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Claims for Patent: 9,192,590

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Claims for Patent: 9,192,590

Title:Enterically coated cysteamine, cystamine and derivatives thereof
Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Inventor(s): Dohil; Ranjan (San Diego, CA), Schneider; Jerry (La Jolla, CA)
Assignee: The Regents of the University of California (Oakland, CA)
Application Number:14/752,499
Patent Claims: 1. A method of treating a patient with cystinosis comprising administering to said patient twice per day a composition comprising cysteamine, or a pharmaceutically acceptable salt thereof, and one or more materials that provides increased delivery of said cysteamine to the small intestine, wherein said composition is formulated to provide white blood cell cystine suppression with a 12 hour level below 1 nmol1/2 cystine/mg protein.

2. The method of claim 1, wherein each dose of cysteamine is about 0.5-1.0 g/m.sup.2 body surface area.

3. The method of claim 1, wherein the total daily dose of cysteamine is about 1.35 g/m.sup.2 body surface area or less.

4. The method of claim 1, wherein the one or more materials increases delivery to the proximal small intestine.

5. The method of claim 1, wherein the one or more materials increases delivery to the mid-small intestine.

6. The method of claim 1, wherein the one or more materials increases delivery to the duodenum.

7. The method of claim 1, wherein the one or more materials increases delivery to the jejunum.

8. The method of claim 1, wherein the one or more materials increases delivery to the mid-ileum.

9. The method of claim 1, wherein the composition is in the form of a tablet.

10. The method of claim 1, wherein the composition is in the form of a capsule.

11. The method of claim 1, wherein the cysteamine salt is cysteamine bitartrate.

12. A method of treating a patient with cystinosis comprising administering to said patient twice per day a composition comprising cysteamine, or a pharmaceutically acceptable salt thereof, and an enteric coating that provides increased delivery of cysteamine to the small intestine, wherein said composition is formulated to provide white blood cell cystine suppression with a 12 hour level below 1 nmol1/2 cystine/mg protein.

13. The method of claim 12, wherein each dose of cysteamine is about 0.5-1.0 g/m.sup.2 body surface area.

14. The method of claim 12, wherein the total daily dose of cysteamine is about 1.35 g/m.sup.2 body surface area or less.

15. The method of claim 12, wherein the enteric coating begins to dissolve in an aqueous solution at pH of about 5.5.

16. The method of claim 12, wherein the composition increases delivery to a region of the gastrointestinal tract of a subject in which the pH is greater than pH 5.5.

17. The method of claim 12, wherein the coating is selected from the group consisting of polymerized gelatin, shellac, methacrylic acid copolymer type CNF, cellulose butyrate phthalate, cellulose hydrogen phthalate, cellulose proprionate phthalate, polyvinyl acetate phthalate (PVAP), cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate, dioxypropyl methylcellulose succinate, carboxymethyl ethylcellulose (CMEC), hydroxypropyl methylcellulose acetate succinate (HPMCAS), and acrylic acid polymers and copolymers formed from methyl acrylate, ethyl acrylate, methyl methacrylate and/or ethyl methacrylate with copolymers of acrylic and methacrylic acid esters.

18. The method of claim 12, wherein the cysteamine salt is cysteamine bitartrate.

19. An improved method of administering cysteamine comprising administering to a patient in need thereof, twice per day, a composition comprising cysteamine, or a pharmaceutically acceptable salt thereof, and one or more materials that provides increased delivery of said cysteamine to the small intestine, wherein said composition is capable of providing white blood cell cystine suppression with a 12 hour level below 1 nmol1/2 cystine/mg protein.

20. The method of claim 19, wherein each dose of cysteamine is about 0.5-1.0 g/m.sup.2 body surface area.

21. The method of claim 19, wherein the total daily dose of cysteamine is about 1.35 g/m.sup.2 body surface area or less.

22. The method of claim 19, wherein the one or more materials increases delivery to a region of the gastrointestinal tract of a subject in which the pH is greater than pH 5.5.

23. The method of claim 19, wherein the composition comprises an enteric coating.

24. The method of claim 23, wherein the enteric coating begins to dissolve in an aqueous solution at pH of about 5.5.
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