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US 10,300,142 B2Granted
Compositions with a rheological modifier to reduce dissolution variability
AssigneeDurect Corporation
InventorsSu Il Yum, Wendy Chao, Huey-Ching Su, Roger Fu, Michael S. Zamloot, Karl Bratin, Ravi M. Shanker
Life of this patent
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Abstract
The present disclosure provides compositions (e.g., extended release compositions) which exhibit a desirable pharmacokinetic profile of an active agent while providing reduced dissolution sample variability, e.g., in the form of reduced inter-capsule variability and/or a reduction in storage-time dependent change in mean release of the active agent from the composition. Related methods of making and administering the disclosed compositions are also provided.
Claims20
A composition comprising:
- a pharmacologically active agent;
- a high viscosity liquid carrier material (HVLCM) having a viscosity of at least 5000 cP at 37° C. that does not crystallize neat at 25° C. and 1 atmosphere, wherein the HVLCM is present in an amount ranging from about 35% by weight to about 45% by weight relative to the total weight of the composition;
- a solvent, wherein the solvent is present in an amount ranging from about 31% by weight to about 45% by weight relative to the total weight of the composition;
- a network former, wherein the network former is present in an amount ranging from about 2% by weight to about 10% by weight relative to the total weight of the composition;
- water, wherein the composition does not comprise more than 2.0% water by weight, based on total weight of the composition;
- and
- a mineral particle, wherein the mineral particle is present in the composition in an amount ranging from 2.4% by weight to about 5.4% by weight relative to the total weight of the composition.
4 more elements
Dependencies are inferred from the claim text.