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US 12,533,314 B2Granted
Low sodium oxybate once nightly composition
AssigneeTris Pharma, Inc.
InventorsMahesh Chavan Patil, Hiren Patel, Devins Patel, Alfred Liang, Paras Rameshlal Jain
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Abstract
Compositions providing a once-a-night dose of oxybate are provided. The compositions containing bilayer-coated oxybate anion exchange resin complex multiparticulates provide modified release of the oxybate for 5 to 8 hours post-dosing. Also provided are methods of treating patients in need thereof with pharmaceutical compositions containing the oxybate—anion exchange resin complex.
Claims29
An extended release oxybate powder for oral suspension (POS) which provides a once-a-night oxybate dose, said powder for oral suspension comprising a blend of oxybate-containing multiparticulates having different release profiles as defined in (a), (b) and (c):
- (a) immediate release oxybate—anion exchange resin complex multiparticulates which comprises oxybate bound to ion exchange sites in an anion exchange resin;
- (b) pH-independent diffusion barrier coated oxybate—anion exchange resin complex—optional matrix multiparticulates, wherein the pH-independent diffusion barrier coating layer comprises a water-insoluble film-forming polymer which confers an extended release to the oxybate, and wherein the pH-independent diffusion barrier coating layer is over the oxybate—anion exchange resin complex—optional matrix;
- (c) small intestine targeted drug coating system (SITCS) coated oxybate multiparticulates which comprise a blended coating over pH-independent diffusion barrier coated oxybate—anion exchange resin complex—optional matrix multiparticulates, wherein the pH-independent diffusion barrier coating comprises a water-insoluble film-forming polymer, and wherein the pH-independent diffusion barrier coating layer is over the oxybate—anion exchange resin complex—optional matrix;
- wherein the blended coating comprises a pH-dependent polymer and a pH-independent polymer, wherein the SITCS coating confers a delayed and extended release profile to the oxybate in the coated oxybate—anion exchange resin—optional matrix of (c), and
- wherein the oxybate—anion exchange resin complex—optional matrix of (b) or (c) comprise oxybate bound to ion exchange sites in an anion exchange resin in an optional matrix, wherein when in a matrix, the oxybate—anion exchange complex—matrix further comprises at least one hydrophilic or hydrophobic polymer, wherein the complex—optional matrix in (b) or (c) may be the same or may differ from each other;
- (d) a floating interpenetrating polymer network (IPN) forming system and
- wherein the POS contains less than the equivalent of 200 mg of total sodium per 9 gm oxybate dose of the POS.
4 more elements
An extended release oxybate powder for oral suspension (POS) composition which provides a once-a-night oral oxybate dose comprising:
- (a) oxybate-containing multiparticulates having different release profiles as defined in (i), (ii) and (iii):
- (i) immediate release oxybate—anion exchange resin complex multiparticulates which comprises oxybate bound to ion exchange sites in an anion exchange resin;
- (ii) extended release oxybate—anion exchange resin complex multiparticulates which comprise an oxybate—anion exchange resin complex multiparticulates comprising a first diffusion barrier coating layer which comprises a pH-independent, water-insoluble film-forming polymer which confers an extended release to the oxybate, wherein the first diffusion barrier coating layer is over the oxybate—anion exchange resin complex;
- (iii) delayed extended-release coated oxybate multiparticulates which comprise:
- an oxybate—anion exchange resin complex;
- a pH-independent diffusion barrier coating which is a first coating over the oxybate—anion exchange resin complex and comprises a water-insoluble film-forming polymer which confers an extended release profile to the oxybate in the coated oxybate—anion exchange resin of (iii);
- a second coating over the diffusion barrier coated oxybate—anion exchange resin complex, wherein the second coating comprises a blend having a pH-dependent polymer and a pH-independent polymer which confers a delayed and extended release profile to the oxybate in the coated oxybate—anion exchange resin complex,
- wherein the first coating and the second coating confer a delayed and extended release profile to the oxybate in the coated oxybate—anion exchange resin of (iii), and
- wherein the oxybate—anion exchange resin complex of (i), (ii) and (iii) comprise oxybate bound to ion exchange sites in an anion exchange resin;
- and
- (b) one or more of at least two anionic hydrophilic polymers, at least one ionic cross-linking agent for the at least two anionic polymers, a gas generating agent, and a non-ionic hydrophilic polymer, microcrystalline cellulose, and at least one preservative;
- wherein the POS contains less than the equivalent of 200 mg of total sodium per 9 gm oxybate dose of the POS.
9 more elements
Dependencies are inferred from the claim text.