FIELD: medicine, pharmaceutical industry.
SUBSTANCE: invention relates to a composition comprising human recombinant interferon-α. Proposed composition comprises hydrophilic conglomerate of human recombinant interferon-α adsorbed by polyethylene glycol 4000-6000 Da, polyglucin and a cross-linking agent chosen from the following order: maltose, mannitol, glucose and fructose and having particles size 250 mcm, not above, and not exceeding an average size of swelling and dispersing substance particles, a swelling and dispersing substance chosen from the order: cellulose, methylcellulose, acetylphthalylcellulose, carboxymethylcellulose sodium, croscarmellose sodium, starch glycolate sodium, mixture of starch glycolate sodium and carboxymethylcellulose, crospovidon, cross-linked carboxymethyl-starch with particles size 300 mcm, not above, and a special additive with particles size 250 mcm, not above, not exceeding an average size of swelling and dispersing substance particles, in the following ratio of components in 1.0 g of the composition: human recombinant interferon-α, 10000-300000 IU, polyethylene glycol 4000-6000 Da, 0.0001-0.5; polyglucin, 0.001-0.1; cross-linking agent, 0.01-0.8; swelling and dispersing substance, 0.001-0.1, and a special additive, the balance. The composition can comprise a mixture of polyvinylpyrrolidine and microcrystalline cellulose as a special additive for a tablet forming. The composition can comprise calcium stearate as a special additive for formation of a capsule forming. Invention provides enhancing bioavailability of human recombinant interferon-α in using the proposed composition.
EFFECT: improved and valuable medicinal and pharmaceutical properties of composition.
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Authors
Dates
2007-02-10—Published
2006-03-03—Filed