Polyoxaester suspending vehicles for use with implantable delivery systems
First Claim
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1. An implantable osmotic dosage form comprising:
- a pharmaceutical suspension comprising (i) particles comprising a protein or peptide, and (ii) a suspending vehicle comprising a polyoxaester with an approximately 1;
1 molar ratio of polyglycolic diacid and ethyleneglycol and having a density of about 1.2 g/mL, wherein the pharmaceutical suspension is substantially homogeneous for at least 3 months at 37°
C.;
a first wall that maintains its physical and chemical integrity and is substantially impermeable to the pharmaceutical suspension;
a second wall that is partially permeable to an exterior fluid;
an osmotic pump in contact with the first wall and the second wall;
a compartment defined by the first wall and the osmotic pump, wherein the pharmaceutical suspension is positioned within the compartment; and
an exit port in communication with the compartment, wherein the pharmaceutical suspension is flowable through the exit port under a force exerted by the osmotic pump.
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Abstract
Liquid polyoxaester polymer materials are provided as suspending vehicles suitable for dispensing of pharmaceutically active agents, such as proteins, from delivery devices, for example, pump-driven dosage forms. Polyoxaesters are made from at least one diacid and at least one diol. Through the use of polyoxaesters virtually solvent-free pharmaceutical suspensions can be created.
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Citations
18 Claims
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1. An implantable osmotic dosage form comprising:
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a pharmaceutical suspension comprising (i) particles comprising a protein or peptide, and (ii) a suspending vehicle comprising a polyoxaester with an approximately 1;
1 molar ratio of polyglycolic diacid and ethyleneglycol and having a density of about 1.2 g/mL, wherein the pharmaceutical suspension is substantially homogeneous for at least 3 months at 37°
C.;a first wall that maintains its physical and chemical integrity and is substantially impermeable to the pharmaceutical suspension; a second wall that is partially permeable to an exterior fluid; an osmotic pump in contact with the first wall and the second wall; a compartment defined by the first wall and the osmotic pump, wherein the pharmaceutical suspension is positioned within the compartment; and an exit port in communication with the compartment, wherein the pharmaceutical suspension is flowable through the exit port under a force exerted by the osmotic pump. - View Dependent Claims (2, 3, 4, 5, 6)
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7. An implantable osmotic dosage form comprising:
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a pharmaceutical suspension comprising (i) particles comprising a protein or peptide, and (ii) a suspending vehicle comprising a polyoxaester with an approximately 1;
1 molar ratio of polyglycolic diacid and ethyleneglycol and having a viscosity of about 100 poise at 35°
C. and a density of 1.18 g/mL+/−
0.006, wherein the pharmaceutical suspension is substantially homogeneous for at least 3 months at 37°
C.;a first wall that maintains its physical and chemical integrity and is substantially impermeable to the pharmaceutical suspension; a second wall that is partially permeable to an exterior fluid; an osmotic pump in contact with the first wall and the second wall; a compartment defined by the first wall and the osmotic pump, wherein the pharmaceutical suspension is positioned within the compartment; and an exit port in communication with the compartment, wherein the pharmaceutical suspension is flowable through the exit port under a force exerted by the osmotic pump. - View Dependent Claims (8, 9, 10, 11, 12)
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13. An implantable osmotic dosage form comprising:
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a pharmaceutical suspension comprising (i) particles comprising a protein or peptide, and (ii) a suspending vehicle comprising a polyoxaester with an approximately 1;
1 molar ratio of polyglycolic diacid and ethyleneglycol and having a viscosity of about 1000 poise at 35°
C. and a density of 1.18 g/mL+/−
0.003, wherein the pharmaceutical suspension is substantially homogeneous for at least 3 months at 37°
C.;a first wall that maintains its physical and chemical integrity and is substantially impermeable to the pharmaceutical suspension; a second wall that is partially permeable to an exterior fluid; an osmotic pump in contact with the first wall and the second wall; a compartment defined by the first wall and the osmotic pump, wherein the pharmaceutical suspension is positioned within the compartment; and an exit port in communication with the compartment, wherein the pharmaceutical suspension is flowable through the exit port under a force exerted by the osmotic pump. - View Dependent Claims (14, 15, 16, 17, 18)
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Specification