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
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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 and formulations are also provided.
Claims30
A composition comprising:
- a pharmacologically active agent;
- about 35% by weight to about 45% by weight, based on total weight of the composition, of 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;
- about 31% by weight to about 45% by weight, based on total weight of the composition, of a solvent;
- about 2% by weight to about 10% by weight, based on total weight of the composition, of a rheology modifier;
- and
- a cellulose acetate butyrate.
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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;
- a solvent;
- a rheology modifier;
- and
- a cellulose acetate butyrate,
- wherein the composition is encapsulated within a hydroxypropylmethylcellulose capsule, and
- wherein the composition within the capsule comprises less than 5% water by weight, based on total weight of the composition within the capsule.
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A composition comprising:
- an opioid;
- sucrose acetate isobutyrate (SAIB);
- triacetin;
- isopropyl myristate (IPM);
- cellulose acetate butyrate (CAB);
- hydroxyethyl cellulose (HEC);
- and
- silicon dioxide, wherein the silicon dioxide is present in the composition in an amount from about 2.4% by weight to about 5.4% by weight relative to the total weight of the composition.
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Dependencies are inferred from the claim text.