KR870000920A - 9-데옥소-11-데옥시-9,11-[이미노[2-(2-메톡시에톡시) 에틸리덴]-옥시]-(9s)-에리트로마이신을 함유하는 경구투여용 고형 약제학적 제제의 제조방법 - Google Patents

9-데옥소-11-데옥시-9,11-[이미노[2-(2-메톡시에톡시) 에틸리덴]-옥시]-(9s)-에리트로마이신을 함유하는 경구투여용 고형 약제학적 제제의 제조방법 Download PDF

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KR870000920A
KR870000920A KR1019860005492A KR860005492A KR870000920A KR 870000920 A KR870000920 A KR 870000920A KR 1019860005492 A KR1019860005492 A KR 1019860005492A KR 860005492 A KR860005492 A KR 860005492A KR 870000920 A KR870000920 A KR 870000920A
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에티엔느 알랭
그루버 페터
부쉬 울리히
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닥터 칼 토메 게젤샤프트 미트 베슈랭크터 하프퉁
디이터라우디엔, 게르하르트 후버
닥터칼토메 게젤샤프트 미트 베슈랭크터 하프퉁
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Abstract

내용 없음.

Description

9-데옥소-11-데옥시-9,11-[이미노[2-(2-메톡시에톡시) 에틸리덴]-옥시]-(9s)-에리트로마이신을 함유하는 경구투여용 고형 약제학적 제제의 제조방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 부형제를 함유하지 않은 정제와 비교하여, pH6의 인공장액 중에서 실시예 1에 따라 제조된 정제의 용해프로필(profile)을 나타내는 그래프.

Claims (9)

  1. 활성물질을, 활성물질 1몰에 대해 염기성 부형제 2g-당량 이상의 비로, 염기성 부형제와 완전히 혼합한후, a) 이 완전 혼합물을 추가의 부형제를 첨가한 후에 과립화시키고, 압축시켜 정제를 제조하거나, b) 이 완전 혼합물을 점착제 물질과 결합시켜 펠렛화 시키거나, c) 이 완전 혼합물을 압축시킨 다음 과립으로 분쇄하여 목적하는 크기의 과립 분획을 선별하거나, d) 이 완전 혼합물을 용융물 중에 현탁시키고 용융물을 냉각탑에서 분무하여 특정 직경의 구형 입자를 제조하고, 이렇게 하여 수득된 제제를 이어서 pH5.5 내지 6.8의 범위에서 활성물질을 방출하는 위액-저항성 락커의 피복물로 피복시키고, 원하는 경우 단계 c) 또는 d)에 따라 수득된 입자를 현탁매질 중에 현탁시켜 시럽제를 제조함을 특징으로 하여, 활성물질로 9-데옥소-11-데옥시-9,11-[이미노-[2-(2-메톡시에톡시)에틸리덴]-옥시]-(9s)-에리트로마이신을 함유하는 경구투여용 고형 약제학적 제제를 제조하는 방법.
  2. 제1항에 있어서, 경구 투여용 약제학적 제제가 붕해제를 함유함을 특징으로 하는 방법.
  3. 제1항 또는 2항에 있어서, 활성물질과 염기성 부형제와의 완전 혼합물을 통상적 부형제와 함께 압축시켜 정제를 제조하고 이정재를 pH5.5 내지 6.8의 범위에서 활성물질을 방출하는 락커로 피복시킴을 특징으로 하는 방법.
  4. 제1항 또는 2항에 있어서, 활성물질과 염기성 부형제와의 완전 혼합물을 펠렛 형태로 제조하고 이 펠렛을 pH5.5 내지 6.8의 범위에서 활성물질을 방출하는 락커로 피복시킴을 특징으로 하는 방법.
  5. 제1항 또는 2항에 있어서, 활성물질과 염기성 부형재와의 완전 혼합물을 과립형태로 제조하고, 이 과립을 pH 5.5 내지 6.8의 범위에서 활성 물질을 특징으로 하는 방법.
  6. 제1항 또는 2항에 있어서, 활성물질과 염기성부형재의 완전 혼합물을, pH5.5내지 6.8의 범위에서 활성물질을 방출하는 락커로 피복시킨 분무-경화된 구형 입자의 형태로 제조함을 특징으로하는 방법.
  7. 제1항 내지 6항 중 어느 한 항에서, 경구투여용 고형 약제학적 제제가 pH 6.0 내지 6.4의 범위에서 활성물질을 방출하는 락커로 피복됨을 특징으로 하는 방법.
  8. 제1항 내지 7항 중 어느 한 항에서, 사용된 염기성 부형제가 산화마그네슘, 수산화 마그네슘, 탄산마그네슘, 탄산수소 마그네슘, 수산화칼슘, 탄산칼슘, 수산화 알루미늄 마그네슘, 마그네슘 알루미네이트, 탄산나트륨, 탄산수소 나트륨, 탄산칼륨, 탄산수소칼륨, 수산화나트륨 수산화칼륨 또는 제 3 인산 나트륨이고 이는 활성물질 1g-몰에 대해 염기성 부형제 2내지 50g-당량의 비로 사용되며, 제제는 피복물이 2시간까지의 기간동안 위액에 대해 저항성이 유지되도록 하는 양의, 히드록시프로필메틸 셀룰로오즈 프탈레이트, 메타크릴산과 메틸메타크릴레이트의 공중합체, 셀룰로오즈 아세테이트 프탈레이트 또는 이들 화합물의 혼합물로 이루어진 락커로 피복시키며, 활성물질과 염기성 부형제와의 혼합물이 또한 추가의 보조제를 함유함을 특징으로 하는 방법.
  9. 제8항에 있어서, 염기성부형제로서 상이한 염기성 부형제들의 혼합물이 사용됨을 특징으로하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019860005492A 1985-07-10 1986-07-08 9-데옥소-11-데옥시-9,11-[이미노[2-(2-메톡시에톡시)에틸리덴]옥시]-(9s)-에리트로마이신을 함유하는 경구투여용 고형 약제학적 제제의 제조방법 KR930010586B1 (ko)

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DE19853524572 DE3524572A1 (de) 1985-07-10 1985-07-10 Feste arzneimittelformen zur peroralen anwendung enthaltend 9-deoxo-11-deoxy-9,11-(imino(2-(2-methoxyethoxy)ethyliden)-oxy)-(9s)-erythromycin und verfahren zu ihrer herstellung
DEP3524572.7 1985-07-10

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KR870000920A true KR870000920A (ko) 1987-03-10
KR930010586B1 KR930010586B1 (ko) 1993-10-30

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KR (1) KR930010586B1 (ko)
AT (1) ATE63819T1 (ko)
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CA (1) CA1271138A (ko)
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DE (2) DE3524572A1 (ko)
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ZA865105B (en) 1988-03-30
PT82949A (de) 1986-08-01
HUT42945A (en) 1987-09-28
ATE63819T1 (de) 1991-06-15
EP0208971A3 (en) 1988-01-27
IE861842L (en) 1987-01-10
PH26147A (en) 1992-03-18
JPS6212717A (ja) 1987-01-21
DD248057A5 (de) 1987-07-29
US4755385A (en) 1988-07-05
SG72191G (en) 1991-11-22
DK324786A (da) 1987-01-11
DK324786D0 (da) 1986-07-08
HU195730B (en) 1988-07-28
NL970004I1 (nl) 1997-04-01
NO175351B (no) 1994-06-27
NL970004I2 (nl) 1997-06-02
EP0208971A2 (de) 1987-01-21
CA1271138A (en) 1990-07-03
DK165670C (da) 1993-06-07
FI85649B (fi) 1992-02-14
KR930010586B1 (ko) 1993-10-30
FI85649C (fi) 1992-05-25
HK79791A (en) 1991-10-18
IL79375A (en) 1990-01-18
DE3679463D1 (de) 1991-07-04
IE58951B1 (en) 1993-12-01
FI862898A (fi) 1987-01-11
FI862898A0 (fi) 1986-07-10
MX9202785A (es) 1992-06-30
AU586262B2 (en) 1989-07-06
NZ216794A (en) 1988-11-29
IL79375A0 (en) 1986-10-31
DK165670B (da) 1993-01-04
AU5987686A (en) 1987-01-15
NO862772D0 (no) 1986-07-09
NO862772L (no) 1987-01-12
EP0208971B1 (de) 1991-05-29
NO175351C (no) 1994-10-05
DE3524572A1 (de) 1987-01-15
ES2000269A6 (es) 1988-02-01
GR861762B (en) 1986-11-10
PT82949B (pt) 1989-01-30
JPH0688905B2 (ja) 1994-11-09

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