KR20140027319A - 생리학상 활성제의 경피 투여를 위한 조성물 - Google Patents
생리학상 활성제의 경피 투여를 위한 조성물 Download PDFInfo
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- KR20140027319A KR20140027319A KR1020137031156A KR20137031156A KR20140027319A KR 20140027319 A KR20140027319 A KR 20140027319A KR 1020137031156 A KR1020137031156 A KR 1020137031156A KR 20137031156 A KR20137031156 A KR 20137031156A KR 20140027319 A KR20140027319 A KR 20140027319A
- Authority
- KR
- South Korea
- Prior art keywords
- composition
- pain
- isopropanol
- physiologically active
- diclofenac
- Prior art date
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- 239000013543 active substance Substances 0.000 title claims abstract description 30
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- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 claims description 15
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Classifications
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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Landscapes
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- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
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- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
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Abstract
생리학상 활성제, 예를 들어 약물 또는 수의약의 경피 투여를 위한 조성물이 개시된다. 상기 조성물은 끈적임이 없고, "우수한 장기 효능을 갖는" 매우 가요성인 필름을 형성하는 것을 특징으로 한다.
Description
본 발명은 생리학상 활성제, 특히 제약 활성 화합물(또한 예를 들어 니코틴 또는 수의약물과 같은 작용제)의 경피 투여를 위한 조성물에 관한 것이다. 본 출원서 전체에서, "경피"란 하나 이상의 국부, 국소 또는 전신적 생리 효과를 얻기 위해 대상체의 피부 위에, 피부 안에 또는 피부를 통해 생리학상 활성제를 투여하는 임의의 경로를 의미하도록 의도된다. 피부의 국소 치료란 또한, 예를 들어 상기 조성물을, 예를 들어 항생제로 이염을 치료하기 위해 귀에 적용하는 것을 포함한다. 더욱 구체적으로, 본 발명은 향상된 장기 효능을 갖는, 경피에 의한 제약 및 수의학, 특히 제약 조성물에 관한 것이다.
더욱 구체적으로, 본 발명은 피부에 적용시, 1종 이상의 생리학상 활성제, 특히 제약 활성 물질을 포함하는 내구성의 가요성 필름을 신속하게 형성하는 조성물에 관한 것이다.
상기 필름 형성 조성물은 당 분야에 알려져 있다. 그러나, 상기 공지된 필름 형성 조성물(예를 들어 US 6,211,250 참조)은 다양한 단점을 갖는데, 예를 들어 피부에 적용시 한동안 끈적임이 있을 수 있으며, 즉 이들은 예를 들어 일정 시간 동안 의복에 들러붙을 수 있음을 의미한다.
본 발명은 끈적임이 없고, 내구성이 있으며, 매우 가요성인 필름을 신속하게 형성하는, 바람직하게는 겔 형태인 필름 형성 조성물을 제공함으로써 상기 문제점들을 극복한다.
따라서, 본 발명은
(a) 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체,
(b) 에탄올, 이소프로판올 또는 이들의 혼합물,
(c) 물, 및
(d) 적어도 1종의 생리학상 활성제
를 포함하는, 생리학상 활성제의 경피 투여를 위한 조성물에 관한 것이다.
에틸 아크릴레이트/메틸 메타크릴레이트 (EA/MMA) 공중합체는 전형적으로 조성물에서 필름 형성 중합체로 작용한다. EA/MMA 공중합체(a)는 에탄올 및/또는 이소프로판올(b) 및 물(c)과 조합될 경우 전형적으로 겔을 제공하는 유익한 필름 형성 중합체인 것으로 확인되었다. 본 발명의 수득되는 조성물은 예를 들어 임의의 종래 국부용 반-고체 형태와 같은 튜브에 포장되거나 겔-같은 조성물을 분무할 수 있도록 개발된 특수 장치, 예를 들어 트루-스프레이(Tru-Spray)®를 통해 피부에 적용될 수 있다. 제제의 점도는 중량비 (a):(b), 즉 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체: 에탄올/이소프로판올을 조절함으로써 특정 패키지에 대하여 요구되는 최적의 점도로 조절될 수 있다. 에탄올/이소프로판올의 양을 증가시킴으로써, 제제의 점도는 감소되고, 그 반대도 마찬가지이다. 매우 적은 양의 (a) [예, 2-5%, 바람직하게는 4-5%] 및 매우 많은 양의 (b)[예, 70-90%]를 사용할 경우, 점성의 액체가 - 겔 대신 - 수득될 수 있다 (실시예 10-11 참조). 이들도 역시 피부 위에 유익한 필름을 형성하며, 따라서, 본 발명의 범위 내에 있다. 이들은 예를 들어 스프레이로 피부에 적용될 수 있다.
상기 및 하기에 기재되는 모든 백분율은 달리 명시되지 않는 한 중량%이다.
에틸 아크릴레이트/메틸 메타크릴레이트 (EA/MMA) 공중합체(a)는 순수한 형태로, 또는 예를 들어 분산액 또는 용액의 형태로도 사용될 수 있다. 바람직하게는, 이들은 예를 들어 모두 에보닉 인더스트리즈(Evonik Industries)의 제품인 유드라짓(Eudragit)® NE 시리즈, 예를 들어 유드라짓® NE 30 D 또는 유드라짓® NE 40 D, 또는 유드라짓 NM 30 D의 제품과 같이 수성 현탁액의 형태로 사용된다. 예를 들어, 유드라짓® NE 40 D는 40%의 EA/MMA 공중합체 및 60%의 물을 포함한다. 전형적으로, 본 발명의 조성물은 - 예를 들어, 존재할 수도 있는 임의의 용매를 배제한 순수한 형태로 계산시 - 적어도 2%, 바람직하게는 적어도 5%, 더욱 바람직하게는 적어도 10%의 양으로, 또는 2 내지 30%, 특히 5 내지 25%의 양으로 EA/MMA 공중합체(a)를 함유한다.
사용되는 용매 또는 용매의 혼합물(b), 즉 에탄올 및/또는 이소프로판올은 휘발성이어서, 투여 후 신속하게 증발되고 피부 위에 필름의 형성을 가능하게 한다. (b)로 바람직한 것은 이소프로판올 또는 이소프로판올과 에탄올의 혼합물, 특히 이소프로판올이다. 전형적으로, 본 발명의 조성물은 적어도 30%, 바람직하게는 적어도 40%의 양으로, 또는 35% 내지 90%, 또는 35% 내지 80%, 또는 40 내지 70%의 양으로 용매 또는 용매의 혼합물(b)을 함유한다.
전형적으로, 본 발명의 조성물은 - 순수한 형태로 계산시 - EA/MMA 공중합체(a) 및 성분 (b)[=에탄올 및/또는 이소프로판올]를 1:1 내지 1:45, 바람직하게는 1:1 내지 1:25, 특히 1:1 내지 1:15, 특히 1:1 내지 1:10의 중량비로 함유한다.
물(c)은 전형적으로 성분 (a), 예를 들어 유드라짓® NE 40 D의 수성 분산액을 사용하여 도입되고/거나 별도로 조성물에 첨가된다. 전형적으로, 본 발명의 조성물은 물(c)을 적어도 1%, 바람직하게는 적어도 5%, 더욱 바람직하게는 적어도 10%, 특히 적어도 15%, 또는 1% 내지 50%, 바람직하게는 5% 내지 40%, 특히 15% 내지 35%의 양으로 함유한다.
생리학상 활성제(d)는 특히 제약 활성 화합물이지만, 금연에 도움을 주는 물질, 예를 들어 니코틴, 또는 수의약물을 또한 포함한다.
경피 전달에 적합한 임의의 제약 - 또는 수의학적 - 활성 물질이 생리학상 활성제(d)로 사용될 수 있다. 통상적으로 경구, 비경구 또는 직장 경로로 전달되는 생리학상 활성제도 고려될 수 있다.
생리학상 활성제(d)가 생리학상 허용되는 염, 전구약물, 수화물 또는 용매화물을 형성할 수 있다면, 이들도 유리된 중성 형태로 (d)라고 통칭된다.
생리학상 활성제(a)의 예는 다음과 같다:
심장작용 의약, 예를 들어 니트로글리세린, 이소소르비드 디니트레이트 및 이소소르비드 모노니트레이트와 같은 유기 니트레이트; 퀴니딘 술페이트; 프로카인아미드; 벤드로플루메티아지드, 클로로티아지드, 및 히드로클로로티아지드와 같은 티아지드; 니페디핀; 니카르디핀; 아드레날린 차단제, 예컨대 티몰롤 및 프로프라놀롤; 베라파밀; 딜티아젬; 카프토프릴; 클로니딘 및 프라조신.
안드로겐성 스테로이드, 예컨대 테스토스테론, 메틸테스토스테론 및 플루옥시메스테론.
에스트로겐, 예컨대 공액 에스트로겐, 에스테르화 에스트로겐, 에스트로피페이트, 17베타 에스트라디올, 17베타-에스트라디올 발레레이트, 에퀼린, 메스트라놀, 에스트론, 에스트리올, 17베타-에티닐 에스트라디올, 및 디에틸스틸보에스트롤. 황체호르몬 물질, 예컨대 프로게스테론, 19-노르프로게스테론, 노르에틴드론, 노르에틴드론 아세테이트, 멜렌게스트롤, 클로르마디논, 에티스테론, 메드록시프로게스테론 아세테이트, 히드록시프로게스테론 카프로에이트, 에티노디올 디아세테이트, 노레티노드렐, 17알파 히드록시프로게스테론, 디드로게스테론, 디메티스테론, 에티닐에스트레놀, 노르게스트렐, 데메게스톤, 프로메게스톤, 및 메게스트롤 아세테이트.
중추 신경계에 대한 작용을 갖는 약물, 예를 들어 진정제, 수면제, 항불안제, 진통제 및 마취제, 예컨대 클로랄, 부프레노르핀, 날록손, 할로페리돌, 플루페나진, 펜토바비탈, 페노바비탈, 세코바비탈, 코데인, 펜타닐 및 니코틴.
국소 마취제, 예를 들어 리도카인, 테트라카인, 디클로나인, 벤조카인, 디부카인, 메토카인, 프로카인, 메피바카인, 부피바카인, 에티도카인 또는 프릴로카인.
영양제, 예컨대 비타민, 예를 들어 비타민 B12, 필수 아미노산, 및 필수 지방.
항염증제, 예컨대 스테로이드, 예를 들어 히드로코르티손, 데소니드, 코르티손, 덱사메타손, 플루오시놀론, 트리암시놀론, 메드리손, 프레드니솔론, 플루란드레놀리드, 프레드니손, 할시노니드, 메틸프레드니솔론, 플루란드레놀리드, 프레드니손, 할시노니드, 메틸프레드니솔론, 플루드로코르티손, 코르티코스테론, 파라메타손, 베타메타손; 및 비-스테로이드성 항염증 약물, 예를 들어 디클로페낙, 이부프로펜, 나프록센, 페노프로펜, 펜부펜, 플루르비프로펜, 인도프로펜, 케토프로펜, 수프로펜, 인도메타신, 피록시캄, 아스피린, 살리실산, 디플루니살, 메틸 살리실레이트, 페닐부타존, 술린닥, 메페남산, 메클로페나메이트 나트륨 또는 톨메틴.
특히 수의약에 종종 사용되는 항염증제, 예를 들어 트리암시놀론, 베타메타손, 덱사메타손, 이소플루프레돈, 히드로코르티손 또는 프레드니솔론.
항히스타민제, 예컨대 디메틴덴, 디펜히드라민, 디멘히드리네이트, 퍼페나진, 트리프롤리딘, 피릴아민, 클로르시클리진, 프로메타진, 카비녹사민, 트리펠렌아민, 브롬페니라민, 히드록시진, 시클리진, 메클리진, 클로르프레날린, 터페나딘 및 클로르페니라민.
항구토제, 예를 들어 스코폴아민.
항고혈압 약물, 예를 들어 클로니딘.
호흡기약, 예컨대 테오필린 및 베타2-아드레날린 작용제, 예컨대 알부테롤, 터부탈린, 메타프로테레놀, 리토드린, 카부테롤, 페노테롤, 퀸테레놀, 리미테롤, 솔메파몰, 소테레놀, 및 테트로퀴놀.
교감신경유사약, 예컨대 도파민, 노르에피네프린, 페닐프로판올아민, 페닐에프린, 슈도에페드린, 암페타민, 프로필헥세드린, 및 에피네프린. 축동제, 예를 들어 필로카르핀. 콜린성 작용제, 예턴대 콜린, 아세틸콜린, 메타콜린, 카바콜, 베타네콜, 필로카르핀, 무스카린 및 아레콜린.
항무스카린 또는 무스카린성 콜린성 차단제, 예컨대 아트로핀, 스코폴아민, 호마트로핀, 메트스코폴아민, 호마트로핀 메틸브로아미드, 메탄텔린, 시클로펜톨레이트, 트로피카미드, 프로판텔린, 아니소트로핀, 디시클로민, 및 유카트로핀. 동공확대제, 예컨대 아트로핀, 시클로펜톨레이트, 호마트로핀, 스코폴아민, 트로피카미드, 유카트로핀 및 히드록시암페타민.
정신 활력제, 예를 들어 3-(2-아미노프로필)인돌 또는 3-(2-아미노부틸)인돌.
항생제, 예를 들어 클린다마이신, 에리트로마이신, 테트라사이클린, 페니실린, 클로람페니콜, 술파세트아미드, 술파메타진, 술파디아진, 술파메라진, 술파메티졸 또는 술피속사졸.
특히 수의약에 종종 사용되는 항생제, 예를 들어 벤질페니실린, 메티실린, 암필리신, 아목시실린, 스트렙토마이신, 네오마이신, 테트라사이클린, 클로람페니콜, 에리트로마이신, 그리세오풀빈, 티오스트렙톤, 플로르페니콜, 엔로플록사신, 바시트라신, 겐타마이신, 폴리믹신 B, 클로람페니콜, 마르보플록사신 또는 프라메시틴.
특히 수의약에 종종 사용되는 항기생충제, 예를 들어 말라카이트 그린, 메틸렌 블루, 클로라민 T 또는 B, 에마멕틴 벤조에이트 또는 알파-시퍼메트린.
특히 수의약에 종종 사용되는 구충제, 예를 들어 아레콜린, 이베르멕틴, 프라지퀀텔, 메벤다졸 또는 티아벤다졸.
건선치료제, 예를 들어 칼시포트리올 또는 칼시포트리올/베타메타손 조합물.
항바이러스제, 예를 들어 펜시클로버, 아시클로버 또는 이독수리딘.
항여드름제, 예를 들어 벤조일 퍼옥시드.
피부과약, 예컨대 비타민 A 및 E.
체액제, 예컨대 천연 및 합성의 프로스타글란딘, 예를 들어 PGE1, PGF2알파, 및 PGF2알파, 및 PGE1 유사체 미소프로스톨.
진경약, 예컨대 아트로핀, 메탄텔린, 파파베린, 신나메드린 및 메트스코폴아민.
항우울 약물, 예컨대 셀레길린, 이소카르복사지드, 페넬진, 트라닐시프로민, 이미프라민, 아미트립틸린, 트리미프라민, 독세핀, 데시프라민, 노르트립틸린, 프로트립틸린, 아목사핀, 마프로틸린, 및 트라조돈.
알츠하이머 병 치료 약물, 예를 들어 리바스티그민.
요실금 치료 약물, 예를 들어 옥시부티닌.
피임약, 예를 들어 노렐게스트로민과 에티닐 에스트라디올의 혼합물.
당뇨병약, 예컨대 인슐린, 및 항암 약물, 예컨대 타목시펜 및 메토트렉세이트.
식욕억제 약물, 예컨대 덱스트로암페타민, 메트암페타민, 페닐프로판올아민, 펜플루라민, 디에틸프로피온, 마진돌, 및 펜터민.
항알레르기약, 예컨대 안타졸린, 메타피릴렌, 클로르페니라민, 피릴아민 및 페니라민.
신경안정제, 예컨대 레서핀, 클로르프로마진, 및 항불안 벤조디아제핀, 예컨대 알프라졸람, 클로르디아제폭시드, 클로라젭테이트, 할라제팜, 옥사제팜, 프라제팜, 클로나제팜, 플루라제팜, 트리아졸람, 로라제팜 및 디아제팜.
정신병약, 예컨대 티오프로파제이트, 클로르프로마진, 트리플루프로마진, 메소리다진, 피페라세타진, 티오리다진, 아세토페나진, 플루페나진, 퍼페나진, 트리플루오페라진, 클로르프라틱센, 티오틱센, 할로페리돌, 브롬페리돌, 록사핀 및 몰린돈.
충혈제거제, 예를 들어 자일로메타졸린, 옥시메타졸린, 페닐에프린, 에페드린 또는 나파졸린.
해열제, 예를 들어 아세틸살리실산 또는 살리실아미드.
편두통약, 예를 들어 디히드로에르고타민 또는 피조틸린.
구역 및 구토 치료 약물, 예컨대 클로르프로마진, 페르페나진, 프로클로르페라진, 프로메타진, 트리에틸페라진, 트리플루프로마진, 및 트리메프라진.
항말라리아약, 예컨대 4-아미노퀴놀린, 알파-아미노퀴놀린, 클로로퀸 및 피리메타민.
항궤양제, 예컨대 미소프로스톨, 오메프라졸 및 엔프로스틸.
펩티드 및 단백질, 예컨대 파킨슨병, 경직 및 급성 근육 연축에 대한 약물, 예컨대 레보도파, 카르비도파, 아만타딘, 아포모르핀, 브로모크립틴, 셀레길린 (데프레닐), 트리헥시페니딜 히드로클로라이드, 벤즈트로핀 메실레이트, 프로시클리딘 히드로클로라이드, 바클로펜, 디아제팜, 단트롤렌, 인슐린, 에리트로포이에틴 및 성장 호르몬.
항-에스트로겐 또는 호르몬제, 예컨대 타목시펜 또는 사람 융모성 생식샘자극호르몬.
뉴클레오티드 및 핵산 (예, DNA).
항진균제, 예를 들어 테르비나핀, 나프티핀, 부테나핀, 비포나졸, 클로트리마졸, 에코나졸, 이소코나졸, 케토코나졸, 미코나졸, 옥시코나졸, 세르타코나졸, 술코나졸, 티오코나졸, 톨나프테이트, 테르코나졸, 아모롤핀, 시클로피록스 또는 운데실렌산.
특히 수의약에 종종 사용되는 항진균제, 예를 들어 플루코나졸, 케토코나졸, 이소코나졸, 미코나졸, 암포테리신 B, 플루시토신, 테르비나핀, 니스타틴, 티아벤다졸 및 클로트리마졸.
생리학상 활성제(d)는 어떤 형태가 최적의 전달 특성을 가져오는지에 따라, 다양한 형태의 조성물로 존재할 수 있다. 예를 들어, 이들은 유리 염기 또는 산 형태, 또는 염, 에스테르, 또는 임의의 다른 약리학적으로 허용되는 유도체의 형태로, 또는 예를 들어 분자 복합체의 성분으로 존재할 수 있다.
바람직한 생리학상 활성제(d)는 니코틴, 리도카인, 히드로코르티손, 디클로페낙, 이부프로펜, 나프록센, 인도메타신, 피록시캄, 메틸 살리실레이트, 페닐부타존, 메페남산, 베타메타손, 디메틴덴, 스코폴아민, 벤조일 퍼옥시드, 칼시포트리올, 펜시클로버, 아시클로버, 비타민 A, 비타민 E, 자일로메타졸린, 옥시메타졸린, 페닐에프린, 에페드린, 나파졸린, 테르비나핀, 나프티핀, 부테나핀, 비포나졸, 클로트리마졸, 에코나졸, 이소코나졸, 케토코나졸, 미코나졸, 옥시코나졸, 세르타코나졸, 술코나졸, 티오코나졸, 톨나프테이트, 테르코나졸, 아모롤핀, 시클로피록스, 운데실렌산, 클로니딘, 테스토스테론, 니트로글리세린, 셀레길린, 리바스티그민 및 옥시부티닌이다.
특히 바람직한 생리학상 활성제(d)는 니코틴, 리도카인, 히드로코르티손, 디클로페낙, 디메틴덴, 스코폴아민, 벤조일 퍼옥시드, 칼시포트리올, 펜시클로버, 아시클로버, 자일로메타졸린, 테르비나핀, 톨나프테이트, 클로트리마졸 및 리바스티그민이다.
본 발명의 특정 실시양태에서, 생리학상 활성제(d)는 통증-완화 제약 활성 물질, 항히스타민제, 항진균제 및 니코틴으로 이루어진 군에서 선택된다.
통증-완화 제약 활성 물질은 예를 들어 비-스테로이드성 항염증 약물("NSAID"), 또는 국소 마취제, 또는 가온제, 예를 들어 캡사이신 또는 바닐린 부틸 에테르이고, 바람직하게는 NSAID이다.
NSAID는 예를 들어 디클로페낙, 인도메타신, 이부프로펜, 피록시캄, 아세틸살리실산 (아스피린®), 나프록센, 메틸 살리실레이트, 케토프로펜, 톨페남산, 페닐부타존, 피록시캄, 니메술리드, 루미라콕십, 및 임의의 상기 화합물의 제약상 허용되는 염이다. NSAID로 바람직한 것은 디클로페낙 또는 그의 제약상 허용되는 염이다. 특히 바람직한 것은 디클로페낙 유리산, 디클로페낙 나트륨, 디클로페낙 칼륨, 디클로페낙 디에틸암모늄 및 디클로페낙 에폴아민, 더욱 특별하게는 디클로페낙 나트륨 및 디클로페낙 디에틸암모늄, 특히 디클로페낙 나트륨이다.
국소 마취제는 예를 들어 리도카인, 벤조카인, 디부카인 또는 프로카인이다.
또한, 예를 들어 NSAID와 가온제, 또는 NSAID와 국소 마취제의 조합이 통증-완화 활성 물질로 고려된다.
본 발명의 조성물은 당 분야에 공지된 추가의 부형제, 예를 들어 방향제/향료, 산화방지제, 예를 들어 부틸히드록시톨루엔, 항균 보존제, 예를 들어 벤질 알콜, 벤잘코늄 클로라이드 또는 파라벤, 착색제 또는 pH 조절제 성분(종종 약물의 침투성을 적정화하기 위해 필요한)을 임의로 포함할 수 있다.
본 발명의 조성물은 전형적으로 눈에 띄지 않는 가요성 투명 필름을 형성한다. 필요하다면, 이들은 예를 들어 상응하는 착색제를 가함으로써 불투명 백색 또는 유색의 필름을 형성하도록 변경될 수도 있다.
본 발명의 특수한 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 0.5 내지 8% (w/w) - 바람직하게는 1 내지 6% (w/w), 특히 1.5 내지 4% (w/w)의, 올레일 알콜, 올레산, 리놀레일 알콜, 리놀레산, 미리스틸 알콜, 디메틸 술폭시드, 티몰, 멘톨, 바람직하게는 레보멘톨, 및 이들의 임의의 혼합물로 이루어진 군에서 선택된 화합물을 추가로 포함한다. 특히 바람직한 것은 레보멘톨 및 올레일 알콜의 혼합물이다.
본 발명의 또 다른 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 에틸 아세테이트를 함유하지 않는다.
본 발명의 추가의 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 C1-C10 알콜과 C1-C10 카르복실산의 에스테르를 함유하지 않는다.
본 발명의 추가의 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 에틸 아세테이트와 살리실산을 둘 다 함유하지 않는다.
본 발명의 또 다른 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 C1-C10 알콜과 C1-C10 카르복실산의 에스테르 및 살리실산을 둘 다 함유하지 않는다.
본 발명의 또 다른 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 에틸 아세테이트, 살리실산 및 셀룰로오스 니트레이트를 모두 함유하지 않는다.
본 발명의 또 다른 실시양태에서, 상기 또는 하기에 정의되는 바와 같이, 본 발명의 경피 투여용 조성물은 각질용해 활성제를 함유하지 않으며, 특히 각질층으로부터 각질세포의 분해 및 분리를 수행하는 데 적합한 물질로 정의되는 각질용해 활성제를 함유하지 않으며, 상기 각질용해 활성제는 예를 들어 레티노이드 수용체 작용제, 예컨대 아다팔렌 및 레티노이드, 특히 트레티노인, 이소트레티노인, 모트레티니드, 타자로텐 및/또는 레티놀; 우레아; 유기산, 특히 히드록시 카르복실산, 특히 글리콜산, 아세트산, 젖산 및/또는 살리실산; 및 이들의 혼합물로 이루어진 군에서 선택된다.
본 발명의 바람직한 실시양태는 전술한 및 후술하는 본 발명의 모든 정의 및 실시양태에서 (청구항 포함) "~을 포함하는 [조성물...]"을 "~으로 본질적으로 이루어진 [조성물...]"로 대체함으로써 특징된다.
본 발명의 더 더욱 바람직한 실시양태는 전술한 및 후술하는 본 발명의 모든 정의 및 실시양태에서 (청구항 포함) "~을 포함하는 [조성물...]"을 "~으로 이루어진 [조성물...]"로 대체함으로써 특징된다.
본 발명의 경피 투여용 조성물은 그 자체 공지된 방식으로, 예를 들어 이하의 실시예 부분에 기재된 바와 같은 통상의 혼합 및 균질화 방법에 의해 제조될 수 있다.
본 발명의 경피 투여용 조성물은 특히 우수한 장기 효능, 기계적 견고성 및 방수성, 뿐만 아니라 원하는 만큼 긴 시간에 걸쳐 약물의 높은 피부 침투성을 나타낸다. 상기 유익한 성질은 이하의 시험에 의해 입증될 수 있다.
(1) 필름의 기계적 성질은 특히, 필름의 인장 강도, 영 탄성률 및 신장률을 측정함으로써 시험된다. 더욱이, 필름은 예를 들어 전단 시험, 응력 이완 또는 탄성 변형 시험에서 시험된다.
(2) 필름의 견고성은 한 조각의 거즈를, 그 위에 100 mg의 시험 조성물을 고르게 펴바르고 50℃에서 10분 동안 방치하여 건조시킨 유리 슬라이드 위로 왕복운동시킴으로써 결정된다.
(3) 시험되는 본 발명 조성물의 도포에 관련된 특이적 성질은 그들의 펴발림성, 그들의 방수성 및 그들의 피부 접착성이다.
(4) 방수성은 예를 들어 유리 슬라이드 위에 시험 조성물을 고르게 펴바르고, 그것을 방치하여 건조시킨 다음, 그 유리 슬라이드를 건조된 필름과 함께 칭량함으로써 결정된다. 유리 슬라이드를 탈이온수의 비커에 20℃에서 20분 동안 담근다. 다음, 그들을 꺼내고, 50℃의 오븐에서 건조시키고 다시 칭량한다. 방수성은 수처리 전과 후의 유리 슬라이드의 무게로부터 계산한다.
(5) 약물 성분의 체외 피부 보유: 약물의 피부 수준은 시험 조성물을 24시간 후 피부 표면 위에와 24시간 후 표피 내에 도포한 후 결정되었다. 절개된 인체 표피를 사용하는 체외 확산 세포를 사용한다. 시험 조성물을 표피막에 도포하고, 그 후 침투하는 약물의 양을 측정하였다 (HPLC 및 UV 검출).
본 발명의 또 다른 실시양태는 통증의 치료에 사용하기 위한, 적어도 1종의 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 을 포함하는 본 발명의 경피 투여용 조성물에 관한 것이다.
본 발명의 또 다른 실시양태는 통증 부위에서 내구성 필름을 형성하여 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 이 장시간에 걸쳐 피부를 통해 침투하게 할 수 있는, 환자의 요통 뿐만 아니라 사지 또는 접합부(관절)에서의 통증을 치료하는 데 사용하기 위한, 적어도 1종의 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 을 포함하는 본 발명의 경피 투여용 조성물에 관한 것이다. "장시간"이란 전형적으로 8시간 내지 7일, 바람직하게는 8시간 내지 4일, 특히 8시간 내지 48시간을 의미한다.
특히, 적어도 1종의 NSAID를 포함하는 상기 경피 투여용 조성물은 발목 통증 - 예를 들어 발목 염좌 -, 손목 통증, 무릎 통증 - 예를 들어 무릎 염좌 또는 무릎 골관절염 -, 팔꿈치 통증 - 예를 들어 테니스 팔꿈치 또는 팔꿈치 골관절염 -, 어깨 통증, 손가락 통증 - 예를 들어 손가락 염좌 또는 손가락 골관절염, 예컨대 엄지 골관절염, 또는 요통을 치료하는 데 적합하다.
본 발명의 또 다른 실시양태는 통증의 치료에 사용하기 위한 조성물의 제조에 있어서, (a) 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체, (b) 에탄올, 이소프로판올 또는 이들의 혼합물, (c) 물, 및 (d) 적어도 1종의 비-스테로이드성 항염증 약물 - 특히 디클로페낙 - 의 용도에 관한 것이다.
적어도 1종의 NSAID를 포함하는 상기 경피 투여용 조성물의 유익한 성질은 예를 들어 다음 시험에 의해 입증된다:
(1) 24h에 인체 피부 위의 체외 누적 침투 (μg 디클로페낙/cm2[조성물의 적용된 면적]으로 측정): 실시예 1-11의 조성물은 24h에 높은 인체 피부 위의 누적 침투를 나타낸다.
(2) 통증 완화: 실시예 1-11의 조성물은 발목 염좌 또는 요통으로 고생하는 환자들에 각각 적용시 높은 통증 완화를 나타낸다.
이하의 실시예는 본 발명을 예시하기 위한 것이다.
실시예 1: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 투명한 균질의 겔
실시예 2: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 투명한 균질의 겔
실시예 3: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 투명한 균질의 겔
실시예 4: 4.6% (w/w)의 디클로페낙 나트륨을 포함하는 약간 유백광의 겔
실시예 5: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 투명한 균질의 겔
실시예 6: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 투명 겔
실시예 7: 5.1% (w/w)의 디클로페낙 디에틸암모늄을 포함하는 투명 겔
실시예 8: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 겔
실시예 9: 4.0% (w/w)의 디클로페낙 나트륨을 포함하는 점성의 겔
실시예 10: 4.6% (w/w)의 디클로페낙 나트륨을 포함하는 점성의 액체
실시예 11: 4.6% (w/w)의 디클로페낙 나트륨을 포함하는 점성의 액체
실시예 1-11의 제제를 다음과 같이 제조한다: 디클로페낙 염, 레보멘톨 및 올레일 알콜을 유드라짓 NE40D와 추가의 물(존재할 경우)의 혼합물에 용해시킨다. 다음, 이소프로판올 및/또는 에탄올을 강력한 혼합 하에 가한다 (실시예 10-11을 제외하고는 겔이 형성됨).
Claims (12)
- (a) 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체,
(b) 에탄올, 이소프로판올 또는 이들의 혼합물,
(c) 물, 및
(d) 적어도 1종의 생리학상 활성제
를 포함하는, 생리학상 활성제의 경피 투여를 위한 조성물. - 제1항에 있어서, (b)가 이소프로판올인 조성물.
- 제1항 또는 제2항에 있어서, 적어도 1종의 생리학상 활성제(d)가 통증-완화 제약 활성 물질, 항히스타민제, 항진균제 및 니코틴으로 이루어진 군에서 선택되는 것인 조성물.
- 제3항에 있어서, 적어도 1종의 생리학상 활성제(d)가 디클로페낙 또는 그의 제약상 허용되는 염인 조성물.
- 제1항 내지 제4항 중 어느 한 항에 있어서, EA/MMA 공중합체(a)를 - 순수한 형태로 계산시 - 2% 내지 30% (w/w)의 양으로 함유하는 조성물.
- 제1항 내지 제5항 중 어느 한 항에 있어서, 성분 (b)[= 에탄올 및/또는 이소프로판올]를 35% 내지 90% (w/w)의 양으로 함유하는 조성물.
- 제1항 내지 제6항 중 어느 한 항에 있어서, 물(c)을 5% 내지 40% (w/w)의 양으로 함유하는 조성물.
- 제1항 내지 제7항 중 어느 한 항에 있어서, EA/MMA 공중합체(a) - 순수한 형태로 계산시 - 및 성분 (b)[= 에탄올 및/또는 이소프로판올]를 1:1 내지 1:45의 중량비로 함유하는 조성물.
- 제1항 내지 제8항 중 어느 한 항에 있어서, 올레일 알콜, 올레산, 리놀레일 알콜, 리놀레산, 미리스틸 알콜, 디메틸 술폭시드, 티몰, 멘톨, 및 이들의 임의의 혼합물로 이루어진 군에서 선택된 화합물 0.5 내지 8% (w/w)를 추가로 포함하는 조성물.
- 제3항 내지 제9항 중 어느 한 항에 있어서, 통증의 치료에 사용하기 위한, 적어도 1종의 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 을 포함하는 조성물.
- 제3항 내지 제9항 중 어느 한 항에 있어서, 통증 부위에서 내구성 필름을 형성하여 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 이 8시간 내지 7일의 기간에 걸쳐 피부를 통해 침투하게 할 수 있는, 환자의 요통 뿐만 아니라 사지 또는 접합부(관절)에서의 통증을 치료하는 데 사용하기 위한, 적어도 1종의 통증-완화 제약 활성 물질 - 바람직하게는 비-스테로이드성 항염증 약물, 특히 디클로페낙 - 을 포함하는 조성물.
- 통증의 치료에 사용하기 위한 조성물의 제조에 있어서,
(a) 에틸 아크릴레이트/메틸 메타크릴레이트 공중합체,
(b) 에탄올, 이소프로판올 또는 이들의 혼합물,
(c) 물, 및
(d) 적어도 1종의 비-스테로이드성 항염증 약물 - 특히 디클로페낙 -의 용도.
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FR2808685B1 (fr) * | 2000-05-12 | 2004-10-08 | Sanofi Synthelabo | Compositions pharmaceutiques pour administration transdermique d'agents anti-inflammatoires |
KR100452972B1 (ko) * | 2000-05-16 | 2004-10-14 | 주식회사 삼양사 | 경피투여용 하이드로젤 조성물 |
AU2003242238A1 (en) * | 2002-06-18 | 2003-12-31 | Pola Chemical Industries Inc. | Antifungal medicinal compositions |
US8907153B2 (en) * | 2004-06-07 | 2014-12-09 | Nuvo Research Inc. | Adhesive peel-forming formulations for dermal delivery of drugs and methods of using the same |
CA2633515C (en) * | 2005-12-14 | 2011-10-18 | Jie Zhang | Compositions and methods for dermally treating pain |
JP5432716B2 (ja) * | 2006-10-17 | 2014-03-05 | ヌーボ リサーチ インコーポレイテッド | ジクロフェナクゲル |
-
2012
- 2012-05-24 KR KR1020137031156A patent/KR20140027319A/ko not_active Application Discontinuation
- 2012-05-24 JP JP2014511867A patent/JP2014515365A/ja active Pending
- 2012-05-24 CA CA2835716A patent/CA2835716A1/en not_active Abandoned
- 2012-05-24 CN CN201280023158.XA patent/CN103533927A/zh active Pending
- 2012-05-24 MX MX2013013772A patent/MX2013013772A/es unknown
- 2012-05-24 US US14/119,634 patent/US20140100285A1/en not_active Abandoned
- 2012-05-24 EP EP12725349.0A patent/EP2714019A1/en not_active Withdrawn
- 2012-05-24 AU AU2012260904A patent/AU2012260904B2/en not_active Ceased
- 2012-05-24 WO PCT/EP2012/059670 patent/WO2012160125A1/en active Application Filing
- 2012-05-24 RU RU2013157834/15A patent/RU2013157834A/ru not_active Application Discontinuation
- 2012-05-24 BR BR112013030365A patent/BR112013030365A2/pt active Search and Examination
Also Published As
Publication number | Publication date |
---|---|
CN103533927A (zh) | 2014-01-22 |
BR112013030365A2 (pt) | 2016-11-29 |
MX2013013772A (es) | 2014-01-08 |
JP2014515365A (ja) | 2014-06-30 |
CA2835716A1 (en) | 2012-11-29 |
EP2714019A1 (en) | 2014-04-09 |
AU2012260904A1 (en) | 2013-11-21 |
WO2012160125A1 (en) | 2012-11-29 |
AU2012260904B2 (en) | 2017-05-04 |
RU2013157834A (ru) | 2015-07-10 |
US20140100285A1 (en) | 2014-04-10 |
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