KR19990082367A - Treatment Methods and Pharmaceutical Compositions - Google Patents

Treatment Methods and Pharmaceutical Compositions Download PDF

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KR19990082367A
KR19990082367A KR1019980706097A KR19980706097A KR19990082367A KR 19990082367 A KR19990082367 A KR 19990082367A KR 1019980706097 A KR1019980706097 A KR 1019980706097A KR 19980706097 A KR19980706097 A KR 19980706097A KR 19990082367 A KR19990082367 A KR 19990082367A
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phenyl
loratadine
pharmaceutical composition
sodium
leukotriene antagonist
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KR1019980706097A
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스벤-에릭 다렌
에드워드 엠. 스콜닉
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폴락 돈나 엘.
머크 앤드 캄파니 인코포레이티드
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Priority claimed from GBGB9608927.1A external-priority patent/GB9608927D0/en
Application filed by 폴락 돈나 엘., 머크 앤드 캄파니 인코포레이티드 filed Critical 폴락 돈나 엘.
Publication of KR19990082367A publication Critical patent/KR19990082367A/en

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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
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
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    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
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Abstract

본 발명의 천식, 알레르기 및 염증을 치료하는 방법은 류코트리엔 길항제 및 로라타딘을 분리 복용형으로 동시에 또는 단독 약제학적 조성물 형태로 배합하여 치료함을 포함한다.Methods of treating asthma, allergies and inflammation of the present invention include treating leukotriene antagonist and loratadine in separate dosage forms simultaneously or in the form of a single pharmaceutical composition.

Description

치료 방법 및 약제학적 조성물Treatment Methods and Pharmaceutical Compositions

관련 출원에 대한 참조Reference to related application

본 출원은 1996년 2월 8일자로 출원된 가출원 번호 제60/011,328호에 기초하여 우선권을 주장한다.This application claims priority based on Provisional Application No. 60 / 011,328, filed February 8, 1996.

본 발명은 로라타딘의 유효량 및 류코트리엔 길항제의 유효량을 실질적으로 동시에 투여하거나 단독 약제학적 조성물 형태로 배합하여 투여함으로써 천식, 알레르기 및 염증을 치료하는 방법에 관한 것이고, 여기서 류코트리엔 길항제는 하기로부터 선택된다.The present invention relates to a method for treating asthma, allergy and inflammation by administering an effective amount of loratadine and an effective amount of a leukotriene antagonist substantially simultaneously or in combination in the form of a single pharmaceutical composition, wherein the leukotriene antagonist is selected from the following.

A. 나트륨 1-(((R)-(3-(2-(7-클로로-2-퀴놀리닐)에테닐)페닐)-3-(2-(2-하이드록시-2-프로필)페닐)티오)메틸)사이클로프로판아세테이트, EP 480,717A. Sodium 1-(((R)-(3- (2- (7-chloro-2-quinolinyl) ethenyl) phenyl) -3- (2- (2-hydroxy-2-propyl) phenyl ) Thio) methyl) cyclopropane acetate, EP 480,717

, ,

B. 나트륨 1-(((R)-(3-(2-(6,7-디플루오로-2-퀴놀리닐)에테닐)페닐)-3-(2-(2-하이드록시-2-프로필)페닐)티오)메틸)사이클로프로판아세테이트, U.S. 5,270,324B. Sodium 1-(((R)-(3- (2- (6,7-difluoro-2-quinolinyl) ethenyl) phenyl) -3- (2- (2-hydroxy-2 -Propyl) phenyl) thio) methyl) cyclopropane acetate, US 5,270,324

, ,

C. 1-((1(R)-(3-(2-(2,3-디클로로티에노[3,2-b]피리딘-5-일)-(E)-에테닐)페닐)-3-(2-(1-하이드록시-1-메틸에틸)페닐)프로필)티오)메틸)사이클로프로판아세트산 또는 이의 나트륨 염, U.S. 5,472,964C. 1-((1 (R)-(3- (2- (2,3-dichlorothieno [3,2-b] pyridin-5-yl)-(E) -ethenyl) phenyl) -3 -(2- (1-hydroxy-1-methylethyl) phenyl) propyl) thio) methyl) cyclopropaneacetic acid or its sodium salt, US 5,472,964

, ,

D. N-[4-옥소-2-(1H-테트라졸-5-일)-4H-1-벤조피란-8-일]-p-(4-페닐부톡시)벤즈아미드, EP 173,516D. N- [4-oxo-2- (1H-tetrazol-5-yl) -4H-1-benzopyran-8-yl] -p- (4-phenylbutoxy) benzamide, EP 173,516

및 And

E. 사이클로펜틸-3-[2-메톡시-4-[(o-톨릴설포닐)카바모일]-벤질]-1-메틸인돌-5-카바메이트, EP 199,543E. cyclopentyl-3- [2-methoxy-4-[(o-tolylsulfonyl) carbamoyl] -benzyl] -1-methylindole-5-carbamate, EP 199,543

로라타딘(Loratadine)은 알레르기 치료에 유용한 H-수용체 길항 특성을 갖는 항히스타민제이고, 미국 특허 제4,282,233호에 기술되어 있다.Loratadine is an antihistamine with H-receptor antagonistic properties useful for the treatment of allergies and is described in US Pat. No. 4,282,233.

류코트리엔(Leucotriene) 길항제는 천식, 알레르기성 반응 및 염증의 치료에 유용하다고 공지되어 있다.Leucotriene antagonists are known to be useful in the treatment of asthma, allergic reactions and inflammation.

이제, 본 발명에 이르러 각각의 물질 그 자체보다 더욱 효과적인 이러한 두 물질의 배합으로 천식, 알레르기 및 염증을 치료하는 방법이 제공된다.The present invention now provides a method of treating asthma, allergies and inflammation with a combination of these two substances that is more effective than the respective substances themselves.

본 발명의 약제학적 조성물은 활성 성분으로서의 로라타딘과 상기 기술된 A, B, C, D 및 E로부터 선택된 류코트리엔 길항제의 배합물과 장용성 또는 비경구 투여에 적합한 임의의 약제학적으로 허용되는 담체를 포함한다. 제형은 고체형, 예를 들면 정제 및 캡슐 또는 액체형, 예를 들면 시럽, 엘릭서제, 유제 및 주사용 제제일 수 있다. 약제학적 복용형의 제형에 있어서, 일반적으로 물, 젤라틴, 락토오즈 전분, 마그네슘 스테아레이트, 활석, 식물성 오일, 벤질 알콜, 검, 폴리알킬렌 글리콜 및 석유 젤리와 같은 부형제가 유용하다. 바람직한 제형은 하기 실시예에 기술되어 있다.The pharmaceutical composition of the present invention comprises a combination of loratadine as the active ingredient and a leukotriene antagonist selected from A, B, C, D and E described above and any pharmaceutically acceptable carrier suitable for enteric or parenteral administration. . The formulations may be in solid form such as tablets and capsules or in liquid form such as syrups, elixirs, emulsions and injectable preparations. In formulations of pharmaceutical dosage forms, excipients such as water, gelatin, lactose starch, magnesium stearate, talc, vegetable oils, benzyl alcohol, gums, polyalkylene glycols and petroleum jelly are generally useful. Preferred formulations are described in the examples below.

본 발명의 치료 방법에 있어서, 로라타딘 및 류코트리엔 길항제는 실질적으로 분리 복용형으로 동시에 투여되거나 본 발명의 약제학적 제형 형태로 배합될 수 있다.In the method of treatment of the invention, the loratadine and leukotriene antagonist may be administered substantially simultaneously in separate dosage forms or formulated in the form of a pharmaceutical formulation of the invention.

필요한 복용량은 환자 연령, 성별, 체중 및 치료될 상태의 중증 정도와 같은 인자에 의해 결정되고, 바람직한 사람의 경구 복용량 범위는 하루에 1 내지 3회, 로라타딘 약 5 내지 20㎎, 바람직하게는 하루에 1회, 약 10㎎이다. 류코트리엔의 경우, 사람 복용량 범위는 또한, 하루에 1 내지 3회, 약 5 내지 20㎎, 바람직하게는 하루에 1회, 약 10㎎이다.The dosage required is determined by factors such as the patient's age, sex, weight and the severity of the condition to be treated, and the preferred oral dosage range of a person is 1 to 3 times a day, loratadine about 5 to 20 mg, preferably 1 day Once, about 10 mg. In the case of leukotriene, the human dosage range is also about 1 to 3 times a day, about 5 to 20 mg, preferably once a day, about 10 mg.

몬텔루카스트 나트륨 10㎎ 및 로라타딘 10㎎ 제피정10 mg of montelukast sodium and 10 mg of loratadine

양/정제Volume / tablet 성분ingredient 코아Core 10.4㎎10.0㎎66.6㎎100.0㎎6.0㎎(60.0㎎)1.0㎎10.4 mg 10.0 mg 66.6 mg 100.0 mg 6.0 mg (60.0 mg) 1.0 mg 몬텔루카스트 나트륨로라타딘미세결정 셀룰로즈, NF락토오즈 일수화물, NF크로스카멜로즈 나트륨, NF정제수, USP마그네슘 스테아레이트, NFMontelukast sodium loratadine microcrystalline cellulose, NF lactose monohydrate, NF croscarmellose sodium, NF purified water, USP magnesium stearate, NF 200.0㎎200.0mg 코아 정제Core tablets 제피Jaffe 2.25㎎1.25㎎1.50㎎(33.5)㎎2.25 mg 1.25 mg 1.50 mg (33.5) mg 하이드록시프로필 메틸셀룰로즈 6 cps하이드록시프로필 셀룰로즈 LF이산화티탄정제수Hydroxypropyl methylcellulose 6 cpshydroxypropyl cellulose LF titanium dioxide 205.0㎎205.0mg 제피정Retreat

Claims (12)

활성 성분으로서의 로라타딘 및 (A) 몬텔루카스트 나트륨; (B) 나트륨 1-(((R)-(3-(2-(6,7-디플루오로-2-퀴놀리닐)에테닐)페닐)-3-(2-(2-하이드록시-2-프로필)페닐)티오)메틸)사이클로프로판아세테이트; (C) 1-((1(R)-(3-(2-(2,3-디클로로티에노[3,2-b]피리딘-5-일)-(E)-에테닐)페닐)-3-(2-(1-하이드록시-1-메틸에틸)페닐)프로필)티오)메틸)사이클로프로판아세트산 또는 이의 나트륨 염; (D) 프란루카스트 및 (E) 자피르루카스트로부터 선택된 루코트리엔 길항제 및 약제학적으로 허용되는 담체를 포함하는 약제학적 조성물.Loratadine and (A) montelukast sodium as active ingredients; (B) Sodium 1-(((R)-(3- (2- (6,7-difluoro-2-quinolinyl) ethenyl) phenyl) -3- (2- (2-hydroxy- 2-propyl) phenyl) thio) methyl) cyclopropane acetate; (C) 1-((1 (R)-(3- (2- (2,3-dichlorothieno [3,2-b] pyridin-5-yl)-(E) -ethenyl) phenyl)- 3- (2- (1-hydroxy-1-methylethyl) phenyl) propyl) thio) methyl) cyclopropaneacetic acid or its sodium salt; A pharmaceutical composition comprising a leukotriene antagonist selected from (D) franlukast and (E) zafirlukast and a pharmaceutically acceptable carrier. 제1항에 있어서, 경구 투여용으로 고안된 조성물.The composition of claim 1 designed for oral administration. 제2항에 있어서, 로라타딘 10㎎과 (A), (B), (C), (D) 및 (E)로부터 선택된 류코트리엔 길항제 10㎎을 포함하는 조성물.The composition of claim 2 comprising 10 mg of loratadine and 10 mg of a leukotriene antagonist selected from (A), (B), (C), (D) and (E). 제1항에 있어서, 류코트리엔 길항제가 몬텔루카스트 나트륨인 조성물.The composition of claim 1 wherein the leukotriene antagonist is montelukast sodium. 제4항에 있어서, 경구 투여용으로 고안된 조성물.The composition of claim 4 designed for oral administration. 제5항에 있어서, 활성 성분을 각각 10㎎ 포함하는 조성물.6. The composition of claim 5, wherein the composition comprises 10 mg of each active ingredient. 천식, 알레르기 및 염증 치료가 필요한 환자에게 로라타딘 유효량과 (A) 몬텔루카스트 나트륨; (B) 나트륨 1-(((R)-(3-(2-(6,7-디플루오로-2-퀴놀리닐)에테닐)페닐)-3-(2-(2-하이드록시-2-프로필)페닐)티오)메틸)사이클로프로판아세테이트; (C) 1-((1(R)-(3-(2-(2,3-디클로로티에노[3,2-b]피리딘-5-일)-(E)-에테닐)페닐)-3-(2-(1-하이드록시-1-메틸에틸)페닐)프로필)티오)메틸)사이클로프로판아세트산 또는 이의 나트륨 염; (D) 프란루카스트 및 (E) 자피르루카스트로부터 선택된 루코트리엔 길항제 유효량을 분리 복용형으로 실질적으로 동시에 투여하거나 제1항에 따르는 단독 약제학적 조성물 형태로 배합하여 투여함으로써 천식, 알레르기 및 염증을 치료하는 방법.Effective amounts of loratadine and (A) montelukast sodium in patients in need of treatment for asthma, allergies and inflammation; (B) Sodium 1-(((R)-(3- (2- (6,7-difluoro-2-quinolinyl) ethenyl) phenyl) -3- (2- (2-hydroxy- 2-propyl) phenyl) thio) methyl) cyclopropane acetate; (C) 1-((1 (R)-(3- (2- (2,3-dichlorothieno [3,2-b] pyridin-5-yl)-(E) -ethenyl) phenyl)- 3- (2- (1-hydroxy-1-methylethyl) phenyl) propyl) thio) methyl) cyclopropaneacetic acid or its sodium salt; Asthma, allergy, by administering an effective amount of a leukotriene antagonist selected from (D) franlukast and (E) zafirlukast in a separate dosage form substantially simultaneously or in the form of a single pharmaceutical composition according to claim 1 And how to treat inflammation. 제7항에 있어서, 약제학적 조성물이 경구 투여용으로 고안된 방법.8. The method of claim 7, wherein the pharmaceutical composition is designed for oral administration. 제7항에 있어서, 분리 복용형 및 단독 약제학적 조성물이 로라타딘 10㎎과 (A), (B), (C), (D) 및 (E)로부터 선택된 류코트리엔 길항제 10㎎을 포함하는 방법.8. The method of claim 7, wherein the isolated dosage and single pharmaceutical composition comprises 10 mg of loratadine and 10 mg of a leukotriene antagonist selected from (A), (B), (C), (D) and (E). 제7항에 있어서, 류코트리엔 길항제가 (A) 몬텔루카스트 나트륨인 방법.8. The method of claim 7, wherein the leukotriene antagonist is (A) montelukast sodium. 제10항에 있어서, 분리 복용형 및 단독 약제학적 조성물이 경구 투여용으로 고안된 방법.The method of claim 10, wherein the separate dosage forms and the single pharmaceutical composition are designed for oral administration. 제11항에 있어서, 분리 복용형 및 단독 약제학적 조성물이 로라타딘 10㎎과 (A) 몬텔루카스트 나트륨 10mg을 포함하는 방법.The method of claim 11, wherein the discrete dosage and single pharmaceutical composition comprises 10 mg of loratadine and 10 mg of (A) montelukast sodium.
KR1019980706097A 1996-02-08 1997-02-04 Treatment Methods and Pharmaceutical Compositions KR19990082367A (en)

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