EP1014972A1 - Method of treatment and pharmaceutical composion - Google Patents

Method of treatment and pharmaceutical composion

Info

Publication number
EP1014972A1
EP1014972A1 EP97905757A EP97905757A EP1014972A1 EP 1014972 A1 EP1014972 A1 EP 1014972A1 EP 97905757 A EP97905757 A EP 97905757A EP 97905757 A EP97905757 A EP 97905757A EP 1014972 A1 EP1014972 A1 EP 1014972A1
Authority
EP
European Patent Office
Prior art keywords
phenyl
loratadine
pharmaceutical formulation
sodium
leukotriene antagonist
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97905757A
Other languages
German (de)
French (fr)
Other versions
EP1014972A4 (en
Inventor
Sven-Erik Dahlen
Edward M. Scolnick
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck and Co Inc
Original Assignee
Merck and Co Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB9608927.1A external-priority patent/GB9608927D0/en
Application filed by Merck and Co Inc filed Critical Merck and Co Inc
Publication of EP1014972A1 publication Critical patent/EP1014972A1/en
Publication of EP1014972A4 publication Critical patent/EP1014972A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—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
    • 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
    • A61K31/4365—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 the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—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
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Landscapes

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

Abstract

A method of treating asthma, allergy and inflammation comprises treatment with a leukotriene inhibitor and loratadine either concurrently in separate doses or combined in a single pharmaceutical formulation.

Description

CROSS REFERENCE TO RELATED APPLICAΗON
This application is based on, and claims priority from, provisional application number 60/011,328 filed February 8, 1996.
TITLE OF THE INVENTION
METHOD OF TREATMENT AND PHARMACEUTICAL
COMPOSITION
BACKGROUND OF THE INVENTION
Loratadine is an antihistamine with H-receptor antagonist properties useful in the treatment of allergies and is described in U.S. Patent 4,282,233.
Leukotriene antagonists are known to be useful in the treatment of asthma, allergic reactions, and inflammation.
Now with the present invention, there is provided a method of treating asthma, allergy and inflammation with a combination of these two agents which is more efficacious than either agent by itself.
SUMMARY OF THE INVENTION
This invention is concerned with a method of treatment of asthma, allergy and inflammation by administration of an effective amount of loratadine and an effective amount of a leukotriene antagonist either by essentially concurrent administration or combined in a single pharmaceutical composition wherein the leukotriene antagonist is selected from:
A. Sodium 1 -(((R)-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2- (2-hydroxy-2-propyl)phenyl)thio)methyl)cyclopropaneacetate, EP 480,717
Montelukast Sodium
Sodium l-(((R)-(3-(2-(6,7-difluoro-2-quinolinyl)ethenyl)- phenyl)-3-(2-(2-hydroxy-2-propyl)phenyl)thio)methyl)cyclo- propaneacetate. U.S. 5,270,324
l-(((l(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 sodium salt thereof. U.S. 5,472,964
N-[4-oxo-2-(lH-tetrazol-5-yl)-4H-l-benzopyran-8-yl]-p-(4- phenylbutoxy)benzamide. EP 173,516
Pranlukast
Cyclopentyl- 3- [2-methoxy-4- [(o-tol ylsulf ony l)carbamoyl] - benzyl]- l-methylindole-5-carbamate. EP 199,543
Zafirlukast
DETAILED DESCRIPTION OF THE INVENTION
The novel pharmaceutical composition of this invention comprises a combination of loratadine and a leukotriene antagonist selected from A, B, C, D and E, described above, as active ingredients, and optionally a pharmaeutically acceptable carrier suitable for enteral or parenteral administration. The formulations may be in solid form, as for example tablets and capsules, or in liquid form, as for example, syrups, elixirs, emulsions and injectables. In the formulation of pharmaceutical dosage forms there generally is utilized excipients such as water, gelatin, lactose starches, magnesium stearate, talc, vegetable oils, benzyl alcohol, gums, polyalkylene glycols, and petroleum jelly. A preferred formulation is mere fully described in the following Example.
In the novel method of treatment of this invention, the loratadine and leukotriene antagonist can be administered substantially concurrently as separate dosage forms or combined in the novel pharmaceutical formulation of this invention.
Although the required dosage will be determined by such factors as the patients age, sex, weight and severity of the condition being treated, the preferred human oral dosage range is about 5 to 20 mg., loratadine, 1 to 3 times per day; preferably about 10 mg. once a day. In the case of the leukotrienes, the human dosage range is also about 5 to 20 mg 1 to 3 times per day; preferably about 10 mg. once a day. EXAMPLE
Montelukast Sodium 10 mg and Loratadine 10 mg Film Coated Tablet
Amt. Per Ingredient Tablet
Core
10.4 mg Montelukast Sodium
10.0 mg Loratadine
66.6 mg Microcrystalline Cellulose, NF
100.0 mg Lactose Monohydrate, NF
6.0 mg Croscarmellose Sodium, NF
(60.0 mg) Purified Water, USP
1.0 mg Magnesium Stearate, NF
200.0 mg Core Tablet
Film Coating
2.25 mg Hydroxypropyl Methylcellulose 6 cps
1.25 mg Hydroxypropyl Cellulose LF
1.50 mg Titanium Dioxide
(33.5) mg Purified Water
205.0 mg Film Coated Tablet

Claims

WHAT IS CLAIMED IS:
1. A pharmaceutical formulation comprising as active ingredients loratadine and a leukotriene antagonist selected from (A) montelukast sodium;
(B) Sodium l-(((R)-(3-(2-(6,7-difluoro-2-quinolinyl) ethenyl)phenyl) -3-(2-(2-hydroxy-2-propyl)phenyl) thio)methylcyclopropaneacetate;
(C) l-(((l(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 a sodium salt thereof;
(D) pranlukast; and
(E) zafϊrlukast; and a pharmaceutically acceptable carrier.
2. The composition of Claim 1 which is designed for oral administration.
3. 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).
4. The composition of Claim 1, wherein the leukotriene antagonist is montelukast sodium.
5. The composition of Claim 4 which is designed for oral administration.
6. The composition of Claim 5, comprising 10 mg of each active ingredient.
7. A method of treating asthma, allergy and inflammation in a patient in need of such treatment by the administration of an effective amount of loratadine and an effective amount of a leukotriene antagonist selected from:
(A) montelukast sodium;
(B) sodium l-(((R)-(3-(2-(6,7-difluror-2-quinolinyl)ethenyl)phenyl)-3- (2-(2-hydroxy-2-propyl)phenyl)thio)methyl)cyclopropaneactate;
(C) l-(((l(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 a sodium salt thereof; (D) pranlukast; and (E) zafirlukast; either substantially concurrently in separate dosage forms or combined in the single pharmaceutical formulation of Claim 1.
8. The method of Claim 7, wherein the pharmaceutical formulation is designed for oral administration.
9. The method of Claim 7 wherein the separate dosage forms and the single pharmaceutical formulation comprise 10 mg of loratadine and 10 mg of a leukotriene antagonist selected from (A), (B), (C), (D) and (E).
10. The method of Claim 7 wherein the leukotriene antagonist is (A) montelukast sodium.
11. The method of Claim 10 wherein the separate dosage forms and single pharmaceutical formulation are designed for oral administration.
12. The method of Claim 11 wherein the separate dosage forms and the single pharmaceutical formulation comprise 10 mg of loratadine and 10 mg of (A), montelukast sodium.
EP97905757A 1996-02-08 1997-02-04 Method of treatment and pharmaceutical composion Withdrawn EP1014972A4 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US1132896P 1996-02-08 1996-02-08
US11328P 1996-02-08
GBGB9608927.1A GB9608927D0 (en) 1996-04-29 1996-04-29 Method of treatment and pharmaceutical composition
GB9608927 1996-04-29
PCT/US1997/001799 WO1997028797A1 (en) 1996-02-08 1997-02-04 Method of treatment and pharmaceutical composion

Publications (2)

Publication Number Publication Date
EP1014972A1 true EP1014972A1 (en) 2000-07-05
EP1014972A4 EP1014972A4 (en) 2004-12-08

Family

ID=26309231

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97905757A Withdrawn EP1014972A4 (en) 1996-02-08 1997-02-04 Method of treatment and pharmaceutical composion

Country Status (19)

Country Link
EP (1) EP1014972A4 (en)
JP (1) JPH11504044A (en)
KR (1) KR19990082367A (en)
CN (1) CN1210465A (en)
AU (1) AU732671B2 (en)
BG (1) BG102669A (en)
BR (1) BR9707369A (en)
CA (1) CA2245162A1 (en)
CZ (1) CZ248798A3 (en)
EE (1) EE9800234A (en)
IL (1) IL125446A0 (en)
IS (1) IS4805A (en)
NO (1) NO983641L (en)
NZ (1) NZ331160A (en)
PL (1) PL328074A1 (en)
SK (1) SK105698A3 (en)
TR (1) TR199801511T2 (en)
WO (1) WO1997028797A1 (en)
YU (1) YU33298A (en)

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US7214683B1 (en) 1994-12-30 2007-05-08 Sepracor Inc. Compositions of descarboethoxyloratadine
US7211582B1 (en) 1994-12-30 2007-05-01 Sepracor Inc. Methods for treating urticaria using descarboethoxyloratadine
GB9723985D0 (en) 1997-11-14 1998-01-14 Zeneca Ltd Pharmaceutical compositions
IL136461A0 (en) * 1997-12-23 2001-06-14 Schering Corp Composition for treating respiratory and skin diseases, comprising at least one leukotriene antagonist and at least one antihistamine
US6194431B1 (en) 1998-04-14 2001-02-27 Paul D. Rubin Methods and compositions using terfenadine metabolites in combination with leukotriene inhibitors
US6384038B1 (en) 1998-04-14 2002-05-07 Sepracor Inc. Methods and compositions using cetirizine in combination with leukotriene inhibitors or decongestants
US6248308B1 (en) 1998-04-14 2001-06-19 Sepracor Inc. Methods of using norastemizole in combination with leukotriene inhibitors to treat or prevent asthma
US6262066B1 (en) 1998-07-27 2001-07-17 Schering Corporation High affinity ligands for nociceptin receptor ORL-1
ID29137A (en) * 1998-07-27 2001-08-02 Schering Corp HIGH AFINITY LIGANS FOR ORL-1 NOSISEPTIN RECEPTORS
PE20001070A1 (en) * 1998-09-10 2000-10-19 Schering Corp METHODS AND COMPOSITIONS TO TREAT SINUSITIS, OTITIS MEDIA AND OTHER RELATED DISORDERS USING ANTIHISTAMINES
AU3924500A (en) * 1999-03-29 2000-10-16 Schering Corporation Methods and compositions for treating allergic and related disorders using fluorinated descarboethoxyloratadine
DE10007203A1 (en) 2000-02-17 2001-08-23 Asta Medica Ag Composition for treating allergic and/or vasomotor rhinitis or allergic conjunctivitis by topical or oral administration, contains synergistic combination of non-sedating antihistamine and leukotriene antagonist
AU2002227240A1 (en) * 2000-10-30 2002-05-15 Schering Corporation Treatment and method using loratadine and montelukast
US20020198228A1 (en) * 2001-04-03 2002-12-26 Kaura Sita R. Composition and method for the treatment of respiratory desease
WO2004087095A2 (en) * 2003-03-31 2004-10-14 Osmotica Costa Rica, Sociedad Anonima Osmotic controlled release device containing zafirlukast and an h1-antagonist
WO2005037245A2 (en) * 2003-10-21 2005-04-28 Direct-Haler A/S A multiple route medication for the treatment of rhinitis and asthma
WO2005089748A1 (en) * 2004-03-17 2005-09-29 Pfizer Limited Combination for treating inflammatory diseases
CA2585122A1 (en) 2004-10-25 2006-05-04 Schering Corporation M1 and/or m3 receptor antagonists in combination with other actives for treating respiratory disorders
TR200806298A2 (en) * 2008-08-22 2010-03-22 Bi̇lgi̇ç Mahmut Pharmaceutical formulation
AR077101A1 (en) 2009-06-16 2011-08-03 Schering Corp STEROIDS OF HETEROARILO (3,2-C), AS GLUCOCORTICOID RECEPTOR AGONISTS, COMPOSITIONS AND USES OF THE SAME
KR101540191B1 (en) * 2014-02-24 2015-07-28 성균관대학교산학협력단 Composition comprising Loratadine for anti-inflammation
WO2020143744A1 (en) * 2019-01-10 2020-07-16 Jiangyin Mucocare Pharmaceutical Co., Ltd. New formulations containing leukotriene receptor antagonists

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Also Published As

Publication number Publication date
EE9800234A (en) 1998-12-15
NO983641D0 (en) 1998-08-07
KR19990082367A (en) 1999-11-25
NO983641L (en) 1998-08-07
BR9707369A (en) 1999-07-20
IS4805A (en) 1998-07-22
BG102669A (en) 1999-04-30
NZ331160A (en) 2000-07-28
PL328074A1 (en) 1999-01-04
AU2257997A (en) 1997-08-28
SK105698A3 (en) 1999-05-07
EP1014972A4 (en) 2004-12-08
YU33298A (en) 1999-11-22
WO1997028797A1 (en) 1997-08-14
TR199801511T2 (en) 1998-10-21
CN1210465A (en) 1999-03-10
JPH11504044A (en) 1999-04-06
CZ248798A3 (en) 1999-01-13
CA2245162A1 (en) 1997-08-14
IL125446A0 (en) 1999-03-12
AU732671B2 (en) 2001-04-26

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