Claims for Patent: 11,020,361

Summary for Patent: 11,020,361

Title:	Nasal formulations of metoclopramide
Abstract:	Nasal formulations of metoclopramide, which remain stable and/or colorless upon storage over a period of time, are provided. Also provided are methods of treating disorders treatable with metoclopramide, comprising administering the nasal solutions to patients in need thereof.
Inventor(s):	D'Onofrio; Matthew J. (San Diego, CA), Gonyer; David A. (Cardiff, CA), Shah; Shirish A. (Phoenix, AZ), Madden; Stuart J. (Ellicott City, MD)
Assignee:	Evoke Pharma, Inc. (Solana Beach, CA)
Application Number:	16/181,841
Patent Claims:	1. A method of treating gastroparesis in a patient, comprising intranasally administering to the patient an amount of a metoclopramide composition effective to deliver about 15 mg of metoclopramide, or a pharmaceutically-acceptable salt thereof, to the patient, wherein the composition comprises citrate in a concentration of at least about 10 millimolar, and wherein the intranasally administering is effective to treat gastroparesis. 2. The method of claim 1, wherein the metoclopramide composition further comprises a buffer. 3. The method of claim 1, wherein the metoclopramide composition further comprises benzalkonium chloride. 4. The method of claim 3, wherein the metoclopramide composition has a concentration of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v). 5. The method of claim 1, wherein the metoclopramide composition has a pH of above about 4.5. 6. The method of claim 1, wherein the metoclopramide composition further comprises benzyl alcohol. 7. The method of claim 1, wherein the metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg. 8. The method of claim 2, wherein the buffer is selected from the group consisting of citric acid/phosphate, acetate, barbital, borate, Britton-Robinson, cacodylate, citrate, collidine, formate, maleate, McIlvaine, phosphate, Prideaux-Ward, succinate, citrate-phosphate-borate (Teorell-Stanhagen), veronal acetate, IVIES (2-(N-morpholino)ethanesulfonic acid), BIS-TRIS (bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane), ADA (N-(2-acetamido)-2-iminodiacetic acid), ACES (N-(carbamoylmethyl)-2-aminoethanesulfonaic acid), PIPES (piperazine-N,N'-bis(2-ethanesulfonic acid)), MOPSO (3-(N-morpholino)-2-hydroxypropanesulfonic acid), BIS-TRIS PROPANE (1,3-bis(tris(hydroxymethyl)methylamino)propane), BES (N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonaic acid), MOPS (3-(N-morpholino)propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), HEPES (N-(2-hydroxyethyl)piperazine-N'-(2-ethanesulfonic acid), DIPSO (3-(N,N-bis(2-hydroxyethyl)amino)-2-hydroxypropanesulfonic acid), MOBS (4-(N-morpholino)butanesulfonic acid), TAPSO (3-(N-tris(hydroxymethyl)methylamino)-2-hydroxy-propanesulfonic acid), tris(hydroxymethylaminomethane, HEPPSO(N-(2-hydroxyethyl)piperazine-N'-(2-hydroxypropanesulfonic acid), POPSO (piperazine-N,N'-bis(2-hydroxypropanesulfonic acid)), TEA (triethanolamine), EPPS(N-(2-hydroxyethyl)piperazine-N'-(3-propane-sulfonic acid), TWINE (N-tris(hydroxymethyl)methylglycine), GLY-GLY (glycylglycine), BICINE (N,N-bis(2-hydroxyethyl)glycine), HEPBS (N-(2-hydroxyethyl)piperazine-N'-(4-butanesulfonic acid)), TAPS(N-tris(hydroxy-methypmethyl-3-aminopropanesulfonic acid), or AMPD (2-amino-2-methyl-1,3-propanediol) buffer. 9. The method of claim 8, wherein the buffer comprises sodium acetate. 10. The method of claim 8, wherein the buffer comprises sodium citrate. 11. The method of claim 1, wherein the patient has a disorder that is treatable with metoclopramide. 12. The method of claim 9, wherein the disorder that is treatable with metoclopramide is selected from the group consisting of gastroparesis, emesis, delayed emesis, and nausea. 13. The method of claim 6, wherein the metoclopramide composition has a benzyl alcohol concentration from about 0.01% (w/v) to about 0.8% (w/v). 14. The method of claim 1, wherein the metoclopramide composition further comprises at least one member of the group consisting of a salt, EDTA, sorbitol, a sugar, or a flavoring agent. 15. The method of claim 1, wherein the intranasal administration comprises an intranasal spray. 16. The method of claim 15, wherein the intranasal spray is administered as two sprays. 17. The method of claim 1, wherein the patient is human.