CN102264358A - Pharmaceutical composition comprising ibuprofen, pseudoephedrine and chlorpheniramine - Google Patents
Pharmaceutical composition comprising ibuprofen, pseudoephedrine and chlorpheniramine Download PDFInfo
- Publication number
- CN102264358A CN102264358A CN2009801449091A CN200980144909A CN102264358A CN 102264358 A CN102264358 A CN 102264358A CN 2009801449091 A CN2009801449091 A CN 2009801449091A CN 200980144909 A CN200980144909 A CN 200980144909A CN 102264358 A CN102264358 A CN 102264358A
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- CN
- China
- Prior art keywords
- compositions
- content
- ibuprofen
- sodium bicarbonate
- chlorphenamine
- 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.)
- Pending
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K31/435—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
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Pulmonology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Emergency Medicine (AREA)
- Molecular Biology (AREA)
- Otolaryngology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention relates to a pharmaceutical composition comprising ibuprofen as the active agent, preferably chloropheniramine maleate as an antihistaminic agent, preferably pseudoephedrine HCl as a sympathomimetic amine, and an alkaline salt, such as sodium bicarbonate, in an amount adequate to maintain the final solution's pH level between 7 and 9.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, comprise active component ibuprofen, hydryllin chlorphenamine, sympathomimetic amine class pseudoephedrine HCl and basic salt, all sodium bicarbonate that can make the amount of pH between 7-9 of final solution in this way.
Background technology
Ibuprofen is a kind of known ingredient with analgesia, antiinflammatory and refrigeration function.For example in US5100675, disclose a kind of pharmaceutical composition that comprises it and pseudoephedrine, can alleviate the symptom of flu-like symptom and flu, fever, sinusitis or nasal obstruction, headache and general malaise.
US5071643 and US5360615 disclose a kind of solvent system that is used to prepare the high concentration medicament, comprise the highly concentrated solution of acid medicine, wherein contain the ibuprofen of tablet or soft capsule or capsule.Solution according to the US5071643 relevant with ibuprofen, it comprises the polyglycol solution of 40-80% ibuprofen, 0.1-1.5 mole hydroxyl ion/every mole of ibuprofen, 1-20 weight % water and 4-12% propylene glycol or glycerol (referring to US5071643, the 5th hurdle, 18-24 is capable, and US5360615, the 5th hurdle, 21-26 is capable), this solution also comprises metal carbonate, such as potassium bicarbonate, sodium bicarbonate, potassium carbonate.
Acidic nature as the ibuprofen that US5071643 and US5360615 put down in writing can cause the coat of the stomach of the highstrung user of acid ingredient in the medicine is produced ill effect.In addition, because lower blood plasma absorbability and dissolubility, the ibuprofen with acidic nature will have lower bioavailability.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition that alleviates flu-like symptom and flu, fever, sinusitis or nasal obstruction, headache and general malaise symptom.
This purpose is achieved by the pharmaceutical composition with higher bioavailability, said composition comprises ibuprofen, pseudoephedrine HCI, chlorphenamine and one or more basic salts, a kind of Sodium ibuprofen salt component is provided thus, has more approached neutral level, and can be absorbed in the blood plasma quickly.
Chlorphenamine, a kind of histamine H 1 receptor antagonist, known it can alleviate rhinorrhea, have a stuffy nose, drop tears and symptom that eyes are rubescent; And pseudoephedrine HCI, a kind of sympathomimetic amine, known is a kind of upper respiratory tract congestion agent of brute force.
According to pharmaceutical composition of the present invention, comprise 4 to 200mg/ml ibuprofen, 0.6 to 30mg/ml pseudoephedrine HCI, 0.04 to 2mg/ml chlorphenamine and 1.5 to 300mg/ml sodium bicarbonate.Comprise 10 to 100mg/ml ibuprofen, 1 to 6mg/ml pseudoephedrine HCI, 0.1 to 1mg/ml chlorphenamine and 6 to 200mg/ml sodium bicarbonate according to preferred pharmaceutical composition of the present invention.Comprise 15 to 25mg/ml ibuprofen, 2 to 4mg/ml pseudoephedrine HCI, 0.15 to 0.25mg/ml chlorphenamine and 15 to 20mg/ml sodium bicarbonate according to most preferred pharmaceutical composition of the present invention.
Also comprise adjuvant according to compositions of the present invention, such as glycerol, soluble metyl hydroxybenzoate, sugar, flavoring banana essence, sunset yellow and deionized water.
Can comprise the substitute of basic salt according to compositions of the present invention as sodium bicarbonate, such as sodium hydroxide, potassium hydroxide, calcium carbonate, magnesium hydroxide or its mixture.
Foundation compositions of the present invention is syrup preferably, but also can make oral fluid agent arbitrarily, comprises the suspension liquor.Thereby, to compare with tablet, oral administration is easier to use, especially concerning the child.Above-mentioned " liquid agent " also comprises it is dissolved in carries out oral effervescent tablet and comprises the little packed of single using dosage in the water.
Listed the composition that can constitute below according to exemplary composition of the present invention:
Embodiment 1
Embodiment 2
Embodiment 3
Below listed the step of preparation 500L according to pharmaceutical composition of the present invention:
In making container (production vessel), add 300L deionized water and heating.To wherein adding 200kg sugar, turn on agitator is dissolved sugar fully, transfers in the additional reservoir (auxiliary vessel).
The 500g soluble metyl hydroxybenzoate is dissolved in the 20L deionized water, and joins in the container.
In additional reservoir, add 50L water, add 9kg sodium bicarbonate and 10kg ibuprofen again, make the ibuprofen sodium salt, transfer to and make in the container.
In additional reservoir, add the 10kg deionized water.Add 1.5kg pseudoephedrine HCL and 0.1kg chlorphenamine, dissolving, and transfer to and make in the container.
In making container, add 100kg glycerol.
With yellow the adding in the reaction of the 245g setting sun that is dissolved in the 20L water.
Add 3g essence, add deionized water and make final mixture reach 500L, stirred 1 hour, be filled in the sedimentation container.
Carry out the monitoring between each procedure.
Claims (9)
1. pharmaceutical composition that can alleviate flu-like symptom and flu, fever, sinusitis or nasal obstruction, headache and general malaise symptom, it is characterized in that comprising 4 to 200mg/ml ibuprofen, 0.6 to 30mg/ml pseudoephedrine HCI, 0.04 to 2mg/ml chlorphenamine and in order to the PH that keeps final composition between about 7 to about 9 basic salt or the mixture of basic salt.
2. according to the compositions of claim 1, it is characterized in that described basic salt is a sodium bicarbonate.
3. according to the compositions of claim 2, the amount that it is characterized in that described sodium bicarbonate is 1.5 to 300mg/ml.
4. according to the compositions of claim 1, it is characterized in that described basic salt is selected from sodium hydroxide, potassium hydroxide, calcium carbonate, magnesium hydroxide or its mixture.
5. according to the compositions of above-mentioned each claim, the content that it is characterized in that ibuprofen is 10 to 100mg/ml, and the content of pseudoephedrine HCI is 1 to 6mg/ml, and the content of chlorphenamine is 0.1 to 1mg/ml, and the content of sodium bicarbonate is 6 to 30mg/ml.
6. according to the compositions of above-mentioned each claim, the content that it is characterized in that ibuprofen is 15 to 25mg/ml, the content of pseudoephedrine HCI is 2 to 4mg/ml, and the content of chlorphenamine is 0.15 to 0.25mg/ml, and the content of sodium bicarbonate is 16 to 20mg/ml.
7. according to the compositions of above-mentioned each claim, it is characterized in that also comprising glycerol, soluble metyl hydroxybenzoate, sugar, flavoring banana essence, sunset yellow and deionized water.
8. according to the compositions of above-mentioned each claim, it is characterized in that described compositions is the liquid oral dosage form, comprise syrup and suspension liquor.
9. according to the compositions of claim 8, it is characterized in that described liquid oral dosage form also comprises it is dissolved in carries out oral effervescent tablet and comprises the little packed of single using dosage in the water.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TR200808511 | 2008-11-11 | ||
| TR2008/08511 | 2008-11-11 | ||
| PCT/TR2009/000046 WO2010056216A1 (en) | 2008-11-11 | 2009-03-30 | Pharmaceutical composition comprising ibuprofen, pseudoephedrine and chlorpheniramine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102264358A true CN102264358A (en) | 2011-11-30 |
Family
ID=41055188
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009801449091A Pending CN102264358A (en) | 2008-11-11 | 2009-03-30 | Pharmaceutical composition comprising ibuprofen, pseudoephedrine and chlorpheniramine |
Country Status (4)
| Country | Link |
|---|---|
| CN (1) | CN102264358A (en) |
| RU (1) | RU2011123762A (en) |
| TR (1) | TR201107202T1 (en) |
| WO (1) | WO2010056216A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2965746B1 (en) | 2014-07-10 | 2019-03-13 | Santa Farma Ilaç Sanayi A.S. | An oral pharmaceutical composition comprising ibuprofen, ibuprofen sodium dihydrate, pseudoephedrine hydrochloride and chlorpheniramine maleate |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5071643A (en) * | 1986-10-17 | 1991-12-10 | R. P. Scherer Corporation | Solvent system enhancing the solubility of pharmaceuticals for encapsulation |
| CA2084028A1 (en) * | 1991-11-27 | 1993-05-28 | Harish B. Pandya | Hot flu composition |
| US6383471B1 (en) * | 1999-04-06 | 2002-05-07 | Lipocine, Inc. | Compositions and methods for improved delivery of ionizable hydrophobic therapeutic agents |
| AU2001261744A1 (en) * | 2000-05-19 | 2001-12-03 | Npd Llc | Chewing gums, lozenges, candies, tablets, liquids, and sprays for efficient delivery of medications and dietary supplements |
| KR100507771B1 (en) * | 2002-11-08 | 2005-08-17 | 한미약품 주식회사 | A composition for oral administration of water-insoluble anti-cold drug and a preparation method thereof |
| TWI313598B (en) * | 2002-12-18 | 2009-08-21 | Wyeth Corp | Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines |
| DE10359790A1 (en) * | 2003-12-19 | 2005-07-21 | Bayer Healthcare Ag | Effervescent preparation of a basic pharmaceutically active substance |
| WO2005063219A2 (en) * | 2003-12-23 | 2005-07-14 | Ranbaxy Laboratories Limited | Ibuprofen-containing soft gelatin capsules |
| US8956652B2 (en) * | 2005-09-15 | 2015-02-17 | Tower Laboratories, Ltd. | Effervescent rehydrating beverage tablet/granules |
| US20070110676A1 (en) * | 2005-11-17 | 2007-05-17 | The Procter & Gamble Company | Compositions useful for prevention and treatment of common cold and influenza-like symptoms |
| US20070254027A1 (en) * | 2006-04-28 | 2007-11-01 | The Procter & Gamble Company | Compositions and methods useful for treatment of respiratory illness |
-
2009
- 2009-03-30 WO PCT/TR2009/000046 patent/WO2010056216A1/en active Application Filing
- 2009-03-30 RU RU2011123762/15A patent/RU2011123762A/en not_active Application Discontinuation
- 2009-03-30 TR TR2011/07202T patent/TR201107202T1/en unknown
- 2009-03-30 CN CN2009801449091A patent/CN102264358A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| TR201107202T1 (en) | 2012-02-21 |
| WO2010056216A1 (en) | 2010-05-20 |
| RU2011123762A (en) | 2012-12-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20111130 |