Pharmaceutical suspensions containing drug particles, devices for their administration, and methods of their use
First Claim
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1. A method of administering a pharmaceutical composition to a subject, the method comprising:
- (a) inserting a drug delivery device having a reservoir containing the pharmaceutical composition into the mouth of the subject;
(b) continuously or semicontinuously administering the pharmaceutical composition from the delivery device into the mouth of a patient at a rate between 0.001 mL/hour and 1.25 mL/hour, wherein said pharmaceutical composition comprises a suspension comprising (i) from about 35% to 70% (w/w) drug particles, (ii) from 19% to 30% (w/w) of one or more water-immiscible compounds, (iii) from 2% to 16% (w/w) water, and (iv) from 1% to 8% (w/w) surfactant, wherein the pharmaceutical composition is physically stable; and
(c) removing said drug delivery device from the subject'"'"'s mouth.
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Abstract
The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.
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Citations
30 Claims
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1. A method of administering a pharmaceutical composition to a subject, the method comprising:
(a) inserting a drug delivery device having a reservoir containing the pharmaceutical composition into the mouth of the subject;
(b) continuously or semicontinuously administering the pharmaceutical composition from the delivery device into the mouth of a patient at a rate between 0.001 mL/hour and 1.25 mL/hour, wherein said pharmaceutical composition comprises a suspension comprising (i) from about 35% to 70% (w/w) drug particles, (ii) from 19% to 30% (w/w) of one or more water-immiscible compounds, (iii) from 2% to 16% (w/w) water, and (iv) from 1% to 8% (w/w) surfactant, wherein the pharmaceutical composition is physically stable; and
(c) removing said drug delivery device from the subject'"'"'s mouth.- View Dependent Claims (6, 10, 13, 16, 19, 22, 25, 28)
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2. A method of administering a pharmaceutical composition to a subject, the method comprising:
(a) inserting a drug delivery device having a reservoir containing the pharmaceutical composition into the mouth of the subject;
(b) continuously or semicontinuously administering the pharmaceutical composition from the delivery device into the mouth of a patient at a rate between 0.001 mL/hour and 1.25 mL/hour, wherein said pharmaceutical composition comprises a suspension comprising (i) from about 20% to about 80% (w/w) solid excipients;
(ii) from about 5% to 60% (w/w) drug particles, (iii) from 19% to 30% (w/w) of one or more water-immiscible compounds, (iv) from 2% to 25% (w/w) water, and (v) from 1% to 10% (w/w) surfactant, wherein the pharmaceutical composition is physically stable; and
(c) removing said drug delivery device from the subject'"'"'s mouth.- View Dependent Claims (7, 11, 14, 17, 20, 23)
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3. A method of administering a pharmaceutical composition to a subject suffering from Parkinson'"'"'s disease, the method comprising:
- (a) inserting a drug delivery device having a reservoir containing the pharmaceutical composition into the mouth of the subject;
(b) continuously or semicontinuously administering the pharmaceutical composition from the delivery device into the mouth of a patient at a rate between 0.001 mL/hour and 1.25 mL/hour, wherein said pharmaceutical composition comprises suspension comprising (i) an oil, and (ii) from about 35% to 70% (w/w) solid drug particles comprising levodopa or a levodopa prodrug and/or carbidopa or a carbidopa prodrug, wherein the pharmaceutical composition has a dynamic viscosity of at least 100 cP at 37°
C.; and
(c) removing said drug delivery device from the subject'"'"'s mouth. - View Dependent Claims (4, 5, 8, 9, 12, 15, 18, 21, 24, 26, 27, 29)
- (a) inserting a drug delivery device having a reservoir containing the pharmaceutical composition into the mouth of the subject;
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30. A method of treating a disease comprising administering a pharmaceutical composition comprising one or more drugs into the mouth of a patient via continuous or frequent intermittent administration for a period of at least 4 hours, said method comprising:
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(i) inserting a drug delivery device into the mouth of a patient; (ii) administering said pharmaceutical composition into the mouth of said patient via continuous or frequent intermittent administration at a rate between 0.001 mL/hour and 1.25 mL/hour for a period of at least 4 hours; and (iii) removing said drug delivery device from the mouth of said patient; wherein said pharmaceutical composition has a dynamic viscosity greater than 100 poise at 37°
C. and comprises greater than about 35% (w/w) of said one or more drugs, and wherein the fluctuation index of one of said one or more drugs is less than or equal to 2.0 during said period.
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Specification