Delayed release cysteamine bead formulation, and methods of making and using same

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.