GLUCAGON-LIKE PEPTIDE 1 (GLP-1) PHARMACEUTICAL FORMULATIONS
First Claim
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1. A dry powder composition comprising a GLP-1 molecule and a diketopiperazine or a pharmaceutically acceptable salt thereof.
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Abstract
A composition is disclosed comprising glucagon-like peptide 1 (GLP-1) particles in combination with diketopiperazine (DKP) that is stable both in vitro and in vivo. The composition has utility as a pharmaceutical formulation for treating diseases such as diabetes, cancers, and obesity but is not limited to such diseases or conditions. In particularly, the composition has utility as a pharmaceutical formulation for pulmonary delivery.
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Citations
43 Claims
- 1. A dry powder composition comprising a GLP-1 molecule and a diketopiperazine or a pharmaceutically acceptable salt thereof.
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9. A process for forming a particle comprising a GLP-1 molecule and a diketopiperazine comprising the steps of:
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providing a GLP-1 molecule; providing a diketopiperazine in a form selected from particle-forming diketopiperazine, diketopiperazine particles, and combinations thereof, and combining said GLP-1 molecule and said diketopiperazine in the form of a co-solution, wherein said particle comprising said GLP-1 molecule and said diketopiperazine is formed. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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- 35. A method of administering an effective amount of a GLP-1 molecule to a subject in need thereof said method comprising providing to said subject a particle comprising GLP-1 and diketopiperazine.
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40. A method of forming a powder composition with an improved GLP-1 pharmacokinetic profile, comprising the steps of:
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providing a GLP-1 molecule; providing a particle-forming diketopiperazine in a solution; forming diketopiperazine particles; combining said GLP-1 molecule and said solution to form a co-solution; and
,removing solvent from said co-solution by spray-drying to form a powder with an improved GLP-1 pharmacokinetic profile. - View Dependent Claims (41, 42, 43)
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Specification