Pharmaceutical suspensions containing drug particles, devices for their administration, and methods of their use
AssigneeSynAgile Corporation
InventorAdam Heller
Life of this patent
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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.
Claims30
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.
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.
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.
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:
- (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.
Dependencies are inferred from the claim text.