Novel cyclosporin analog formulations
AssigneeIsotechnika Inc.
InventorsSelvaraj A. Naicker, Randall W. Yatscoff, Robert T. Foster
Life of this patent
Estimating the term…
Abstract
The present invention relates to formulations containing cyclosporin analogs that are structurally similar to cyclosporin A, in particular isomeric mixtures of cyclosporin analogs that are structurally similar to cyclosporin A. The formulations form stable microemulsion preconcentrates and may provide superior drug bioavailability and/or may reduce one or more adverse effects associated with the administration of cyclosporin. Also disclosed are methods for using and preparing the formulations.
Claims45
A microemulsion preconcentrate comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) an emulsifier selected from the group consisting of Tween 40 and Tween 80;
- and
- e) ethanol.
A pharmaceutical formulation comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) Tween 40;
- and
- e) ethanol.
A pharmaceutical formulation comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) Tween 80;
- and
- e) ethanol.
A pharmaceutical formulation comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) MCT oil;
- c) Tween 80;
- d) triacetin;
- and
- e) ethanol.
A pharmaceutical formulation comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Tween 80;
- c) Vitamin E TPGS;
- d) ethanol;
- and
- e) isopropyl myristate.
A pharmaceutical formulation preconcentrate comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) Tween 40;
- and
- e) ethanol;
- wherein the preconcentrate when mixed with an aqueous media forms a clear stable microemulsion solution.
A microemulsion preconcentrate comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) Tween 40;
- and
- e) ethanol;
- wherein the preconcentrate, when mixed with an aqueous media in a ratio of about 1 part preconcentrate to about 10 to about 100 parts aqueous media forms a clear stable microemulsion solution.
A pharmaceutical formulation comprising:
- a) a pharmaceutically effective amount of ISATx247;
- b) Vitamin E TPGS;
- c) MCT oil;
- d) Tween 40;
- and
- e) ethanol;
- wherein the pharmaceutical formulation is suitable for subcutaneous or intramuscular administration.
Dependencies are inferred from the claim text.