Oral compositions of proteinaceous medicaments
AssigneeApplied Analytical Industries, Inc.
InventorAshok J. Desai
Life of this patent
Estimating the term…
Abstract
Proteinaceous medicaments such as erythropoetin, insulin and calcitonin are formulated in a medium comprising a polyol pharmaceutical solvent combined as co-solvent with a lipid pharmaceutical solvent. The formulation is adapted for oral administration as a liquid as well as a filled hard or soft gelatin capsule. The preferred polyol solvent is polyethylene glycol/propylene glycol; the preferred lipid solvent is oleic acid.
Claims13
A pharmaceutical enteric coated composition adapted for oral administration comprising:
- (a) a dosage unit of a protease inhibitor and of a proteinaceous medicament which is a member selected from the group consisting of erythropoietin, insulin, a growth hormone, calcitonin, growth colony stimulating factor, cyclosporine, vasopressin, a vasopressin agonist, a vasopressin antagonist, t-PA, vampire bat plasminogen amplifier, urokinase, streptokinase, interferon and interleukin each in a biologically effective, non-toxic quantity;
- (b) a phospholipid;
- (c) cholesterol;
- (d) a hydrophyllic or hydrophobic surfactant;
- and
- (e) a substantially non-aqueous, non-alcoholic pre-emulsion emulsifiable solution medium therefor comprising from 15 to 35% of a liquid polyol pharmaceutical solvent for said proteinaceous medicament which is selected from the group consisting of propylene glycol and a polyethylene glycol combined with from 30 to 60% of a liquid lipid pharmaceutical solvent for said proteinaceous medicament which is selected from the group consisting of oleic acid, isostearic acid, linoleic acid and linolenic acid.
In the preparation of an enteric coated pharmaceutical composition adapted for the oral administration of a protease inhibitor and of a proteinaceous medicament which is a member selected from the group consisting of erythropoietin, insulin, a growth hormone, calcitonin, growth colony stimulating factor, cyclosporine, vasopressin, a vasopressin agonist, a vasopressin antagonist, t-PA, vampire bat plasminogen amplifier, urokinase, streptokinase, interferon and interleukin each in a biologically effective, non-toxic quantity, the improvement comprising the incorporation into an enteric coated composition of a liquid medium containing said medicament which is a substantially non-aqueous, non-alcoholic mixture of a liquid polyol pharmaceutical solvent for said medicament selected from the group consisting of propylene glycol and a liquid polythylene glycol combined with a liquid lipid pharmaceutical solvent for said medicament which is selected from the group consisting of oleic acid, isostearic acid, linoleic acid and linolenic acid.
Dependencies are inferred from the claim text.