Compositions with a rheological modifier to reduce dissolution variability
First Claim
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1. 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.
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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.
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Citations
20 Claims
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1. A composition comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification