Pharmaceutical formulation
AssigneeKlaria Pharma Holding AB
InventorsScott Boyer, Shengzhen Cai, Fredrik Hübinette, Leif Ingemarsson
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Abstract
The present invention relates to a film comprising an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation, and a compound of Formula (I), such as adrenaline, or a pharmaceutically acceptable salt thereof. The present invention further relates to methods for manufacturing such a film, and the use of such a film in the treatment of a human patient, in particular the use of such a film in the treatment of a condition selected from anaphylaxis, superficial bleeding and cardiac arrest.
Claims26
A film suitable for administration to an oral cavity comprising:
- (i) an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation, wherein said alginate salt is a sodium alginate or a potassium alginate;
- (ii) an active pharmaceutical ingredient (API) which is adrenaline or a pharmaceutically acceptable salt thereof;
- (iii) an antioxidant selected from the group consisting of sodium metabisulfite, sodium bisulfite, and combinations thereof;
- and
- (iv) at least one plasticizer which is selected from sorbitol, glycerol, or both sorbitol and glycerol,
- further wherein the alginate salt of a monovalent cation (a) comprises from 25 to 35% by weight of β-D-mannuronate and from 65 to 75% by weight of α-L-guluronate, and (b) has a weight average molecular weight of from 30,000 g/mol to 90,000 g/mol,
- wherein the film is stable for 83 days at room temperature.
Dependencies are inferred from the claim text.