Methods and compositions for delivering mycophenolic acid active agents to non-human mammals
AssigneeOkava Pharmaceuticals, Inc.
InventorsMichael Klotsman, Padmaja Shivanand, Wayne H. Anderson, Gayatri Sathyan
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Abstract
The present disclosure provides methods and compositions for modified delivery of mycophenolic acid active agents, including sodium mycophenolate, in veterinary subjects. Presently disclosed methods and compositions are useful, for example, to treat autoimmune diseases, blood disorders associated with IMPDH activity, and immune rejection related to transplant or graft procedures.
Claims12
A method for delivering a sodium mycophenolate composition to a dog, comprising delivering a plurality of modified-release compositions to a lower gastrointestinal tract of the dog via oral administration, wherein the modified-release compositions comprise:
- i. a core having a diameter from about 0.5 mm to about 3 mm;
- ii. a sodium mycophenolate layer disposed over at least a portion of the core;
- iii. a seal coat disposed over the sodium mycophenolate layer;
- iv. a modified-release layer disposed over the seal coat layer;
- and
- v. a protective layer disposed over the modified-release layer,
- wherein the modified-release layer comprises ethyl cellulose from about 15 wt % to about 35 wt % of the composition, the protective layer comprises a methacrylate-based polymer from about 8 wt % to about 15 wt % of the composition and does not dissolve at a pH below 6.0, the sodium mycophenolate is from about 20 wt % to about 90 wt % of the composition, and the sodium mycophenolate is released in the dog according to the following schedule:
- Hours Following
- % Sodium
- Administration
- Mycophenolate Released
- 0.5
- about 0.0 to about 1.0
- 2
- about 3.0 to about 10.0
- 2.5
- about 10.0 to about 30.0
- 3
- about 15.0 to about 40.0
- 4
- about 25.0 to about 55.0
- 6
- about 40.0 to about 75.0
- 7
- about 50.0 to about 80.0
- 10
- about 60.0 to about 90.0
- 14
- about 70.0 to about 100.
Dependencies are inferred from the claim text.