Dissolvable films and methods of their use
AssigneeBoard of Regents, The University of Texas System
InventorsMaria A. CROYLE, Stephen Clay SCHAFER
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Abstract
Disclosed herein are compositions and methods for storing biologically active polypeptides. When the biologically active polypeptides are formulated appropriately within the compositions, they can be stored at room temperature for extended periods of time and retain a significant amount of activity prior to storage. Examples of the activity that is retained is at least about 70% to 95% activity prior to storage. Duration of storage may be for extended amounts of time, for example 1 week, 2 weeks, 1 month, 2 months, 4 months, 6 months, 8 months, or longer than a year. Methods for administering, formulating and stabilizing the biologically active polypeptides are also disclosed.
Claims30
A therapeutic composition for mucosal delivery comprising an amorphous, substantially solid film having an average thickness of 0.005 to 5 mm, which is soluble in an aqueous solution, said film comprising a biologically active polypeptide, a sugar, 0.1% w/v to 10% w/v of hydroxypropyl methylcellulose (HPMC), and an amphipathic surfactant, wherein the biologically active polypeptide is an antibody, an enzyme, a ligand, a receptor, or a cytokine and wherein the composition has retained at least 70% activity of the starting activity of the biologically active polypeptide after storage at room temperature for at least 1 week as evaluated by measuring percent recovery of the biologically active polypeptide.
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A composition comprising an amorphous substantially solid film comprising a biologically active polypeptide, a sugar, HPMC, and an amphipathic surfactant, said composition produced by a method comprising:
- (i) providing an aqueous solution comprising the biologically active polypeptide, the sugar, HPMC, and the amphipathic surfactant;
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- (ii) drying the solution sufficiently to form an amorphous, substantially solid film, which is soluble in an aqueous solution.
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Dependencies are inferred from the claim text.