Oral polypeptide formulations
AssigneeBhami's Research Laboratory, Pvt. Ltd.
InventorsBhami Shenoy, Suryakanth Motilal Pai
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Abstract
The present disclosure provides, among other things, methods and compositions for the oral administration of polypeptides. Many polypeptides are typically administered in liquid solutions by intravenous or subcutaneous injection. The present disclosure provides methods and compositions that include a polypeptide formulation, e.g., truffle, tablet, globule, or candy formulation suitable for buccal/sublingual administration, where the formulation includes an amorphous polypeptide composition or a crystallized polypeptide composition and a pharmaceutically acceptable carrier.
Claims18
A polypeptide formulation comprising:
- a core comprising a crystallized polypeptide component consisting of a pharmaceutically active polypeptide;
- and
- a pharmaceutically acceptable shell consisting of lactose or cane sugar that dissolves when placed buccally or sublingually, so that the pharmaceutically active crystallized polypeptide component is released into mouth tissue and is absorbed through such mouth tissue into the bloodstream, such that once in the bloodstream, at least 5% bioavailability of administered pharmaceutically active polypeptide, compared to injection, is achieved.
A method of administering a therapeutic polypeptide to a subject in need thereof, the method comprising:
- sublingually administering to the subject a polypeptide formulation comprising:
- a core and a pharmaceutically acceptable shell consisting of lactose or cane sugar wherein:
- the core comprises a polypeptide component consisting of the therapeutic polypeptide that is unmodified or is modified by one or more of acetylation, acylation, amidation, glycation, glycosylation, lipidation, mannosylation, methylation, nitrosylation, phosphorylation, sulfation, palmitoylation, pegylation, and prenylation, which polypeptide is in a crystallized form;
- and
- the shell dissolves when placed buccally or sublingually, so that the crystallized polypeptide component is released into mouth tissue and is absorbed through such mouth tissue into the bloodstream, such that once in the bloodstream, at least 5% bioavailability of administered therapeutic polypeptide, compared to injection, is achieved.
Dependencies are inferred from the claim text.