KR20130008588A - 속용성 약학 조성물 - Google Patents
속용성 약학 조성물 Download PDFInfo
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- KR20130008588A KR20130008588A KR1020127027215A KR20127027215A KR20130008588A KR 20130008588 A KR20130008588 A KR 20130008588A KR 1020127027215 A KR1020127027215 A KR 1020127027215A KR 20127027215 A KR20127027215 A KR 20127027215A KR 20130008588 A KR20130008588 A KR 20130008588A
- Authority
- KR
- South Korea
- Prior art keywords
- pharmaceutical composition
- active ingredient
- inulin
- composition according
- matrix
- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 41
- 239000004480 active ingredient Substances 0.000 claims abstract description 60
- 239000011159 matrix material Substances 0.000 claims abstract description 58
- 239000000203 mixture Substances 0.000 claims description 105
- 229920001202 Inulin Polymers 0.000 claims description 83
- 229940029339 inulin Drugs 0.000 claims description 82
- JYJIGFIDKWBXDU-MNNPPOADSA-N inulin Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)OC[C@]1(OC[C@]2(OC[C@]3(OC[C@]4(OC[C@]5(OC[C@]6(OC[C@]7(OC[C@]8(OC[C@]9(OC[C@]%10(OC[C@]%11(OC[C@]%12(OC[C@]%13(OC[C@]%14(OC[C@]%15(OC[C@]%16(OC[C@]%17(OC[C@]%18(OC[C@]%19(OC[C@]%20(OC[C@]%21(OC[C@]%22(OC[C@]%23(OC[C@]%24(OC[C@]%25(OC[C@]%26(OC[C@]%27(OC[C@]%28(OC[C@]%29(OC[C@]%30(OC[C@]%31(OC[C@]%32(OC[C@]%33(OC[C@]%34(OC[C@]%35(OC[C@]%36(O[C@@H]%37[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O%37)O)[C@H]([C@H](O)[C@@H](CO)O%36)O)[C@H]([C@H](O)[C@@H](CO)O%35)O)[C@H]([C@H](O)[C@@H](CO)O%34)O)[C@H]([C@H](O)[C@@H](CO)O%33)O)[C@H]([C@H](O)[C@@H](CO)O%32)O)[C@H]([C@H](O)[C@@H](CO)O%31)O)[C@H]([C@H](O)[C@@H](CO)O%30)O)[C@H]([C@H](O)[C@@H](CO)O%29)O)[C@H]([C@H](O)[C@@H](CO)O%28)O)[C@H]([C@H](O)[C@@H](CO)O%27)O)[C@H]([C@H](O)[C@@H](CO)O%26)O)[C@H]([C@H](O)[C@@H](CO)O%25)O)[C@H]([C@H](O)[C@@H](CO)O%24)O)[C@H]([C@H](O)[C@@H](CO)O%23)O)[C@H]([C@H](O)[C@@H](CO)O%22)O)[C@H]([C@H](O)[C@@H](CO)O%21)O)[C@H]([C@H](O)[C@@H](CO)O%20)O)[C@H]([C@H](O)[C@@H](CO)O%19)O)[C@H]([C@H](O)[C@@H](CO)O%18)O)[C@H]([C@H](O)[C@@H](CO)O%17)O)[C@H]([C@H](O)[C@@H](CO)O%16)O)[C@H]([C@H](O)[C@@H](CO)O%15)O)[C@H]([C@H](O)[C@@H](CO)O%14)O)[C@H]([C@H](O)[C@@H](CO)O%13)O)[C@H]([C@H](O)[C@@H](CO)O%12)O)[C@H]([C@H](O)[C@@H](CO)O%11)O)[C@H]([C@H](O)[C@@H](CO)O%10)O)[C@H]([C@H](O)[C@@H](CO)O9)O)[C@H]([C@H](O)[C@@H](CO)O8)O)[C@H]([C@H](O)[C@@H](CO)O7)O)[C@H]([C@H](O)[C@@H](CO)O6)O)[C@H]([C@H](O)[C@@H](CO)O5)O)[C@H]([C@H](O)[C@@H](CO)O4)O)[C@H]([C@H](O)[C@@H](CO)O3)O)[C@H]([C@H](O)[C@@H](CO)O2)O)[C@@H](O)[C@H](O)[C@@H](CO)O1 JYJIGFIDKWBXDU-MNNPPOADSA-N 0.000 claims description 82
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Abstract
본 발명은 약제학적인 활성 성분을 수송하는 개방형 매트릭스 네트워크를 포함하는 약학 조성물로서, 개방형 매트릭스 네트워크가 이뉼린(linulin)을 포함하는 약학 조성물에 관한 것이다.
Description
본 발명은 속용성 약학 조성물, 이의 제조 방법, 및 포유류, 특히 인간 질환의 치료 및 예방에 있어서의 이의 용도에 관한 것이다.
구강에서 활성 성분을 방출하도록 설계된 속용성 약학 제형들은 잘 알려져 있으며, 매우 다양한 약물의 전달에 이용될 수 있다 (Critical Reviews in Therapeutic Drug Carrier Systems, 21(6):433-475 (2004); Seager H. (1998), J. Phar. Pharmacol 50:375-382; Bandari et al. (January 2008), Asian Journal of Pharmaceutics 2-11).
속용성 제형에서, 약물은 예컨대 만니톨 및 어류 젤라틴 (EP 1501534; EP1165053), 변형 전분 (US6509040), 아미노산과 조합된 풀룰란 (EP1803446), 또는 소르비톨과 조합된 말토덱스트린 (US2004/0228919)으로 구성된 매트릭스내에 물리적으로 트랩핑(trapping)될 수 있다. 약물과 캐리어 물질의 용액, 현탁액 또는 분산제는 블리스터 공동에 충전되어, 냉동된 후 동결건조될 수 있다. 언제나 기술의 임의 결과물들은 여전히 개선될 여지가 있다.
본 발명은 개선된 급속-분산성 제형을 제공하는 것이다.
본 발명은 전형적으로 단위 제형으로, 전형적으로 경구 동결건조체 (또한, 구강 붕해정이라 함) 형태의 새로운 속용성 경구 약학 조성물을 제공한다.
일 구현예에서, 본 발명은, 개방형 매트릭스 네트워크가 이뉼린(inulin)을 포함하는, 약제학적인 활성 성분을 수송하는 개방형 매트릭스 네트워크를 포함하는 약학 조성물을 제공한다.
다른 구현예에서, 본 발명은, 이뉼린을 포함하는 매트릭스가 수용액 또는 타액과의 접촉시 신속하게 붕해되는, 약제학적인 활성 성분을 수송하는 매트릭스를 포함하는 약학 조성물을 제공한다.
본 발명의 약학 조성물은, 수성 매질 또는 타액과의 접촉시 신속하게 용해된다는 점에서 특징적이며, 구체적으로, 조성물은 경구 복용시 신속하게 붕해된다. 수성 매질 중에서 또는 섭취시 구강내(타액과의 접촉시 붕해가 이루어지는 장소)에서의 붕해는 전형적으로 10초 이내이고, 때로는 9초 이내, 8초 이내, 7초 이내, 6초 이내, 5초 이내, 4초 이내, 3초 이내, 2초 이내 또는 심지어 1초 이내에 이루어진다.
이에, 본 발명은 약제학적 활성 성분을 포함하며, 조성물의 80% 이상이 수성 매질 또는 타액 중에서 10초 이내에 붕해되는, 신속한 용해 속도를 가진, 약학 조성물을 제공한다. 다른 구현예에서, 조성물의 90%가 수성 매질 또는 타액 중에서 10초 이내에 붕해된다. 다른 구현예에서, 조성물의 100%가 수성 매질 또는 타액 중에서 10초 이내에 붕해된다.
본 발명의 약학 조성물은 용매 (예, 물)를 예컨대 냉동 건조 공정에서, 활성 성분과 매트릭스 형성용 성분(들)을 용액 형태로 포함하는 액체 조제물로부터 승화시킴으로써, 수득할 수 있다.
일 구현예에서, 규정량의 활성 성분을 포함하는 액체 조제물의 단위 투약량을 오목부(depression)에 도입하고, 이를 승화시켜 (승화 후) 단위 제형으로 약학 조성물을 수득한다. 상기 오목부는 개방형 블리스터 팩의 오목브이고, 상기 승화 단계를 수행한 후, 상기 오목부에서 상기 조성물의 고형 단위 제형이 형성되며, 상기 오목부 위에 실링 필름 또는 호일을 배치하여, 밀봉된 블리스터 팩을 만든다.
따라서, 본 발명은, 약제학적 활성 성분과 이뉼린을 용매 중에서 포함하는 액체 조제물로부터 용매를 승화시키는 단계를 포함하는, 약학 조성물의 제조 방법을 제공한다.
아울러, 본 발명은, (a) 용매 중에 이뉼린과 활성 성분을 포함하는 용액을 제조하는 단계; (b) 상기 용액을 동결시키는 단계; (c) 상기 동결시킨 용액에서 용매를 승화시키는 단계를 포함하는 약학 조성물의 제조 방법으로서, 이러한 방법으로 수득되는 약학 조성물이 수용액 또는 타액과의 접촉시 10초 이내에 붕해되는 급속-분산형 제형(fast-dispersing dosage form)인, 약학 조성물의 제조 방법을 제공한다.
본 발명은, 활성 성분과 하나 이상의 부형제를 포함하는, 단위 제형, 전형적으로 경구 동결건조체로 통상적으로 제조 및 제공되는, 속용성의, 전형적인 구강 분산성(orodispersible) 약학 조성물을 제공하다. 부형제들 중 하나 이상, 일반적으로 매트릭스 형성용 주성분은 다당류 이뉼린이다.
청구항과, 본 명세서의 상기 및 하기에서 사용되는 용어들 중 일부는 아래와 같다:
용어 "활성 성분" 또는 "약제학적 활성 성분"은 본원에서 상호 호환적으로 사용될 것이다.
용어 "약학 조성물" 및 "조성물"은 상호 호환적으로 본 발명의 약학 조성물을 지칭한다.
용어 "단위 제형" 또는 "제형"은 타겟 개체에게 1회 투여량으로서 투여하기 위한 투여량의 활성 약학 성분 (API)의 양으로 제형화된 상기 조성물을 지칭하는데 사용될 것이다. 단위 제형은 활성 성분의 특성, 증상, 질병 단계 및 자체 공지된 다양한 다른 인자들에 따라, 매일 1회, 2회, 3회 또는 임의의 그외 횟수로의 투여에 적합할 수 있다.
용어 캐리어(carrier)와 관련하여 "수송하는"은 매트릭스가 활성 성분의 양을 보유 및/또는 함유할 수 있으며, 매트릭스의 붕해시 매질로 상기 활성 성분을 방출시키는, 활성 성분과 매트릭스 간의 임의 형태의 상호작용을 포괄하는 것으로 이해되어야 한다.
용어 "매트릭스"는 활성 성분에 대한 고형 캐리어 매질을 지칭하는 것으로 이해되어야 한다. 매트릭스는 하나 이상의 부형제를 포함한다. 매트릭스를 형성하는 부형제는 본원에서 때로는 "매트릭스 형성용 성분들"과 "매트릭스 형성용 성분"과 같은 각각의 물질을 지칭할 수 있다.
용어 "개방형 매트릭스 네트워크"는 간극이 전체적으로 분산되어 있는 수용성 또는 수-분산성 캐리어 물질로 구성된 매트릭스를 포괄하는 것으로 이해되어야 한다. 매트릭스는 수용액 또는 타액과의 접촉시 신속하게 붕해된다.
일 구현예에서, 이뉼린이 조성물에서 유일한 매트릭스 형성용 성분이다. 다른 구현예에서, 하나 이상의 제2 매트릭스 형성용 성분이 조성물에 존재할 수 있다.
제2 매트릭스 형성용 성분으로서 사용가능한, 당, 당 알코올, 단당류, 이당류, 삼당류, 다당류, 단백질, 아미노산, 검 등에 대한 비제한적인 예로는, 만니톨, 트레할로스, 라피노스, 풀룰란, 이노시톨, 슈크로스, 락토스, 덱스트로스, 에리트리톨, 자일리톨, 락티톨, 말티톨, 이소말트, 알라닌, 아르기닌, 트레오닌, 글리신, 시스테인, 세린, 히스티딘, 발린, 프롤린, 라이신, 아스파라긴, 글루타민, 리보스, 글루코스, 갈락토스, 프럭토스, 말토스, 말토트리오스, 구아르검, 잔탄검, 트라가칸트 검, 비검(veegum) 등이 있으나, 이들로 한정되는 것은 아니다.
일반적으로, 제형화물의 잔량(balance)은 매트릭스일 수 있다. 따라서, 이뉼린 매트릭스의 퍼센트는 100%에 가까울 수 있다. 본 발명에 따라 사용가능한 제2 매트릭스 형성용 성분은 약 0 내지 약 90%의 범위일 수 있다.
본 발명의 일 구현예에서, 이뉼린이 매트릭스 형성용 주성분이다. 다른 구현예에서, 조성물은 제2 매트릭스 형성용 성분으로서 만니톨, 라피노스, 트레할로스 또는 이들의 조합물을 더 포함한다.
일 구현예에서, 이뉼린은 조성물의 총 중량에서 10 - 99.99%를 구성하는 매트릭스 형성용 성분이다. 다른 구현예에서, 이뉼린은 조성물의 총 중량에서 30 - 80%를 차지한다. 또 다른 구현예에서, 이뉼린은 조성물의 총 중량에서 40 - 75%를 차지한다. 또 다른 구현예에서, 이뉼린은 조성물의 총 중량에서 50 - 65%를 차지한다.
다른 구현예에서, 만니톨, 트레할로스, 라피노스 또는 이의 조합물이 제2 매트릭스 형성용 성분들로서 사용되며, 조성물의 총 중량의 0 - 89.99%를 차지한다. 일 구현예에서, 이러한 제2 매트릭스 형성용 성분은 조성물의 총 중량의 4 - 50%를 차지한다. 다른 구현예에서, 이러한 제2 매트릭스 형성용 성분은 조성물의 총 중량의 25 - 50%를 차지한다.
따라서, 본 발명의 조성물은, 매트릭스 형성용 주성분으로서 이뉼린과 제2 매트릭스 형성용 성분으로서 만니톨, 트레할로스 또는 라피노스 (또는 이들의 조합)를 포함하며, 이뉼린이 10 - 99.99% (성분의 모든 %는 w/w이며, 이는 조합된 조성물의 모든 구성 성분들의 중량 중에서 언급된 성분의 중량을 의미함)를 구성하며, 제2 매트릭스 형성용 성분이 0 - 89.99%, 전형적으로 4 - 50%를 구성하는, 조성물일 수 있다. 활성 성분의 함량은 전형적으로는 전체 조성물의 최대 90%일 수 있으며(그러나 이로 한정되지 않음), 전형적으로 활성 성분의 성질에 따라 약 0.01 - 80%의 범위일 수 있다. 일 구현예에서, 활성 성분은 조성물의 총 중량 중 0.01 - 1%를 차지한다. 다른 구현예에서, 활성 성분은 조성물의 총 중량 중 0.4 - 2%를 차지한다. 또 다른 구현예에서, 활성 성분은 조성물의 총 중량 중 10 - 25%를 차지한다. 다른 구현예에서, 활성 성분은 조성물의 총 중량 중 18 - 40%를 차지한다. 또 다른 구현예에서, 활성 성분은 조성물의 총 중량 중 60 - 90%를 차지한다.
일 구현예에서, 본 발명의 조성물은 어류 젤라틴을 포함하지 않는다. 다른 구현예에서, 본 발명의 조성물은 변형 전분을 포함하지 않는다. 다른 구현예에서, 본 발명의 조성물은 풀루란을 아미노산과 조합하여 포함하지 않는다. 다른 구현예에서, 본 발명의 조성물은 말토덱스트린을 소르비톨과 조합하여 포함하지 않는다.
"붕해 시간" 및 "용해 시간"은 본원에서 상호 호환적으로 사용되며, 본 발명의 조성물이 수용액 중에서 또는 구강내 타액으로 용해 또는 붕해되는데 걸리는 시간을 의미하는 것으로 이해되어야 한다.
"경구 용해 시간"은 본원에서 본 발명의 조성물이 구강에서 용해되는데 걸리는 시간을 의미하는 것으로 이해되어야 한다.
"빠른/급속 붕해/용해"는 본원에서 본 발명의 조성물의 80% 이상이, 전형적으로 조성물의 90%, 보다 전형적으로 100%가, 수성 매질 또는 (구강내) 타액 중에서 10초 이내에, 때로는 심지어 9초 이내에, 8초 이내에, 7초 이내에, 6초 이내에, 5초 이내에, 4초 이내에, 3초 이내에, 2초 이내에, 또는 1초 이내에 붕해되는 것을 포괄하는 것으로 이해되어야 한다.
본원에서 수성 매질의 예로는, 물 또는 완충제 (예, 포타슘 디하이드로겐 포스페이트, 디포타슘 하이드로겐 포스페이트, 소듐 하이드로겐 포스페이트) 또는 Morjaria et. al (May 2004), Dissolution Technologies 12 - 15에 기술된 바와 같은 인공 타액이 있다.
본원에서 타액은 포유류 특히 인간의 구강에 존재하는 타액을 지칭한다.
일 구현예에서, 본 발명의 약학 조성물은 조성물의 80% 이상이 수성 매질 또는 타액 중에서 10초 이내에 용해되는 빠른 용해 속도를 가진다. 다른 구현예에서, 본 발명의 약학 조성물은 조성물의 90% 이상이 수성 매질 또는 타액 중에서 10초 이내에 용해되는 빠른 용해 속도를 가진다. 또 다른 구현예에서, 본 발명의 약학 조성물은 조성물의 100%가 수성 매질 또는 타액 중에서 10초 이내에 용해되는 빠른 용해 속도를 가진다.
상기 개방형 매트릭스 네트워크는 액체가 간극을 통해 제형을 유입시켜 안으로 침투시킬 수 있게 한다. 수성 매질 (예, 타액, 물 등)에 의한 침투는 제형의 내부 및 외부 양쪽의 캐리어 물질을 수성 매질의 작용에 노출시키며, 그로 인해 캐리어 물질로 구성된 네트워크는 신속하게 붕해된다.
상기 개방형 매트릭스 구조는, 다공성 특성의 구조이며, (과립 또는 압축) 정제, 환제, 캡슐제, 좌제 및 페서리제 등의 통상적인 고체 형상의 약학 제형과 비교하여, 제형의 붕해를 강화한다. 신속한 붕해로 인해 매트릭스에 의해 수송되는 활성 성분들이 신속하게 방출된다.
본 발명에서, 개방형 매트릭스 네트워크의 캐리어 물질은 이뉼린 또는 이의 유도체이다.
이뉼린은 전형적으로 말단 글루코스를 가지며 프럭토스 C6H12O6의 폴리머이다. 이뉼린은 프럭토스 고리들이 베타-(2->1)로 연결된 다당류로, 숫자는 프럭토스 고리에서 연결된 탄소 원자를 나타내며, 베타는 입체화학적 관계를 설명한다. 이뉼린은 다수 타입의 식물들에서 제조된다.
이뉼린은 본원에서 비제한적인 예로서 이뉼린을 고농도로 함유하는 식물, 비제한적인 예로서, 국화과(Elecampane)(Inula helenium); 민들레(Dandelion)(Taraxacum officinale); 야생 참마(Wild Yam) (Dioscorea spp.); 예루살렘 아르티코케스(Jerusalem artichokes)(Helianthus tuberosus); 치커리(Chicory)(Cichorium intybus); 히커머(Jicama)(Pachyrhizus erosus); 우엉속 식물(Burdock)(Arctium lappa); 양파(Onion)(Allium cepa); 마늘(Allium sativum); 용설란(Agave)(Agave spp.); 야콘(Smallanthus sonchifolius spp.); 및 애기백합(Camas)(Camassia spp.)과 같은 임의 소스로부터 유래되는 이뉼린을 포함하는 것으로 이해되어야 한다. 구체적인 구현예에서, 이뉼린은 치커리(Cichorium intybus)로부터 수득된다.
약제학적 활성 성분은 약물, 화합물, 펩타이드, 뉴클레오티드 등과 같은 임의의 약제학적 성분을 포괄할 수 있다.
본 발명의 개방형 매트릭스 네트워크를 통해 수송될 수 있는 약물에 대한 비제한적인 예로는, 진통제, 알파 차단제, 항-알레르기제, 항-천식제, (알레르기성 비염, 만성 두드러기), 항염증제, 제산제, 구충제, 항-부정맥제, 항-관절염제, 항-세균제, 항-불안제, 항-응고제, 항-우울제, 항-당뇨병제, 항-설사제, 항-이뇨제, 항-간질병제, 항-진균제, 항-통풍제, 항-고혈압제, 항-요실금제, 항-불면증제, 항-말라리아제, 항-편두통제, 항-무스카린제, 항-신생물제, 면역억제제, 항-원충제, 항-류마티스제, 항-비염제, 항-경련제, 항-갑상선제, 항-바이러스제, 불안 치료제, 진정제, 최면제, 신경이완제, 베타-차단제, 항-양성 비대증(BHP), 심근 수축제(cardiac inotropic), 코르티코스테로이드, 진해제(cough suppressant), 세포독성제, 충혈 완화제, 당뇨병성 위 정체제(diabetic gastric stasis), 이뇨제, 효소제, 항-파킨슨제, 위장제(gastro-intestinal), 히스타민 수용체 길항제, 불임 치료제, 자궁내막증 치료제, 호르몬 대체 요법제, 지질 조절제(lipid regulating agent), 국소 마취제, 신경근육제(neuromuscular agent), 질산염제, 항-협심증제, 월경이상 치료제, 멀미약, 항-통증제, 항-구역질제, 운동장애 치료제, 영양제, 마약성 진통제, 경구 백신, 단백질 약물, 펩타이드 약물, 재조합 약물, 화학요법 유발성 구토 및 수술 후 구토의 예방제, 구토 프로톤 펌프 저해제, 정신분열제, 성 호르몬, 피임약, 뇌졸증/공황 장애 약물, (남성 및 여성의) 성기능 장액 약물, 살정자제, 자극제 배출 기능장애(stimulants voiding dysfunctions) 약물, 수의과 약물 등이 있다.
이러한 약물들에 대한 구체적인 비제한적인 예는 다음과 같다:
알파 차단제: 탐술로신(Tamsulosine)
진통제 및 항염증제: 아스피린, 알로시프린(aloxiprin), 아우라노핀(auranofin), 아자프로파존(azapropazone), 베노릴레이트(benorylate), 디플루니살(diflunisal), 데토돌락(etodolac), 펜부펜(fenbufen), 페노프로펜 칼슘(fenoprofen calcium), 플루르비프로펜(flurbiprofen), 이부프로펜(ibuprofen), 인도메타신(indomethacin), 케토프로펜(ketoprofen), 메클로페남산(meclofenamic acid), 메페남산(mefenamic acid), 나부메톤(nabumetone), 나프록센(naproxen), 옥사프로진(oxaprozin), 옥시펜부타존(oxyphenbutazone), 페닐부타존(phenylbutazone), 피록시캄(piroxicam), 술린닥(sulindac), 파라세타몰(paracetamol).
제산제: 알루미늄 하이드록사이드(aluminum hydroxide), 마그네슘 카보네이트(magnesium carbonate), 마그네슘 트리실리케이트(magnesium trisilicate), 하이드로탈시트(hydrotalcite), 디메티콘(dimethicone).
구충제: 알벤다졸(albendazole), 베페늄 하이드록시나프토에이트(bephenium hydroxynaphthoate), 캄벤다졸(cambendazole), 디클로로펜(dichlorophen), 이베멕틴(ivermectin), 메벤다졸(mebendazole), 옥삼니퀸(oxamniquine), 옥스펜다졸(oxfendazole), 옥산텔 엠보네이트(oxantel embonate), 프라지퀀텔(praziquantel), 피란텔 엠보네이트(pyrantel embonate), 티아벤다졸(thiabendazole).
항-알레르기제: 데스 로라티딘(des loratidine), 로라티딘(loratidine), 몬텔루카스트(Montelukast), 몬델루카스트 소듐(몬텔루카스트 소듐), 세티리진(Cetirizin), 펙소페나딘(Fexofenadin), 에바스틴(Ebastine).
항-부정맥제: 아미오다론(amiodarone) HCl, 디소피라미드(disopyramide), 플레카이니드 아세테이트(flecainide acetate), 퀴니딘 설페이트(quinidine sulphate).
항-세균제: 베네타민 페니실린(benethamine penicillin), 시녹삭신(cinoxacin), 시프로플록삭신(ciprofloxacin) HCl, 클라리트로마이신(clarithromycin), 클로파지민(clofazimine), 클록삭실린(cloxacillin), 데메클로사이클린(demeclocycline), 독시사이클린(doxycycline), 에리트로마이신(erythromycin), 에티온아미드(ethionamide), 이미페넴(imipenem), 날리딕스산(nalidixic acid), 니트로푸란토인(nitrofurantoin), 리팜피신(rifampicin), 스피라마이신(spiramycin), 설파벤자미드(sulphabenzamide), 설파독신(sulphadoxine), 설파머라진(sulphamerazine), 설프아세트아미드(sulphacetamide), 설파디아진(sulphadiazine), 설파푸라졸(sulphafurazole), 설파메톡사졸(sulphamethoxazole), 설파피리딘(sulphapyridine), 테트라사이클린(tetracycline), 트리메토프림(trimethoprim).
항-응고제: 디쿠마롤(dicoumarol), 디피리다몰(dipyridamole), 니코말론(nicoumalone), 펜인디온(phenindione).
항-우울증제: 아목사핀(amoxapine), 시클라진돌(ciclazindol), 마프로틸린(maprotiline) HCl, 미안세린(mianserin) HCl, 노르트립틸린(nortriptyline) HCl, 트라조돈(trazodone) HCl, 트리미프라민 말리에이트(trimipramine maleate).
항-당뇨병제: 아세토헥사미드(acetohexamide), 클로르프로파미드(chlorpropamide), 글리벤클라미드(glibenclamide), 글리클라지드(gliclazide), 글리피지드(glipizide), 톨라자미드(tolazamide), 톨부타미드(tolbutamide).
항-설사제: 어트로핀 설페이트(atropine sulphate), 코데인 포스페이트(codeine phosphate), 코-페노트로프(co-phenotrope), 디페녹신(difenoxin), 로페라미드 하이드로클로라이드(loperamide hydrochloride), 서파솔라진(suphasolazine), 메살라진(mesalazine), 올살라진(olsalazine), 코르티코스테로이드(corticosteroid), 프레드니솔론(prednisolone).
항-이뇨제: 데스모프레신(desmopressin), 데스모프레신 아세테이트(desmopressin acetate).
항-간질병제: 베클라미드(beclamide), 카르바마제핀(carbamazepine), 클로나제팜(clonazepam), 에토토인(ethotoin), 메토인(methoin), 메트숙시미드(methsuximide), 메틸페노바르비톤(methylphenobarbitone), 옥스카르바제핀(oxcarbazepine), 파라메타디온(paramethadione), 펜아세미드(phenacemide), 페노바르비톤(phenobarbitone), 페니토인(phenytoin), 펜숙시미드(phensuximide), 프리미돈(primidone), 설티암(sulthiame), 발프록산(valproic acid).
항-진균제: 암포테리신(amphotericin), 부토코나졸 나이트레이트(butoconazole nitrate), 클로트리마졸(clotrimazole), 에코나졸 나이트레이트(econazole nitrate), 플루코나졸(fluconazole), 플루사이토신(flucytosine), 그리세오풀빈(griseofulvin), 이트라코나졸(itraconazole), 케토코나졸(ketoconazole), 미코나졸(miconazole), 나타마이신(natamycin), 니스타틴(nystatin), 술코나졸 나이트레이트(sulconazole nitrate), 테르비나핀(terbinafine) HCl, 테르코나졸(terconazole), 티코나졸(tioconazole), 운데세노익산(undecenoic acid).
항-통풍제: 알로푸리놀(allopurinol), 프로베네시드(probenecid), 설핀피라존(sulphinpyrazone).
항-고혈압제: 암로피딘(amlopidine), 베니디핀(benidipine), 다로디핀(darodipine), 딜리타젬(dilitazem) HCl, 디아족시드(diazoxide), 펠로디핀(felodipine), 구아나벤즈 아세테이트(guanabenz acetate), 인도라민(indoramin), 이스라디핀(isradipine), 미녹시딜(minoxidil), 니카르디핀(nicardipine) HCl, 니페디핀(nifedipine), 니모디핀(nimodipine), 페녹시펜즈아민(phenoxybenzamine) HCl, 프라조신(prazosin) HCl, 리세르핀(reserpine), 테라조신(terazosin) HCl.
항-불면증제: 졸피뎀(Zolpidem).
항-말라리아제: 아모디아퀸(amodiaquine), 클로로퀸(chloroquine), 클로로프로구아닐(chloroproguanil) HCl, 할로판트린(halofantrine) HCl, 메플로퀸(mefloquine) HCl, 프로구아닐(proguanil) HCl, 피리메타민(pyrimethamine), 퀴닌 설페이트(quinine sulphate).
항-편두통제: 리자트립탄(rizatriptan), 디하이드로에르고타민 메실레이트(dihydroergotamine mesylate), 에르고타민 타르트레이트(ergotamine tartrate), 메티세르지드 말리에이트(methysergide maleate), 피조티펜 말리에이트(pizotifen maleate), 수마트립탄(sumatriptan), 숙시네이트(succinate), 카페인(caffeine).
항-무스카린제: 옥시부티닌(oxybutinin), 톨테로딘(tolterodin), 어트로핀(atropine), 벤즈헥솔(benzhexol) HCl, 비페리덴(biperiden), 에토프로파진(ethopropazine) HCl, 히오신 부틸 브로마이드(hyoscine butyl bromide), 히오시아민(hyoscyamine), 메펜졸레이트 브로마이드(mepenzolate bromide), 오르페나드린(orphenadrine), 옥시펜사일시민(oxyphencylcimine) HCl, 트로피카미드(tropicamide).
항-신생물제 및 면역억제제: 아미노글루테티미드(aminoglutethimide), 암사크린(amsacrine), 아자티오프렌(azathioprene), 부설판(busulphan), 클로람부실(chlorambucil), 사이클로스포린(cyclosporin), 다카르바진(dacarbazine), 에스트라무스틴(estramustine), 에토포시드(etoposide), 로무스틴(lomustine), 멜팔란(melphalan), 머캅토푸린(mercaptopurine), 메토트렉세이트(methotrexate), 미토마이신(mitomycin), 미토탄(mitotane), 미토잔트론(mitozantrone), 프로카바진(procarbazine) HCl, 타목시펜 시트레이트(tamoxifen citrate), 테스톨락톤(testolactone).
항-원충제: 벤즈니다졸(benznidazole), 클로퀴놀(clioquinol), 데코퀴네이트(decoquinate), 디아이도하이드록시퀴놀린(diiodohydroxyquinoline), 딜록사니드 푸르케이트(diloxanide furcate), 디니톨미드(dinitolmide), 푸르졸리돈(furzolidone), 메트로니다졸(metronidazole), 니모라졸(nimorazole), 니트로푸라존(nitrofurazone), 오르니다졸(ornidazole), 티니다졸(tinidazole).
항-류마티스제: 이부프로펜(ibuprofen), 아세클로페낙(aceclofenac), 아세메타신(acemetacin), 아자프로파존(azapropazone), 디클로페낙 소듐(diclofenac sodium), 디플루니살(diflunisal), 에토돌락(etodolac), 케토프로펜(ketoprofen), 인도메타신(indomethacin), 메페남산(mefenamic acid), 나프록센(naproxen), 피록시캄(piroxicam), 아스피린(aspirin), 베노릴레이트(benorylate), 아우라노핀(auranofin), 페니실아민(penicillamine).
항-비염제, 항-두드러기제: 세티리진(Cetirizin), 펙소페나딘(fexofenadin), 에바스틴(ebastine), 로라티딘(loratidin), 몬텔루카스트(montelukast).
항-경련제: 플로로글루시놀 안하이드리(phloroglucinol anhydre)
항-갑상선제: 카비마졸(carbimazole), 프로필티오우라실(propylthiouracil).
항-바이러스제: 아시클로비르(acyclovir), 아만타딘 하이드로클로라이드(amantadine hydrochloride), 팜시클로비르(famciclovir), 지도바딘(zidovadine), 디다노신(didanosine), 잘시타빈(zalcitabine), 소프카르넷 소듐(foscarnet sodium).
불안 치료제, 진정제, 최면제 및 신경이완제: 알프라졸람(alprazolam), 아밀로바르비톤(amylobarbitone), 바르비톤(barbitone), 벤타제팜(bentazepam), 브로마제팜(bromazepam), 브롬페리돌(bromperidol), 브로티졸람(brotizolam), 부토바르비톤(butobarbitone), 카브로말(carbromal), 클로르디아제폭시드(chlordiazepoxide), 클로르페니라민(Chlorpheniramine), 클로르메티아졸(chlormethiazole), 클로르프로마진(chlorpromazine), 클로바잠(clobazam), 클로나제판(clonazepan), 클로티아제팜(clotiazepam), 클로자핀(clozapine), 디아제팜(diazepam), 드로페리돌(droperidol), 에티나메이트(ethinamate), 플루나니손(flunanisone), 플루니트라제팜(flunitrazepam), 플루오프로마진(fluopromazine), 플루펜티솔 데카노에이트(flupenthixol decanoate), 플루페나진 데카노에이트(fluphenazine decanoate), 플루라제팜(flurazepam), 할로페리돌(haloperidol), 로라제팜(lorazepam), 로르메타제팜(lormetazepam), 메다제팜(medazepam), 메프로바메이트(meprobamate), 메타쿠알론(methaqualone), 미다졸람(midazolam), 니트라제팜(nitrazepam), 옥사제팜(oxazepam), 펜토바르비톤(pentobarbitone), 페르페나진(perphenazine), 페닐에프린(phenylephrine), 피모지드(pimozide), 프로클로르페라진(prochlorperazine), 슈도에페드린(pseudoephedrine) HCl, 설프라이드(sulpride), 테마제팜(temazepam), 티오리다진(thioridazine), 트리아졸람(triazolam), 조픽클론(zopiclone).
베타-차단제: 아세부톨롤(acebutolol), 알프레놀롤(alprenolol), 아테놀롤(atenolol), 라베탈롤(labetalol), 메토프롤롤(metoprolol), 나돌롤(nadolol), 옥스프레놀롤(oxprenolol), 핀돌롤(pindolol), 프로파놀롤(propanolol).
심근 수축제: 암리논(amrinone), 디지톡신(digitoxin), 디곡신(digoxin), 에녹시몬(enoximone), 라나토시드(lanatoside) C, 메디고옥신(medigoxin).
코르티코스테로이드제: 베클로메타손(beclomethasone), 베타메타손(betamethasone), 부데소니드(budesonide), 코르티손 아세테이트(cortisone acetate), 데속시메타손(desoxymethasone), 덱사메타손(dexamethasone), 플루드로코르티손 아세테이트(fludrocortisone acetate), 플루니솔라이드(flunisolide), 플루코르톨론(flucortolone), 플루티카손 프로피오네이트(fluticasone propionate), 하이드로코르티손(hydrocortisone), 메틸프레드니솔론(methylprednisolone), 프레드니솔론(prednisolone), 프레드니손(prednisone), 트리암시놀론(triamcinolone).
진해제: 코데인 포스페이트(codeine phosphate), 덱소메토르판(dexomethorphan), 구아이페네신(guaifenesin), 폴코딘(pholcodine), 디아모르핀(diamorphine), 메타돈(methadone).
세포독성제: 이포스파미드(ifosfamide), 클로람부실(chlorambucil), 멜팔란(melphalan), 부설판(busulphan), 세포독성 항체(cytotoxic antibodies), 독소루비신(doxorubicin), 에피루비신(epirubicin), 플리카마이신(plicamycin), 블레오마이신(bleomycin), 메토트렉세이트(methotrexate), 시타라빈(cytarabine), 플루다라빈(fludarabine), 젠시타빈(gencitabine), 플루오로우라실(fluorouracil), 머캅토푸린(mercaptopurine), 티오구아닌(thioguanine), 빈크리스틴(vincristine), 빈블라스틴(vinblastine), 빈데신(vindesine), 에토포시드(etoposide).
충혈 완화제: 슈도에페드린 하이드로클로라이드(pseudoephedrine hydrochloride).
이뇨제: 아세타졸아미드(acetazolamide), 아밀로라이드(amiloride), 벤드로플루아지드(bendrofluazide), 부메타니드(bumetanide), 클로로티아지드(chlorothiazide), 클로르탈리돈(chlorthalidone), 에타크린산(ethacrynic acid), 프루세미드(frusemide), 메톨라존(metolazone), 스피로놀락톤(spironolactone), 트리암테렌(triamterene).
효소제: 판트레아틴, 펩신, 리파제.
간질 치료제: 가바펜틴(Gabapentin)
항-파킨슨제: 브로모크립틴 메실레이트(bromocriptine mesylate), 라이수리드 말리에이트(lysuride maleate), 셀레길린(selegiline), 파라-플루오로셀레길린(para-fluoroselegiline), 라자베미드(lazabemide), 라사길린(rasagiline), 2-BUMP [N-(2-부틸)-N-메틸프로파르길아민], M-2-PP [N-메틸-N-(2-펜틸)-프로파르길아민], MDL-72145 [베타-(플루오로메틸렌)-3,4-디메톡시-벤젠에탄아민], 모페길린(mofegiline), 아포모르핀(apomorphine), N-프로필노라포르핀(propylnoraporphine), 카베르골린(cabergoline), 메테르골린(metergoline), 낙사골리드(naxagolide), 퍼골리드(pergolide), 피리베딜(piribedil), 로피니롤(ropinirole), 테르구라이드(terguride), 퀴나골라이드(quinagolide).
위장제: 비사코딜(bisacodyl), 시메티딘(cimetidine), 시사프라이드(cisapride), 디페녹실레이트(diphenoxylate) HCl, 돔페리돈(domperidone), 메토클로프라미드(metoclopramide), 파모티딘(famotidine), 로페라미드(loperamide), 메살라진(mesalazine), 니자티딘(nizatidine), 에소메프라졸(esomeprazole), 메토피마진(metopimazine), 판토프라졸(pantoprazole), 온단세트론(ondansetron) HCl, 그라니세트론(Granisetron), 트로피세트론(tropisetron), 돌라세트론(dolasetron), 라니티딘(ranitidine) HCl, 설파살라진(sulphasalazine), 란조프라졸(Lanzoprazole).
히스타민 수용체 길항제: 아크리바스틴(acrivastine), 아스테미졸(astemizole), 신나리진(cinnarizine), 사이클리진(cyclizine), 사이프로펩타딘(cyproheptadine) HCl, 디멘하이드리네이트(dimenhydrinate), 플루나리진(flunarizine) HCl, 로라타딘(loratadine), 메클로진(meclozine) HCl, 옥사토미드(oxatomide), 테르페나딘(terfenadine), 트리프롤리딘(triprolidine).
호르몬 대체 요법제: 디드로게스테론(dydrogesterone)
고혈압: 에날라프릴(Enalapril)
수유(Lactation): 옥시톡신(Oxytocin), 옥시톡신 작용제(oxytocin agonist).
지질 조절제: 베자피브레이트(bezafibrate), 클로피브레이트(clofibrate), 페노피브레이트(fenofibrate), 겜피브로질(gemfibrozil), 프로부콜(probucol).
국소 마취제: 아메토카인(amethocaine), 아밀로카인(amylocaine), 벤조카인(benzocaine), 부크리카인(bucricaine), 부피바카인(bupivacaine), 부타카인(butacaine), 부타닐리카인(butanilicaine), 부톡시카인(butoxycaine), 부틸 아미노벤조에이트(butyl aminobenzoate), 카르티카인(carticaine), 클로로프로카인(chloroprocaine), 신코카인(cinchocaine), 클리부카인(clibucaine), 클로르메카인(clormecaine), 코카(coca), 코카인(cocaine), 사이클로메티카인(cyclomethycaine), 디메티소퀸(dimethisoquin), 디페로돈(diperodon), 디클로카인(dyclocaine), 에틸 클로라이드(ethyl chloride), 에틸 p-피페리디노아세틸아미노벤조에이트, 에티도카인(etidocaine), 헥실카인(hexylcaine), 이소부탐벤(isobutamben), 케토카인(ketocaine), 리그노카인(lignocaine), 메피바카인(mepivacaine), 메프릴카인(meprylcaine), 미르테카인(myrtecaine), 옥타카인(octacaine), 옥세타자인(oxethazaine), 옥시부프로카인(oxybuprocaine), 파르에톡시카인(parethoxycaine), 프라목신(pramoxine), 프릴로카인(prilocaine), 프로카인(procaine), 프로프라노카인(propranocaine), 프로폭시카인(propoxycaine), 프록시메타카인(proxymetacaine), 로피바카인(ropivacaine), 톨리카인(tolycaine), 트리카인(tricaine), 트리메카인(trimecaine), 바도카인(vadocaine).
운동장애 치료제: 디펜하이드라민(diphenhydramine).
신경근육제: 피리도스티그민(pyridostigmine).
질산염제 및 그외 항-협심증제: 아밀 나이트레이트(amyl nitrate), 글리세릴 트리나이트레이트(glyceryl trinitrate), 이소소르비드 디나이트레이트(isosorbide dinitrate), 이소소르비드 모노나이트레이트(isosorbide mononitrate), 펜타에리트리톨 테트라니트레이트(pentaerythritol tetranitrate).
영양제: 베타카로텐(betacarotene), 비타민, 예로 비타민 A, 비타민 B2, 비타민 D, 비타민 E, 비타민 K, 미네랄류.
마약성 진통제: 코데인(codeine), 덱스트로프로피옥시펜(dextropropyoxyphene), 디아모르핀(diamorphine), 디하이드로코데인(dihydrocodeine), 멥타지놀(meptazinol), 메타돈(methadone), 모르핀(morphine), 날부핀(nalbuphine), 펜타족신(pentazocine).
경구 백신: 인플루엔자(Influenza), 결핵(Tuberculosis), 수막염(Meningitis), 간염(Hepatitis), 백일해(Whooping Cough), 소아마비(Polio), 파상풍(Tetanus), 디프테리아(Diphtheria), 말라리아(Malaria), 콜레라(Cholera), 헤르페스(Herpes), 장티푸스(Typhoid), HIV, AIDS, 홍역(Measles), 라임병(Lyme disease), 여행자 설사증(Traveller's Diarrhea), A형, B형 및 C형 간염, 중이염(Otitis Media), 뎅기열(Dengue Fever), 광견병(Rabies), 파라인플루엔자(Parainfluenza), 풍진(Rubella), 황열(Yellow Fever), 이질(Dysentery), 재향군인병(Legionnaires Disease), 주혈 원충병(Toxoplasmosis), Q-열, 출혈열(Haemorrhegic Fever), 아르헨티나 출혈열(Argentina Haemorrhegic Fever), 충치(Caries), 샤가스병(Chagas Disease), 대장균으로 인한 비뇨관 감염(E. coli에 의해 유발되는 비뇨관 감염), 폐렴 질환(Pneumococcal Disease), 유행성 이하선염(Mumps), 치쿤구니아(Chikungunya), 건초열(Hayfever), 천식(Asthma), 류마티스 관절염(Rheumatoid Arthritis), 암(Carcinomas), 콕시디아증(Coccidiosis), 뉴캐슬병(Newcastle Disease), 풍토병성 폐렴(Enzootic pneumonia), 고양이 백혈병(Feline leukemia), 위축성 비염(Atrophic rhinitis), 단독(Erysipelas), 구제역(Foot and Mouth disease) 및 돼지 폐렴과 같은 질환들의 증상을 예방 또는 완화시키기 위한 약물, 또는 비브리오(Vibrio) 종, 살모넬라(Salmonella) 종, 보르데텔라(Bordetella) 종, 헤모필러스(Haemophilus) 종, 톡소플라모시스 곤디(Toxoplasmosis gondii), 사이토메갈로바이러스(Cytomegalovirus), 클라미디아(Chlamydia) 종, 스트렙토코커스(Streptococcal) 종, 노르월크 바이러스(Norwalk Virus), 에셰리키아 콜리(Escherischia coli), 헬리코박터 필로리(Helicobacter pylori), 로타바이러스(Rotavirus), 네이세리아 고노헤(Neisseria gonorrhae), 나이세리아 메닝기디티스(Neisseria meningiditis), 아데노바이러스(Adenovirus), 엡스타인 바르 바이러스(Epstein Barr Virus), 일본 뇌염 바이러스(Japanese Encephalitis Virus), 뉴모시스티스 카리니(Pneumocystis carini), 헤르페스 심플렉스(Herpes simplex), 클로스트리디아(Clostridia) 종, 호흡기 신시티아 바이러스(Respiratory Syncytial Virus), 클렙시엘라(Klebsiella) 종, 시겔라(Shigella) 종, 슈도모나스 에어루지노사(Pseudomonas aeruginosa), 파르보바이러스(Parvovirus), 캄필로박터(Campylobacter) 종, 리케차(Rickettsia) 종, 바리셀라 조스터(Varicella zoster), 예르시니아(Yersinia) 종, 로스 리버 바이러스(Ross River Virus), J.C. 바이러스, 로도코커스 에퀴(Rhodococcus equi), 모락셀라 카타르할리스(Moraxella catarrhalis), 보렐리아 부그그도르페리(Borrelia burgdorferi) 및 파스튜렐라 헤몰리티카(Pasteurella haemolytica)에 의해 야기되는 질환들의 증상을 예방 또는 완화하기 위한 약제.
배출 기능장애제: 탐술로신(Tamsulosine), 트로스피움 클로라이드(trospium chloride), 톨테로딘(tolterodine), 옥시부티닌(oxybutinin).
단백질, 펩타이드 및 재조합 약물: 재조합 호르몬제와 이소-호르몬제, 재조합 사이토카인, 재조합 플라스미노겐, TNF 수용체 융합 단백질, 단일클론 항체, 핵산, 안티센스 올리고뉴클레오티드, 올리고뉴클레오티드, 당단백질 및 부착 분자들.
수의학적 관절염제: 테폭살린(Tepoxalin)
성 호르몬 및 피임제: 클로미펜 시트레이트(clomiphene citrate), 다나졸(danazol), 데소게스트렐(desogestrel), 에티닐오에스트라디올(ethinyloestradiol), 에티노디올(ethynodiol), 에티노디올 디아세테이트(ethynodiol diacetate), 레보노르게스트렐(levonorgestrel), 메드록시프로게스테론 아세테이트(medroxyprogesterone acetate), 메스트라놀(mestranol), 메틸테스토스테론(methyltestosterone), 노르에티스테론(norethisterone), 노르에티스테론 엔안테이트(norethisterone enanthate), 노르게스트렐(norgestrel), 에스트라디올(estradiol), 접합된 에스트로겐(conjugated estrogen), 디드로게스테론(dydrogesterone), 프로게스테론(progesterone), 스타노졸롤(stanozolol), 스틸보에스트롤(stilboestrol), 테스토스테론(testosterone), 티볼론(tibolone).
정신분열증: 올란자핀(Olanzapine), 니세르골린(Nicergoline).
성 기능장애: 카베르골린(Cabergolin), 옥시톡신(oxytocin), 타달라필(tadalafil), 실데나필(sildenafil), 바르데나필(vardenafil).
살정자제: 노녹시놀(nonoxynol) 9.
자극제: 암페타민(amphetamine), 덱사암페타민(dexamphetamine), 덱스펜플루라민(dexfenfluramine), 펜플루라민(fenfluramine), 마진돌(mazindol), 페몰린(pemoline).
구체적이고 비제한적인 구현예에서, 활성 성분은 데스모프레신 아세테이트이다. 본 구현예에서, 제형은, 배뇨 지연, 또는 요실금, 일차 야간 유뇨증(PNE: primary nocturnal enuresis), 야뇨증 또는 중추성 요붕증(central diabetes insipidu)의 치료 또는 예방에 사용될 수 있다. 일 구현예에서, 조성물내 데스모프레신 아세테이트의 양은 0.01 - 2.75% w/w이다. 다른 구현예에서, 조성물내 데스모프레신 아세테이트의 양은 0.06 - 2.00% w/w이다.
구체적인 비제한적인 구현예에서, 활성 성분은 로라티딘이다. 이러한 구현예에서, 제형은, 예컨대 알레르기성 비염 및 만성 특발성 두드러기의 코 또는 코 이외의 증상을 완화시키기 위해 사용될 수 있다. 일 구현예에서, 조성물내 로라티딘의 양은 15-20% w/w이다. 다른 구현예에서, 조성물내 로라티딘의 양은 약 19% w/w이다.
구체적인 비제한적인 구현예에서, 활성 성분은 파모티딘이다. 본 구현예에서, 제형은 예컨대 위식도 역류 질환, 십이지장 및 위 궤양, 병리학적 과분비 병태들 (예, 졸린거-엘리슨 증후군 및 다발성 내분비 선종)의 치료에 사용될 수 있다. 일 구현예에서, 조성물내 파모티딘의 양은 20-90% w/w이다. 다른 구현에에서, 조성물내 파모티딘의 양은 30-85% w/w이다.
구체적이고 비제한적인 구현예에서, 활성 성분은 몬텔루카스트 소듐이다. 본 구현예에서, 제형은 예컨대 천식, 알레르기성 비염 및 운동-유발성 기관지 수축증의 예방과 장기간의 치료에 사용될 수 있다. 일 구현예에서, 조성물내 몬텔루카스트 소듐의 양은 5-30% w/w이다. 다른 구현예에서, 조성물내 몬젤루카스트 소듐의 양은 10-25% w/w이다.
본 발명의 약학 제형은 유체 (수성 매질 또는 타액)와의 접촉시 붕해되어 활성 성분이 방출된다.
전형적으로, 본 발명의 약학 제형은 입안에서 10초 또는 그 미만 이내에 붕해되는 구강분산성(orodispersible) 약학 제형이다.
용어 "구강분산성"은 본원에서 입안에서 (대부분) 10초 이내에 붕해 또는 용해되는 고형 제형을 포괄하는 것으로 이해되어야 한다. 다른 구현예에서, 구강붕해성 제형은 입안에서 9, 8, 7, 6, 5, 4, 3, 2 또는 심지어 1초 이내에 붕해된다.
본 발명의 제형의 적합한 투여 경로는 볼 및 설하 투여를 비롯한 경구 투여이다. 구체적인 구현예에서, 제형은 설하로 투여된다. 또한, 본 발명의 제형은 혀 위에 두거나 또는 볼이나 잇몸에 접하게 둘 수 있다.
본 발명의 약학 제형은 활성 성분을 예로 구강으로 공급하도록 할 수 있다. 활성 성분은 투여 부위에서 점막, 예컨대 설하 점막을 통해, 및/또는 경구 투여의 경우에는 구강으로부터 (예, 볼 또는 잇몸 점막을 통해) 및/또는 전신 분포를 위해 위장관으로부터 흡수될 수 있다.
제형의 정확한 투여량과 투여 요법은 달성할 치료학적 효과에 따라 필연적으로 결정될 것이며, 구체적인 활성 성분, 투여 경로, 약제를 투여받는 개개 개체의 연령과 증상에 따라 달라질 수 있다. 때로 환자는 단위 제형 2개 또는 임의의 그외 갯수로 1회 투여시 복용하도록 처방받을 수 있거나, 또는 단위 제형을 일부만, 예컨대 1/2 또는 1/4만 1회 투여시 복용하도록 처방받을 수 있다.
본 발명의 제형은 성능 밸런스를 달성한다: 안정성 및 신속한 붕해성. 본 제형은 공지의 동결건조 기법으로 제조할 수 있다. 이는 블리스터에 보관 (및 팩킹)시킬 수 있다. 본 발명은 이러한 결과를 한 단계 처리 공정으로 달성하며, 과립화 등의 다단계에 의존할 필요가 없다.
앞에서 언급한 성분들 외에도, 매트릭스는 다른 부형제들 (보조제, 부속제), 예컨대, 비제한적인 예로서, 매트릭스-형성제, 증점제 (비제한적인 예로서 구아르검 및 잔탄검), 결합제, 희석제, 윤활제, pH 조절제, 보호제, 점성 증강제, 심지제(wicking agent), 비발포성 붕해제, 발포성 붕해제, 계면활성제, 항산화제, 습윤제, 착색제, 향제, 고미차폐제(taste-masking agent), 감미제, 보존제 등을 포함할 수 있다.
일 구현예에서, 본 발명의 조성물은 활성 성분, 이뉼린, 및 선택적으로 제2 매트릭스 형성제(들)를 용매 중에 포함하는 액체 조제물로부터 용매를 승화시킴으로써 수득가능하다. 전형적으로, 액체 조제물은 몰드에 배치되며, 예컨대, 승화 후, 전형적으로 투여량 단위의 고체 조성물이 몰드 안에서 형성된다. 몰드는, 고형 투여량 단위를 블리스터 팩의 오목부에서 형성시킨 후 실링 필름 또는 호일로 밀봉하는, 개방형 블리스터 팩(open blister pack)일 수 있다.
일 구현예에서, 방법은 개방형 블리스터 팩의 오목부에 상기 조제물을 단위 투여량으로 넣은 다음, 이 조제물을 승화시켜 상기 오목부 안에서 고체 제형을 수득하는 단계를 포함한다.
승화는 활성 성분, 이뉼린 및 선택적으로 제2 매트릭스 형성제(들)를 용매 중에서 포함하는 조제물을 냉동 건조시킴으로써 수행할 수 있다. 일 구현예에서, 상기 용매는 물이다.
이에, 본 발명은 활성 성분, 이뉼린 및 선택적으로 제2 매트릭스 형성제(들)의 조합을 동결건조함으로써 급속-분산성 제형을 제조하는 방법을 개시한다. 상기 급속-분산성 제형은 활성 성분과 캐리어 이뉼린을 포함하는 네트워크를 포함하며, 상기 네트워크는 활성 성분, 이뉼린 및 다른 선택적인 매트릭스 형성제를 포함하는 액체 조제물로부터 용매를 승화시킴으로써 획득된 것이다. 상기 조제물은 용액, 현탁물 또는 분산물일 수 있다.
전형적으로, 활성 성분, 이뉼린 및 선택적으로 제2 매트릭스 형성제(들)를 용매 중에서 포함하는 초기 조제물을 제조한 다음, 이를 승화시킨다. 승화는 상기 조제물을 냉동 건조시킴으로써 수행될 수 있다.
냉동 건조 공정에서, 활성 성분, 이뉼린 및 임의의 다른 선택적으로 매트릭스 형성제를 용매 중에서 포함하는 (액체 형태의) 조제물을 몰드에 충전한다. 각 몰드에 전형적으로 규정량의 활성 성분과 더불어 규정량의 상기 용액을 수용시킨다. 그런 후, 몰드 안의 조제물을 예컨대 몰드 위로 기체 냉각 매질을 통과시킴으로써 동결시킨다. 조제물이 동결된 후, 조제물로부터 용매는 승화된다. 승화는 냉동 건조기에서 이루어진다. 그 결과, 활성 성분을 포함하고 있는 용액에 함유된, 이뉼린, 및 선택적으로 다른 매트릭스 형성제와 함께 이루어진 개방형 매트릭스 네트워크가 그로인해 형성된다.
조제물은 임의의 원하는 형태로 고체 형태를 만들기 위해 동결-건조 공정 동안에 몰드 안에 수용된다. 동결건조하기 전에, 몰드를 예컨대 액체 질소 또는 고체 이산화탄소를 이용하여 (예, 급속-동결 터널에서 또는 동결건조기의 선반대에서) 냉각 및 냉동시킬 수 있다.
동결건조 후, 동결건조된 조성물은 필요에 따라 몰드에서 꺼내거나 또는 추후 사용할 때까지 그 안에 보관시킬 수 있다. 전형적으로, 각 몰드는 조성물의 단위 제형을 제조하도록 설계된다. 이렇게 수득되는 조성물은 급속-분산성이며, 유체와의 접촉시 10초 이내에 붕해된다.
용매는 물일 수 있지만, 선택적으로 화합물의 용해성을 개선시키기 위해 공-용매 (예, 알코올, 예, tert-부틸 알코올)를 포함할 수 있다.
조성물은, 제형이 pH 2-10, 전형적으로 3.5 - 9.5 또는 4.5 - 8의 범위내에서 제조되는 용액의 pH를 적정하기 위해, pH 조절제를 포함할 수 있다. 시트르산, 소듐 하이드록사이드 및 소듐 카보네이트를 pH 조절제로서 하지만, 염산 및 말산 등의 다른 것들도 사용할 수 있다. 비-휘발성 pH 조절제는 동결 건조에 의해 또는 다른 승화 공정에 의해 제거되지 않을 것이며, 그래서 최종 산물에 존재할 수 있다.
몰드는 그 안에 원통형 또는 다른 형태의 오목부 시리즈를 포함할 수 있으며, 오목부 각각의 크기는 형성시킬 제형의 원하는 크기와 일치한다.
일 구현예에서, 몰드는 필름성 물질(filmic material)의 시트내 오목부이다. 필름성 물질은 2개 이상의 오목부를 가질 수 있다. 필름성 물질은 경구 피임정 및 유사 의약제 형태들을 포장하기 위해 사용되는 통상적인 블리스터 팩에서 사용되는 것과 유사할 수 있다. 예컨대, 필름성 물질은 가열성형 또는 냉각성형에 의해 형성된 오목부를 구비한 열가소성 물질로 제작될 수 있다. 폴리비닐 클로라이드 필름이 필름성 물질로서 사용될 수 있다. 또한, 필름성 물질로 이루어진 라미네이트도 사용할 수 있다.
실시예
본 발명은 아래 실시예들에서 더욱 설명되며, 아래 실시예들은 어떠한 방식으로도 청구되는 본 발명의 범위를 제한하는 것으로 의도되지 않는다.
A)
아래 제시된 실시예들에서 사용되는 재료들
물질 | 입수처 |
이뉼린 (치커리 뿌리 유래) | Beneo Orafti, Belgium |
시트르산 | Merck, India |
만니톨 | Merck, India |
데스모프레신 아세테이트 | Polypeptide Labs A/S에서 제조, Ferring에서 판매 |
로라타딘 | Ultratech India Ltd |
파모타딘 | Exim Pharma International, India |
몬텔루카스트 소듐 | MSN Pharma Chem Pvt. Ltd., India |
구아르검 | Merck, India |
잔탄건 | SD Fine Chem Ltd., India |
소듐 시트레이트 | Merck, India |
풀룰란 | Hyashibara, Japan |
글리신 | Sigma Aldrich |
하이드로프로필 메틸 셀룰로스 (HPMC) | Shin-Etsu Chemical Co. Japan |
메틸 셀룰로스 | Shin-Etsu Chemical Co. Japan |
트라가칸트검 | Merck, India |
네오탐 | Nutrasweet, USA |
체리향 | Virginia Dare, USA |
B) 위약 제형의 제조법
1) 이뉼린과 존재하는 경우 다른 부형제를 정제수에 200 - 500 rpm으로 교반하면서, 용해한다.
2) 시트르산 용액 또는 NaOH로 상기 용액의 pH를 조정한다.
3) 상기 용액의 최종 부피를 정제수로 맞춘다.
4) 상기 용액을 다시 15분간 200 - 500 rpm으로 교반하면서 혼합한다.
5) 사전제조된 블리스터 시트의 각 공동에 (바람직하게는 할당 파이펫을 이용하여) 상기 용액을 넣는다.
6) 충전시킨 블리스터를 -20 내지 -110℃의 온도 범위에서 냉동시킨다.
7) 상기 블리스터를 동결건조기에서 동결 건조한다.
8) 건조된 동결건조물이 든 상기 블리스터 시트를 블리스터 포장 기계의 펀칭 캐리어 웹(punched carrier web) 위에 두어, 상기 블리스터 시트를 포장 기계의 밀봉 스테이션을 통과 이동시킨다
9) 상기 블리스터를 덮개 호일로 밀봉하고 최종 블리스터로 펀칭한다.
C)
제형
상기 방법 섹션 "B"에 기술된 방법을 이용하여, 아래 제형들을 제조하였다.
실시예 1
구성 성분 | 함량/unit | % w/w |
이뉼린 | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 2
구성 성분 | 함량 | % w/w |
이뉼린 | 12.5 mg | 50 |
만니톨 | 12.5 mg | 50 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 3
구성 성분 | 함량 | % w/w |
이뉼린 | 12.5 mg | 49.99 |
만니톨 | 12.5 mg | 49.99 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 4
구성 성분 | 함량 | % w/w |
이뉼린 | 18.75 mg | 49.99 |
만니톨 | 18.75 mg | 49.99 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 5
구성 성분 | 함량 | % w/w |
이뉼린 | 18.75 mg | 74.99 |
라피노스 | 6.25 mg | 24.99 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 6
구성 성분 | 함량 | % w/w |
이뉼린 | 18.75 mg | 74.99 |
트레할로스 | 6.25 mg | 24.99 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 7
구성 성분 | 함량 | % w/w |
이뉼린 | 37.5 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 8
구성 성분 | 함량 | % w/w |
이뉼린 | 37.5 mg | 99.99 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 9
구성 성분 | 함량 | % w/w |
이뉼린 | 37.5 mg | 71.39 |
만니톨 | 15 mg | 28.59 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
D) 데스모프레신 함유 제형의 제조법
1) 이뉼린과 다른 부형제를 정제수에 200 - 500 rpm으로 교반하면서, 용해한다.
2) 정제수에 데스모프레신 아세테이트를 용해하여, 이를 단계 1에서 준비한 용액에 첨가한다.
3) 시트르산 용액 (5% w/v)으로 상기 용액의 pH를 조정한다.
4) 상기 용액의 최종 부피를 정제수로 맞춘다.
5) 상기 용액을 다시 5 - 15분간 200 - 500 rpm으로 교반하면서 혼합한다.
6) 사전제조된 블리스터 시트의 각 공동에 (바람직하게는 할당 파이펫을 이용하여) 상기 용액을 넣는다.
7) 충전시킨 블리스터를 -20 내지 -110℃의 온도 범위에서 냉동시킨다.
8) 상기 블리스터를 동결건조기에서 동결 건조한다.
9) 건조된 동결건조물이 든 상기 블리스터 시트를 블리스터 포장 기계의 펀칭 캐리어 웹 위에 두어, 상기 블리스터 시트를 포장 기계의 밀봉 스테이션을 통과 이동시킨다.
10) 상기 블리스터를 덮개 호일로 밀봉하고 최종 블리스터로 펀칭한다.
E) 데스모프레신 제형
상기 방법 섹션 "D"에 기술된 방법을 이용하여, 아래 데스모프레신 동결건조 제형들을 제조하였다.
실시예 10
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.63 |
이뉼린 | 37.5 mg | 99.36 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 11
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.45 |
이뉼린 | 37.5 mg | 71.10 |
만니톨 | 15 mg | 28.44 |
시트르산 (5%w/v) | pH 4.5로 적정하는 양 | pH 4.5로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 12
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.63 |
이뉼린 | 37.5 mg | 99.36 |
시트르산 (5%w/v) | pH 4.0으로 적정하는 양 | pH 4.0으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 13
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.95 |
이뉼린 | 12.5 mg | 49.52 |
만니톨 | 12.5 mg | 49.52 |
소듐 시트레이트 완충액 (2.5 mM) | pH 4.8로 적정하는 양 | pH 4.8로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 14
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.95 |
이뉼린 | 12.5 mg | 49.52 |
만니톨 | 12.5 mg | 49.52 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 15
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
60 ㎍ | 0.24 |
이뉼린 | 12.5 mg | 49.88 |
만니톨 | 12.5 mg | 49.88 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 16
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
25 ㎍ | 0.09 |
이뉼린 | 12.5 mg | 49.95 |
만니톨 | 12.5 mg | 49.95 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 17
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
10 ㎍ | 0.04 |
이뉼린 | 12.5 mg | 49.98 |
만니톨 | 12.5 mg | 49.98 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 18
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.95 |
이뉼린 | 12.5 mg | 49.52 |
만니톨 | 12.5 mg | 49.52 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 19
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.56 |
이뉼린 | 30.0 mg | 70.19 |
만니톨 | 12.5 mg | 29.24 |
소듐 시트레이트 완충액(2.5 mM) | pH 4.8로 적정하는 양 | pH 4.8로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 20
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.56 |
이뉼린 | 30.0 mg | 70.19 |
만니톨 | 12.5 mg | 29.24 |
소듐 시트레이트 완충액(2.5 mM) | pH 5.0으로 적정하는 양 | pH 5.0으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 21
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.53 |
이뉼린 | 30.0 mg | 66.31 |
만니톨 | 12.5 mg | 27.63 |
풀룰란 | 2.5 mg | 5.52 |
소듐 시트레이트 완충액(2.5 mM) | pH 4.8로 적정하는 양 | pH 4.8로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 22
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.53 |
이뉼린 | 30.0 mg | 66.31 |
만니톨 | 12.5 mg | 27.63 |
풀룰란 | 2.5 mg | 5.52 |
소듐 시트레이트 완충액 (2.5 mM) | pH 5.0으로 적정하는 양 | pH 5.0으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 23
구성 성분 | 함량/unit | % w/w |
데스모프레신 아세테이트 데스모프레신과 균등체 |
240 ㎍ | 0.86 |
이뉼린 | 12.5 mg | 45.06 |
만니톨 | 12.5 mg | 45.06 |
풀룰란 | 2.5 mg | 9.01 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
F) 로라타딘 함유 제형의 제조법
1) 200 - 500 rpm에서 교반 하에 검을 정제수에 분산시킨다.
2) 이뉼린 및 기타 부형제의 수용액을 200 - 500 rpm에서 교반 하에 제조하고, 이 용액에 단계 1에서 제조한 검 용액을 교반하면서 첨가한다.
3) 단계 2에서 수득한 용액에 로라타딘을 계속 교반하면서 첨가하여, 현탁액을 제조한다.
4) 로라타딘 현탁액을 20분간 균질화하여, 균일한 현탁액을 만든다.
5) 시트르산 용액 (5% w/v)을 이용하여 상기 현탁액의 pH를 조정한다.
6) 상기 현탁액의 최종 부피를 정제수로 맞춘다.
7) 상기 현탁액을 다시 15분간 200 - 500 rpm으로 교반하여 혼합한다.
8) 상기 현탁액이 균일하게 유지되도록 간헐적으로 교반하면서, 사전제조된 블리스터 시트의 각 공동에 제조한 현탁물을 넣는다.
9) 충전시킨 블리스터를 -20 내지 -110℃의 온도 범위에서 냉동시킨다.
10) 상기 블리스터를 동결건조기에서 동결 건조한다.
11) 건조된 동결건조물이 든 상기 블리스터 시트를 블리스터 포장 기계의 펀칭 캐리어 웹 위에 두어, 상기 블리스터 시트를 포장 기계의 밀봉 스테이션을 통과 이동시킨다.
12) 상기 블리스터를 덮개 호일로 밀봉하고 최종 블리스터로 펀칭한다.
G) 로라타딘 제형
상기 방법 섹션 "F"에 기술된 방법을 이용하여, 아래 로라티딘 동결건조 제형들을 제조하였다.
실시예 24
구성 성분 | 함량/unit | % w/w |
로라타딘 | 10 mg | 19.89 |
이뉼린 | 37.5 mg | 74.59 |
만니톨 | 2.4 mg | 4.77 |
잔탄검 | 0.375 mg | 0.74 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 25
구성 성분 | 함량/unit | % w/w |
로라타딘 | 10 mg | 19.86 |
이뉼린 | 37.5 mg | 74.48 |
만니톨 | 2.4 mg | 4.76 |
구아르검 | 0.45 mg | 0.89 |
시트르산 (5%w/v) | pH 4.3으로 적정하는 양 | pH 4.3으로 적정하는 양 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
H) 파모티딘 함유 제형의 제조법
1) 200 - 500 rpm에서 교반 하에 구아르검을 정제수에 분산시킨다.
2) 200 - 500 rpm으로의 교반 하에 단계 1에서 수득한 용액에 이뉼린 및 기타 부형제를 용해한다.
3) 적절한 현탁액이 형성될 때까지 계속 교반하면서, 단계 2의 상기 용액에 파모티딘을 첨가한다.
4) 단계 3에서 수득한 파모티딘 현탁액을 10분간 균질화하여, 균일한 현탁액을 만든다.
5) 상기 현탁액의 최종 부피를 정제수로 맞춘다.
6) 상기 현탁액을 다시 15분간 200 - 500 rpm으로 교반하여 혼합한다.
7) 상기 현탁액이 균일하게 유지되도록 간헐적으로 교반하면서, 사전제조된 블리스터 시트의 각 공동에 제조한 현탁물을 넣는다.
8) 충전시킨 블리스터를 -20 내지 -110℃의 온도 범위에서 냉동시킨다.
9) 상기 블리스터를 동결건조기에서 동결 건조한다.
10) 건조된 동결건조물이 든 상기 블리스터 시트를 블리스터 포장 기계의 펀칭 캐리어 웹 위에 두어, 상기 블리스터 시트를 포장 기계의 밀봉 스테이션을 통과 이동시킨다.
11) 상기 블리스터를 덮개 호일로 밀봉하고 최종 블리스터로 펀칭한다.
I) 파모티딘 제형
상기 방법 섹션 "H"에 기술된 방법을 이용하여, 아래 파모티딘 동결건조 제형들을 제조하였다.
실시예 26
구성 성분 | 함량/unit | % w/w |
파모티딘 | 40 mg | 81.80 |
이뉼린 | 5 mg | 10.22 |
만니톨 | 3 mg | 6.13 |
구아르검 | 0.90 mg | 1.84 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 27
구성 성분 | 함량/unit | % w/w |
파모티딘 | 20 mg | 32.57 |
이뉼린 | 37.5 mg | 61.08 |
만니톨 | 3 mg | 4.88 |
구아르검 | 0.90 mg | 1.46 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
J. 몬텔루카스트 함유 제형의 제조법
1) 200 - 500 rpm에서 교반 하에 몬텔루카스트 소듐을 정제수에 용해한다.
2) 이뉼린과 기타 부형제를 단계 1의 몬텔루카스트 용액에 200 - 500 rpm으로의 교반 하에 용해한다.
3) 상기 용액의 최종 부피를 정제수로 맞춘다.
4) 상기 용액을 추가로 15분간 200 - 500 rpm으로 교반하면서 혼합한다.
5) 상기 용액을 사전제조된 블리스터의 각 공동에 넣는다.
6) 충전시킨 블리스터를 -20 내지 -110℃의 온도 범위에서 냉동시킨다.
7) 상기 블리스터를 동결건조기에서 동결 건조한다.
8) 건조된 동결건조물이 든 상기 블리스터 시트를 블리스터 포장 기계의 펀칭 캐리어 웹 위에 두어, 상기 블리스터 시트를 포장 기계의 밀봉 스테이션을 통과 이동시킨다.
9) 상기 블리스터를 덮개 호일로 밀봉하고 최종 블리스터로 펀칭한다.
K. 몬텔루카스트 제형
상기 방법 섹션 "J"에 기술된 방법을 이용하여, 아래 몬텔루카스트 구강분산성 제형들을 제조하였다.
실시예 28
구성 성분 | 함량/unit | % w/w |
몬텔루카스트 소듐 몬텔루카스트와 균등체 |
10 mg | 21.05 |
이뉼린 | 37.5 mg | 78.94 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 29
구성 성분 | 함량/unit | % w/w |
몬텔루카스트 소듐 몬텔루카스트와 균등체 |
10 mg | 19.04 |
이뉼린 | 37.5 mg | 71.42 |
만니톨 | 5 mg | 9.52 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 30
구성 성분 | 함량/unit | % w/w |
몬텔루카스트 소듐 몬텔루카스트와 균등체 |
10 mg | 24.27 |
이뉼린 | 20 mg | 48.54 |
만니톨 | 10 mg | 24.27 |
잔탄검 | 0.5 mg | 1.21 |
네오탐 | 0.2 mg | 0.48 |
체리향 | 0.5 mg | 1.21 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 31
구성 성분 | 함량/unit | % w/w |
몬텔루카스트 소듐 몬텔루카스트와 균등체 |
4 mg | 11.48 |
이뉼린 | 20 mg | 57.44 |
만니톨 | 10 mg | 28.72 |
잔탄검 | 0.5 mg | 1.43 |
네오탐 | 0.12 mg | 0.34 |
체리향 | 0.2 mg | 0.57 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 32
구성 성분 | 함량/unit | % w/w |
몬텔루카스트 소듐 몬텔루카스트와 균등체 |
5 mg | 13.96 |
이뉼린 | 20 mg | 55.83 |
만니톨 | 10 mg | 27.92 |
잔탄검 | 0.5 mg | 1.39 |
네오탐 | 0.12 mg | 0.33 |
체리향 | 0.2 mg | 0.56 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
L) 비교예
실시예 33
이뉼린 대신 풀룰란을 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
풀룰란 | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 34
이뉼린 대신 HPMC를 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
HPMC | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 35
이뉼린 대신 메틸 셀룰로스를 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
메틸 셀룰로스 | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 36
이뉼린 대신 트라가칸트 검을 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
트라가칸트 검 | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 37
이뉼린 대신 어류 젤라틴을 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
어류 젤라틴 | 25 mg | 100 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
실시예 38
이뉼린 대신 어류 젤라틴을 사용하고, 상기 방법 섹션 "B"에 기술된 방법을 이용하여, 비교 동결건조체를 제조하였다.
구성 성분 | 함량/unit | % w/w |
어류 젤라틴 | 12.5 mg | 50 |
만니톨 | 12.5 mg | 50 |
정제수 | 총 250 ㎕을 맞추기 위한 잔량 | - |
M) 붕해 검사
Ma) 페트리 디쉬에서 붕해 검사
본 검사는, 본 발명의 조성물이 수성 매질에서 붕해되는 예상 시간을 축정하는 것으로, 상기 시간은 타액에서의 붕해 시간을 의미한다.
젖은 필터지 상에서의 동결건조체들의 붕해 속도를 WO2009002084 12쪽 129 단락에 기술된 방법에 따라 측정하였고, 본 검사는 약 25 ± 2℃의 온도에서 수행하였다.
Mb) 위약의 구강 용해 시간(ODT)의 측정
구강에서의 위약 동결건조체의 용해 시간을 PCT 출원 WO2009002084 12쪽 129 단락에 기술된 방법에 따라 측정하였고, 동결건조체를 건강한 성인의 혀 위에 둔 후, 동결건조체를 혀와 입 천장 사이에서 비비면서 완전히 용해되는데 소요되는 시간을 측정하였다. 건강한 성인 5명으로부터 수득한 결과들로부터 평균 ODT를 계산하였다.
N) 붕해 시간의 검사 방법 (시험관내 DT)
본 검사는, 타액에서의 붕해 시간을 의미하는, 수성 매질에서의 본 발명의 조성물의 붕해 시간을 측정한다.
장치 : Electrolab, 모델 : ED2 SAPO
절차 :
본 방법은 USP 31-NF 26 (General Chapters, <701>Disintegration) 및 Ph Eur. 1997 (2.9.1. Disintegration of tablets and capsules)에 따라 수행하였다. 비이커에 물을 넣고, 수조를 이용하여 37℃ ± 0.5℃로 유지시켰다. 동결건조체들을 직경 약 0.5 mm (±0.05 mm) 및 길이 약 15 mm의 구리선으로 만들어진 봉돌(sinker)에 넣었다. 그런 후, 동결건조체를 바스켓 랙 어셈블리의 바스켓에 넣고, 기구를 설정하였다. 붕해 시간은 초로 기재하였다.
O) 용해 방법
본 검사는, 조성물로부터의 활성 성분의 방출율을 의미하는, 수성 매질 중에서의 본 발명의 조성물로부터의 활성 성분의 용해율 (%)을 측정한다.
장치 : Varian, 모델 : VK7025
절차 :
본 방법은 USP 32-NF 27 (General Chapters, <711>Dissolution)에 따른다. 조성물내 활성 성분에 따라 용해 매질 (0.1N HCl, 포스페이트 완충액 pH 6.8, 아세테이트 완충액 pH 4.5, 또는 0.5% SLS 수용액)을 선택하였다. 용해 볼에 조성물내 활성 성분에 따라 적절한 매질을 소정의 부피(500 mL 및 900 mL)로 채우고, 매질의 온도를 수조를 이용하여 37℃ ± 0.5℃로 유지시켰다. 사용한 장치는 USP 타입 II (Paddle)이며, 테스트 과정에 따라 필수 rpm(50 rpm)으로 설정하였다. 테스트 과정 중에 정해진 시간대 (5분, 10분, 15분 및 30분)에 샘플을 취하였다. 샘플을 테스트 과정에 따라 크로마토그래피 또는 UV로 분석하고, 방출율 %을 계산하였다.
실시예 1 내지 18 및 비교예 19 내지 24에 따라 제조한 동결건조체에 대한 붕해 속도, ODT, 시험관내 DT 및 용해 데이타를 표 40에 제시한다.
실시예 번호 | 페트리 디쉬에서의 붕해 검사 (초) |
구강 용해 시간
(초) |
시험관내 DT
(초) |
용해율
(5분/15분) (%) |
1 | 1 | 3 | 1 | NA |
2 | 2 | 2 | 1 | NA |
3 | 1 | 2 | 2 | NA |
4 | 2 | 2 | 2 | NA |
5 | 1 | 1 | 1 | NA |
6 | 1 | 1 | 1 | NA |
7 | 2 | 3 | 1 | NA |
8 | 3 | 3 | 1 | NA |
9 | 2 | 4 | 1 | NA |
10 | 1 | NA | 1 | 80/85 |
11 | 1 | NA | 1 | 96/95 |
12 | 1 | NA | 2 | 98/99 |
13 | 3 | NA | 3 | 98/99 |
14 | 2 | NA | 2 | 98/99 |
15 | 2 | NA | 2 | 92/96 |
16 | 2 | NA | 2 | 89/95 |
17 | 2 | NA | 2 | 100/102 |
18 | 3 | NA | 3 | 96/97 |
19 | 3 | NA | 3 | 70/86 |
20 | 3 | NA | 2 | 98/99 |
21 | 2 | NA | 3 | 99/101 |
22 | 3 | NA | 2 | 96/101 |
23 | 3 | NA | 3 | 102/102 |
24 | 4 | NA | 3 | 96/105 |
25 | 7 | NA | 2 | 103/113 |
26 | 5 | NA | 8 | 70/85 |
27 | 5 | NA | 6 | 78/91 |
28 | 4 | NA | 2 | 95/95 |
29 | 4 | NA | 2 | 100/99 |
30 | 4 | NA | 2 | 96/96 |
31 | 2 | NA | 2 | 89/92 |
32 | 5 | NA | 3 | 106/106 |
33 | 32 | 30 | 196 | NA |
34 | 35 | 51 | 128 | NA |
35 | > 300 | 192 | > 30 분 | NA |
36 | 36 | 30 | 20 | NA |
37 | 2 | 5 | < 2 | NA |
38 | 2 | 4 | < 2 | NA |
NA - 위약 동결건조체들에서만 구강 용해 시간을 측정하였으므로, 3번째 칸에는 해당 안 됨.
NA - 약물 물질이 포함된 동결건조체들에서만 용해 시간을 측정하였으므로, 5번째 칸에는 해당 안 됨.
Claims (25)
- 약제학적 활성 성분을 수송하는 개방형 매트릭스 네트워크(open matrix network)를 포함하며,
상기 개방형 매트릭스 네트워크가 이뉼린(inulin)을 포함하는, 약학 조성물. - 약제학적 활성 성분을 포함하는 매트릭스를 포함하며,
상기 매트릭스는 수용액 또는 타액과의 접촉시 급속하게 붕해되며,
상기 매트릭스는 이뉼린을 포함하는, 약학 조성물. - 제1항 또는 제2항에 있어서, 상기 이뉼린은 매트릭스 형성용 주성분인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제3항 중 어느 한항에 있어서, 상기 매트릭스는 이뉼린 및 만니톨을 포함하는 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제3항 중 어느 한항에 있어서, 상기 매트릭스는 이뉼린 및 트레할로스를 포함하는 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제3항 중 어느 한항에 있어서, 상기 매트릭스는 이뉼린 및 라피노스를 포함하는 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제6항 중 어느 한항에 있어서, 상기 조성물의 80% 이상이 10초 이내에 수성 매질 또는 타액에 용해되는 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제7항 중 어느 한항에 있어서, 경구 제형인 것을 특징으로 하는 약학 조성물.
- 제8항에 있어서, 설하 투여용인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제9항 중 어느 한항에 있어서, 용매 중에 상기 활성 성분과 이뉼린을 포함하는 액체 조제물로부터 용매를 승화시킴으로써 수득가능한 것을 특징으로 하는 약학 조성물.
- 제10항에 있어서, 상기 승화는 상기 조제물을 동결 건조시킴으로써 수행되는 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제11항 중 어느 한항에 있어서, 상기 활성 성분은 데스모프레신 아세테이트(desmopressin acetate)인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제11항 중 어느 한항에 있어서, 상기 활성 성분은 로라티딘(loratidine)인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제11항 중 어느 한항에 있어서, 상기 활성 성분은 파모티딘(famotidine)인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제11항 중 어느 한항에 있어서, 상기 활성 성분은 몬텔루카스트 소듐(montelukast sodium)인 것을 특징으로 하는 약학 조성물.
- 용매 중에 약제학적 활성 성분과 이뉼린을 포함하는 액체 조제물로부터 용매를 승화시키는 단계를 포함하는, 약학 조성물의 제조 방법.
- 제16항에 있어서,
(a) 상기 액체 조제물의 단위 투여량들을 개방형 블리스터 팩의 오목부(depression)에 도입하는 단계; 및
(b) 상기 조제물을 승화시켜, 상기 오목부 안에서 고체 단위 제형을 제조하는 단계를 포함하는 것을 특징으로 하는 방법. - 제17항에 있어서, 상기 상기 승화는 상기 조제물을 동결 건조시킴으로써 수행되는 것을 특징으로 하는 방법.
- 제16항에 있어서, 상기 용매는 물인 것을 특징으로 하는 방법.
- 제16항 내지 제19항 중 어느 한항에 있어서, 상기 활성 성분은 데스모프레신인 것을 특징으로 하는 방법.
- 제16항 내지 제19항 중 어느 한항에 있어서, 상기 활성 성분은 로라티딘(loratidine)인 것을 특징으로 하는 방법.
- 제16항 내지 제19항 중 어느 한항에 있어서, 상기 활성 성분은 파모티딘(famotidine)인 것을 특징으로 하는 방법.
- 제16항 내지 제19항 중 어느 한항에 있어서, 상기 활성 성분은 몬텔루카스트 소듐(montelukast sodium)인 것을 특징으로 하는 방법.
- 약학 조성물의 제조 방법으로서,
(a) 용매 중에 이뉼린과 활성 성분을 포함하는 용액을 제조하는 단계;
(b) 상기 용액을 동결시키는 단계;
(c) 상기 동결시킨 용액에서 용매를 승화시키는 단계를 포함하며,
수득되는 약학 조성물은 수용액 또는 타액과의 접촉시 10초 이내에 붕해되는 것을 특징으로 하는 약학 조성물의 제조 방법. - 제24항에 있어서, 상기 조성물은 제1항 내지 제15항 중 어느 한항에 따른 조성물인 것을 특징으로 하는 방법.
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PCT/EP2011/054698 WO2011120903A2 (en) | 2010-03-29 | 2011-03-28 | A fast dissolving pharmaceutical composition |
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US10512695B2 (en) | 2019-12-24 |
AR080736A1 (es) | 2012-05-02 |
JP5907945B2 (ja) | 2016-04-26 |
JO3112B1 (ar) | 2017-09-20 |
WO2011120903A3 (en) | 2012-05-03 |
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MX2012011204A (es) | 2012-11-23 |
AU2011234636A1 (en) | 2012-10-11 |
RU2012141141A (ru) | 2014-05-10 |
EP2552403A2 (en) | 2013-02-06 |
TWI513477B (zh) | 2015-12-21 |
CN102821755A (zh) | 2012-12-12 |
AU2011234636B2 (en) | 2015-01-15 |
NZ602441A (en) | 2014-01-31 |
JP2013523676A (ja) | 2013-06-17 |
IL222086A (en) | 2017-01-31 |
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SA111320317B1 (ar) | 2015-05-11 |
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PL2552403T3 (pl) | 2016-01-29 |
BR112012024428A2 (pt) | 2016-05-31 |
US10086078B2 (en) | 2018-10-02 |
KR101725173B1 (ko) | 2017-04-10 |
US20180369392A1 (en) | 2018-12-27 |
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US20130123180A1 (en) | 2013-05-16 |
ZA201207176B (en) | 2013-05-29 |
DK2552403T3 (en) | 2015-10-05 |
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