KR950703937A - 안정한 서방성 경구 투여 조성물(Stable extended release oral dosage composition) - Google Patents

안정한 서방성 경구 투여 조성물(Stable extended release oral dosage composition) Download PDF

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KR950703937A
KR950703937A KR1019950701529A KR19950701529A KR950703937A KR 950703937 A KR950703937 A KR 950703937A KR 1019950701529 A KR1019950701529 A KR 1019950701529A KR 19950701529 A KR19950701529 A KR 19950701529A KR 950703937 A KR950703937 A KR 950703937A
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core
oral dosage
coating
composition
matrix core
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KR1019950701529A
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KR100283709B1 (ko
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케이. 콴 헨리
엠. 리보위츠 스티븐
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노만 씨, 둘락
쉐링 코포레이션(Schering Corpation)
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Cosmetics (AREA)

Abstract

본 발명은 코 울혈제거제인 슈도에페드린, 또는 이의 염, 예를 들어 슈도에페드린 설페이트를 함유하는 독특한 중합체 매트릭스 코어(core) 및 코어상에 비진정 항히스타민제인 로라타딘을 함유하는 막 피복물을 함유하는, 서빙성 제피 경구 투여 조성물에 관한 것이고, 이러한 조성물은 상부 호흡기 질환 및 코 울혈과 관련된 징후 및 증상을 나타내는 환자를 치료하는데 사용된다.

Description

안정한 서방성 경구 투여 조성물(Stable extended release oral dosage composition)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (7)

  1. a. 하기 성분을 포함하는 매트릭스 코어 ;
    mg/코어
    슈도에페드린 설페이트 120 내지 360
    하이드록시프로필 메틸셀룰로오즈
    2208 100,000cps 160 내지 480
    에틸셀룰로우즈 40 내지 120
    이염기성 인삼칼슘 2수화물 56 내지 164
    포비돈 20 내지 60
    이산화규서 6 내지 12
    및
    마그네슘 스테아레이트 2 내지 6
    매트릭스 코어 중량 범위 : 400 내지 1200mg
    및
    b. 하기 성분을 포함하는 코어상의 피복물 ;
    mg/정제
    로라타딘 5 내지 15
    하이드록시프로필 메틸셀룰로오즈
    2910 6cps 17 내지 50
    폴리에틸렌 글리콜 400 0.25 내지 5.0
    폴리에틸렌 글리콜 3350 3.4 내지 10.2
    대략적인 피복물 중량 범위; 26 내지 80mg
    을 포함하며 매트릭스 코어 및 피복물의 조성물 중량 범위가 대략 426 내지 1280mg인 서방성 제피 경구 투여 조성물.
  2. 상부 호흡기 질환 및 코울혈과 관련된 징후 및 증상을 나타내는 환자에게 제1항의 경우 투여 조성물을 투여함을 포함하여 상기 환자를 치료하는 방법.
  3. 제1항에 있어서, 매트릭스 코어중의 슈도에페드린 설페이트가 240mg이고 피복물 중의 로라타딘이 10mg인 경구 투여 조성물.
  4. a. 하기 성분을 포함하느 매트릭스 코어;
    mg/코어
    슈도에페드린 설페이트 240
    하이드록시프로필 메틸셀룰로오즈
    2208 100,000cps 160 내지 480
    에틸셀룰로우즈 40 내지 120
    이염기성 인삼칼슘 2수화물 56 내지 164
    포비돈 20 내지 60
    이산화규소 6 내지 12
    및
    마그네슘 스테아레이트 2 내지 6
    대략적인 매트릭스 코어 중량 범위 : 254 내지 1082mg
    및
    b. 하기 성분을 포함하는 코어상의 피복물;
    mg/정제
    로라타딘 10
    하이드록시프로필 메틸셀룰로오즈
    2910 6cps 17 내지 50
    폴리에틸렌 글리콜 400 0.25 내지 5.0
    폴리에틸렌 글리콜 3350 3.4 내지 10.2
    대략적인 피복물 중량 범위; 31 내지 75mg
    을 포함하며 매트릭스 코어 및 피복물의 증량 범위가 대략 555 내지 1157mg인 서방성 제피 경구 투여 조성물
  5. 상부 호흡기 질환 및 코울혈과 관련된 징후 및/또는 증상을 나타내는 환자에게 제4항의 경구 투여 조성물을 투여함을 포함하여 상기 환자를 치료하는 방법.
  6. a. 하기 성분을 포함하는 매트릭스 코어;
    mg/코어
    슈도에페드린 설페이트 USP 240
    하이드록시프로필 메틸셀룰로오즈
    2208 100,000cps 320
    에틸셀룰로우즈 NF 형 7 80
    이염기성 인삼칼슘 USP 2수화물 108
    포비돈 USP 40
    이산화규소 NF 8
    및
    마그네슘 스테아레이트 NF 4
    대략적인 매트릭스 코어 중량 : 800mg
    및
    b. 하기 성분을 포함하는 코어상의 피복물;
    mg/정제
    미세화된 로라타딘 10
    하이드록시프로필 메틸셀룰로오즈 2910
    USP 6cps 33
    폴리에틸렌 글리콜 400 NF 0.67
    폴리에틸렌 글리콜 3350 NF 6.75
    색상 분산액(고체) 6.25
    대략적인 피복물 중량; 57mg
    을 포함하며 매트릭스 코어 및 피복물의 조성물 중량 범위가 대략 857mg인 서방성 제피 경구 투여 조성물.
  7. 상부 호흡기 질환 및 코울혈과 관련된 징후 및/또는 증상을 나타내는 환자에게 제6항의 경구 투여 조성물을 투여함을 포함하여 상기 환자를 치료하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950701529A 1992-10-23 1993-10-21 안정한 서방성 경구 투여 조성물 KR100283709B1 (ko)

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Application Number Priority Date Filing Date Title
US07/965470 1992-10-23
US7/965470 1992-10-23
US07/965,470 US5314697A (en) 1992-10-23 1992-10-23 Stable extended release oral dosage composition comprising loratadine and pseudoephedrine
PCT/US1993/009873 WO1994009761A1 (en) 1992-10-23 1993-10-21 Stable extended release oral dosage composition

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KR100283709B1 KR100283709B1 (ko) 2001-03-02

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US (1) US5314697A (ko)
EP (1) EP0665744B1 (ko)
JP (1) JP3580815B2 (ko)
KR (1) KR100283709B1 (ko)
CN (1) CN1038474C (ko)
AT (1) ATE161420T1 (ko)
AU (1) AU676229B2 (ko)
CA (1) CA2147606C (ko)
CZ (1) CZ287687B6 (ko)
DE (1) DE69316023T2 (ko)
DK (1) DK0665744T3 (ko)
EE (1) EE03106B1 (ko)
ES (1) ES2110633T3 (ko)
FI (1) FI112916B (ko)
GR (1) GR3026198T3 (ko)
HK (1) HK1004327A1 (ko)
HU (1) HU220629B1 (ko)
IL (1) IL107354A (ko)
MY (1) MY109090A (ko)
NO (1) NO308771B1 (ko)
NZ (1) NZ257447A (ko)
PH (1) PH29940A (ko)
PL (1) PL172862B1 (ko)
SG (1) SG42947A1 (ko)
SK (1) SK281090B6 (ko)
TW (1) TW251239B (ko)
WO (1) WO1994009761A1 (ko)
ZA (1) ZA937830B (ko)

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HK1004327A1 (en) 1998-11-20
TW251239B (ko) 1995-07-11
CN1038474C (zh) 1998-05-27
IL107354A0 (en) 1994-01-25
DE69316023T2 (de) 1998-04-23
MY109090A (en) 1996-11-30
ATE161420T1 (de) 1998-01-15
PL172862B1 (pl) 1997-12-31
FI951901A0 (fi) 1995-04-21
FI112916B (fi) 2004-02-13
HU9501143D0 (en) 1995-06-28
SK52295A3 (en) 1997-05-07
CA2147606C (en) 2000-10-10
NZ257447A (en) 1996-09-25
NO951527D0 (no) 1995-04-21
IL107354A (en) 1998-02-08
SG42947A1 (en) 1997-10-17
PH29940A (en) 1996-09-16
CZ287687B6 (en) 2001-01-17
US5314697A (en) 1994-05-24
NO951527L (no) 1995-06-20
WO1994009761A1 (en) 1994-05-11
AU676229B2 (en) 1997-03-06
NO308771B1 (no) 2000-10-30
KR100283709B1 (ko) 2001-03-02
ZA937830B (en) 1994-04-21
JPH08502516A (ja) 1996-03-19
DK0665744T3 (da) 1998-09-07
SK281090B6 (sk) 2000-11-07
JP3580815B2 (ja) 2004-10-27
CZ101495A3 (en) 1996-02-14
EP0665744A1 (en) 1995-08-09
EE03106B1 (et) 1998-08-17
DE69316023D1 (de) 1998-02-05
AU5405094A (en) 1994-05-24
ES2110633T3 (es) 1998-02-16
HUT71682A (en) 1996-01-29
HU220629B1 (hu) 2002-03-28
GR3026198T3 (en) 1998-05-29
EP0665744B1 (en) 1997-12-29
CN1089471A (zh) 1994-07-20
PL308491A1 (en) 1995-08-07
FI951901A (fi) 1995-04-21
CA2147606A1 (en) 1994-05-11

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