Levodopa and carbidopa intestinal gel and methods of use
AssigneeAbbVie Inc.
InventorsAlexandru DEAC, Ye HUANG, John M. LIPARI, Alexander RUGGLES, Thin Yu TUN
Life of this patent
Estimating the term…
Abstract
The present disclosure provides (a) a pharmaceutical composition comprising a levodopa active agent and a carbidopa active agent and (b) methods of treating Parkinson's disease and associated conditions comprising administering the pharmaceutical composition to a subject with Parkinson's disease.
Claims20
A pharmaceutical composition for intraduodenal administration comprising:
- (a) a levodopa active agent in an amount of about 4.0 w/w % of the total composition;
- (b) a carbidopa active agent in an amount of about 1.0 w/w % of the total composition;
- (c) a polymer-based suspending agent in an amount of about 0.1 w/w % to about 5 w/w % of the total composition;
- and
- (d) a liquid vehicle,
- wherein:
- (i) the liquid vehicle is water, polyethylene glycol, or a mixture of water and polyethylene glycol;
- (ii) the acceptance value of the pharmaceutical composition is less than or equal to 15 with respect to the levodopa active agent and less than or equal to 15 with respect to the carbidopa active agent;
- and
- (iii) the yield value of the pharmaceutical composition is at least about 0.3 Pa,
- wherein:
- the acceptance value and yield value are measured after exposing the pharmaceutical composition to a temperature of about 25° C. and relative humidity of about 60% for a period of at least about 8 weeks.
A method of preparing the pharmaceutical composition comprising a levodopa active agent and a carbidopa active agent for intraduodenal administration, wherein
- (i) the pharmaceutical composition has an acceptance value of the pharmaceutical composition is less than or equal to 15 with respect to the levodopa active agent and less than or equal to 15 with respect to the carbidopa active agent;
- and
- (ii) the pharmaceutical composition has a yield value of at least about 0.3 Pa,
- wherein:
- the acceptance value and yield value are measured after exposing the pharmaceutical composition to a temperature of about 25° C. and relative humidity of about 60% for a period of at least about 8 weeks,
- the method comprising:
- adding a acrylic acid-based polymer suspending agent to water to form a dispersion;
- adding a neutralizing agent to the dispersion to bring the pH to about 6.5 to form a medium;
- adding a levodopa active agent and a carbidopa active agent to water to form a slurry;
- and
- adding the slurry to the medium to form the pharmaceutical composition.
A method of preparing the pharmaceutical composition comprising a levodopa active agent and a carbidopa active agent for intraduodenal administration, wherein
- (i) the pharmaceutical composition has an acceptance value of the pharmaceutical composition is less than or equal to 15 with respect to the levodopa active agent and less than or equal to 15 with respect to the carbidopa active agent;
- and
- (ii) the pharmaceutical composition has a yield value of at least about 0.3 Pa,
- wherein:
- the acceptance value and yield value are measured after exposing the pharmaceutical composition to a temperature of about 25° C. and relative humidity of about 60% for a period of at least about 8 weeks,
- the method comprising:
- adding a hydrocolloid polymer suspending agent to water to form a dispersion;
- adding a levodopa active agent and a carbidopa active agent to water to form a slurry;
- and
- adding the slurry to the medium to form the pharmaceutical composition.
Dependencies are inferred from the claim text.