KR970064599A - 서방성 제형 - Google Patents

서방성 제형 Download PDF

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Publication number
KR970064599A
KR970064599A KR1019970008590A KR19970008590A KR970064599A KR 970064599 A KR970064599 A KR 970064599A KR 1019970008590 A KR1019970008590 A KR 1019970008590A KR 19970008590 A KR19970008590 A KR 19970008590A KR 970064599 A KR970064599 A KR 970064599A
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KR
South Korea
Prior art keywords
sustained release
total weight
venlafaxine
release formulation
hydroxypropylmethylcellulose
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KR1019970008590A
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English (en)
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KR101096512B1 (ko
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데보라 엠 셔맨
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버그 이곤 이
아메리칸 홀 프로덕츠 코포레이션
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants

Abstract

본 발명은 항우울제인 벤라팍신 하이드로클로라이드의 24시간 서방성 투여제형 및 이의 단위 투여형에 관한 것으로서, 이는 하루 두번 이상 투여되어야 하는 종래의 정제 제형보다 혈중 혈장 수준의 조절이 우수하고 더욱이 종래의 정제보다 구토기 및 구토의 회수를 더 낮춰준다.

Description

서방성 제형
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (10)

  1. 벤라팍신 하이드로클로라이드, 미세결정성 셀룰로즈 및 하이드록시프로필레틸셀룰로즈을 포함하고 에틸셀룰로즈 및 하이드록시프로필메틸셀룰로즈로 코팅된 타원체의 치료학적 유효량을 함유하는 경질 젤라틴 캡슐을 포함하는, 벤자팍신 하이드로클로라이드의 캡슐화된 서방성 제형.
  2. 제1항에 있어서, 타원체가 벤라팍신 하이드로클로라이드 약 37.3중량%, 하이드록시프로필메틸셀룰로즈 2208 약 0.5중량% 및 미세결정성 셀룰로즈 약 62.17중량을 포함하는 서방성 제형.
  3. 제1항에 있어서, 박막 코팅이 에틸 셀룰로즈(총 중량의 4.81%) 및 하이드록시프로필메틸셀룰로즈(총 중량의 0.85%)을 포함하는 서방성 제형.
  4. 제1항에 있어서, 박막 코팅이 에틸 셀룰로즈(총 중량의 4.04%) 및 하이드록시프로필메틸셀룰로즈(총 중량의 0.714%)을 포함하는 서방성 제형.
  5. 제1항에 있어서, 박막 코팅이 에틸 셀룰로즈(총 중량의 2.48%) 및 하이드록시프로필메틸셀룰로즈(총 중량의 0.437%)을 포함하는 서방성 제형.
  6. 에톡시 그룹의 함량이 44.0 내지 51.0%인 에틸 셀로로즈(총 중량의 15%) 및 메톡시의 함량이 28.0 내지 30.0%이고 하이드록시프로폭시 그룹의 함량이 7.0 내지 12.0%인 하이드록시프로필메틸셀룰로즈(총 중량의 85%)을 포함하는 박막 코팅 조성물.
  7. 벤라팍신 37.3% 미세결정성 셀룰로즈 62.17% 및 하이드록시프로필메틸셀룰로즈 2208형 0.5%을 함유하고, 에틸 셀룰로즈 HG 2834형 15%아 하이드록시프로필메틸셀룰로오즈 2910형 85%을 포함하는, 24시간 동안에 걸쳐 목적하는 방출 속도를 나타내는 용해 프로파일을 갖는 코팅된 타원체를 제공하기에 충분한 양의 혼합물로 코팅된 타원체를 포함하는, 1일 1회 투여를 위한 벤라팍신 하이드로클로라이드의 서방성 제형.
  8. 제7항에 있어서, 24시간 동안에 걸쳐 150ng/㎖ 이하의 낮은 피크 혈청 수준 및 지속적인 치료학적 유효 혈장 수준을 제공하는 벤라팍신 하이드로클로라이드의 지속성 서방성 제형.
  9. 약 4 내지 약 8시간 내에 혈중 혈장 피크 수준의 벤라칵신을 제공하고, 활성성분으로서 벤라팍신 하이드로 클로라이드를 함유하는 캡슐화된 서방성 제형을 이를 필요로 하는 환자에게 경구로 투여하는 단계를 포함하며, 구토기 및 구토의 회수를 감소시키면서 24시간 동안에 걸쳐 벤라팍신의 치료적인 혈중 혈장 농도를 제공하는 방법.
  10. 약 4 내지 약 8시간내에 혈중 혈장 피크 수준의 벤라팍신을 제공하고, 활성 성분으로서 벤라팍신 하이드로콜로라이드를 함유하는 캡슐화된 서방성 제형을 이를 필요로 하는 환자에게 경구로 투여하는 단계를 포함하며, 1일 수 차례 투여량의 치료적 대사에 수반된 환자의 혈중 혈장중의 약제의 트로프 및 피크를 제거하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019970008590A 1996-03-25 1997-03-14 벤라팍신하이드로클로라이드의서방성제형및이를사용하여벤라팍신의치료적혈장농도를제공하는방법 KR101096512B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1400696P 1996-03-25 1996-03-25
US60/014,006 1996-03-25

Publications (2)

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KR970064599A true KR970064599A (ko) 1997-10-13
KR101096512B1 KR101096512B1 (ko) 2014-11-28

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Country Status (34)

Country Link
EP (2) EP2881110A1 (ko)
JP (2) JP4771565B2 (ko)
KR (1) KR101096512B1 (ko)
CN (2) CN1090018C (ko)
AR (1) AR006519A1 (ko)
AT (1) ATE257011T1 (ko)
AU (1) AU727653B2 (ko)
BR (1) BR9701304A (ko)
CA (1) CA2199778C (ko)
CO (1) CO4761054A1 (ko)
CY (1) CY2442B1 (ko)
CZ (1) CZ291637B6 (ko)
DE (1) DE69727000T2 (ko)
DK (1) DK0797991T3 (ko)
EG (1) EG24198A (ko)
ES (1) ES2210454T3 (ko)
HK (1) HK1056686A1 (ko)
HU (1) HU224617B1 (ko)
IL (1) IL120382A (ko)
IN (1) IN187337B (ko)
NO (2) NO320355B1 (ko)
NZ (1) NZ314442A (ko)
PA (1) PA8426401A1 (ko)
PE (1) PE57198A1 (ko)
PL (2) PL188444B1 (ko)
PT (1) PT797991E (ko)
RU (1) RU2176912C2 (ko)
SK (1) SK281530B6 (ko)
SV (1) SV1997000015A (ko)
TR (1) TR199700190A2 (ko)
TW (1) TW493993B (ko)
UA (1) UA44904C2 (ko)
UY (1) UY24613A1 (ko)
ZA (1) ZA972403B (ko)

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UA44904C2 (uk) 2002-03-15
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ATE257011T1 (de) 2004-01-15
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