Peptide/protein suspending formulations
First Claim
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1. A beneficial agent delivery device comprising a housing including a fluid impermeable wall section and a fluid permeable wall section, which sections define and surround an internal compartment, wherein the device delivers a formulation over an extended delivery period, and wherein the device contains a formulation comprising:
- (a) at least 5% by weight beneficial agent in the form of solid particles having a particle size of 0.3 to 50 microns; and
(b) a liquid suspension vehicle for suspending the particles in the formulation, wherein the liquid suspension formulation viscosity is sufficient to prevent settling of the agent in the liquid suspension formulation in the device over the extended delivery period.
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Abstract
The present invention provides improved compositions for improving the chemical and physical stability of peptides and proteins. The invention provides a liquid beneficial agent formulation containing a liquid suspension comprising at least 5% by weight beneficial agent and having a viscosity and beneficial agent size which minimizes settling of the agent in suspension over the extended delivery period.
137 Citations
21 Claims
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1. A beneficial agent delivery device comprising a housing including a fluid impermeable wall section and a fluid permeable wall section, which sections define and surround an internal compartment, wherein the device delivers a formulation over an extended delivery period, and wherein the device contains a formulation comprising:
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(a) at least 5% by weight beneficial agent in the form of solid particles having a particle size of 0.3 to 50 microns; and (b) a liquid suspension vehicle for suspending the particles in the formulation, wherein the liquid suspension formulation viscosity is sufficient to prevent settling of the agent in the liquid suspension formulation in the device over the extended delivery period. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 18)
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14. A beneficial agent delivery device comprising a housing including a fluid impermeable wall section and a fluid permeable wall section, which sections define and surround an internal compartment, wherein the device delivers a formulation over an extended delivery period, and wherein the device contains a formulation comprising:
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(a) 0.5 to 70% by weight beneficial agent in the form of solid particles having a particle size of 0.3 to 50 microns; and (b) a non-aqueous liquid vehicle comprising a non-aqueous vehicle for suspending the particles in the formulation, polyethylene glycol with a molecular weight of 200 to 1000, and a thickening agent, which is characterized by a formulation viscosity of 100 to 100,000 poise at 37°
C. wherein said formulation viscosity is sufficient to prevent settling of the agent in the suspension formulation in the delivery device over the extended delivery period. - View Dependent Claims (15, 16, 17, 19, 20, 21)
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Specification