61K31/502 

FIELD: medicine; pharmaceutics.

SUBSTANCE: invention relates to pharmacology and pharmaceutical industry and concerns a method for preparing a solid dosage form of Tameron in the form of solid enteric capsules filled with granules or modified release granules containing an active pharmaceutical substance sodium aminodihydrophthalazinedione. Granules for filling have the following versions of composition. Composition 1, wt.%: sodium aminodihydrophthalazinedione: 25–35; hydroxypropyl cellulose: 1–10, or hydroxymethyl cellulose: 1–10, or hydroxypropyl methylcellulose: 1–10; colloidal silicon dioxide: 1; magnesium stearate: 1; mannitol: up to 100 or sorbitol: up to 100. Composition 2: wt.%: sodium aminodihydrophthalazinedione: 25–35; hydroxypropyl cellulose: 1–10, or hydroxymethyl cellulose: 1–10, or hydroxypropyl methylcellulose: 1–10; polyvinylpyrrolidone: 1–5; dextran: 3–25, or sodium alginate: 3–25, or chitosan: 3–25; colloidal silicon dioxide: 1%; magnesium stearate: 1%; mannitol: up to 100% or sorbitol: up to 100%. Technical result consists in preparing a solid form of a drug preparation Tameron based on sodium aminodihydrophthalazinedione in the form of solid enteric capsules, which nucleus is composed of granules or granules with modified release, which provides the possibility of using various technologies of capsule filling by means of manual, semi-automatic and automatic methods.

EFFECT: ease of use of the preparation Tameron, manufacturability, preservation of biological activity and physical properties of the preparation, storage stability, high bioavailability, safety of use and efficacy of releasing the medicinal substance of the given dosage form.

1 cl, 2 tbl, 1 ex