CH656308A5 - PHARMACEUTICAL COMPOSITIONS CONTAINING SALBUTAMOL. - Google Patents
PHARMACEUTICAL COMPOSITIONS CONTAINING SALBUTAMOL. Download PDFInfo
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- CH656308A5 CH656308A5 CH2779/83A CH277983A CH656308A5 CH 656308 A5 CH656308 A5 CH 656308A5 CH 2779/83 A CH2779/83 A CH 2779/83A CH 277983 A CH277983 A CH 277983A CH 656308 A5 CH656308 A5 CH 656308A5
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- Prior art keywords
- pharmaceutical composition
- cellulose
- composition according
- salbutamol
- liquid
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- 239000008194 pharmaceutical composition Substances 0.000 title claims description 23
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 title claims description 19
- 229960002052 salbutamol Drugs 0.000 title claims description 16
- 229920002678 cellulose Polymers 0.000 claims description 19
- 239000001913 cellulose Substances 0.000 claims description 19
- 150000003839 salts Chemical class 0.000 claims description 11
- 239000007788 liquid Substances 0.000 claims description 9
- 239000001866 hydroxypropyl methyl cellulose Chemical class 0.000 claims description 7
- 229920003088 hydroxypropyl methyl cellulose Chemical class 0.000 claims description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 7
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical class OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 7
- 229920000663 Hydroxyethyl cellulose Chemical class 0.000 claims description 5
- 239000004354 Hydroxyethyl cellulose Chemical class 0.000 claims description 5
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 5
- 229920002134 Carboxymethyl cellulose Chemical class 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Chemical class 0.000 claims description 3
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 3
- 239000008112 carboxymethyl-cellulose Chemical class 0.000 claims description 3
- 239000006185 dispersion Substances 0.000 claims description 3
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical class CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 2
- 229920001479 Hydroxyethyl methyl cellulose Chemical class 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Chemical class 0.000 claims description 2
- 125000000217 alkyl group Chemical group 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 239000001761 ethyl methyl cellulose Chemical class 0.000 claims description 2
- 235000010944 ethyl methyl cellulose Nutrition 0.000 claims description 2
- 229920013819 hydroxyethyl ethylcellulose Chemical class 0.000 claims description 2
- 229920003063 hydroxymethyl cellulose Chemical class 0.000 claims description 2
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Chemical class 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 229920000609 methyl cellulose Chemical class 0.000 claims description 2
- 239000001923 methylcellulose Chemical class 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 1
- 239000012458 free base Substances 0.000 claims 1
- -1 hydroxyalkyl ether Chemical compound 0.000 claims 1
- 239000000203 mixture Substances 0.000 description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 13
- BNPSSFBOAGDEEL-UHFFFAOYSA-N albuterol sulfate Chemical compound OS(O)(=O)=O.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 BNPSSFBOAGDEEL-UHFFFAOYSA-N 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 229960002303 citric acid monohydrate Drugs 0.000 description 3
- 238000001246 colloidal dispersion Methods 0.000 description 3
- 239000012153 distilled water Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 235000013355 food flavoring agent Nutrition 0.000 description 2
- 235000003599 food sweetener Nutrition 0.000 description 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 2
- 239000001509 sodium citrate Substances 0.000 description 2
- 229960000999 sodium citrate dihydrate Drugs 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- 239000003765 sweetening agent Substances 0.000 description 2
- 239000002562 thickening agent Substances 0.000 description 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 2
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 description 1
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 1
- 239000005711 Benzoic acid Substances 0.000 description 1
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- UDIPTWFVPPPURJ-UHFFFAOYSA-M Cyclamate Chemical compound [Na+].[O-]S(=O)(=O)NC1CCCCC1 UDIPTWFVPPPURJ-UHFFFAOYSA-M 0.000 description 1
- WINXNKPZLFISPD-UHFFFAOYSA-M Saccharin sodium Chemical compound [Na+].C1=CC=C2C(=O)[N-]S(=O)(=O)C2=C1 WINXNKPZLFISPD-UHFFFAOYSA-M 0.000 description 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229920013820 alkyl cellulose Polymers 0.000 description 1
- 150000005215 alkyl ethers Chemical class 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 239000013011 aqueous formulation Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 235000010233 benzoic acid Nutrition 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000000337 buffer salt Substances 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 229960004106 citric acid Drugs 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000000625 cyclamic acid and its Na and Ca salt Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 229920013821 hydroxy alkyl cellulose Polymers 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 229940085605 saccharin sodium Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 229960001462 sodium cyclamate Drugs 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (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)
- Inorganic 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
La présente invention se rapporte à une composition pharmaceutique comprenant comme principe actif le ß-stimulant salbutamol. The present invention relates to a pharmaceutical composition comprising as active ingredient β-stimulant salbutamol.
Le salbutamol [(a1-tert.-butylaminométhyl-4-hydroxy-m-xylène-cs',a3-diol)] et ses sels physiologiquement acceptables sont décrits dans l'exposé d'invention britannique GB 1 200 886. Dans cet exposé, on fait référence aux compositions pharmaceutiques comprenant du salbutamol et on trouve une description de préparations solides et liquides à usage oral et intraveineux. Salbutamol [(a1-tert.-butylaminomethyl-4-hydroxy-m-xylene-cs', a3-diol)] and its physiologically acceptable salts are described in the description of the British invention GB 1 200 886. In this presentation , reference is made to pharmaceutical compositions comprising salbutamol and there is a description of solid and liquid preparations for oral and intravenous use.
Les préparations liquides de salbutamol et/ou d'un de ses sels physiologiquement acceptables sont normalement à base aqueuse et, pour l'usage oral, les préparations contiennent du saccharose ou du sorbitol qui agissent à la fois comme agent édulcorant et comme agent épaississant. Liquid preparations of salbutamol and / or one of its physiologically acceptable salts are normally aqueous-based and, for oral use, the preparations contain sucrose or sorbitol which act both as a sweetening agent and as a thickening agent.
De telles compositions pharmaceutiques ont été mises sur le marché avec succès. Cependant, il est connu que la présence d'une substance telle que le saccharose, le sorbitol ou le glycérol dans des compositions aqueuses de salbutamol ou d'un de ses sels physiologiquement actifs conduit à accélérer la détérioration de la stabilité du salbutamol dans la composition. Such pharmaceutical compositions have been successfully marketed. However, it is known that the presence of a substance such as sucrose, sorbitol or glycerol in aqueous compositions of salbutamol or of a physiologically active salt thereof leads to accelerating the deterioration of the stability of salbutamol in the composition. .
On a maintenant trouvé, de façon surprenante, que la stabilité du salbutamol dans des formulations aqueuses peut être significati-vement augmentée par la présence d'un dérivé de cellulose qui forme une dispersion colloïdale dans l'eau. It has now been surprisingly found that the stability of salbutamol in aqueous formulations can be significantly increased by the presence of a cellulose derivative which forms a colloidal dispersion in water.
La présente invention concerne donc une composition pharmaceutique améliorée qui comprend une dispersion aqueuse d'un ou plusieurs dérivés de cellulose contenant du salbutamol et/ou un ou plusieurs de ses sels physiologiquement acceptables. 5 De préférence, la composition pharmaceutique selon l'invention est formulée comme préparation liquide pour administration orale, dans laquelle le dérivé de cellulose est avantageusement utilisé comme agent épaississant. The present invention therefore relates to an improved pharmaceutical composition which comprises an aqueous dispersion of one or more cellulose derivatives containing salbutamol and / or one or more of its physiologically acceptable salts. Preferably, the pharmaceutical composition according to the invention is formulated as a liquid preparation for oral administration, in which the cellulose derivative is advantageously used as a thickening agent.
Les dérivés de cellulose convenables sont ceux qui forment une io dispersion dans l'eau optiquement transparente ou opalescente, de préférence une dispersion colloïdale optiquement transparente. Suitable cellulose derivatives are those which form an optically transparent or opalescent water dispersion, preferably an optically transparent colloidal dispersion.
Des dérivés de cellulose préférés comprennent les dérivés non ioniques tels que les alkyl et/ou hydroxyalkyl éthers de cellulose, particulièrement les C|4 alkyl et/ou hydroxy CM alkyléthers de cellulose, 15 par exemple l'éthyl cellulose, la méthyl cellulose, l'êthylméthyl cellulose, l'hydroxyméthyl cellulose, l'hydroxyéthyl cellulose, l'hydroxypropyl cellulose, l'hydroxyéthyl méthylcellulose, l'hydroxypropyl méthylcellulose et l'hydroxyéthyl éthylcellulose. Preferred cellulose derivatives include nonionic derivatives such as alkyl and / or hydroxyalkyl cellulose ethers, particularly C 4 alkyl and / or hydroxy CM cellulose alkyl ethers, e.g. ethyl cellulose, methyl cellulose, ethylmethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl methylcellulose and hydroxyethyl ethylcellulose.
Des dérivés de cellulose convenables, ioniques, comprennent la 20 carboxyméthylcellulose et ses sels, tels que les sels de calcium ou de sodium. Suitable ionic cellulose derivatives include carboxymethylcellulose and its salts, such as calcium or sodium salts.
Les dérivés de cellulose plus particulièrement préférés sont l'hydroxyéthyl cellulose et surtout l'hydroxypropyl méthylcellulose. The most particularly preferred cellulose derivatives are hydroxyethyl cellulose and especially hydroxypropyl methylcellulose.
Un des sels préférés du salbutamol pour l'usage dans la composi-25 tion pharmaceutique selon la présente invention est le sulfate. One of the preferred salbutamol salts for use in the pharmaceutical composition of the present invention is sulfate.
La quantité totale de dérivés de cellulose dispersibles présents dans la composition pharmaceutique est telle que la dispersion colloïdale résultante présente l'augmentation de stabilité désirée et a une viscosité adaptée au mode d'administration visé. De préférence, 30 les compositions pharmaceutiques contiennent au moins 0,1% en poids de dérivés de cellulose. The total amount of dispersible cellulose derivatives present in the pharmaceutical composition is such that the resulting colloidal dispersion has the desired increase in stability and has a viscosity suitable for the intended mode of administration. Preferably, the pharmaceutical compositions contain at least 0.1% by weight of cellulose derivatives.
Pour les préparations liquides destinées à l'administration orale, la quantité totale de dérivés de cellulose sera déterminée principalement par le désir d'obtenir une solution avec une viscosité convena-35 ble, de préférence comprise entre 5 x 10"3 et 10 Pa • s, et mieux encore entre 10 '" et 10"' Pa • s. For liquid preparations intended for oral administration, the total amount of cellulose derivatives will be determined mainly by the desire to obtain a solution with a suitable viscosity, preferably between 5 × 10 -3 and 10 Pa • s, and better still between 10 '"and 10"' Pa • s.
La concentration du salbutamol ou de ses sels dans la formulation peut être ajustée en fonction de l'utilisation que l'on désire faire de la composition et/ou des besoins du patient. Par exemple, pour The concentration of salbutamol or its salts in the formulation can be adjusted according to the use that one wishes to make of the composition and / or the needs of the patient. For example, for
49 un usage oral, la concentration présente, typiquement, un équivalent en salbutamol de 1 à 4 mg, de préférence 2 mg, exprimé comme salbutamol base libre, par 5 ml de liquide. 49 for oral use, the concentration typically has a salbutamol equivalent of 1 to 4 mg, preferably 2 mg, expressed as salbutamol free base, per 5 ml of liquid.
De préférence, le pH de la composition pharmaceutique est compris entre 2,5 et 7, plus particulièrement 3,5, résultat que l'on 45 obtient aisément en utilisant un tampon. Pour des compositions orales, on peut choisir les tampons parmi les tampons de citrate de sodium/acide citrique. Preferably, the pH of the pharmaceutical composition is between 2.5 and 7, more particularly 3.5, a result which is easily obtained using a buffer. For oral compositions, the pads can be chosen from sodium citrate / citric acid pads.
La composition pharmaceutique selon l'invention peut également contenir un agent de préservation antimicrobien, tel que l'acide The pharmaceutical composition according to the invention may also contain an antimicrobial preservative, such as acid
50 benzoïque ou un de ses sels qui génère l'acide in situ, ou un hydroxy-benzoate de méthyle, éthyle, propyle ou butyle. Pour un usage oral, la composition comprend également, de préférence, un agent aromatisant ou édulcorant tel que la saccharine sodium ou un cyclamate de sodium ainsi qu'un agent colorant. 50 benzoic acid or a salt thereof which generates acid in situ, or a methyl, ethyl, propyl or butyl hydroxy benzoate. For oral use, the composition also preferably includes a flavoring or sweetening agent such as sodium saccharin or sodium cyclamate as well as a coloring agent.
55 Pour la préparation de la composition pharmaceutique, on peut disperser un ou plusieurs dérivés de cellulose dans l'eau, puis ajouter ou mélanger le salbutamol ou l'un de ses sels physiologiquement actifs, convenablement dissous dans l'eau, avec, si désiré, les constituants optionnels de la composition. 55 For the preparation of the pharmaceutical composition, one or more cellulose derivatives can be dispersed in water, then add or mix salbutamol or one of its physiologically active salts, suitably dissolved in water, with, if desired , the optional constituents of the composition.
60 La présente invention est illustrée par les exemples de formulations donnés ci-après, exprimées pour une dose de 5 ml d'administration orale: The present invention is illustrated by the examples of formulations given below, expressed for a dose of 5 ml of oral administration:
fj5 Exemple I : fj5 Example I:
Sulfate de salbutamol 2,40 mg Salbutamol sulfate 2.40 mg
Hvdroxyéthyl cellulose 22,5 mg Hvdroxyethyl cellulose 22.5 mg
Eau distillée à 5 ml Distilled water to 5 ml
3 3
656 308 656,308
Pour préparer la formulation, l'hydroxyéthyl cellulose est dispersée dans l'eau, puis mélangée avec une solution de sulfate de salbutamol dans l'eau. To prepare the formulation, the hydroxyethyl cellulose is dispersed in water, then mixed with a solution of salbutamol sulfate in water.
Exemple 2: Example 2:
Sulfate de salbutamol 2,40 mg Salbutamol sulfate 2.40 mg
Dihydrate de citrate de sodium 9,60 mg Sodium citrate dihydrate 9.60 mg
Monohydrate d'acide citrique 15,15 mg Citric acid monohydrate 15.15 mg
Natrosol250H . 15,0 mg Natrosol250H. 15.0 mg
Eau distillée à 5,0 ml 5.0 ml distilled water
Pour préparer la formulation, l'hydroxyéthyl cellulose est dispersée dans l'eau, puis mélangée avec une solution de salbutamol et des sels tampons dans l'eau. To prepare the formulation, the hydroxyethyl cellulose is dispersed in water, then mixed with a solution of salbutamol and buffer salts in water.
Exemple 3: Example 3:
Sulfate de salbutamol 2,40 mg Salbutamol sulfate 2.40 mg
Dihydrate de citrate de sodium 9,60 mg Sodium citrate dihydrate 9.60 mg
Monohydrate d'acide citrique 15,25 mg Citric acid monohydrate 15.25 mg
Hydroxypropyl méthylcellulose viscosité type 4000 22,5 mg Hydroxypropyl methylcellulose viscosity type 4000 22.5 mg
Eau distillée à 5 ml Distilled water to 5 ml
5 Exemple 4: 5 Example 4:
Sulfate de salbutamol B.P. 2,40 mg Salbutamol sulfate B.P. 2.40 mg
Citrate de sodium B.P. 7,5 mg Sodium citrate B.P. 7.5 mg
Monohydrate d'acide citrique B.P. 25,0 mg Hydroxypropyl méthylcellulose io viscosité type 4000 22,5 mg B.P. citric acid monohydrate 25.0 mg Hydroxypropyl methylcellulose io viscosity type 4000 22.5 mg
Benzoate de sodium B.P. 10,0 mg Sodium benzoate B.P. 10.0 mg
Saccharine sodium B.P. 2,5 mg Saccharin sodium B.P. 2.5 mg
Agent aromatisant qs„ Flavoring agent qs „
Eau purifiée à 5 ml Purified water to 5 ml
15 Pour préparer les formulations des exemples 3 et 4, l'hydroxypropyl méthylcellulose est dispersée dans de l'eau chaude, refroidie, puis mélangée avec une solution aqueuse contenant du sulfate de salbutamol et les autres composants de la formulation. To prepare the formulations of Examples 3 and 4, the hydroxypropyl methylcellulose is dispersed in hot water, cooled, then mixed with an aqueous solution containing salbutamol sulfate and the other components of the formulation.
R R
Claims (11)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB8215502 | 1982-05-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CH656308A5 true CH656308A5 (en) | 1986-06-30 |
Family
ID=10530673
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CH2779/83A CH656308A5 (en) | 1982-05-27 | 1983-05-20 | PHARMACEUTICAL COMPOSITIONS CONTAINING SALBUTAMOL. |
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 PH PH28974A patent/PH19601A/en unknown
- 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 FI FI831893A patent/FI81257C/en not_active IP Right Cessation
- 1983-05-27 IE IE1267/83A patent/IE55139B1/en not_active IP Right Cessation
- 1983-05-27 ZW ZW118/83A patent/ZW11883A1/en unknown
- 1983-05-27 BE BE0/210866A patent/BE896870A/en not_active IP Right Cessation
- 1983-05-27 AU AU15039/83A patent/AU567675B2/en not_active Expired
- 1983-05-27 SE SE8303012A patent/SE454946B/en not_active IP Right Cessation
- 1983-05-27 AT AT0195283A patent/AT390191B/en not_active IP Right Cessation
- 1983-05-27 NZ NZ204385A patent/NZ204385A/en unknown
- 1983-05-27 IL IL68805A patent/IL68805A0/en not_active IP Right Cessation
- 1983-05-27 JP JP58093896A patent/JPH0629181B2/en not_active Expired - Lifetime
- 1983-05-27 LU LU84828A patent/LU84828A1/en unknown
- 1983-05-27 IT IT48384/83A patent/IT1174759B/en active Protection Beyond IP Right Term
- 1983-05-27 CA CA000429095A patent/CA1203176A/en not_active Expired
- 1983-05-27 PT PT76773A patent/PT76773B/en unknown
- 1983-05-27 DK DK241783A patent/DK167558B1/en not_active IP Right Cessation
- 1983-05-27 ZA ZA833854A patent/ZA833854B/en unknown
- 1983-05-27 ES ES522752A patent/ES8502336A1/en not_active Expired
-
1987
- 1987-12-30 MY MY275/87A patent/MY8700275A/en unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PL | Patent ceased |