Polypeptide formulations comprising crystal or amorphous polypeptides and vitamin E
AssigneeBhami's Research Laboratory, Pvt. Ltd.
InventorsSuryakanth Motilal Pai, Bhami Shenoy
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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 for oral delivery that includes a core and a pharmaceutically acceptable capsule, where the core includes an amorphous polypeptide composition or a crystallized polypeptide composition and a pharmaceutically acceptable carrier comprising a vitamin E agent.
Claims18
A liquid polypeptide formulation for oral delivery comprising a polypeptide component that consists of the polypeptide in a solid form, wherein the solid form is a crystallized form or an amorphous form;
- wherein:
- (a) the polypeptide component:
- (i) is chosen from a GLP-1 receptor agonist, trastuzumab, or insulin, and wherein the GLP-1 receptor agonist is at least 94% homologous to human GLP-1, and
- (ii) is suspended in a pharmaceutically acceptable liquid carrier consisting of vitamin E, optionally combined with wheat germ oil;
- and
- (b) the polypeptide formulation:
- (i) consists of about 0.05 mg/kg to about 220 mg/kg of the polypeptide component, and
- (ii) has a pH within a range of about 4.5 to 7.5;
- and
- wherein the weight percent ratio of polypeptide:vitamin E and optionally wheat germ oil is within a range of about 6:1 to 1:300.
Dependencies are inferred from the claim text.