Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Cerilliant
Queensland Health
US Army
Johnson and Johnson
Fish and Richardson
Teva
Colorcon
Accenture

Generated: September 24, 2018

DrugPatentWatch Database Preview

Details for Patent: 9,814,689

« Back to Dashboard

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)
Filing Date:Oct 27, 2016
Application Number:15/336,405
Claims:1. A composition comprising: delayed and extended release enterically coated cysteamine bitartrate granules, each of the cysteamine bitartrate granules comprising: a core granule comprising cysteamine bitartrate and a binder; and an enteric coating surrounding the core granule, wherein the enteric coating releases the cysteamine bitartrate at a pH of 4.5 or greater and provides a time to C.sub.max of between 2-4 hours after administration.

2. The composition of claim 1, wherein the enteric coating is selected from the group consisting of polymerized gelatin, shellac, methacrylic acid copolymer type C NF, 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, typically formed from methyl acrylate, ethyl acrylate, methyl methacrylate and/or ethyl methacrylate with copolymers of acrylic and methacrylic acid esters.

3. The composition of claim 1, wherein the delayed and extended release enterically coated cysteamine bitartrate granules are loaded in a capsule.

4. The composition of claim 1, wherein the composition is formulated for oral administration.

5. The composition of claim 1, wherein the composition comprises a dose of cysteamine bitartrate of about 0.5-1.0 g/m.sup.2 body surface area.

6. The composition of claim 1, wherein the composition comprises a dose of cysteamine bitartrate of about 0.7-0.8 g/m.sup.2 body surface area.

7. The composition of claim 1, wherein the enteric coating begins dissolution in the small intestine.

8. The composition of claim 1, wherein the cysteamine bitartrate is released during transit in the small intestine.

9. The composition of claim 1, wherein the composition further comprises a stabilizer.

10. A method of treating a subject with cystinosis comprising administering a composition of claim 1 less than 4 times per day, wherein the total daily dose of cysteamine bitartrate is about 1.35 g/m.sup.2 body surface area or less.

11. A method of treating a subject with cystinosis comprising administering a composition of claim 1 at a dose of cysteamine bitartrate of about 0.5-1.0 g/m.sup.2 body surface area.

12. A method of treating a subject with cystinosis comprising administering a composition of claim 1 less than 4 times per day in an amount to provide white blood cell cystine suppression with a 12 hour level below 1 nm/1/2 cystine/mg protein.

13. A method of treating a subject with cystinosis comprising administering a composition of claim 1 twice per day in an amount to provide white blood cell cystine suppression with a 12 hour level below 1 nm/1/2 cystine/mg protein.

14. A method of treating a subject with Huntington's Disease comprising administering the composition of claim 1 comprising a dose of about 100 mg to 1000 mg of cysteamine bitartrate.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Merck
Fish and Richardson
Express Scripts
Dow
Daiichi Sankyo
Cantor Fitzgerald
Citi
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.