Pharmaceutical compositions containing orally absorbable glycosamimoglycans
AssigneeAlfa Wasserman S.p.A.
InventorsManlio Cristofori, Egidio Marchi, Leone G. Rotini
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Abstract
Pharmaceutical compositions for oral use, preferably selected from capsules, tablets or sugar coated tablets, coated by an enterosoluble gastroresistant film, containing a lyophilizate consisting of therapeutically effective amounts of a glycosaminoglycan, a thickening substance and surfactants, and process for obtaining them. The compositions make possible the absorption of the orally administered glycosaminoglycans in the duodenum and in the intestine and the consequent performance of their anticoagulant, fibrinolytic, antithrombotic, antiatherosclerotic and antihyperlipoproteinemic properties.
Claims9
A pharmaceutical composition for oral use in unit dosage form which consists of a) a coating, b) a non-coated portion, and c) a non-protective first coating, said non-coated portion b) comprising a lyophilizate, said lyophilizate consisting of 25-500 mgs by weight of a glycosaminoglycan, 5-100 mgs by weight of at least one thickening agent, 25-500 mgs by weight of at least one surfactant, said glycosaminoglycan being a member selected from the group consisting of heparin of molecular weight between 6,000 and 30,000 Daltons and alkaline and alkali-earth salts thereof, fractions of low molecular weight heparin of molecular weight between 1,500 and 8,000 Daltons, low molecular weight fractions of dermatan sulfate of average molecular weight between 2,000 and 8,000 Daltons and glucuronylglycosaminoglycan sulfate known as sulodexide (INN), said coating a) consisting of a gastroresistant enterosoluble film in the amount of 2-10% by weight with respect to said non-coated portion b), said non-protective first coating c) being interposed between said lyophilizate and said gastroresistant enterosoluble film and being obtained by spraying a suspension of 3.5-21 mgs of hydroxypropylmethylcellulose, 0.2-1.2 mgs of polyethylene glycol 6000, 0.8-4.8 mgs of titanium dioxide and 0.8-4.8 mgs of talc in a 22:1 mixture of 95% ethyl alcohol and water, in such an amount that the weight of said non-protective first coating c) is between 1% and 5% as to the weight of said non-coated portion b).
A pharmaceutical composition for oral use in unit dosage form which consists of a) a coating, b) a non-coated portion, c) a non-protective first coating, and d) a sugar coating said non-coated portion b) comprising a lyophilizate, said lyophilizate consisting of 25-500 mgs by weight of a glycosaminoglycan, 5-100 mgs by weight of at least one thickening agent, 25-500 mgs by weight of at least one surfactant, said glycosaminoglycan being a member selected from the group consisting of heparin of molecular weight between 6,000 and 30,000 Daltons and alkaline and alkali-earth salts thereof, fractions of low molecular weight heparin of molecular weight between 1,500 and 8,000 Daltons low molecular weight fractions of dermatan sulfate of average molecular weight between 2,000 and 8,000 Daltons and glucuronylglycosaminoglycan sulfate known as sulodexide (INN), said coating a) consisting of a gastroresistant enterosoluble film in the amount of 2-10% by weight with respect to said non-coated portion b), said non-protective first coating c) being interposed between said lyophilizate and said gastroresistant enterosoluble film and being obtained by spraying a suspension of 3.5-21 mgs of hydroxypropylmethylcellulose, 0.2-1.2 mgs of polyethylene glycol 6000, 0.8-4.8 mgs of titanium dioxide and 0.8-4.8 mgs of talc in a 22:1 mixture of 95% ethyl alcohol and water, in such an amount that the weight of said non-protective first coating is between 1% and 5% as to the weight of said non-coated portion and d) a sugar coating externally to said coating a).
Dependencies are inferred from the claim text.