WO2003089007A1 - Pharmaceutical compositions comprising a decongenstant and further active ingredients for treating cough and flu - Google Patents
Pharmaceutical compositions comprising a decongenstant and further active ingredients for treating cough and flu Download PDFInfo
- Publication number
- WO2003089007A1 WO2003089007A1 PCT/IB2003/001197 IB0301197W WO03089007A1 WO 2003089007 A1 WO2003089007 A1 WO 2003089007A1 IB 0301197 W IB0301197 W IB 0301197W WO 03089007 A1 WO03089007 A1 WO 03089007A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pharmaceutically acceptable
- combination
- pharmaceutical composition
- decongestant
- derivatives
- Prior art date
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
- A61K31/415—1,2-Diazoles
- A61K31/416—1,2-Diazoles condensed with carbocyclic ring systems, e.g. indazole
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/50—Pyridazines; Hydrogenated pyridazines
- A61K31/503—Pyridazines; Hydrogenated pyridazines spiro-condensed
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- This invention relates to pharmaceutical compositions and their use in the symptomatic relief of cough and flu.
- a pharmaceutical composition comprising a combination of a decongestant such as phenylephrine, pseudoephedrine or phenylpropanolamine or a pharmaceutically acceptable salt or derivative thereof, and at least one other active ingredient selected from a non-steriodal anti-inflammatory, an anti-histamine, a local anaesthetic, an antiseptic anaesthetic and a cough suppressant, and a pharmaceutically acceptable carrier.
- a decongestant such as phenylephrine, pseudoephedrine or phenylpropanolamine or a pharmaceutically acceptable salt or derivative thereof
- at least one other active ingredient selected from a non-steriodal anti-inflammatory, an anti-histamine, a local anaesthetic, an antiseptic anaesthetic and a cough suppressant, and a pharmaceutically acceptable carrier.
- the non-steroidal anti-inflammatory is preferably benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof.
- the antihistamine is preferably selected from the group comprising diphenhydramine, chlorpheniramine, loratadine, terbinafine and fexofenadine, and pharmaceutically acceptable salts and derivatives thereof.
- the local anaesthetic is preferably benzocaine or a pharmaceutically acceptable salt or derivative thereof.
- the antiseptic anaesthetic is preferably selected from the group comprising chlorhexidine gluconate, povidone iodine, cetylpy dinium chloride, cetalkonium chloride and cetrimide, and pharmaceutically acceptable salts and derivatives thereof.
- the cough suppressant is preferably selected from the group comprising dextromethorphan, codeine and pholcodi ⁇ e benzocaine, and pharmaceutically acceptable salts and derivatives thereof.
- the pharmaceutical composition is preferably provided in the form of a lozenge, tablet, capsule, mouthwash, gargle or spray, in particular a lozenge.
- the invention extends to the use of a combination as defined above in a method of providing symptomatic relief of cough and/or flu, in particular that associated with sore throats and/or congested nasal passages, comprising administering to a patient in need thereof a therapeutically effective amount of the combination.
- the invention also extends to the use of a combination as defined above in the manufacture of a medicament for the treatment of cough and/or flu, in particular that associated with sore throats and/or congested nasal passages.
- a further aspect of the invention is 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 as defined above in a pharmaceutically acceptable carrier.
- compositions of the invention are suitable for the symptomatic relief of cough and flu, including but not limited to that associated with sore throats and congested nasal passages.
- the pharmaceutical compositions of the invention provide relief from a sore throat as well as that of congested nasal passages in a single pharmaceutical dosage form that will allow for both topical and systemic delivery of appropriate medicaments.
- the pharmaceutical compositions of the invention allow for convenient drug delivery, appropriate dosage forms including a lozenge, tablet, capsule, mouthwash, gargle or spray that is applied or ingested via the oral or nasal route. Lozenges are particularly preferred. Although currently available lozenge formats make use of agents like menthol and/or eucalyptus, these provide only transient relief of nasal congestion.
- Pharmacologically active agents including decongestants such as phenylephrine, however, provide predictable and sustained relief from nasal congestion. Painful throats are also relieved by pharmaceutically active ingredients such as benzydamine and benzocaine. In order to be able to provide the required symptomatic relief, a combination of pharmacologically active ingredients is proposed.
- compositions of the invention provide combinations of:
- a decongestant such as phenylephrine, pseudoephedrine, phenylpropanolamine or a pharmaceutically acceptable salt or derivative thereof;
- an anti-histamine such as diphenhydramine, chlorpheniramine, loratadine, terbinafine, fexofenadine or a pharmaceutically acceptable salt or derivative thereof;
- a local anaesthetic such as benzocaine or a pharmaceutically acceptable salt or derivative thereof
- an antiseptic anaesthetic such as chlorhexidine gluconate, povidone iodine, cetylpyhdinium chloride, cetalkonium chloride, cetrimide or a pharmaceutically acceptable salt or derivative thereof; and (vi) a cough suppressant such as dextromethorphan, codeine, pholcodine benzocaine or a pharmaceutically acceptable salt or derivative thereof.
- An overage may be included to prevent loss during the production process.
- Phenylephrine Decongestant 1 0 mg to 10,0 mg, in particular 5 mg.
- An overage may be included to prevent loss during the production process.
- An overage may be included to prevent loss during the production process.
- Phenylephrine Decongestant 1 0 mg to 10,0 mg, in particular 5 mg.
- An overage may be included to prevent loss during the production process.
- Cetylpyridium Chloride Antiseptic 0.5 mg to 3 mg, in particular 1 ,5 mg. An overage may be included to prevent loss during the production process.
- Phenylephrine Decongestant 1 ,0 mg to 10,0 mg, in particular 5 mg. An overage may be included to prevent loss during the production process.
- Cetylpyridinium Chloride Antiseptic 0.5 mg to 3 mg, in particular 1 ,5 mg. An overage may be included to prevent loss during the production process.
- Benzocaine Local anaesthetic 5 mg to 20 mg, in particular 12 mg.
- An overage may be included to prevent loss during the production process.
- Phenylephrine Decongestant 1 0 mg to 10,0 mg, in particular s mg.
- An overage may be included to prevent loss during the production process.
- Cetylpyridinium Chloride Antiseptic 0.5 mg to 3 mg, in particular 1 ,5 mg. An overage may be included to prevent loss during the production process.
- Benzocaine Local anaesthetic 5 mg to 20 mg, in particular 12 mg.
- An overage may be included to prevent loss during the production process.
- Dextromethorphan HBr Cough suppressant 2,5 mg to 10 mg, in particular 5 mg.
- An overage may be included to prevent loss during the production process.
- a pharmaceutical composition comprising a combination of the above 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, xanthan gum, menthol, eucalyptus, maltitol, mannitol.
- the pharmaceutical composition may be provided in any appropriate dosage form such as, for example, lozenges, tablets, capsules, granules, suspensions, solutions or other liquid forms, and is intended for oral or nasal administration. Such a pharmaceutical composition is intended for the symptomatic relief of cough and flu.
- the dosage form will typically be administered to a patient from 1 to 6 times per day.
- Example 1 provides both rapid and prolonged nasal decongestant effects while reducing pain and inflammation in a patient's throat. It is believed that similar symptomatic relief can be achieved by using the other formulations of the invention.
- compositions could be effective despite one or more ingredients being sub-therapeutic, that is the combined effect of the active ingredients may be of an additive or synergistic nature.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Ophthalmology & Optometry (AREA)
- Emergency Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003219348A AU2003219348A1 (en) | 2002-04-22 | 2003-04-02 | Pharmaceutical compositions comprising a decongenstant and further active ingredients for treating cough and flu |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ZA200203159 | 2002-04-22 | ||
ZA2002/3159 | 2002-04-22 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2003089007A1 true WO2003089007A1 (en) | 2003-10-30 |
WO2003089007B1 WO2003089007B1 (en) | 2003-12-24 |
Family
ID=29251519
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2003/001197 WO2003089007A1 (en) | 2002-04-22 | 2003-04-02 | Pharmaceutical compositions comprising a decongenstant and further active ingredients for treating cough and flu |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU2003219348A1 (en) |
WO (1) | WO2003089007A1 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1572206A2 (en) * | 2002-12-18 | 2005-09-14 | Wyeth | Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines |
EP1720537A2 (en) * | 2004-02-17 | 2006-11-15 | Wyeth | Compositions of non-steroidal anti-inflammatory drugs and decongestants or anti-histamines |
WO2006135254A1 (en) | 2005-06-17 | 2006-12-21 | Aft Pharmaceuticals Limited | Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion |
EP1755561A2 (en) * | 2004-06-02 | 2007-02-28 | Wyeth | Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines |
WO2007066068A2 (en) * | 2005-12-08 | 2007-06-14 | The University Of Hull | Calcium ion channel receptor antagonist |
WO2009023434A2 (en) * | 2007-08-13 | 2009-02-19 | Mcneil-Ppc, Inc. | Method for stabilizing phenylephrine |
WO2009063223A1 (en) * | 2007-11-15 | 2009-05-22 | Reckitt Benckiser Healthcare (Uk) Limited | Use of anti-bacterial compounds having an anaesthetic effect |
US20100215776A1 (en) * | 2006-07-12 | 2010-08-26 | Thomas L. Jones | Method of treating a sore throat |
CN103385804A (en) * | 2013-07-24 | 2013-11-13 | 阎昭良 | Nano-silver mouth wash for preventing and treating oral diseases and preparation method thereof |
US9078824B2 (en) | 2007-09-24 | 2015-07-14 | The Procter & Gamble Company | Composition and method of stabilized sensitive ingredient |
WO2016126217A1 (en) * | 2015-02-03 | 2016-08-11 | Pharmacti̇ve Ilaç Sanayi̇ Ve Ti̇caret A. Ş. | Stable pharmaceutical combination containing benzydamine |
US10918618B2 (en) | 2005-03-10 | 2021-02-16 | 3M Innovative Properties Company | Methods of reducing microbial contamination |
Citations (7)
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---|---|---|---|---|
EP0431276A2 (en) * | 1989-12-06 | 1991-06-12 | Klaus Wörz | Worktop cleaning device |
WO1995002396A1 (en) * | 1993-07-12 | 1995-01-26 | Smithkline Beecham Corporation | Matrix-entrapped beadlet preparation |
WO1995023602A1 (en) * | 1994-03-01 | 1995-09-08 | Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A. | Antitussive composition containing an antitussive and benzydamine |
WO1996026724A1 (en) * | 1995-02-28 | 1996-09-06 | Smithkline Beecham S.P.A. | Pharmaceutical compositions containing a benzydamine or its salt and an antimicrobial agent |
WO1996029997A1 (en) * | 1995-03-29 | 1996-10-03 | The Procter & Gamble Company | Soft gelatin capsule with a gelatin shell comprising xanthine derivative |
WO1998052540A1 (en) * | 1997-05-22 | 1998-11-26 | The Boots Company Plc | Pharmaceutical compositions |
WO1998052545A1 (en) * | 1997-05-22 | 1998-11-26 | The Boots Company Plc | Pharmaceutical compositions of flurbiprofen and burn-masking agent for treating sore throat |
-
2003
- 2003-04-02 WO PCT/IB2003/001197 patent/WO2003089007A1/en not_active Application Discontinuation
- 2003-04-02 AU AU2003219348A patent/AU2003219348A1/en not_active Abandoned
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0431276A2 (en) * | 1989-12-06 | 1991-06-12 | Klaus Wörz | Worktop cleaning device |
WO1995002396A1 (en) * | 1993-07-12 | 1995-01-26 | Smithkline Beecham Corporation | Matrix-entrapped beadlet preparation |
WO1995023602A1 (en) * | 1994-03-01 | 1995-09-08 | Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.P.A. | Antitussive composition containing an antitussive and benzydamine |
WO1996026724A1 (en) * | 1995-02-28 | 1996-09-06 | Smithkline Beecham S.P.A. | Pharmaceutical compositions containing a benzydamine or its salt and an antimicrobial agent |
WO1996029997A1 (en) * | 1995-03-29 | 1996-10-03 | The Procter & Gamble Company | Soft gelatin capsule with a gelatin shell comprising xanthine derivative |
WO1998052540A1 (en) * | 1997-05-22 | 1998-11-26 | The Boots Company Plc | Pharmaceutical compositions |
WO1998052545A1 (en) * | 1997-05-22 | 1998-11-26 | The Boots Company Plc | Pharmaceutical compositions of flurbiprofen and burn-masking agent for treating sore throat |
Cited By (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7863287B2 (en) | 2002-12-18 | 2011-01-04 | Wyeth Llc | Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines |
EP1572206A2 (en) * | 2002-12-18 | 2005-09-14 | Wyeth | Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines |
AU2003301188B2 (en) * | 2002-12-18 | 2009-07-02 | Pf Consumer Healthcare 1 Llc | Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines |
EP1572206A4 (en) * | 2002-12-18 | 2007-07-18 | Wyeth Corp | Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines |
EP1720537A2 (en) * | 2004-02-17 | 2006-11-15 | Wyeth | Compositions of non-steroidal anti-inflammatory drugs and decongestants or anti-histamines |
EP1720537A4 (en) * | 2004-02-17 | 2007-10-03 | Wyeth Corp | Compositions of non-steroidal anti-inflammatory drugs and decongestants or anti-histamines |
EP1755561A2 (en) * | 2004-06-02 | 2007-02-28 | Wyeth | Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines |
EP1755561B1 (en) * | 2004-06-02 | 2016-11-23 | Wyeth LLC | Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines |
US10918618B2 (en) | 2005-03-10 | 2021-02-16 | 3M Innovative Properties Company | Methods of reducing microbial contamination |
EP1896022A4 (en) * | 2005-06-17 | 2008-08-06 | Aft Pharmaceuticals Ltd | Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion |
EP1896022A1 (en) * | 2005-06-17 | 2008-03-12 | AFT Pharmaceuticals Limited | Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion |
US8603523B2 (en) | 2005-06-17 | 2013-12-10 | Aft Pharmaceuticals Limited | Pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion |
WO2006135254A1 (en) | 2005-06-17 | 2006-12-21 | Aft Pharmaceuticals Limited | Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion |
WO2007066068A3 (en) * | 2005-12-08 | 2007-08-23 | Univ Hull | Calcium ion channel receptor antagonist |
WO2007066068A2 (en) * | 2005-12-08 | 2007-06-14 | The University Of Hull | Calcium ion channel receptor antagonist |
US20100215776A1 (en) * | 2006-07-12 | 2010-08-26 | Thomas L. Jones | Method of treating a sore throat |
US20100221342A1 (en) * | 2006-07-12 | 2010-09-02 | Thomas L. Jones, DDS | Composition and method of treating a sore throat |
US8362036B2 (en) * | 2006-07-12 | 2013-01-29 | Jones Thomas L | Composition and method of treating a sore throat |
US8367703B2 (en) * | 2006-07-12 | 2013-02-05 | Jones Thomas L | Method of treating a sore throat |
EP2246045A1 (en) * | 2007-08-13 | 2010-11-03 | McNeil-PPC, Inc. | Method for stabilizing phenylephrine |
US8323695B2 (en) | 2007-08-13 | 2012-12-04 | Mcneil-Ppc, Inc. | Method for stabilizing phenylephrine |
WO2009023434A2 (en) * | 2007-08-13 | 2009-02-19 | Mcneil-Ppc, Inc. | Method for stabilizing phenylephrine |
WO2009023434A3 (en) * | 2007-08-13 | 2009-04-09 | Mcneil Ppc Inc | Method for stabilizing phenylephrine |
US9078824B2 (en) | 2007-09-24 | 2015-07-14 | The Procter & Gamble Company | Composition and method of stabilized sensitive ingredient |
AU2008322739B2 (en) * | 2007-11-15 | 2014-07-10 | Reckitt Benckiser Healthcare (Uk) Limited | Use of anti-bacterial compounds having an anaesthetic effect |
WO2009063223A1 (en) * | 2007-11-15 | 2009-05-22 | Reckitt Benckiser Healthcare (Uk) Limited | Use of anti-bacterial compounds having an anaesthetic effect |
AU2008322739C1 (en) * | 2007-11-15 | 2018-08-30 | Reckitt Benckiser Healthcare (Uk) Limited | Use of anti-bacterial compounds having an anaesthetic effect |
EP2570123A1 (en) * | 2007-11-15 | 2013-03-20 | Reckitt Benckiser Healthcare (UK) Limited | Use of 2,4-dichlorobenzyl alcohol having an anaesthetic effect |
CN103385804A (en) * | 2013-07-24 | 2013-11-13 | 阎昭良 | Nano-silver mouth wash for preventing and treating oral diseases and preparation method thereof |
WO2016126217A1 (en) * | 2015-02-03 | 2016-08-11 | Pharmacti̇ve Ilaç Sanayi̇ Ve Ti̇caret A. Ş. | Stable pharmaceutical combination containing benzydamine |
Also Published As
Publication number | Publication date |
---|---|
AU2003219348A1 (en) | 2003-11-03 |
WO2003089007B1 (en) | 2003-12-24 |
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