[특허]Modified release tablet of bupropion hydrochloride

Modified release tablet of bupropion hydrochloride 원문보기

IPC분류정보
국가/구분	United States(US) Patent 등록
국제특허분류(IPC7판)	A61K-009/20 A61K-009/22 A61K-009/24 A61K-009/28 A61K-009/30 A61K-009/36 A61K-009/42
출원번호	UP-0451496 (2006-06-13)
등록번호	US-7537784 (2009-07-01)
발명자 / 주소	Oberegger, Werner Eradiri, Okponanabofa Zhou, Fang Maes, Paul
출원인 / 주소	Biovail Laboratories International SRL
대리인 / 주소	Oblon, Spivak, McClelland, Maier & Neustadt, P.C
인용정보	피인용 횟수 : 0 인용 특허 : 111

초록 ▼

A modified-release tablet of bupropion hydrochloride comprising (i) a core comprising an effective amount of bupropion hydrochloride, a binder, a lubricant; and (ii) a control releasing coat surrounding said core; and (iii) a moisture barrier surrounding said control releasing coat, wherein the modi

대표청구항 ▼

The invention claimed is: 1. A modified-release tablet comprising: (i) a core comprising an effective amount of bupropion hydrochloride, polyvinyl alcohol, and glyceryl behenate, wherein said bupropion hydrochloride is present in an amount of at least about 94% by weight of the core dry weight, said polyvinyl alcohol is present in an amount of about 3% by weight of the core dry weight, and said glyceryl behenate is present in an amount of about 3% by weight of each core dry weight; (ii) a control-releasing coat completely surrounding and contacting said core, said control-releasing coat comprising ethyl cellulose grade PR 100, polyethylene glycol 1450, and polyvinylpyrrolidone, wherein said ethyl cellulose grade PR 100 is present in an amount of from about 45% to about 50% by weight of the control-releasing coating dry weight, said polyethylene glycol 1450 is present in an amount of about 12% by weight of the control-releasing coating dry weight, and said polyvinylpyrrolidone is present in an amount of from about 25% to about 50% of the control-releasing coat dry weight, wherein the amount of said control-releasing coat applied is from about 9% to about 15% by weight of the dry tablet core; and (iii) a moisture barrier surrounding said control-releasing coat, said moisture barrier comprising methacrylic acid copolymer, polyethylene glycol 1450, triethyl citrate and silicon dioxide, wherein said methacrylic acid copolymer is present in an amount of about 66% by weight of said moisture barrier dry weight, said polyethylene glycol 1450 and triethyl citrate is present in an amount of about 10% by weight of said moisture barrier dry weight in a proportion of 1 part triethyl citrate to 2 parts polyethylene glycol 1450, and said silicon dioxide is present in an amount of about 25% by weight of said moisture barrier dry weight, wherein the amount of the said moisture barrier applied is no more than about 2.5% of the tablet dry weight, wherein the tablet provides an extended-release of the bupropion hydrochloride such that after about 2 hours about 5% of the bupropion hydrochloride content is released, after about 4 hours about 32% of the bupropion hydrochloride content is released, after about 8 hours about 74% of the bupropion hydrochloride content is released and after about 16 hours no less than about 99% of the bupropion hydrochloride content is released, and wherein the ratio of the ethyl cellulose grade PR 100:polyethylene glycol 1450:polyvinylpyrrolidone is from about 3:1:4 to about 5:1:3. 2. The modified release tablet of claim 1 wherein said modified-release tablet provides a Cmax of bupropion in the blood plasma at between about 3 hours and about 8 hours (Tmax) after administration in the fasted state. 3. The modified-release tablet of claim 1 wherein said modified-release tablet provides a Cmax of bupropion ranging from about 60 ng/ml to about 280 ng/ml in the blood plasma at about 5 hours (Tmax) after administration of a once daily 300 mg dose of said modified-release bupropion hydrochloride tablet or a 2×150 mg dose once daily of said modified-release bupropion hydrochloride tablet in the fasted state. 4. The modified-release tablet of claim 1 wherein said modified-release tablet exhibits an AUC(0-t) for bupropion from about 800 ng.hr/ml to about 2850 ng.hr/ml after administration of a once daily 300 mg dose of said modified-release bupropion hydrochloride tablet or a 2×150 mg dose once daily of said modified-release bupropion hydrochloride tablet in the fasted state. 5. The modified-release tablet of claim 1 wherein said modified-release tablet exhibits an AUC(0-inf) for bupropion from about 840 ng.hr/ml to about 3000 ng.hr/ml after administration of a once daily 300 mg dose of said modified-release bupropion hydrochloride tablet or a 2×150 mg dose once daily of said modified-release bupropion hydrochloride tablet in the fasted state. 6. The modified-release tablet of claim 1 which when administered in a once-daily bupropion treatment regimen to a patient in need of treatment provides a Cmax for bupropion ranging from about 60 ng/ml to about 280 ng/ml at between 3 hours and 8 hours (Tmax) and an AUC(0-t) for bupropion ranging from about 800 ng.hr/ml to about 2850 ng.hr/ml. 7. The modified-release tablet of claim 1 wherein the moisture content of said modified-release tablet is no more than about 0.4 % in said tablet when stored at 40° C.±2° C./75% RH±5% RH in an open dish after about 10 days. 8. The modified-release tablet of claim 1 wherein the moisture content of said modified-release tablet is no more than about 1% in said tablet when stored at 40° C.±2° C./75% RH±5% RH after storage for about 6 months. 9. The modified-release tablet of claim 1 wherein said modified-release tablet contains at least about 95% undegraded bupropion hydrochloride after storage for 12 months at about 25° C.±2° C./60% RH±5% RH. 10. The modified-release tablet of claim 1 wherein said modified-release tablet contains at least about 95% undegraded bupropion hydrochloride after storage for 18 months at about 25° C.±2° C./60% RH±5% RH. 11. The modified-release tablet of claim 1, wherein said tablet contains 150 mg of bupropion hydrochloride. 12. The modified-release tablet of claim 1, wherein said tablet contains 300 mg of bupropion hydrochloride. 13. The modified release tablet of claim 1 which does not exhibit any food effects. 14. A method of treating depression in a patient in need thereof comprising administering to the patient the modified-release tablet of claim 1. 15. The method of claim 14 wherein said modified-release tablet contains a 300 mg dose. 16. The method of claim 14 wherein said modified-release tablet contains a 150 mg dose.

이 특허에 인용된 특허 (111)

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IPC	Description
A	생활필수품
A62	인명구조; 소방(사다리 E06C)
A62B	인명구조용의 기구, 장치 또는 방법(특히 의료용에 사용되는 밸브 A61M 39/00; 특히 물에서 쓰이는 인명구조 장치 또는 방법 B63C 9/00; 잠수장비 B63C 11/00; 특히 항공기에 쓰는 것, 예. 낙하산, 투출좌석 B64D; 특히 광산에서 쓰이는 구조장치 E21F 11/00)
A62B-1/08	.. 윈치 또는 풀리에 제동기구가 있는 것

내보내기 구분	파일저장 인쇄 메일전송
구성항목	기본정보 상세정보 관리번호, 국가코드, 자료구분, 상태, 출원번호, 출원일자, 공개번호, 공개일자, 등록번호, 등록일자, 발명명칭(한글), 발명명칭(영문), 출원인(한글), 출원인(영문), 출원인코드, 대표IPC 관리번호, 국가코드, 자료구분, 상태, 출원번호, 출원일자, 공개번호, 공개일자, 공고번호, 공고일자, 등록번호, 등록일자, 발명명칭(한글), 발명명칭(영문), 출원인(한글), 출원인(영문), 출원인코드, 대표출원인, 출원인국적, 출원인주소, 발명자, 발명자E, 발명자코드, 발명자주소, 발명자 우편번호, 발명자국적, 대표IPC, IPC코드, 요약, 미국특허분류, 대리인주소, 대리인코드, 대리인(한글), 대리인(영문), 국제공개일자, 국제공개번호, 국제출원일자, 국제출원번호, 우선권, 우선권주장일, 우선권국가, 우선권출원번호, 원출원일자, 원출원번호, 지정국, Citing Patents, Cited Patents
저장형식	Text(ASCII format) Excel format PIAS분석(.xls)
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

연합인증

Modified release tablet of bupropion hydrochloride 원문보기

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연합인증

Modified release tablet of bupropion hydrochloride 원문보기

초록 ▼

대표청구항 ▼

연구과제 타임라인

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IPC 상위 출원인

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