Method of administering amantadine prior to a sleep period
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/22
A61K-009/48
A61K-031/13
A61K-009/00
A61K-009/50
출원번호
US-0430084
(2017-02-10)
등록번호
US-9867793
(2018-01-16)
발명자
/ 주소
Went, Gregory T.
Sathyan, Gayatri
Vermani, Kavita
Ganapati, Gangadhara
Coffee, Michael
Shek, Efraim
Katdare, Ashok
출원인 / 주소
Adamas Pharma, LLC
대리인 / 주소
Cooley LLP
인용정보
피인용 횟수 :
3인용 특허 :
112
초록
Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
대표청구항▼
1. A method of treating levodopa-induced dyskinesia (LID) in a human patient with Parkinson's disease, comprising orally administering to said human patient with Parkinson's disease and levodopa-induced dyskinesia, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 m
1. A method of treating levodopa-induced dyskinesia (LID) in a human patient with Parkinson's disease, comprising orally administering to said human patient with Parkinson's disease and levodopa-induced dyskinesia, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer,wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer,wherein said one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles) at 50 rpm with 500 ml of water at 37° C. as the dissolution medium, andwherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study. 2. A method of administering amantadine, or a pharmaceutically acceptable salt thereof, to a patient in need thereof, comprising orally administering to said patient in need thereof, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets, wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer,wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer,wherein the one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles at 50 rpm with 500 ml of water at 37° C. as the dissolution medium, andwherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study. 3. A method of reducing sleep disturbances in a subject taking amantadine, comprising orally administering to said subject taking amantadine a pharmaceutical composition once daily 0 to 4 hours before bedtime, the pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer,wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer,wherein the one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles) at 50 rpm with 500 ml of water at 37° C. as the dissolution medium, andwherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study. 4. The method of claim 1, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours. 5. The method of claim 1, wherein said extended release coating polymer comprises ethyl cellulose. 6. The method of claim 5, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer. 7. The method of claim 1, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof. 8. The method of claim 1, wherein the method reduces the severity or frequency of dyskinesia. 9. The method of claim 1, wherein said Tmax for amantadine is 12 hours to 18 hours. 10. The method of claim 1, wherein said pellet core further comprises a seed core and a binder. 11. The method of claim 10, wherein said seed core is a cellulose sphere. 12. The method of claim 10, wherein said binder comprises hydroxypropyl methylcellulose. 13. The method of claim 1, wherein said extended release dosage form comprises one, two,. or three capsules. 14. The method of claim 2, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours. 15. The method of claim 2, wherein said extended release coating polymer comprises ethyl cellulose. 16. The method of claim 15, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer. 17. The method of claim 2, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof. 18. The method of claim 2, wherein the said Tmax for amantadine is 12 hours to 18 hours. 19. The method of claim 2, wherein said pellet core further comprises a seed core and a binder. 20. The method of claim 19, wherein said seed core is a cellulose sphere. 21. The method of claim 20, wherein said binder comprises hydroxypropyl methylcellulose. 22. The method of claim 2, wherein the extended release dosage form comprises one, two, or three capsules. 23. The method of claim 3, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours. 24. The method of claim 3, wherein said extended release coating polymer comprises ethyl cellulose. 25. The method of claim 24, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer. 26. The method of claim 3, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof. 27. The method of claim 3, wherein said Tmax for amantadine is 12 hours to 18 hours. 28. The method of claim 3, wherein said pellet core further comprises a seed core and a binder. 29. The method of claim 28, wherein said seed core is a cellulose sphere. 30. The method of claim 28, wherein said binder comprises hydroxypropyl methylcellulose. 31. The method of claim 3, wherein said extended release dosage form comprises one, two, or three capsules. 32. The method of claim 1, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug. 33. The method of claim 32, wherein said drug is a pharmaceutically acceptable salt of amantadine. 34. The method of claim 32, wherein said drug is amantadine hydrochloride. 35. The method of claim 2, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug. 36. The method of claim 35, wherein said drug is a pharmaceutically acceptable salt of amantadine. 37. The method of claim 35, wherein said drug is amantadine hydrochloride. 38. The method of claim 3, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug. 39. The method of claim 38, wherein said drug is a pharmaceutically acceptable salt of amantadine. 40. The method of claim 38, wherein said drug is amantadine hydrochloride. 41. The method of claim 1, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer. 42. The method of claim 2, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer. 43. The method of claim 3, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (112)
Kelleher Judith A. ; Maples Kirk R. ; Dykman Alina ; Zhang Yong-Kang ; Wilcox Allan L. ; Levell Julian, .alpha.-aryl-N-alkylnitrones and pharmaceutical compositions containing the same.
Bormann Joachim (Frankfurt DEX) Gold Markus R. (Nauheim DEX) Schatton Wolfgang (Eschborn DEX), Adamantane derivatives in the prevention and treatment of cerebral ischemia.
Rudnic Edward M. ; Belendiuk George W. ; McCarty John ; Wassink Sandra ; Couch Richard A., Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine.
Guittard George V. (Cupertino CA) Wong Patrick S. L. (Palo Alto CA) Kuczynski Anthony L. (Mountain View CA) Kidney David J. (Palo Alto CA), Antiviral therapy.
Elger Gordon A. (Huntingdon GBX) Leslie Stewart T. (Cambridge GBX) Malkowska Sandra T. A. (Landbeach GBX) Miller Ronald B. (Basel CHX) Neale Philip J. (Cambridge GBX), Controlled release pharmaceutical composition.
Yang S. Shirley (Succasunna NJ) Boisvert Wayne (Randolph NJ) Muhammad Nouman A. (Long Valley NJ) Weiss Jay (East Brunswick NJ), Controlled release tacrine drug delivery systems and methods for preparing same.
Wong, Patrick S. L.; Dong, Liang C.; Wan, Jiansheng, Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings.
Prausnitz, Mark R.; Allen, Mark G.; Henry, Sebastien; McAllister, Devin V.; Ackley, Donald E.; Jackson, Thomas, Devices and methods for enhanced microneedle penetration of biological barriers.
Vaya, Navin; Karan, Rajesh Singh; Nadkarni, Sunil Sadanand; Gupta, Vinod Kumar, Dosage form for high dose-high solubility active ingredients that provides for immediate release and modified release of the active ingredients.
Edgren David E. (El Granada) Carpenter Howard A. (Palo Alto) Bhatti Gurdish K. (Fremont) Ayer Atul D. (Palo Alto CA), Dosage form for treating central nervous system disorders.
Edgren David E. (El Granada CA) Carpenter Howard A. (Palo Alto CA) Bhatti Gurdish K. (Fremont CA) Ayer Atul D. (Palo Alto CA), Dosage form indicated for the management of abnormal posture, tremor and involuntary movement.
Edgren David E. (El Granada) Carpenter Howard A. (Palo Alto) Bhatti Gurdish K. (Fremont) Ayer Atul D. (Palo Alto CA), Dosage form indicated for the management of abnormal posture, tremor and involuntary movement.
Nrnberg Eberhard (Uttenreuth/Welher DEX) Seiller Erhard (Nidderau DEX) Ritsert Stefan (Eberbach DEX), Memantine-containing solid pharmaceutical dosage forms having an extended two-stage release profile and production there.
Lam, Andrew C.; Shivanand, Padmaja; Ayer, Atul D.; Weyers, Richard G.; Gupta, Suneel K.; Guinta, Diane R.; Christopher, Carol A.; Saks, Samuel R.; Hamel, Lawrence G.; Wright, Jeri D.; Hatamkhany, Zah, Methods and devices for providing prolonged drug therapy.
Chen, Guohua; Lautenbach, Scott D.; Dionne, Keith E.; Jordan, Scott D.; Berry, Steve A.; Rodenberger, Craig I.; Ayer, Rupal, Osmotic delivery system, osmotic delivery system semipermeable body assembly, and method for controlling delivery rate of beneficial agents from osmotic delivery systems.
Buxton Ian R. (Cambridge GBX) Critchley Helen (Cambridge GBX) Leslie Stewart T. (Cambridge GBX) Prater Derek A. (Cambridge GBX) Miller Ronald B. (Basle CHX) Malkowska Sandra T. A. (Cambridge GBX), Pharmaceutical spheroid formulation.
Rudnic Edward M. ; Burnside Beth A. ; Flanner Henry H. ; Wassink Sandra E. ; Couch Richard A. ; Pinkett Jill E., Soluble form osmotic dose delivery system.
Peery, John R.; Dionne, Keith E.; Eckenhoff, James B.; Landrau, Felix A.; Lautenbach, Scott D.; Magruder, Judy A.; Wright, Jeremy C., Sustained delivery of an active agent using an implantable system.
Hanns Ludwig DE; Detlef Dietrich DE; Hinderk M. Emrich DE; Liv Bode DE, USE OF ADAMANTANE AMINES OR STRUCTURALLY SIMILAR COMPOUNDS FOR COMBATING BORNA DISEASE VIRUS AND FOR THE PREVENTION AND TREATMENT OF AFFECTIVE DISEASES AND OTHER DISORDERS ASSOCIATED WITH BDV INFECTI.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.