Claims for Patent: 10,357,570

Summary for Patent: 10,357,570

Title:	Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Abstract:	A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
Inventor(s):	Ng; Steven Y. (San Francisco, CA), Shen; Hui-Rong (Fremont, CA), Heller; Jorge (Ashland, OR)
Assignee:	Heron Therapeutics, Inc. (Redwood City, CA)
Application Number:	15/897,093
Patent Claims:	1. A method for the treatment of nausea and vomiting in a patient in need thereof comprising administering to the patient a semi-solid pharmaceutical composition, wherein the semi-solid pharmaceutical composition comprises a polyorthoester, 10-50 weight percent polyethylene glycol monomethyl ether having a molecular weight in a range of 200 to 4,000, and 1-5 weight percent granisetron, the polyorthoester comprising subunits selected from: ##STR00023## where x is an integer from 1-4, the total amount of p is an integer from 1-20, s is an integer from 1-4, the mole percentage of .alpha.-hydroxyacid containing subunits in the polyorthoester is from about 0.1 to about 25 mole percent, and the polyorthoester has a molecular weight in a range of 1000 to 10,000. 2. The method of claim 1, wherein the polyethylene glycol monomethyl ether has a molecular weight of about 550. 3. The method of claim 1, wherein the semi-solid pharmaceutical composition comprises from 2-3 weight percent granisetron. 4. The method of claim 1, wherein the semi-solid pharmaceutical composition comprises 78.4 weight percent polyorthoester, 19.6 weight percent polyethylene glycol monomethyl ether and about 2 weight percent granisetron. 5. The method of claim 1, wherein the polyorthoester has a molecular weight of about 6,500. 6. The method of claim 1, wherein the semi-solid pharmaceutical composition is stable upon irradiation. 7. The method of claim 1, wherein the semi-solid pharmaceutical composition is stable upon sterilization. 8. The method of claim 1, wherein the granisetron is in the form of a solid having a particle size of less than 100 microns. 9. The method of claim 1, wherein the semi-solid pharmaceutical composition is capable of being dispensed from a 16-25 gauge needle. 10. The method of claim 1, wherein the semi-solid pharmaceutical composition is effective to release the granisetron in a sustained and controlled manner after administration. 11. The method of claim 1, wherein the nausea and vomiting is associated with chemotherapy. 12. The method of claim 1, wherein the nausea and vomiting is acute or delayed. 13. The method of claim 1, wherein the semi-solid pharmaceutical composition is administered to the patient in combination with another antiemetic. 14. The method of claim 12, wherein the semi-solid pharmaceutical composition is administered to the patient in combination with another antiemetic. 15. The method of claim 1, wherein the administering is by injection. 16. The method of claim 1, wherein the administering is by subcutaneous injection. 17. The method of claim 16, wherein the administering is by a syringe with a 16 to 25 gauge needle.