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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 PDF

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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
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Prior art keywords
pharmaceutically acceptable
combination
pharmaceutical composition
decongestant
derivatives
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Application number
PCT/IB2003/001197
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French (fr)
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WO2003089007B1 (en
Inventor
Bradley Ryan Parsons
Erica Lynne Du Plessis
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Adcock Ingram Intellectual Property (Proprietary) Limited
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Priority to AU2003219348A priority Critical patent/AU2003219348A1/en
Publication of WO2003089007A1 publication Critical patent/WO2003089007A1/en
Publication of WO2003089007B1 publication Critical patent/WO2003089007B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/4151,2-Diazoles
    • A61K31/4161,2-Diazoles condensed with carbocyclic ring systems, e.g. indazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/50Pyridazines; Hydrogenated pyridazines
    • A61K31/503Pyridazines; Hydrogenated pyridazines spiro-condensed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/14Decongestants or antiallergics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs 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

A pharmaceutical composition comprises 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. The pharmaceutical composition, which is provided in the form of a lozenge, tablet, capsule, mouthwash, gargle or spray, in particular a lozenge, is suitable for the symptomatic relief of cough and flu, including but not limited to that associated with sore throats and congested nasal passages.

Description

PHARMACEUTICAL COMPOSITIONS COMPRISING A DECONGENSTANT AND FURTHER ACTIVE INGREDIENTS FOR TREATING COUGH AND FLU
BACKGROUND OF THE INVENTION
This invention relates to pharmaceutical compositions and their use in the symptomatic relief of cough and flu.
Common symptoms of cough and flu include a sore throat and congested nasal passages. Relief from a sore throat is often obtained through the use of medicated or non-medicated lozenges, which work through local effects. Nasal congestion can be relieved by the use of decongestant nasal sprays or drops. Decongestants can also be taken orally in the form of capsules, syrups, elixirs or tablets. Ingredients like menthol and eucalyptus provide short-lived relief and are frequently inadequate in keeping the nasal passages clear of mucous. SUMMARY OF THE INVENTION
According to one aspect of the invention, there is provided 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.
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 pholcodiπe 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.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The pharmaceutical 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.
In particular, 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.
In particular, the pharmaceutical compositions of the invention provide combinations of:
(i) a decongestant such as phenylephrine, pseudoephedrine, phenylpropanolamine or a pharmaceutically acceptable salt or derivative thereof;
and at least one active ingredient selected from:
(ii) a non-steriodal anti-inflammatory such as benzydamine HCI or a pharmaceutically acceptable salt thereof;
(iii) an anti-histamine such as diphenhydramine, chlorpheniramine, loratadine, terbinafine, fexofenadine or a pharmaceutically acceptable salt or derivative thereof;
(iv) a local anaesthetic such as benzocaine or a pharmaceutically acceptable salt or derivative thereof;
(v) 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.
Formulations which are illustrative of the pharmaceutical compositions of the invention are set out in the following table.
Active Ingredient Indication Dose per Lozenge / Dosage Unit
Benzydamine Anti-inflammatory / 1 ,0 mg to 5,0 mg, in analgesic particular s 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. mmmmmzi
Benzydamine Anti-inflammatory / 1 ,0 mg to 5,0 mg, in analgesic particular s 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.
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.
Figure imgf000008_0001
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.
In order to test the stability of the pharmaceutical compositions of the invention, combinations of each of the active ingredients were combined with acceptable pharmaceutical carriers and exposed to International Conference of Harmonization (ICH) Stability Test conditions. Samples were assayed by High Pressure Liquid Chromatographic (HPLC) methods. The samples comply with the tested parameters up to a period of 6 months. The study is ongoing.
The invention will now be illustrated by way of the following non-limiting examples.
Example 1
Figure imgf000009_0001
Figure imgf000010_0001
Development work indicates a 10% overage is adequate.
Example 2
Figure imgf000010_0002
Development work indicates a 10% overage is adequate.
Example 3
Figure imgf000010_0003
The inventors have reported that the lozenge format of 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.
It is envisaged that the pharmaceutical 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.

Claims

CLAIMS:
1. A pharmaceutical composition comprising a combination of a decongestant 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.
2. A pharmaceutical composition according to claim 1 , wherein the decongestant is selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof.
3. A pharmaceutical composition according to claim 1 or claim 2, wherein the non-steriodal anti-inflammatory is benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof.
4. A pharmaceutical composition according to any one of the preceding claims, wherein the anti-histamine is selected from the group comprising diphenhydramine, chlorpheniramine, loratadine, terbinafine and fexofenadine, and pharmaceutically acceptable salts and derivatives thereof.
5. A pharmaceutical composition according to any one of the preceding claims, wherein the local anaesthetic is benzocaine or a pharmaceutically acceptable salt or derivative thereof.
6. A pharmaceutical composition according to any one of the preceding claims, wherein the antiseptic anaesthetic is selected from the group comprising chlorhexidine gluconate, povidone iodine, cetylpyridinium chloride, cetalkonium chloride and cetrimide, and pharmaceutically acceptable salts and derivatives thereof.
7. A pharmaceutical composition according to any one of the preceding claims, wherein the cough suppressant is selected from the group comprising dextromethorphan, codeine and pholcodine benzocaine, and pharmaceutically acceptable salts and derivatives thereof.
8. A pharmaceutical composition comprising a combination of (i) a decongestant selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof, and (ii) benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof.
9. A pharmaceutical composition comprising a combination of (i) a decongestant selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof, (ii) benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof, and (iii) an antihistamine selected from the group comprising diphenhydramine, chlorpheniramine, loratadine, terbinafine and fexofenadine, and pharmaceutically acceptable salts and derivatives thereof.
10. A pharmaceutical composition comprising a combination" of (i) a decongestant selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof, and (ii) a local anaesthetic which is benzocaine or a pharmaceutically acceptable salt or derivative thereof.
1 1. A pharmaceutical composition comprising a combination of (i) a decongestant selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof, (ii) benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof, and (iii) an antiseptic selected from the group comprising chlorhexidine gluconate, povidone iodine, cetylpyridinium chloride, cetalkonium chloride and cetrimide, and pharmaceutically acceptable salts and derivatives thereof.
12. A pharmaceutical composition comprising a combination of (i) a decongestant selected from the group comprising phenylephrine, pseudoephedrine and phenylpropanolamine, and pharmaceutically acceptable salts and derivatives thereof, (ii) benzydamine HCI or a pharmaceutically acceptable salt or derivative thereof, and (iii) a cough suppressant selected from the group comprising dextromethorphan, codeine and pholcodine benzocaine, and pharmaceutically acceptable salts and derivatives thereof.
13. A pharmaceutical composition according to any one of claims 1 to 12, which is provided in the form of a lozenge, tablet, capsule, mouthwash, gargle or spray.
14. A combination of a decongestant and at least one other active ingredient selected from a non-steriodal anti-inflammatory, an antihistamine, a local anaesthetic, an antiseptic anaesthetic and a cough suppressant, and a pharmaceutically acceptable carrier, 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.
15. A combination according to claim 14, wherein the combination is as defined in any one of claims 2 to 12.
16. A combination according to claim 14 or claim 15, which is administered in a dosage form selected from lozenges, tablets, capsules, mouthwashes, gargles and sprays.
17. A combination according to any one of claims 14 to 16, wherein the cough and/or flu is associated with sore throats and/or congested nasal passages.
18. The use of a combination of a decongestant 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, in the manufacture of a medicament for the treatment of cough and/or flu.
19. A use according to claim 16, wherein the combination is as defined in any one of claims 2 to 12.
20. A use according to claim 18 or claim 19, wherein the medicament is provided in a dosage form selected from lozenges, tablets, capsules, mouthwashes, gargles and sprays.
21. A use according to any one of claims 18 to 20, wherein the cough and/or flu is associated with sore throats and/or congested nasal passages.
22. A method of providing symptomatic relief of cough and/or flu, comprising administering to a patient in need thereof a therapeutically effective amount of a combination of a decongestant 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.
23. A method according to claim 22, wherein the combination is as defined in any one of claims 2 to 12.
24. A method according to claim 22 or claim 23, wherein the combination is administered in a dosage form selected from lozenges, tablets, capsules, mouthwashes, gargles and sprays.
25. A method according to claim 22 or claim 23, wherein the combination is administered by nasal or oral administration.
26. A lozenge comprising a combination of a decongestant 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.
27. A lozenge according to claim 26, wherein the combination is as defined in any one of claims 2 to 12.
PCT/IB2003/001197 2002-04-22 2003-04-02 Pharmaceutical compositions comprising a decongenstant and further active ingredients for treating cough and flu WO2003089007A1 (en)

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Cited By (12)

* Cited by examiner, † Cited by third party
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
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WO2016126217A1 (en) * 2015-02-03 2016-08-11 Pharmacti̇ve Ilaç Sanayi̇ Ve Ti̇caret A. Ş. Stable pharmaceutical combination containing benzydamine

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