Extended release suspension formulation of lurasidone
AssigneeLifeMax Laboratories, Inc.
InventorsChung-Chiang Hsu, Tzu-Ying WU, Wei-Hsiang Wang, Chia-Yu Kuo
Life of this patent
Estimating the term…
Abstract
The present disclosure relates generally to depot formulations of lurasidone and methods of making depot formulations of lurasidone. The depot formulations include a suspending agent and are highly syringeable.
Claims26
A depot formulation of lurasidone comprising crystals of lurasidone or an acid salt thereof and having a mean particle size of about 4 μm to about 100 μm,
- wherein the concentration of lurasidone crystals in the formulation is greater than about 250 mg/mL;
- wherein the formulation comprises a suspending agent from about 0.1% (w/w) to about 7.5% (w/w);
- wherein the depot formulation is suitable for injection via a syringe needle having a gauge size of 20 gauge or smaller;
- and
- wherein, upon administration, the formulation delivers a therapeutic dose of lurasidone for at least about 28 days.
(canceled)
9-11. (canceled)
(canceled)
22-23. (canceled)
A depot formulation of lurasidone comprising crystals of lurasidone or an acid salt thereof and having a mean particle size of about 4 μm to about 100 μm,
- wherein the formulation comprises a suspending agent comprising PEG 4000 in an amount of about 5% (w/w);
- and
- wherein the formulation comprises a surfactant comprising polysorbate 20 in an amount of from about 1% (w/w) to about 2% (w/w);
- and
- wherein the depot formulation is suitable for injection via a syringe needle having a gauge size of 20 gauge or smaller;
- and
- wherein, upon administration, the formulation delivers a therapeutic dose of lurasidone for at least about 28 days.
A depot formulation of lurasidone comprising crystals of lurasidone or an acid salt thereof and having a mean particle size of about 4 μm to about 100 μm,
- wherein the formulation comprises a suspending agent comprising polyvinyl pyrrolidone in an amount of from about 0.5% to about 1%;
- and
- wherein the formulation does not contain a surfactant;
- and
- wherein the depot formulation is suitable for injection via a syringe needle having a gauge size of 20 gauge or smaller;
- and
- wherein, upon administration, the formulation delivers a therapeutic dose of lurasidone for at least about 28 days.
(canceled)
29-38. (canceled)
Dependencies are inferred from the claim text.