Details for Patent: 9,913,910
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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) |
Filing Date: | Sep 19, 2016 |
Application Number: | 15/269,856 |
Claims: | 1. A method for the prophylactic treatment of nausea and vomiting in a patient in need thereof comprising administering to the patient a pharmaceutical composition comprising: (A) a semi-solid delivery vehicle, comprising: (i) a polyorthoester of formula I: ##STR00023## where: R* is ethyl; n is an integer of 5 to 1000; and A is R.sup.1 or R.sup.3, where R.sup.1 is: ##STR00024## where: p is an integer of 1 to 20; R.sup.5 is hydrogen; and R.sup.6 is: ##STR00025## where: s is an integer of 0 to 10; R.sup.3 is: ##STR00026## where: x is an integer of 0 to 30; in which about 0.05 to 30 mol percent of the A units are of the formula R.sup.1; and (ii) polyethylene glycol monomethyl ether; and (B) granisetron in an amount of 1 to 5 weight % of the composition. 2. The method of claim 1, wherein the nausea and vomiting is associated with chemotherapy. 3. The method of claim 1, wherein the nausea and vomiting is acute or delayed. 4. The method of claim 1, wherein the composition is administered to the patient in combination with another antiemetic. 5. The method of claim 3, wherein the composition is administered to the patient in combination with another antiemetic. 6. The method of claim 1, wherein the administering is by injection. 7. The method of claim 1, wherein the administering is by subcutaneous injection. 8. The method of claim 7, wherein the administering is by a syringe with a 16 to 25 gauge needle. 9. The method of claim 1, wherein the polyethylene glycol monomethyl ether has a molecular weight between 200 and 4000. 10. The method of claim 9, wherein the total concentration of the polyethylene glycol monomethyl ether is 5 to 60 weight % of the composition. 11. The method of claim 1, wherein the polyethylene glycol monomethyl ether is polyethylene glycol monomethyl ether 550. 12. The method of claim 9, wherein the polyethylene glycol monomethyl ether is polyethylene glycol monomethyl ether 550. 13. The method of claim 1, wherein the composition comprises 78.4 weight % polyorthoester, 19.6 weight % polyethylene glycol monomethyl ether and 2 weight % granisetron. 14. The method of claim 1, wherein p is an integer of 1 to 7 in a portion of the units of formula I. 15. The method of claim 1, wherein x is 2 in a portion of the units of formula I. 16. The method of claim 1, wherein s is 2 in a portion of the units of formula I. 17. The method of claim 1, wherein the total concentration of the polyethylene glycol monomethyl ether is 5% to 80% weight percent of the composition. 18. The method of claim 1, wherein about 0.1 to 25 mol percent of the A units are of the formula R.sup.1. |