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Claims for Patent: 9,173,851

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Claims for Patent: 9,173,851

Title:Delayed release cysteamine bead formulation, and methods of making and using same
Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Inventor(s): Powell; Kathlene (Cary, NC), Muttavarapu; Ramesh (Durham, NC)
Assignee: RAPTOR PHARMACEUTICALS INC. (Novato, CA)
Application Number:14/751,639
Patent Claims: 1. A pharmaceutical dosage form comprising delayed-release cysteamine beads, the beads comprising: (i) a core particle comprising a mixture of cysteamine bitartrate and a binder, and (ii) an enteric membrane surrounding the core particle; wherein the beads have a distribution of particle sizes in a range of about 0.7 mm to about 2.8 mm; wherein the enteric membrane begins to dissolve within a pH range of about 4.5 to about 6.5; wherein the enteric membrane is present in an amount in a range of about 25% to about 35% by weight, based on the weight of the core particles; and wherein the pharmaceutical dosage form, upon administration in a capsule to fasted healthy normal subjects at 600 mg free cysteamine base, provides: (a) a mean Cmax upon oral dosing in a range of 2.3.+-.0.6 mg/L or in a range of 80% to 125% thereof; and (b) a mean AUC (0-inf_D) upon oral dosing in a range of 0.84.+-.0.19 min*mg/L/mg or in a range of 80% to 125% thereof.

2. The pharmaceutical dosage form of claim 1, wherein the cysteamine (as free base) comprises at least 10 wt. % of the core particle.

3. The pharmaceutical dosage form of claim 1, wherein the cysteamine or pharmaceutically acceptable salt thereof is cysteamine bitartrate.

4. The pharmaceutical dosage form of claim 3, wherein the cysteamine bitartrate comprises at least 50 wt. % of the core particle.

5. The pharmaceutical dosage form of claim 1, wherein the beads provide a mean Cmax and mean AUC (0-inf_D) upon oral dosing, fasted, when administered inside a capsule shell that are bioequivalent to the mean Cmax and mean AUC (0-inf_D) upon oral dosing, fasted, when administered without a capsule shell.

6. The pharmaceutical dosage form of claim 1, wherein the enteric membrane comprises an enteric material that begins to dissolve at pH of about 5.5 in an aqueous solution.

7. The pharmaceutical dosage form of claim 1, wherein the pharmaceutical dosage form, upon administration in a capsule to fasted healthy normal subjects at 600 mg free cysteamine base, provides: (a) a mean Cmax upon oral dosing in a range of 2.3.+-.0.6 mg/L; and (b) a mean AUC (0-inf_D) upon oral dosing in a range of 0.84.+-.0.19 min*mg/L/mg.

8. The pharmaceutical dosage form of claim 1, wherein the pharmaceutical dosage form, upon administration in a capsule to fasted healthy normal subjects at 600 mg free cysteamine base, provides: (a) a mean Cmax upon oral dosing of 2.3 mg/L or in a range of 80% to 125% thereof; and (b) a mean AUC (0-inf_D) upon oral dosing of 0.84 min*mg/L/mg or in a range of 80% to 125% thereof.
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