SE454946B - Aqueous dispersion of salbutamol and a cellulose derivative - Google Patents
Aqueous dispersion of salbutamol and a cellulose derivativeInfo
- Publication number
- SE454946B SE454946B SE8303012A SE8303012A SE454946B SE 454946 B SE454946 B SE 454946B SE 8303012 A SE8303012 A SE 8303012A SE 8303012 A SE8303012 A SE 8303012A SE 454946 B SE454946 B SE 454946B
- Authority
- SE
- Sweden
- Prior art keywords
- composition according
- cellulose derivative
- salbutamol
- per
- aqueous dispersion
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61P11/08—Bronchodilators
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Description
454 946 2 Lämpliga nonjoniska cellulosaderívat innefattar karboximetyl- cellulosa och salter därav, såsom kalcium- och natriumsalterna. Suitable nonionic cellulose derivatives include carboxymethylcellulose and salts thereof, such as the calcium and sodium salts.
Särskilt föredragna cellulosaderívat är hydroxietylcellulosa och framför allt hydroxipropylmetylcellulosa.Particularly preferred cellulose derivatives are hydroxyethylcellulose and especially hydroxypropylmethylcellulose.
Ett föredraget salt av salbutamol för användning i den farma- ceutiska kompositionen enligt uppfinningen är sulfatet.A preferred salt of salbutamol for use in the pharmaceutical composition of the invention is the sulfate.
Den totala mängden dispergerbara cellulosaderívat i den far- maceutiska kompositionen enligt uppfinningen är sådan att den resul- terande kolloidala dispersionen uppvisar den önskade förbättrade stabiliteten och har en viskositet som är lämplig för det föreslagna administreringssättet. Den farmaceutiska kompositionen innehåller företrädesvis cellulosaderivaten i'en mängd av minst 0,1 g per 100 ml.The total amount of dispersible cellulose derivatives in the pharmaceutical composition of the invention is such that the resulting colloidal dispersion exhibits the desired improved stability and has a viscosity suitable for the proposed mode of administration. The pharmaceutical composition preferably contains the cellulose derivatives in an amount of at least 0.1 g per 100 ml.
För flytande preparat lämpade för oral administrering bestäm- mes den totala mängden cellulosaderívat huvudsakligen av kravet att erhålla en lösning med en viskositet lämpad för oral administrering, företrädesvis en viskositet inom intervallet 5-10 000 mPa-s, allra helst 10-1oo mpa-S. ' Koncentrationen av salbutamol eller salter därav i kompositio- nen kan inställas för att passa den avsedda användningen av komposi- tionen och/eller passa patientens behov. För oral användning är koncentrationen lämpligen ekvivalent med 1-4 mg, företrädesvis 2 mg, salbutamol, räknat såsom fri salbutamolbas, per 5 ml vätska.For liquid preparations suitable for oral administration, the total amount of cellulose derivative is mainly determined by the requirement to obtain a solution having a viscosity suitable for oral administration, preferably a viscosity in the range 5-10 000 mPa-s, most preferably 10-100 mpa-S . The concentration of salbutamol or salts thereof in the composition can be adjusted to suit the intended use of the composition and / or to suit the needs of the patient. For oral use, the concentration is suitably equivalent to 1-4 mg, preferably 2 mg, of salbutamol, calculated as free salbutamol base, per 5 ml of liquid.
Den farmaceutiska kompositionen har företrädesvis ett pH-vär- de inom intervallet 2,5-7, allra helst 3,5, och pH-värdet inställes lämpligen genom användning av en buffert. En lämplig buffert för orala kompositioner är en natriumcitrat-citronsyra-buffert.The pharmaceutical composition preferably has a pH value in the range 2.5-7, most preferably 3.5, and the pH value is suitably adjusted by using a buffer. A suitable buffer for oral compositions is a sodium citrate-citric acid buffer.
Den farmaceutiska kompositionen enligt uppfinningen kan även innehålla ett antimikrobiellt konserveringsmedel, såsom bensoesyra eller ett salt därav som alstrar syran in situ, eller ett metyl-, etyl-, propyl- eller butyl-hydroxibensoat. För oral användning inne- håller kompositionen dessutom företrädesvis ett smakämne, ett söt- ningsmedel, såsom sackarinnatrium eller natriumcyklamat, och/eller ett färgämne.The pharmaceutical composition of the invention may also contain an antimicrobial preservative, such as benzoic acid or a salt thereof which produces the acid in situ, or a methyl, ethyl, propyl or butyl hydroxybenzoate. For oral use, the composition further preferably contains a flavoring agent, a sweetening agent, such as saccharin sodium or sodium cyclamate, and / or a coloring agent.
Den farmaceutiska kompositionen enligt uppfinningen kan fram- ställas genom att ett eller flera cellulosaderívat dispergeras i vatten, varefter dispersionen sättes till och blandas med salbutamo- len eller fysiologiskt godtagbara salter därav, lämpligen i vatten- lösning, tillsammans med eventuella valfria komponenter i komppsitio- Den. 454 946 3 Nedan anges exempel på kompositioner enligt uppfinningen (såsom doser om S ml för oral administrering).The pharmaceutical composition of the invention may be prepared by dispersing one or more cellulose derivatives in water, after which the dispersion is added and mixed with the salbutamol or physiologically acceptable salts thereof, suitably in aqueous solution, together with any optional components in the composition. . Examples of compositions according to the invention (such as doses of 5 ml for oral administration) are given below.
Exemgel 1. ' salbutamolsulfat 02,40 mg hydroxietylcellulosa (Natrosol ZSOH) 22,5 mg destillerat vatten till 5 ml För framställning av kompositionen dispergeras hydroxietyl- cellulosan i vatten, varefter den resulterande dispersionen blandas med en lösning av salbutamolsulfat i vatten.Example gel 1. 'Salbutamol sulphate 02.40 mg hydroxyethylcellulose (Natrosol ZSOH) 22.5 mg distilled water to 5 ml To prepare the composition, the hydroxyethylcellulose is dispersed in water, after which the resulting dispersion is mixed with a solution of salbutamol sulphate in water.
Exemgel 2. salbutamolsulfat 2,40 mg natriumcitrat-dihydrat 9,60 mg citronsyra-monohydrat 15,15 mg Natrosol ZSOH 15,0 mg destillerat vatten till 5,0 ml För framställning av kompositionen dispergeras hydroxietyl- cellulosan i vatten, varefter dispersionen blandas med en lösning av salbutamol och buffertsalterna i vatten.Example gel 2. salbutamol sulphate 2.40 mg sodium citrate dihydrate 9.60 mg citric acid monohydrate 15.15 mg Natrosol ZSOH 15.0 mg distilled water to 5.0 ml To prepare the composition, the hydroxyethylcellulose is dispersed in water, after which the dispersion is mixed with a solution of salbutamol and the buffer salts in water.
Exemgel . salbutamolsulfat 2,40 mg natriumcitrat-dihydrat 9,60 mg citronsyra-monohydrat 15,25 mg hydroxipropylmetylcellulosa (viskositetstyp 4000) 22,5 mg destillerat vatten till 5 ml Exemgel 4. salbutamolsulfat B.P. 2,40 mg natriumcitrat B.P. 7,5 mg citronsyra-monohydrat B.P. 25,0 mg hydroxipropylmetylcellulosa (viskositetstyp 4000) 22,5 mg natriumbensoat B.P. 10,0 mg sackarinnatrium B.P. 2,5 mg smakämne önskad mängd renat vatten till 5 ml För framställning av kompositionerna enligt exemplen 3 och 4 dispergeras hydroxipropylmetylcellulosan i varmt vatten, varefter den erhållna dispersionen kyles och blandas med en vattenlösning innehållande salbutamolsulfatet och de andra komponenterna i kom- positionen. ,Exemgel. salbutamol sulphate 2.40 mg sodium citrate dihydrate 9.60 mg citric acid monohydrate 15.25 mg hydroxypropyl methylcellulose (viscosity type 4000) 22.5 mg distilled water to 5 ml Exemgel 4. salbutamol sulphate B.P. 2.40 mg sodium citrate B.P. 7.5 mg citric acid monohydrate B.P. 25.0 mg hydroxypropyl methylcellulose (viscosity type 4000) 22.5 mg sodium benzoate B.P. 10.0 mg saccharin sodium B.P. 2.5 mg of flavor desired amount of purified water to 5 ml To prepare the compositions of Examples 3 and 4, the hydroxypropylmethylcellulose is dispersed in hot water, after which the resulting dispersion is cooled and mixed with an aqueous solution containing the salbutamol sulfate and the other components of the composition. ,
Claims (11)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB8215502 | 1982-05-27 |
Publications (3)
Publication Number | Publication Date |
---|---|
SE8303012D0 SE8303012D0 (en) | 1983-05-27 |
SE8303012L SE8303012L (en) | 1983-11-28 |
SE454946B true SE454946B (en) | 1988-06-13 |
Family
ID=10530673
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SE8303012A SE454946B (en) | 1982-05-27 | 1983-05-27 | Aqueous dispersion of salbutamol and a cellulose derivative |
Country Status (25)
Country | Link |
---|---|
JP (1) | JPH0629181B2 (en) |
AT (1) | AT390191B (en) |
AU (1) | AU567675B2 (en) |
BE (1) | BE896870A (en) |
CA (1) | CA1203176A (en) |
CH (1) | CH656308A5 (en) |
DE (1) | DE3319356C2 (en) |
DK (1) | DK167558B1 (en) |
ES (1) | ES8502336A1 (en) |
FI (1) | FI81257C (en) |
FR (1) | FR2527442B1 (en) |
GR (1) | GR82681B (en) |
IE (1) | IE55139B1 (en) |
IL (1) | IL68805A0 (en) |
IT (1) | IT1174759B (en) |
LU (1) | LU84828A1 (en) |
MY (1) | MY8700275A (en) |
NL (1) | NL192663C (en) |
NO (1) | NO163166C (en) |
NZ (1) | NZ204385A (en) |
PH (1) | PH19601A (en) |
PT (1) | PT76773B (en) |
SE (1) | SE454946B (en) |
ZA (1) | ZA833854B (en) |
ZW (1) | ZW11883A1 (en) |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3624213A (en) * | 1963-10-30 | 1971-11-30 | Merck & Co Inc | Method of sterilizing aqueous pharmaceutical solutions employing propylene oxide and entrained air |
GB1200886A (en) * | 1966-09-23 | 1970-08-05 | Allen & Hanburys Ltd | Phenylaminoethanol derivatives |
GB1453034A (en) * | 1972-12-15 | 1976-10-20 | Boehringer Sohn Ingelheim | Pharmaceutical composition for treating spasticity |
JPS5831210B2 (en) * | 1973-04-09 | 1983-07-05 | 武田薬品工業株式会社 | antennae |
DE2714065A1 (en) * | 1977-03-30 | 1978-10-12 | Boehringer Mannheim Gmbh | INSTILLATION PREPARATION |
-
1983
- 1983-05-20 CH CH2779/83A patent/CH656308A5/en not_active IP Right Cessation
- 1983-05-24 GR GR71454A patent/GR82681B/el unknown
- 1983-05-26 NO NO831875A patent/NO163166C/en not_active IP Right Cessation
- 1983-05-26 FR FR8308722A patent/FR2527442B1/en not_active Expired
- 1983-05-27 PT PT76773A patent/PT76773B/en unknown
- 1983-05-27 CA CA000429095A patent/CA1203176A/en not_active Expired
- 1983-05-27 PH PH28974A patent/PH19601A/en unknown
- 1983-05-27 DK DK241783A patent/DK167558B1/en not_active IP Right Cessation
- 1983-05-27 LU LU84828A patent/LU84828A1/en unknown
- 1983-05-27 IE IE1267/83A patent/IE55139B1/en not_active IP Right Cessation
- 1983-05-27 SE SE8303012A patent/SE454946B/en not_active IP Right Cessation
- 1983-05-27 JP JP58093896A patent/JPH0629181B2/en not_active Expired - Lifetime
- 1983-05-27 IT IT48384/83A patent/IT1174759B/en active Protection Beyond IP Right Term
- 1983-05-27 IL IL68805A patent/IL68805A0/en not_active IP Right Cessation
- 1983-05-27 AU AU15039/83A patent/AU567675B2/en not_active Expired
- 1983-05-27 DE DE3319356A patent/DE3319356C2/en not_active Expired - Lifetime
- 1983-05-27 NL NL8301900A patent/NL192663C/en not_active IP Right Cessation
- 1983-05-27 NZ NZ204385A patent/NZ204385A/en unknown
- 1983-05-27 BE BE0/210866A patent/BE896870A/en not_active IP Right Cessation
- 1983-05-27 ZA ZA833854A patent/ZA833854B/en unknown
- 1983-05-27 ZW ZW118/83A patent/ZW11883A1/en unknown
- 1983-05-27 ES ES522752A patent/ES8502336A1/en not_active Expired
- 1983-05-27 AT AT0195283A patent/AT390191B/en not_active IP Right Cessation
- 1983-05-27 FI FI831893A patent/FI81257C/en not_active IP Right Cessation
-
1987
- 1987-12-30 MY MY275/87A patent/MY8700275A/en unknown
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