WO2003068206A1 - Pharmaceutical compositions comprising terbutaline or salbutamol in combination with guaiphenesine - Google Patents

Pharmaceutical compositions comprising terbutaline or salbutamol in combination with guaiphenesine Download PDF

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Publication number
WO2003068206A1
WO2003068206A1 PCT/IB2003/000475 IB0300475W WO03068206A1 WO 2003068206 A1 WO2003068206 A1 WO 2003068206A1 IB 0300475 W IB0300475 W IB 0300475W WO 03068206 A1 WO03068206 A1 WO 03068206A1
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Prior art keywords
pharmaceutically acceptable
terbutaline
salbutamol
combination
antihistamine
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PCT/IB2003/000475
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French (fr)
Inventor
Erica Lynne Du Plessis
Anna Hatzoudis
Michael Zwelikude Radebe
Bradley Ryan Parsons
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Adcock Ingram Intellectual Property (Proprietary) Limited
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Priority to AU2003205974A priority Critical patent/AU2003205974A1/en
Publication of WO2003068206A1 publication Critical patent/WO2003068206A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • A61K31/09—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon having two or more such linkages
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine

Definitions

  • THIS invention relates to pharmaceutical compositions and their use in the symptomatic relief of cough and flu.
  • Cough is a common symptom of coryza (common cold), croup, tracheobronchitis, pneumonia and influenza.
  • the cause of the underlying disease is usually viral in origin however primary or secondary bacteria infections may arise. The majority of viral cases can be treated symptomatically.
  • Symptomatic therapy with the co-administration of antibiotics is used to treat patients with bacteria or mixed infections.
  • Cough is a protective reflex that can expel secretions, exudates, transudates or extraneous materials from the respiratory tract.
  • the mechanism of cough is complex. A number of treatment options are available depending on whether the cough is productive in nature or not. When a cough is productive, it should rarely be suppressed (unless it is preventing rest, sleep or is exhausting the patient).
  • the pharmacologically treatment of a productive cough usually makes use of one or more classes of drugs used alone or in combination. Expectorants, demulcents, decongestants, antihistamines, bronchodilators and mucolytics are frequently used.
  • a pharmaceutical composition comprises a combination of (i) a bronchodilator selected from salbutamol and terbutaline, and pharmaceutically acceptable salts or derivatives thereof, and (ii) guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, and a pharmaceutically acceptable carrier.
  • a pharmaceutical composition comprises a combination of (i), (ii) and (iii) an antihistamine, or a pharmaceutically acceptable salt or derivative thereof, and a pharmaceutically acceptable carrier.
  • the invention extends to the use of either combination in a method of providing symptomatic relief of cough and/or flu, in particular that associated with bronchoconstriction and mucous production.
  • the invention also extends to the use of a combination of (i) and (ii), or of (i), (ii) and (iii), in the manufacture of a medicament for use in treating or preventing cough and/or flu.
  • the invention also extends to a method of treating or preventing cough and/or flu, comprising administering to a patient in need thereof a combination of (i) and (ii), or of (i), (ii) and (iii).
  • a method of treating or preventing cough and/or flu comprising administering to a patient in need thereof a combination of (i) and (ii), or of (i), (ii) and (iii).
  • compositions of the invention are suitable for the symptomatic relief of cough and/or flu, including but not limited to that associated with bronchoconst ction and excessive mucous production. They can also be used in the treatment or prevention of these illnesses.
  • the first ingredient is a bronchodilator selected from salbutamol and terbutaline, and pharmaceutically acceptable salts or derivatives thereof.
  • Salbutamol which is typically provided as its sulphate salt, is a direct- acting symphathomimetic agent with predominantly beta-ad renergic activity and a selective action on beta 2 receptors. It is a bronchodilator indicated for conditions which result in bronchoconstriction, and is used mostly in the treatment of bronchial asthma.
  • the salbutamol is provided in the composition in an amount such that the daily dose thereof is typically in the range of about 1 mg to about 30 mg, preferably about 4 mg to about 16 mg, expressed in terms of salbutamol base.
  • Terbutaline which is also typically provided as its sulphate salt, is also a direct-acting sympathomimetic agent with actions and uses similar to those of salbutamol. It is also used in the treatment of bronchial asthma.
  • the terbutaline is provided in the composition in an amount such that the daily dose of the terbutaline active ingredient is typically in the range of about 0.5 mg to about 5 mg given orally every 8 hours, preferably about 1.0 mg to about 3 mg, expressed in terms of terbutaline base.
  • the second ingredient is guaiphenesin or a pharmaceutically acceptable salt or derivative thereof. It is an expectorant that is reported to reduce the viscosity of tenacious sputum and is indicated for productive coughs.
  • the guaiphenesin is provided in the composition in an amount such that the daily dose thereof is typically in the range of about 50 mg to about 3500 mg, preferably about 200 mg to about 1600 mg.
  • a pharmaceutical composition comprising a combination of the above two ingredients includes a pharmaceutically acceptable carrier and may include other necessary non-active excipients such as, for example, sorbitol, sucrose, water, alcohol, citric acid propylene glycol, polyethylene glycol, and xanthan gum.
  • the pharmaceutical composition may be provided in any appropriate dosage form such as, for example, tablets, capsules, granules, suspensions, solutions or other liquid forms, and is intended for oral or intravenous administration.
  • Such a pharmaceutical composition is provided for the symptomatic relief of cough, including but not limited to that associated with bronchoconstriction and mucous production.
  • the dosage form will typically be administered to a patient from 1 to 6 times per day.
  • a further pharmaceutical composition of the invention includes the abovementioned two active ingredients in combination with a suitable antihistamine or a pharmaceutically acceptable salt or derivative thereof.
  • Antihistamines dry up excessive mucous and some have a cough suppressant effect.
  • suitable antihistamines include diphenhydramine, chlorpheniramine, diphenylpyraline, dexchlorpheniramine, loratidine and cetirizine. Particularly preferred are diphenhydramine and diphenylpyraline.
  • the daily dose of the antihistamine will depend on the particular active ingredient chosen.
  • the daily dose is typically in the range of about 3.5 mg to about 200 mg, preferably about 7 mg to about 170 mg.
  • diphenylpyraline When diphenylpyraline is incorporated into the pharmaceutical composition of the invention its daily dose is in the range of about 0.5 mg to about 50 mg, preferably about 1.25 mg to about 30 mg.
  • a pharmaceutical composition comprising all three active ingredients in combination includes a pharmaceutically acceptable carrier and may also include other non-active excipients. It may be provided in any appropriate dosage form such as, for example, tablets, capsules, granules, suspensions, solutions or other liquid forms, and is intended for oral or intravenous administration.
  • the pharmaceutical composition is provided for the symptomatic relief of cough and flu, including but not limited to that associated with bronchoconstriction and excessive mucous production.
  • the dosage form will typically be administered to a patient from 1 to 6 times per day.
  • Guaiphenesin produces its anti-tussive effect by decreasing the viscosity of bronchial secretions, thereby facilitating their removal.
  • Expectorants of this type increase the amount of respiratory tract fluid, exerting a demulcent action on the mucosal lining.
  • the effects of bronchospasm are rapidly reversed by the action of bronchodilators.
  • the antihistamines are intended to suppress the cough reflex, dry excess secretions and in some cases may produce sedation which will assist in the patient's rest and sleep patterns.
  • Combinations of each of the active ingredients were combined with acceptable pharmaceutical carriers, including formulations as shown in the above examples, and were exposed to International Conference of Harmonization (ICH) Stability Test conditions. Samples thereof were assayed by High Pressure Liquid Chromatographic (HPLC) methods. The samples complied with the tested parameters up to a period of 6 months.
  • ICH International Conference of Harmonization
  • each of the active ingredients is provided in a therapeutic amount, it is envisaged that one or more of the ingredients may be provided in sub-therapeutic amounts, provided that the pharmaceutical composition is therapeutic.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A pharmaceutical composition comprises a combination of (i) a bronchodilator selected from salbutamol and terbutaline, and pharmaceutically acceptable salts or derivatives thereof, and (ii) guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, and a pharmaceutically acceptable carrier. The pharmaceutical composition may further include an antihistamine, or a pharmaceutically acceptable salt or derivative thereof. The pharmaceutical compositions are used in methods of providing symptomatic relief of cough and/or flu, in particular that associated with bronchoconstriction and mucous production.

Description

PHARMACEUTICAL COMPOSITIONS COMPRISING TERBUTALINE OR SALBUTAMOL IN COMBINATION WITH GUAIPHENESINE
BACKGROUND OF THE INVENTION
THIS invention relates to pharmaceutical compositions and their use in the symptomatic relief of cough and flu.
Cough is a common symptom of coryza (common cold), croup, tracheobronchitis, pneumonia and influenza. The cause of the underlying disease is usually viral in origin however primary or secondary bacteria infections may arise. The majority of viral cases can be treated symptomatically. Symptomatic therapy with the co-administration of antibiotics is used to treat patients with bacteria or mixed infections.
Cough is a protective reflex that can expel secretions, exudates, transudates or extraneous materials from the respiratory tract. The mechanism of cough is complex. A number of treatment options are available depending on whether the cough is productive in nature or not. When a cough is productive, it should rarely be suppressed (unless it is preventing rest, sleep or is exhausting the patient). The pharmacologically treatment of a productive cough usually makes use of one or more classes of drugs used alone or in combination. Expectorants, demulcents, decongestants, antihistamines, bronchodilators and mucolytics are frequently used.
More recently the clinical efficacy of these classes of drugs or combinations thereof when used to treat cough have come under question. Drugs are frequently incorporated into a "cough mixture" at sub-therapeutic doses, which provide little or no proven benefit to patients. Data suggests that decongestants, mucolytics and demulcents have little role to play in the symptomatic treatment of cough. Bronchodilators in cough associated with bronchospasm, such as atropine, ephedrine and theophylline, are no longer considered safe due to their varied pharmacokinetics, addiction potential and side effect profiles.
SUMMARY OF THE INVENTION
According to one aspect of the invention, a pharmaceutical composition comprises a combination of (i) a bronchodilator selected from salbutamol and terbutaline, and pharmaceutically acceptable salts or derivatives thereof, and (ii) guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, and a pharmaceutically acceptable carrier.
According to a further aspect of the invention, a pharmaceutical composition comprises a combination of (i), (ii) and (iii) an antihistamine, or a pharmaceutically acceptable salt or derivative thereof, and a pharmaceutically acceptable carrier.
The invention extends to the use of either combination in a method of providing symptomatic relief of cough and/or flu, in particular that associated with bronchoconstriction and mucous production.
The invention also extends to the use of a combination of (i) and (ii), or of (i), (ii) and (iii), in the manufacture of a medicament for use in treating or preventing cough and/or flu.
The invention also extends to a method of treating or preventing cough and/or flu, comprising administering to a patient in need thereof a combination of (i) and (ii), or of (i), (ii) and (iii). DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The pharmaceutical compositions of the invention are suitable for the symptomatic relief of cough and/or flu, including but not limited to that associated with bronchoconst ction and excessive mucous production. They can also be used in the treatment or prevention of these illnesses.
The first ingredient is a bronchodilator selected from salbutamol and terbutaline, and pharmaceutically acceptable salts or derivatives thereof.
Salbutamol, which is typically provided as its sulphate salt, is a direct- acting symphathomimetic agent with predominantly beta-ad renergic activity and a selective action on beta2 receptors. It is a bronchodilator indicated for conditions which result in bronchoconstriction, and is used mostly in the treatment of bronchial asthma.
The salbutamol is provided in the composition in an amount such that the daily dose thereof is typically in the range of about 1 mg to about 30 mg, preferably about 4 mg to about 16 mg, expressed in terms of salbutamol base.
Terbutaline, which is also typically provided as its sulphate salt, is also a direct-acting sympathomimetic agent with actions and uses similar to those of salbutamol. It is also used in the treatment of bronchial asthma.
The terbutaline is provided in the composition in an amount such that the daily dose of the terbutaline active ingredient is typically in the range of about 0.5 mg to about 5 mg given orally every 8 hours, preferably about 1.0 mg to about 3 mg, expressed in terms of terbutaline base.
The second ingredient is guaiphenesin or a pharmaceutically acceptable salt or derivative thereof. It is an expectorant that is reported to reduce the viscosity of tenacious sputum and is indicated for productive coughs. The guaiphenesin is provided in the composition in an amount such that the daily dose thereof is typically in the range of about 50 mg to about 3500 mg, preferably about 200 mg to about 1600 mg.
A pharmaceutical composition comprising a combination of the above two ingredients includes a pharmaceutically acceptable carrier and may include other necessary non-active excipients such as, for example, sorbitol, sucrose, water, alcohol, citric acid propylene glycol, polyethylene glycol, and xanthan gum. The pharmaceutical composition may be provided in any appropriate dosage form such as, for example, tablets, capsules, granules, suspensions, solutions or other liquid forms, and is intended for oral or intravenous administration. Such a pharmaceutical composition is provided for the symptomatic relief of cough, including but not limited to that associated with bronchoconstriction and mucous production.
The dosage form will typically be administered to a patient from 1 to 6 times per day.
A further pharmaceutical composition of the invention includes the abovementioned two active ingredients in combination with a suitable antihistamine or a pharmaceutically acceptable salt or derivative thereof. Antihistamines dry up excessive mucous and some have a cough suppressant effect. Examples of suitable antihistamines include diphenhydramine, chlorpheniramine, diphenylpyraline, dexchlorpheniramine, loratidine and cetirizine. Particularly preferred are diphenhydramine and diphenylpyraline.
The daily dose of the antihistamine will depend on the particular active ingredient chosen. In the case of diphenhydramine, the daily dose is typically in the range of about 3.5 mg to about 200 mg, preferably about 7 mg to about 170 mg. When diphenylpyraline is incorporated into the pharmaceutical composition of the invention its daily dose is in the range of about 0.5 mg to about 50 mg, preferably about 1.25 mg to about 30 mg.
A pharmaceutical composition comprising all three active ingredients in combination includes a pharmaceutically acceptable carrier and may also include other non-active excipients. It may be provided in any appropriate dosage form such as, for example, tablets, capsules, granules, suspensions, solutions or other liquid forms, and is intended for oral or intravenous administration.
With the inclusion of an antihistamine the pharmaceutical composition is provided for the symptomatic relief of cough and flu, including but not limited to that associated with bronchoconstriction and excessive mucous production.
The dosage form will typically be administered to a patient from 1 to 6 times per day.
Guaiphenesin produces its anti-tussive effect by decreasing the viscosity of bronchial secretions, thereby facilitating their removal. Expectorants of this type increase the amount of respiratory tract fluid, exerting a demulcent action on the mucosal lining. The effects of bronchospasm (tightness of chest, difficulty in breathing, wheeze etc.) are rapidly reversed by the action of bronchodilators. The antihistamines are intended to suppress the cough reflex, dry excess secretions and in some cases may produce sedation which will assist in the patient's rest and sleep patterns. The inventors tested the preparations on themselves and experienced relief from bronchoconstriction. Subjective feedback indicates that mucous expectoration was enhanced. No adverse effects were noted.
The invention will now be described, by way of example only, with reference to the following non-limiting examples. Example 1 Sugar-Free Syrup
Figure imgf000007_0001
Method of Manufacture
Figure imgf000007_0002
Figure imgf000008_0001
Example 2 Soft Elastic Gelatin Capsule
Figure imgf000008_0002
Method of Manufacture
Figure imgf000008_0003
Example 3 Sugar-Free Syrup
Figure imgf000009_0001
Method of Manufacture
Step Action Required
As per Example 1 above.
Example 4 Sugar-Free Syrup
Figure imgf000009_0002
Method of Manufacture
Figure imgf000010_0001
Combinations of each of the active ingredients were combined with acceptable pharmaceutical carriers, including formulations as shown in the above examples, and were exposed to International Conference of Harmonization (ICH) Stability Test conditions. Samples thereof were assayed by High Pressure Liquid Chromatographic (HPLC) methods. The samples complied with the tested parameters up to a period of 6 months.
Although it is preferable that each of the active ingredients is provided in a therapeutic amount, it is envisaged that one or more of the ingredients may be provided in sub-therapeutic amounts, provided that the pharmaceutical composition is therapeutic.

Claims

1. A pharmaceutical composition comprising a combination of a bronchodilator selected from salbutamol and terbutaline, or a pharmaceutically acceptable salt or derivative thereof, and guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, as active ingredients, and a pharmaceutically acceptable carrier.
2. A pharmaceutical composition according to claim 1 , wherein the bronchodilator is salbutamol.
3. A pharmaceutical composition according to claim 1 , wherein the bronchodilator is terbutaline.
4. A pharmaceutical composition according to any one of the preceding claims, further comprising an antihistamine.
5. A pharmaceutical composition according to claim 4, wherein the antihistamine is selected from the group comprising diphenhydramine, chlorpheniramine, diphenylpyraline, dexchlorpheniramine, loratidine and cetirizine.
6. A pharmaceutical composition according to claim 5, wherein the antihistamine is diphenhydramine.
7. A pharmaceutical composition according to claim 5, wherein the antihistamine is diphenylpyraline.
8. A combination of a bronchodilator selected from salbutamol and terbutaline, or a pharmaceutically acceptable salt or derivative thereof, and guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, as active ingredients, for use in a method of providing symptomatic relief of cough, comprising administering to a patient in need thereof a therapeutically effective amount of the combination.
9. A combination according to claim 8, further comprising an antihistamine, for use in a method of providing symptomatic relief of cough and/or flu, comprising administering to a patient in need thereof a therapeutically effective amount of the combination.
10. A combination according to claim 8 or claim 9, wherein the cough and/or flu is associated with bronchoconstriction and/or mucous production.
11. The use of a combination of a bronchodilator selected from salbutamol and terbutaline, or a pharmaceutically acceptable salt or derivative thereof, and guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, as active ingredients, in the manufacture of a medicament for use in treating or preventing cough.
12. The use of claim 11 , wherein the combination further comprises an antihistamine, in the manufacture of a medicament for use in treating or preventing cough and/or flu.
13. The use of claim 11 or claim 12, wherein the cough and/or flu is associated with bronchoconstriction and/or mucous production.
14. The use of any one of claims 11 to 13, wherein the composition is provided in a dosage form selected from tablets, capsules, granules, suspensions, solutions and other liquid forms.
15. The use of claim 14, wherein the composition is formulated for oral or intravenous administration.
16. A method of treating or preventing cough, comprising administering to a patient in need thereof a therapeutically effective amount of a combination of a bronchodilator selected from salbutamol and terbutaline, or a pharmaceutically acceptable salt or derivative thereof, and guaiphenesin, or a pharmaceutically acceptable salt or derivative thereof, as active ingredients.
17. A method according to claim 16, wherein the bronchodilator is salbutamol.
18. A method according to claim 17, wherein the salbutamol is provided in an amount such that the daily dose thereof is from about 1 mg to about 30 mg, expressed in terms of salbutamol base.
19. A method according to claim 18, wherein the daily dose of the salbutamol is from about 4 mg to about 16 mg.
20. A method according to claim 16, wherein the bronchodilator is terbutaline.
21. A method according to claim 20, wherein the terbutaline is provided in an amount such that the daily dose thereof is from about 0.5 mg to about 5 mg, expressed in terms of terbutaline base.
22. A method according to claim 21 , wherein the daily dose of the terbutaline is from about 1.0 mg to about 3 mg.
23. A method according to any one of claims 16 to 22, wherein the guaiphenesin is provided in an amount such that the daily dose thereof is from about 50 mg to about 3500 mg.
24. A method according to claim 23, wherein the daily dose of the guaiphenesin is from about 200 mg to about 1600 mg.
25. A method according to any one of claims 16 to 24, wherein the method further comprises administering an antihistamine to the patient.
26. A method according to claim 25, wherein the antihistamine is selected from the group comprising diphenhydramine, chlorpheniramine, diphenylpyraline, dexchlorpheniramine, loratidine and cetirizine.
27. A method according to claim 26, wherein the antihistamine is diphenhydramine.
28. A method according to claim 27, wherein the diphenhydramine is provided in an amount such that the daily dose thereof is from about 3.5 mg to about 200 mg.
29. A method according to claim 28, wherein the daily dose of the diphenhydramine is from about 7 mg to about 170 mg.
30. A method according to claim 26, wherein the antihistamine is diphenylpyraline.
31. A method according to claim 30, wherein the diphenylpyraline is provided in an amount such that the daily dose thereof is from about 0.5 mg to about 50 mg.
32. A method according to claim 31 , wherein the daily dose of the diphenylpyraline is from about 1.25 mg to about 30 mg.
PCT/IB2003/000475 2002-02-13 2003-02-13 Pharmaceutical compositions comprising terbutaline or salbutamol in combination with guaiphenesine WO2003068206A1 (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2424185B (en) * 2005-03-16 2009-12-30 Atulkumar Sumanbhai Patel A cough mixture
WO2011027248A1 (en) * 2009-09-03 2011-03-10 Sulur Subramaniam Vanangamudi Oral liquid formulation comprising salbutamol and guaifenesin
EP2808010A1 (en) * 2013-05-28 2014-12-03 Sanovel Ilac Sanayi ve Ticaret A.S. Syrup Formulation of Salbutamol
US10105324B2 (en) * 2015-11-13 2018-10-23 Sovereign Pharmaceuticals, Llc Immediate release oral guaifenesin solution

Citations (1)

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WO1996035452A1 (en) * 1995-05-10 1996-11-14 Adcock Ingram Limited Pharmaceutical composition containing acetylcysteine, carbocysteine or erdosteine in combination with a beta 2 agonist and an expectorant for the treatment of respiratory tract disorders

Patent Citations (1)

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WO1996035452A1 (en) * 1995-05-10 1996-11-14 Adcock Ingram Limited Pharmaceutical composition containing acetylcysteine, carbocysteine or erdosteine in combination with a beta 2 agonist and an expectorant for the treatment of respiratory tract disorders

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Title
BIANCHI A ET AL: "Clinical and physiopathological results of a bronchodynamic mucolytic association, RG 089/12, in bronchopneumopathic patients", GAZZETTA MEDICA ITALIANA 1976, vol. 135, no. 7-8, 1976, pages 386 - 392, XP009010537 *
BUNDESVERBAND DER PHARMAZEUTISCHEN INDUSTRIE (EDITOR): "Rote Liste 1985", 1985, EDITIO CANTOR, AULENDORF, XP002240394 *
GRUBER W ET AL: "Symptomatic therapy for coughing in colds. An analysis of controlled studies", MONATSSCHRIFT FUR KINDERHEILKUNDE 2000 GERMANY, vol. 148, no. 2, 2000, pages 156 - 164, XP002240393, ISSN: 0026-9298 *
PEDROZA MELENDEZ A: "A mucolytic-bronchodilator association in the treatment of hypersecretory asthmatic bronchitis in children", INVESTIGACION MEDICA INTERNACIONAL 1988 MEXICO, vol. 15, no. 3, 1988, pages 162 - 168, XP001148025, ISSN: 0185-2108 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2424185B (en) * 2005-03-16 2009-12-30 Atulkumar Sumanbhai Patel A cough mixture
WO2011027248A1 (en) * 2009-09-03 2011-03-10 Sulur Subramaniam Vanangamudi Oral liquid formulation comprising salbutamol and guaifenesin
CN102573796A (en) * 2009-09-03 2012-07-11 苏鲁·苏布拉马尼·瓦南加穆迪 Oral liquid formulation comprising salbutamol and guaifenesin
EP2808010A1 (en) * 2013-05-28 2014-12-03 Sanovel Ilac Sanayi ve Ticaret A.S. Syrup Formulation of Salbutamol
WO2014191414A1 (en) * 2013-05-28 2014-12-04 Sanovel Ilac Sanayi Ve Ticaret A.S. Syrup formulation of salbutamol
US10105324B2 (en) * 2015-11-13 2018-10-23 Sovereign Pharmaceuticals, Llc Immediate release oral guaifenesin solution

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