GLP-2 formulations
AssigneeNPS Allelix Corp.
InventorIndu J. Isaacs
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Abstract
The invention is directed to formulations of GLP-2 peptides and analogs thereof exhibiting superior stability following storage and/or exposure to elevated temperatures. The GLP-2 compositions comprise a GLP-2 peptide or an analog thereof, a phosphate buffer, L-histidine, and mannitol.
Claims54
A GLP-2 formulation comprising:
- (a) a medically useful amount of a naturally occurring GLP-2 peptide or an analog thereof;
- (b) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a physiologically tolerable level;
- (c) L-histidine;
- and
- (d) a bulking agent selected from the group consisting of mannitol and sucrose.
A GLP-2 formulation comprising:
- (a) about 0.1 to about 50 mg/ml of a GLP-2 peptide or an analog thereof;
- (b) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a pharmaceutically tolerable level;
- (e) about 0.5 to about 1% L-histidine;
- and
- (f) about 2 to about 5% mannitol.
A method for making a lyophilized formulation of GLP-2 comprising the following steps:
- (a) preparing a GLP-2 formulation comprising:
- (i) a GLP-2 peptide or an analog thereof;
- (ii) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a pharmaceutically tolerable level;
- (iii) L-histidine;
- and
- (iv) a bulking agent selected from the group consisting of mannitol and sucrose;
- (b) freezing the formulation to −40° C.;
- (c) drying the formulation in a first drying step at −20° C.;
- and
- (d) drying the formulation in a second drying step at +20° C.
A kit comprising:
- (a) a lyophilized GLP-2 formulation comprising:
- (i) a GLP-2 peptide or an analog thereof;
- (ii) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a pharmaceutically acceptable level;
- (iii) L-histidine;
- and
- (iv) a bulking agent selected from the group consisting of mannitol and sucrose;
- (b) a vial of sterile water for reconstitution;
- and
- (c) instructions directing reconstitution.
A method for treating a human or animal having a disorder, disease or condition for which treatment with GLP-2 is indicated, the method comprising the step of administering a therapeutically effective amount of a GLP-2 formulation comprising:
- (a) a GLP-2 peptide or an analog thereof;
- (b) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a pharmaceutically tolerable level;
- (c) L-histidine;
- and
- (d) a bulking agent selected from the group consisting of mannitol and sucrose.
Dependencies are inferred from the claim text.