KR20030038541A - 안정한 약물 전달용 금속 이온-지질 분말 약제학적 조성물및 그것의 사용 방법 - Google Patents
안정한 약물 전달용 금속 이온-지질 분말 약제학적 조성물및 그것의 사용 방법 Download PDFInfo
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- KR20030038541A KR20030038541A KR1020027015136A KR20027015136A KR20030038541A KR 20030038541 A KR20030038541 A KR 20030038541A KR 1020027015136 A KR1020027015136 A KR 1020027015136A KR 20027015136 A KR20027015136 A KR 20027015136A KR 20030038541 A KR20030038541 A KR 20030038541A
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- metal ion
- microparticle
- lipid
- drug
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Abstract
Description
계면활성제 | 분류 | 약전/특별약전 |
알루미늄 모노스테아레이트암모늄 라우릴 술페이트칼슘 스테아레이트디옥틸 칼슘 술포숙시네이트디옥틸 포타슘 술포숙시네이트디옥틸 소듐 술포숙시네이트유화성 왁스마그네슘 라우릴 술페이트마그네슘 스테아레이트모노,디,트리에탄올아민 라우릴 술페이트포타슘 올레에이트소듐 피마자유소듐 세토스테아릴 술페이트소듐 라우릴 에테르 술페이트소듐 라우릴 술페이트소듐 라우릴 술포아세테이트소듐 올레에이트소듐 스테아레이트소듐 스테아릴 푸마레이트소듐 테트라데실 술페이트아연 올레에이트아연 스테아레이트벤잘코늄 클로라이드세트리미드세트리모늄 브로마이드세틸피리디늄 클로라이드 | 음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성음이온성 | USP/NF 마틴데일마틴데일USP/NFEur.Ph. BP 마틴데일마틴데일마틴데일USP/NF BP 마틴데일Eur.Ph. BP 마틴데일마틴데일USP/NFEur.Ph. BP 마틴데일마틴데일마틴데일마틴데일Eur.Ph.BP 마틴데일마틴데일USP/NFEur.Ph. 마틴데일마틴데일마틴데일USP/NF 마틴데일USP/NF 마틴데일BP 마틴데일마틴데일USP/NFEur.Ph. 마틴데일USP/NFEur.Ph. 마틴데일Eur.Ph. BP 마틴데일BP 마틴데일USP/NFEur.Ph. BP 마틴데일 |
계면활성제 | 약전/특별 약전 |
폴리올 에스테르글리세릴 모노스테아레이트모노디글리세리드글리세릴 모노올레에이트글리세릴 베헤네이트소르비탄 모노라우레이트소르비탄 모노팔미테이트소르비탄 모노올레에이트소르비탄 모노스테아레이트소르비탄 세스퀴올레이트소르비탄 트리올레에이트소르비탄 트리스테아레이트폴리소르베이트-20폴리소르베이트-40폴리소르베이트-60폴리소르베이트-65폴리소르베이트-80폴리소르베이트-85디에틸렌 글리콜 모노스테아레이트에틸렌 글리콜 모노스테아레이트프로필렌 글리콜 모노스테아레이트자기유화성 글리세릴 스테아레이트유화성 왁스 NF폴리옥시에틸렌 에스테르 및 에테르PEG-40 스테아레이트PEG-50 스테아레이트PEG-8 스테아레이트폴리옥실-35 피마자유폴리옥실-40 수소첨가된 피마자유라우레트-2라우레트-4라우레트-9세테아레트-20스테아레트-20올레트-10폴록사머폴록사머-188폴록사머-407기타 비이온성 계면활성제논옥시돌-9논옥시놀-10논옥시놀-11프로필렌 글리콜 디아세테이트폴리비닐 알콜 | USP/NFEur.Ph. BP 마틴데일USP/NFEur.Ph. 마틴데일마틴데일USP/NF 마틴데일USP/NFEur.Ph. BP 마틴데일USP/NFEur.Ph. 마틴데일USP/NFEur.Ph. BP 마틴데일USP/NFEur.Ph. BP 마틴데일USP/NF 마틴데일USP/NFEur.Ph. 마틴데일마틴데일USP/NFEur.Ph. BP 마틴데일USP/NF 마틴데일USP/NFEur.Ph. BP 마틴데일마틴데일USP/NFEur.Ph. BP 마틴데일마틴데일마틴데일Eur.Ph. 마틴데일USP/NFEur.Ph. 마틴데일BPUSP/NFUSP/NF* Eur.Ph. 마틴데일USP/NF*Eur.Ph. 마틴데일USP/NF*Eur.Ph. 마틴데일USP/NF*Eur.Ph. 마틴데일USP/NF 마틴데일Eur.Ph. 마틴데일Eur.Ph. 마틴데일Eur.Ph. 마틴데일Eur.Ph. 마틴데일Eur.Ph. 마틴데일USP/NF*Eur.Ph. 마틴데일UDP/NF BP 마틴데일USP/NF 마틴데일USP/NF 마틴데일USP/NF* 마틴데일마틴데일USP/NF* 마틴데일USP/NF 마틴데일 |
치료 효과 | 유효 화합물 | 전형적 농도(mg/mL) |
항진균항기생충불안완화칼슘 길항산중화항빈혈항세균항간질기침 완화항염증항바이러스코막힘 완화면역 촉진(estimulation)장 이동 촉진(estimulation)장 이동 억제 | 케토콘졸피란텔 파모에이트티아벤졸디아제팜니카르디핀알마게이트알루미늄 히드록시드마그네슘 히드록시드엽산제1철 글루셉테이트날리딕스산아목실린암피실린세팔렉신세프라독실클로람페니콜 팔미테이트니트로푸란토인디페닐히단토인코데인덱스트로메토르판이부프로펜아시클로비르페닐프로판올아민팔미드롤시니타프리드알부민 탄네이트 | 2050600.5201307020010301255050505025102560.520803100150 |
방사성 동위원소 | 기호 | 반감기 | 용도 |
탈륨-201갈륨-67인듐-111요오드-123팔라듐-103몰리브덴-99제논-133요오드-131요오드-125불소-18 | TI-201Ga-67In-111I-123Pd-103Mo-99Xe-133I-131I-125F-18 | 3 일3.26 일2.8 일13 시간17 일2.7 일5.3 시간8 일59.4 일110 분 | 진단진단진단진단진단 & 치료진단진단 & 치료진단 & 치료치료진단 |
방사성 동위원소 | 기호 | 용도 | |
게르마늄-68코발트-57아연-65스트론튬-85인-32황-35이트륨-90사마륨-153가돌리늄-153이테르븀-169크로뮴-51망간-54셀레늄-75주석-113 | Ge-68Co-57Zn-65Sr-85P-32S-35Y-90Sm-153Gd-153Yb-169Cr-51Mn-54Se-75Sn-113 | 항체 라벨링기구 측정생화학골 추적골암 치료DNA 라벨링방사성면역치료골암 치료골다공증/진단방사선치료혈액 체적간 진단생화학결장암 치료 |
공기역학적평균체적크기(㎛) | ||
샘플 ID | 건조분말 | 65℃에서 30분간 열처리 |
샘플1i,ii | 2.3 | 20 |
샘플2i | 3.0 | 샘플융합>8㎛ |
샘플3ii | 6.4 | 5.9 |
i)발포제사용ii)칼슘-인지질복합체 |
VMAD1(㎛) | MMAD2(㎛) | GSD3(㎛) | FPF4(%) | |
샘플8 | 2.44 | 3.99 | 1.81 | 59 |
샘플9 | 3.87 | 4.57 | 1.94 | 48 |
1-체적평균공기역학적직경(Amherst Aerosizer)2-평균질량공기역학적직경(Andersen Cascade)3-기하학적표준편차(Andersen Cascade)4-미립자분획(Andersen Cascade) |
MMAD1(㎛) | GSD2(㎛) | FPF3(㎛) | 방사량(%) | |
샘플8 | 4.81 | 2.09 | 57 | 92 |
샘플9 | 4.57 | 1.94 | 48 | 88 |
1-평균질량공기역학적직경(Andersen Cascade)2-기하학적표준편차(Andersen Cascade)3-미립자분획(Andersen Cascade) |
Claims (45)
- 금속 이온-지질 복합체를 포함하는, 약물 전달용 마이크로입자.
- 제 1 항에 있어서, 약물 전달을 위한 권장 저장 온도보다 20 ℃ 이상 초과하는 전이온도를 가지는 마이크로입자.
- 제 1 항에 있어서, 약 25 - 98 % w/w 의 인지질 농도, 약 0 - 80 % w/w 의 약물 또는 유효 성분 농도, 및 0 초과 - 2 의 금속 이온염/지질의 몰비를 가지는 마이크로입자.
- 제 1 항에 있어서, 금속 이온의 존재가 마이크로입자의 Tg를 금속 이온이 없는 동일 마이크로입자의 Tg보다 2 ℃ 이상 초과하도록 승온시키는 마이크로입자.
- 제 1 항에 있어서, 금속 이온-지질 복합체가 약 0.5 - 2 g/cm3범위 내의 He 교체로 측정한 밀도를 갖는 마이크로입자.
- 제 1 항에 있어서, 지질 성분이 2 가지 이상의 지질의 혼합물을 포함하는 마이크로입자.
- 제 1 항에 있어서, 하나 이상의 지질이 인지질인 마이크로입자.
- 제 7 항에 있어서, 인지질이 DPPC, DSPC, DMPC, 디옥틸포스파티딜콜린, 콩 포스파티딜콜린, 란(卵) 포스파티딜콜린, 및 부분 수소첨가된 포스파티드 및 중합성 인지질로 구성된 군에서 선택되는 마이크로입자.
- 제 1 항에 있어서, 금속 이온이 란탄계 금속, 악티니드계 금속, 제 IIa 및 IIIb 족 금속, 전이금속 또는 이들의 혼합물로 구성된 군에서 선택되는 마이크로입자.
- 제 1 항에 있어서, 금속 이온이 수용성 염 형태의 칼슘, 아연, 알루미늄, 철 및 마그네슘, 및 이들의 혼합물로 구성된 군에서 선택되는 마이크로입자.
- 제 1 항에 있어서, 하나 이상의 약물 또는 활성제를 더 포함하는 마이크로입자.
- 제 11 항에 있어서, 약물 또는 활성제가 항알레르기제, 항진균제, 항편두통제, 항빈혈증제, 기관지확장제, 폐 계면활성제, 진통제, 항생제, 류코트리엔 억제제 또는 길항제, 항히스타민제, 항염증제, 항종양제, 항파킨슨제, 마취제, 항결핵제, 이미징제, 심장혈관 제제, 효소, 렉틴, 스테로이드, 유전학적 물질, 바이러스성 벡터, 안티센스제, 단일클론항체, 단백질, 펩티드, 치료적으로 유용한 금속 이온 및 가스, 및 이들의 조합물로 구성된 군에서 선택되는 마이크로입자.
- 금속 이온-지질 복합체를 함유하는, 약물 또는 활성제 전달용 마이크로입자를 다수 포함하는 분말 조성물.
- 제 13 항에 있어서, 약물 또는 활성제가 금속 이온-지질 복합체와 통합된 분말 마이크로입자 조성물.
- 제 14 항에 있어서, 붕해제; 불용성의 무기 또는 유기물, 예컨대 탄산칼슘 또는 폴리에스테르; 다당류; 폴리비닐피롤리돈; 폴리비닐 알콜; 폴리에틸렌 글리콜; 폴록사머; 티록사폴; 폴록사민; 메톡시프로필렌 글리콜; 폴리글리콜 공중합체; 테트로닉; 셀룰로스 에스테르; 키토산 및 유도체; 셀롤로스 에테르; 카르복시메틸셀룰로스; 히드록시메틸셀룰로스; 카르보폴; 폴리아크릴산 및 염; 가교 폴리아크릴산; 폴리악티드; 폴리글리콜리드; 전분과 유도체 또는 전분과 기타 다당류; 메틸화 전분; 에틸화 전분; 가교 전분; 이뉼린; 덱스트란; 덱스트란 술페이트; 시클로덱스트린; 화학식 Y[(A)n-E-H]x(식 중, A 는 폴리옥시알킬렌 부분이고, x 는 2 이상이며, Y 는 x 개 반응성 수소원자를 함유하는 유기 화합물 또는 물로부터 유도되며,E 는 폴리옥시에틸렌 부분이고, n 은 5 - 500 일 수 있다) 의 폴리옥시알킬렌 블록 공중합체; 펩티드; 폴리리신; 폴리아르기닌; 폴리알라닌; 폴리글리신 및 소, 우유, 인간, 계란(卵) 의 단백질 알부민; 지방산 금속염; 가소화제; 습윤제; 유리질화제; 항산화제; BHT; THT; 잔토필스; 토코페롤; 및 이들의 혼합물로 구성된 군에서 선택되는 화합물을 더 포함하는 분말 마이크로입자 조성물.
- 제 13 항에 있어서, 지질이 하나 이상의 인지질을 포함하는 분말 마이크로입자 조성물.
- 제 16 항에 있어서, 하나 이상의 인지질이 DSPC, DPPC, DMPC, 디옥틸포스파티딜콜린, 콩 포스파티딜콜린, 란(卵) 포스파티딜콜린 및 부분 수소첨가된 포스파티드 또는 이들의 혼합물로 구성된 군에서 선택되는 분말 마이크로입자 조성물.
- 제 14 항에 있어서, 마이크로입자가 약 0.5 - 7 ㎛ 의 평균 체적 공기역학적 입자 크기를 갖는 마이크로입자 조성물.
- 제 13 항에 있어서, 알부테롤, 알부테롤 클로라이드, 부데소니드, 플루티카손 프로피오네이트, 살메테롤 진나포에이트, 포르모테롤 푸마레이트, 니코틴 클로라이드, 니코틴 니트레이트, 트리암시놀론 아세토니드, 덱사메타손, 베클로메타손 디프로피오네이트, 겐타미신, 겐타미신 클로라이드, 겐타미신 술페이트, 시프로플록사신 히드로클로라이드, 탁솔, 암포테리신, 아미카신, 아미카신 클로라이드, 토브라마이신, 토브라마이신 클로라이드 및 토브라마이신 니트레이트 또는 이들의 혼합물로 구성된 군에서 선택되는 분말 마이크로입자 조성물.
- 제 13 항에 있어서, 약물 또는 활성제가 인슐린, 알부민, 효소, 풀모자임 및 이뮤노글로불린, 유전자, DNA절단효소, 리보자임, 올리고디누클레오티드 및 단일클론 항체로 구성된 군에서 선택되는 분말 마이크로입자 조성물.
- 제 13 항에 있어서, 마이크로입자가 실질적으로 비중공(non-hollow)이고, 비다공질인 분말 마이크로입자 조성물.
- 제 13 항에 있어서, 분말 변형제를 더욱 함유하는 마이크로입자 조성물.
- 제 22 항에 있어서, 분말 변형제가 탄수화물인 분말 마이크로입자 조성물.
- 제 23 항에 있어서, 탄수화물이 락토스, 수크로스, 히드록시 에틸 전분; 헤타전분, 트레할로스, 만노스 및 만니톨로 구성된 군에서 선택되는 분말 마이크로입자 조성물.
- 약물, 또는 치료적 또는 생물학적 활성제를 대상에게 투여하는 방법으로서,약물 또는 활성제를 더 포함하는 다수의 금속 이온-지질 기재 마이크로입자를 투여하는 것을 포함하는 방법.
- 제 25 항에 있어서, 투여 방법이 약액분무법(nebulization), 취입법, 건조 분말 흡입법 및 에어로졸 흡입법으로 구성된 군에서 선택되는 방법.
- 제 25 항에 있어서, 마이크로입자가 국소, 순환기, 폐, 귀,항문, 눈, 질, 근육내, 정맥내, 기관내, 각피 내, 복강내, 비강내, 인두내, 동(洞 : 도관) 내, 피하, 경막내, 경막외, 조내 및 흉막내 전달 유형들 중 임의의 것에 의해 투여될 수 있는 방법 : .
- 마이크로입자가 하기 공정에 의해 형성된 금속 이온-지질 복합체를 포함하는, 안정한 약물 전달용 마이크로입자 조성물 :- 인지질을 물 중에 분산시켜, 제 1 제제를 제조함;- 금속 화합물 또는 염을 물 중 현탁시켜, 제 2 제제를 제조함;- 약물 또는 활성제를 첨가함;- 제 1 및 제 2 제제를 조합함; 및- 조합된 제제를 분무건조시켜, 안정한 금속 이온-지질 마이크로입자 조성물을 제조함.
- 제 28 항에 있어서, 인지질이 콩 포스파티딜콜린, 란(卵) 포스파티딜콜린, DPPC, DSPC, DMPC, 디옥틸포스파티딜콜린, 및 부분 또는 전부 수소첨가된 포스파티드로 구성된 군에서 선택되는 마이크로입자 조성물.
- 제 28 항에 있어서, 금속 이온이 칼슘염의 형태로 첨가되는 마이크로입자 조성물.
- 제 28 항에 있어서, 조합된 제제가 -10 ~ 200 ℃ 범위 내의 유입 온도 및 -20 ~ 150 ℃ 범위 내의 배출 온도로 분무건조되는 마이크로입자 조성물.
- 제 28 항에 있어서, 조합된 제제가 40 ~ 100 ℃ 범위 내의 유입 온도 및 30 ~ 85 ℃ 의 배출 온도로 분무건조되는 마이크로입자 조성물.
- 제 28 항에 있어서, 약물 또는 활성제가 제 1 제제, 제 2 제제, 및 제 1 제제와 제 2 제제의 조합물로 구성된 군에서 선택되는 제제들 중 하나에 첨가되는 마이크로입자 조성물.
- 제 28 항에 있어서, 약물 또는 활성제가 형성된 금속 이온-지질 복합체에 첨가되는 마이크로입자 조성물.
- 제 28 항에 있어서, 약물 또는 활성제가 알부테롤, 알부테롤 클로라이드, 부데소니드, 플루티카손 프로피오네이트, 살메테롤 진나포에이트, 포르모테롤 푸마레이트, 니코틴 클로라이드, 니코틴 니트레이트, 트리암시놀론 아세토니드, 덱사메타손, 베클로메타손 디프로피오네이트, 겐타미신, 겐타미신 클로라이드, 겐타미신 술페이트, 시프로플록사신 히드로클로라이드, 탁솔, 암포테리신, 아미카신, 아미카신 클로라이드, 토브라마이신, 토브라마이신 클로라이드 및 토브라마이신 니트레이트로 구성된 군에서 선택되는 마이크로입자 조성물.
- 하기 단계들을 포함하는, 안정한 약물 전달용 금속 이온-지질 마이크로입자 조성물의 형성 방법 :- 물 중 인지질을 분산시키고, 금속을 현탁시킴;- 약물 또는 활성제를 첨가함;- 제제를 분무건조시켜, 안정한 금속 이온-지질 마이크로입자 조성물을 제조함.
- 제 13 항에 있어서, 약물 또는 활성제의 방출을 느리게 하기 위해 지방산 또는 지방산염을 더 포함하는 조성물.
- 분말 마이크로입자 조성물을 포함하는 조성물을 대상에 투여함에 의한 당뇨병 치료 방법으로서, 마이크로입자가 금속 이온-지질 조합을 포함하고, 약물 인슐린을 더 포함하는 방법.
- 제 38 항에 있어서, 마이크로입자 조성물이 정량식 흡입기 또는 건조 분말 흡입기에 의해 투여되는 방법.
- 제 38 항에 있어서, 조성물이 폐 전달에 의해 대상에게 전달되는 방법.
- 마이크로입자가, 분산된 금속 이온-지질 복합체 및 약물 또는 활성제를 포함하는 공정에 의해 형성된 금속 이온-지질 복합체를 포함하는 안정한 약물 전달용 마이크로입자 조성물.
- 제 13 항에 있어서, 입자의 형성 동안 또는 형성 후에 형성된 입자 내에 탄산칼슘을 더 포함하는 조성물.
- 제 1 항에 있어서, 금속 이온이 하나 초과의 양전하를 갖는 마이크로입자.
- 치료량의 약물이 가해된 금속 이온-지질 마이크로입자를 투여하는 것을 포함하는 환자의 치료 방법.
- 인지질, 하나 이상의 금속 화합물 및 하나 이상의 약물 또는 활성제의 조합을 분무 건조함으로써 수득되는 안정한 마이크로입자 조성물.
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2000
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- 2001-05-08 MX MXPA02011003A patent/MXPA02011003A/es active IP Right Grant
- 2001-05-08 AU AU2001259637A patent/AU2001259637A1/en not_active Abandoned
- 2001-05-08 KR KR1020087007331A patent/KR20080031532A/ko not_active Application Discontinuation
- 2001-05-08 EP EP14181405.3A patent/EP2851067A1/en not_active Withdrawn
- 2001-05-08 EP EP01933194A patent/EP1282405A2/en not_active Withdrawn
- 2001-05-08 CA CA2408464A patent/CA2408464C/en not_active Expired - Lifetime
- 2001-05-08 JP JP2001581791A patent/JP2003533449A/ja not_active Withdrawn
- 2001-05-08 KR KR1020027015136A patent/KR100845445B1/ko active IP Right Grant
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- 2010-12-14 US US12/967,482 patent/US8349294B2/en not_active Expired - Fee Related
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- 2012-12-06 US US13/707,563 patent/US8877162B2/en not_active Expired - Fee Related
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- 2013-07-12 JP JP2013147090A patent/JP5952231B2/ja not_active Expired - Lifetime
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- 2014-04-02 US US14/243,639 patent/US9439862B2/en not_active Expired - Lifetime
- 2014-09-05 US US14/478,573 patent/US20140377361A1/en not_active Abandoned
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20170125503A (ko) * | 2016-05-04 | 2017-11-15 | 고려대학교 산학협력단 | 생물복합물질로서 분리 정제에 이용 가능한 실리카 코팅된 탄산칼슘입자 |
WO2023158286A1 (ko) * | 2022-02-21 | 2023-08-24 | 주식회사 툴바이오 | 칼시퀘스트린 기반의 금속이온 반응성 입자 및 이의 용도 |
Also Published As
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US20130095153A1 (en) | 2013-04-18 |
EP1282405A2 (en) | 2003-02-12 |
US8349294B2 (en) | 2013-01-08 |
KR20080031532A (ko) | 2008-04-08 |
JP2013237681A (ja) | 2013-11-28 |
WO2001085137A2 (en) | 2001-11-15 |
US7871598B1 (en) | 2011-01-18 |
US20140377361A1 (en) | 2014-12-25 |
EP2851067A1 (en) | 2015-03-25 |
KR100845445B1 (ko) | 2008-07-10 |
AU2001259637A1 (en) | 2001-11-20 |
US20110082076A1 (en) | 2011-04-07 |
US9439862B2 (en) | 2016-09-13 |
MXPA02011003A (es) | 2004-08-19 |
CA2408464C (en) | 2016-01-26 |
US8877162B2 (en) | 2014-11-04 |
WO2001085137A3 (en) | 2002-04-18 |
JP2003533449A (ja) | 2003-11-11 |
CA2408464A1 (en) | 2001-11-15 |
JP5952231B2 (ja) | 2016-07-13 |
LU92678I2 (fr) | 2015-11-02 |
US20140212504A1 (en) | 2014-07-31 |
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