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Claims for Patent: 8,252,305

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Claims for Patent: 8,252,305

Title:Methods of treating emesis utilizing semi-solid delivery pharmaceutical 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: A.P. Pharma (Redwood City, CA)
Application Number:13/279,938
Patent Claims: 1. A method for treating emesis 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 consisting 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 0.05-30 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 1-5 weight % of the composition.

2. The method of claim 1, wherein the emesis is induced by a chemotherapeutic agent.

3. The method of claim 2, wherein the administration is by injection.

4. The method of claim 3, wherein the administration is by subcutaneous injection.

5. The method of claim 3, wherein the administration is by a syringe with a 16-25 gauge needle.

6. The method of claim 1, wherein the polyethylene glycol monomethyl ether has a molecular weight between 200 and 4000.

7. The method of claim 6, comprising polyethylene glycol monomethyl ether 550.

8. The method of claim 6, wherein the total concentration of the polyethylene glycol monomethyl ether is 5-60 weight % of the composition.

9. The method of claim 1, wherein the polyorthoester is a reaction product of 3,9-di(ethylidene)-2,4,8,10-tetraoxaspiro[5.5]undecane (DETOSU), triethylene glycol (TEG) and triethylene glycol diglycolide (TEG-diGL).

10. The method of claim 1, wherein the composition comprises 78.4 weight % polyorthoester, 19.6 weight % polyethylene glycol monomethyl ether and 2 weight % granisetron.

11. The method of claim 1, wherein p is an integer of 1 to 7 in a portion of the units of formula I.

12. The method of claim 1, wherein x is 2 in a portion of the units of formula I.

13. The method of claim 1, wherein s is 2 in a portion of the units of formula I.

14. The method of claim 1, wherein the total concentration of the polyethylene glycol monomethyl ether is 5% to 80% weight percent of the composition.

15. The method of claim 1, wherein: the polyorthoester is a reaction product of 3,9-di(ethylidene)-2,4,8,10-tetraoxaspiro[5.5]undecane (DETOSU), triethylene glycol (TEG) and triethylene glycol diglycolide (TEG-diGL); and the polyethylene glycol monomethyl ether has a molecular weight between 200 and 4000.

16. The method of claim 1, wherein about 0.1-25 mol percent of the A units are of the formula R.sup.1.
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