Suspension formulations of insulinotropic peptides and uses thereof
First Claim
1. A suspension formulation comprising,a particle formulation comprising an insulinotropic peptide, a disaccharide, methionine, and a buffer;
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wherein the suspension vehicle exhibits viscous fluid characteristics, and the particle formulation is dispersed in the vehicle.
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Abstract
A suspension formulation of an insulinotropic peptide (e.g., glucagon-like peptide-1 (GLP-1) or exenatide) is described. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a particle formulation comprising the insulinotropic peptide, wherein the peptide is dispersed in the vehicle. The particle formulation further includes a stabilizing component comprising one or more stabilizers, for example, carbohydrates, antioxidants, amino acids, and buffers. Devices for delivering the suspension formulations and methods of use are also described.
289 Citations
20 Claims
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1. A suspension formulation comprising,
a particle formulation comprising an insulinotropic peptide, a disaccharide, methionine, and a buffer; - and
a non-aqueous, single-phase suspension vehicle comprising one or more pyrrolidone polymer and one or more solvent selected from the group consisting of lauryl lactate, lauryl alcohol, benzyl benzoate, and mixtures thereof; wherein the suspension vehicle exhibits viscous fluid characteristics, and the particle formulation is dispersed in the vehicle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification