Delayed Release Cysteamine Bead Formulation, and Methods of Making and Using Same
AssigneeRaptor Pharmaceuticals Inc.
InventorsKathlene Powell, Ramesh Muttavarapu
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Abstract
An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Claims48
A pharmaceutical dosage form, comprising a plurality of cysteamine beads, the beads comprising a core particle comprising cysteamine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient, and an enteric membrane surrounding the core, wherein the plurality of beads is characterized by a distribution of particle sizes.
A pharmaceutical dosage form comprising a plurality of cysteamine beads, the beads comprising a core particle including cysteamine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient, and an enteric membrane surrounding the core, wherein the plurality of beads is characterized by a distribution of enteric membrane thicknesses.
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A pharmaceutical dosage form, comprising a plurality of cysteamine beads, the beads comprising a core particle comprising cysteamine bitartrate, and an enteric membrane surrounding the core, the dosage form characterized by providing mean pharmacokinetic parameters upon oral dosing, fasted, of:
- Tmax 194±38 minutes, Cmax 2.3±0.6 mg/L, and/or AUC (0-inf_D) 0.84±0.19 min*mg/L/mg, or a bioequivalent Tmax, Cmax or AUC in a range of 80% to 125%, or 80% to 120% of such reference parameter.
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Dependencies are inferred from the claim text.