Claims for Patent: 6,277,391

Summary for Patent: 6,277,391

Title:	Composition and method of treating diseases and disorders of the prostate
Abstract:	This invention relates to a composition and method for treating diseases and disorders of the prostate such as prostatitis, benign prostatic hypertrophy, and prostate carcinoma. The prostate is treated by intraprostatic injection of a biodegradable sustained release formulation. By injecting the treatment substance directly into the prostate, improved treatment results are obtained with a much lower treatment substance dosage. Additionally, by incorporating the treatment substance into a biodegradable sustained release formulation, the need for frequent repetition of injections is eliminated.
Inventor(s):	Seo; Min Hyo (Taejeon, KR), Lee; Jae Yong (Taejeon, KR), Kim; Jee Hyang (Taejeon, KR), Choi; In Ja (Taejeon, KR)
Assignee:	Samyang Corporation (Seoul, KR)
Application Number:	09/325,894
Patent Claims:	1. A method for treating prostate diseases and disorders comprising the steps of: a) selecting at least one therapeutically effective substance for treatment of the prostatic disease or disorder; b) combining a therapeutically effective amount of said at least one therapeutically effective substance with a biodegradable polymer to create a treatment composition; c) forming said treatment composition into microspheres; d) suspending said microspheres in a liquid; e) placing said microsphere containing liquid in a syringe; and f) injecting said microsphere containing liquid directly into a prostate gland through a transurethral, transrectal, or transperineal route, such that the therapeutically effective substance is delivered to the prostate at a sustained rate as said microspheres biodegrade. 2. The method of claim 1 wherein said biodegradable polymer is an aliphatic polyester of a hydroxy acid. 3. The method of claim 2 wherein said aliphatic polyester of hydroxy acid is a member selected from the group consisting of: polylactic acid(L,DL), polyglycolic acid, poly(lactic-co-glycolic) acid, poly(orthoesters), poly(p-dioxanone), poly(alpha hydroxy butyric acid), and their copolymers with polyethylene oxide or polypropylene oxide, and mixtures thereof. 4. The method of claim 1 wherein said at least one therapeutically effective substance is a member selected from the group consisting of: antibiotics, anti-inflammatory drugs, .alpha.-blockers, 5 .alpha.-reductases, cytotoxic drugs, anti-angiogenetic drugs, anti-cancer drugs, and mixtures thereof. 5. The method of claim 4 wherein said therapeutically effective substance comprises about 10% to 50% w/w of the treatment composition. 6. The method of claim 1 wherein said formed microspheres are about 1 .mu.m to 100 .mu.m in size. 7. The method of claim 1 wherein said liquid further comprises at least one pharmaceutically acceptable excipient, such that drug stability and drug release profile control of the incorporated microspheres are increased. 8. The method of claim 1 wherein said liquid further comprises a substance having sol-gel transition properties. 9. The method of claim 8 wherein said liquid is a solution before injection, and a gel in human body temperature such that when injected, the liquid solution turns into a gel immediately upon entry into the human body and inhibits microsphere disbursement. 10. The method of claim 1 wherein a complete treatment is administered in a single injection. 11. The method of claim 1 wherein a complete treatment is administered in a series of injections. 12. The method of claim 11 wherein said series of injections are administered as needed until a desired therapeutic result is obtained. 13. The method of claim 1 wherein said prostatic disease or disorder is prostatitis, and said at least one therapeutically effective substance is a member selected from the group consisting of: antibiotics, anti-inflammatory drugs, and mixtures thereof. 14. The method of claim 1 wherein said prostatic disease or disorder is benign prostatic hypertrophy, and said at least one therapeutically effective substance is a member selected from the group consisting of: .alpha.-blockers, 5 .alpha.-reductase, cytotoxic drugs, anti-angiogenetic drugs, and mixtures thereof. 15. The method of claim 1 wherein said prostatic disease or disorder is prostate carcinoma, and said at least one therapeutically effective substance is an anticancer drug. 16. The method of claim 15 wherein said anticancer drug is a member selected from the group consisting of: alkylating agents, cytotoxic antibiotics, steroid hormones, vinca alkaloids, anti-angiogenetic agents, and mixtures thereof. 17. A method for treating prostatitis comprising the steps of: a) selecting at least one therapeutically effective substance for the treatment of prostatitis from the group consisting of antibiotics, anti-inflammatory drugs, and mixtures thereof; b) selecting a biodegradable polymer from the group consisting of: polylactic acid (L, DL), polyglycolic acid, poly(lactic-co-glycolic) acid, poly(orthoesters), poly(p-dioxanone), poly(alpha hydroxy butyric acid), and their copolymers with polyethylene oxide or polypropylene oxide, and mixtures thereof; c) combining a therapeutically effective amount of the chosen at least one therapeutically effective substance with the chosen biodegradable polymer to create a treatment composition; d) forming said treatment composition into microspheres ranging in size from about 1 um to 100 um; e) suspending said microspheres in about 1 to 5 ml of a sterile diluent which may contain pharmaceutically acceptable excipients for increasing drug stability and drug release control; f) agitating said microsphere containing diluent to obtain a uniform distribution of said microspheres throughout said liquid; g) placing said microsphere containing diluent in a syringe; h) injecting said microsphere containing diluent directly into a prostate gland through a transurethral, transrectal, or transperineal route, such that the therapeutically effective substance is delivered to the prostate at a sustained rate as said microspheres biodegrade and; i) re-administering injections of the microsphere containing diluent at chosen intervals for as long a duration as needed until a desired therapeutic result is obtained. 18. The method of claim 17 wherein said sterile diluent is a liquid solution before injection, and a gel at human body temperature such that when injected, the liquid solution turns into a gel immediately upon entry into the human body and inhibits microsphere disbursement. 19. A method for treating benign prostatic hypertrophy comprising the steps of: a) selecting at least one therapeutically effective substance for the treatment of benign prostatic hypertrophy from the group consisting of: .alpha.-blockers, 5 .alpha.-reductase, cytotoxic drugs, anti-angiogenetic drugs, and mixtures thereof; b) selecting a biodegradable polymer from the group consisting of polylactic acid (L, DL), polyglycolic acid, poly(lactic-co-glycolic) acid, poly(orthoesters), poly(p-dioxanone), poly(alpha hydroxy butyric acid), and their copolymers with polyethylene oxide, polypropylene oxide, and mixtures thereof, c) combining a therapeutically effective amount of the chosen at least one therapeutically effective substance with the chosen biodegradable polymer to create a treatment composition; d) forming said treatment composition into microspheres ranging in size from about 1 um to 1 00 um; e) suspending said microspheres in about 1 to 5 ml of a sterile diluent containing pharmaceutically acceptable excipients for increasing drug stability and drug release control; f) agitating said microsphere containing diluent to obtain a uniform distribution of said microspheres throughout said liquid; g) placing said microsphere containing diluent in a syringe; h) injecting said microsphere containing diluent directly into a prostate gland through a transurethral, transrectal, or transperineal route, such that the therapeutically effective substance is delivered to the prostate at a sustained rate as said microspheres biodegrade and; i) re-administering injections of the microsphere containing diluent at chosen intervals for as long a duration as needed until a desired therapeutic result is obtained. 20. The method of claim 19 wherein said sterile diluent is a liquid solution before injection, and a gel at human body temperature such that when injected, the liquid solution turns into a gel immediately upon entry into the human body and inhibits microsphere disbursement. 21. A method for treating prostate carcinoma comprising the steps of: a) selecting at least one therapeutically effective substance for the treatment of prostate carcinoma; b) selecting a biodegradable polymer from the group consisting of: polylactic acid (L, DL), polyglycolic acid, poly(lactic-co-glycolic) acid, poly(orthoesters), poly(p-dioxanone), poly(alpha hydroxy butyric acid), and their copolymers with polyethylene oxide, polypropylene oxide, and mixtures thereof; c) combining a therapeutically effective amount of the chosen at least one therapeutically effective substance with the chosen biodegradable polymer to create a treatment composition; d) forming said treatment composition into microspheres ranging in size from about 1 um to 100 um; e) suspending said microspheres in about 1 to 5 ml of a sterile diluent containing pharmaceutically acceptable excipients for increasing drug stability and drug release control; f) agitating said microsphere containing diluent to obtain a uniform distribution of said microspheres throughout said liquid; g) placing said microsphere containing diluent in a syringe; h) injecting said microsphere containing diluent directly into a prostate gland through a transurethral, transrectal, or transperineal route, such that the therapeutically effective substance is delivered to the prostate at a sustained rate as said microspheres biodegrade and; i) re-administering injections of the microsphere containing diluent at chosen intervals for as long a duration as needed until a desired therapeutic result is obtained. 22. The method of claim 21 wherein said therapeutically effective substance is a member selected from the group consisting of: alkylating agents, cytotoxic antibiotics, steroid hormones, vinca alkaloids, anti-angiogenetic agents, and mixtures thereof. 23. The method of claim 22 wherein said sterile diluent is a liquid solution before injection, and a gel in human body temperature such that when injected, the liquid solution turns into a gel immediately upon entry into the human body and inhibits microsphere disbursement.

Details for Patent 6,277,391

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2018-06-05