LU84828A1 - PHARMACEUTICAL COMPOSITIONS - Google Patents
PHARMACEUTICAL COMPOSITIONS Download PDFInfo
- Publication number
- LU84828A1 LU84828A1 LU84828A LU84828A LU84828A1 LU 84828 A1 LU84828 A1 LU 84828A1 LU 84828 A LU84828 A LU 84828A LU 84828 A LU84828 A LU 84828A LU 84828 A1 LU84828 A1 LU 84828A1
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- LU
- Luxembourg
- Prior art keywords
- cellulose
- salbutamol
- acceptable salts
- physiologically acceptable
- pharmaceutical composition
- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title claims description 17
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims description 23
- 229920002678 cellulose Polymers 0.000 claims description 23
- 239000001913 cellulose Substances 0.000 claims description 23
- 229960002052 salbutamol Drugs 0.000 claims description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 22
- 150000003839 salts Chemical class 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 9
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 8
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 8
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 6
- 239000006185 dispersion Substances 0.000 claims description 6
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 5
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound 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 5
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 3
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 3
- 239000012458 free base Substances 0.000 claims description 3
- 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 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound 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 Polymers 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 239000004480 active ingredient Substances 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 Substances 0.000 claims description 2
- 235000010944 ethyl methyl cellulose Nutrition 0.000 claims description 2
- 229920013819 hydroxyethyl ethylcellulose Polymers 0.000 claims description 2
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims description 2
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 229960002900 methylcellulose Drugs 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 150000005215 alkyl ethers Chemical class 0.000 claims 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 1
- 125000002768 hydroxyalkyl group Chemical group 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 12
- 238000009472 formulation Methods 0.000 description 6
- 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 5
- 229940071826 hydroxyethyl cellulose Drugs 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 239000000872 buffer Substances 0.000 description 3
- 238000001246 colloidal dispersion Methods 0.000 description 3
- 239000012153 distilled water Substances 0.000 description 3
- 239000001509 sodium citrate Substances 0.000 description 3
- 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 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
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- WINXNKPZLFISPD-UHFFFAOYSA-M Saccharin sodium Chemical compound [Na+].C1=CC=C2C(=O)[N-]S(=O)(=O)C2=C1 WINXNKPZLFISPD-UHFFFAOYSA-M 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
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 2
- 239000002253 acid Substances 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
- -1 hydroxyalkyl ethers Chemical class 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 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
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 125000000217 alkyl group Chemical group 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
- 125000003236 benzoyl group Chemical group [H]C1=C([H])C([H])=C(C([H])=C1[H])C(*)=O 0.000 description 1
- 239000000337 buffer salt Substances 0.000 description 1
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 229940071676 hydroxypropylcellulose Drugs 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
- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 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
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000007787 solid 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)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
t . 1 :ίt. 1: ί
Compositions pharmaceutiques.Pharmaceutical compositions.
, La présente invention concerne une composi tion pharmaceutique contenant, comme ingrédient actif, le salbutamol ß-stimulant.The present invention relates to a pharmaceutical composition containing, as active ingredient, salbutamol ß-stimulant.
S Le salbutamol [(a —tert-butylaminométhyl)-4— hydroxy—m-xylène-a ,o£ — diol)] et ses sels physiologiquement acceptables sont décrits dans le brevet britannique n° 1.200.886. Dans cette spécification, il est fait référence à des compositions pharmaceutiques 10 contenant du salbutamol et l’on donne une description m de préparations solides et liquides pour une utilisation par voie orale et par voie intraveineuse.S Salbutamol [(a — tert-butylaminomethyl) -4— hydroxy — m-xylene-a, o £ - diol)] and its physiologically acceptable salts are described in British Patent No. 1,200,886. In this specification, reference is made to pharmaceutical compositions containing salbutamol and a description is given of solid and liquid preparations for oral and intravenous use.
Les préparations liquides de salbutamol et/ouLiquid preparations of salbutamol and / or
Id’un de ses sels physiologiquement acceptables sont 15 avantageusement à base d’eau et, pour une utilisation par voie orale, ces préparations contiennent du sucrose ou du sorbitol qui agit à la fois comme agent édulcorant et comme agent épaississant.One of its physiologically acceptable salts is advantageously water-based and, for oral use, these preparations contain sucrose or sorbitol which acts both as a sweetening agent and as a thickening agent.
|j Ces compositions pharmaceutiques ont rencontré I 20 du succès dans le commerce. Toutefois, on sait que p la présence d’une substance telle que le sucrose, le } sorbitol ou le glycérol dans des compositions aqueuses i de salbutamol ou d’un de ses sels physiologiquement I acceptables est -associée à une détérioration accélérée % ! 25 de la stabilité du salbutamol dans la composition.These pharmaceutical compositions have met with commercial success. However, it is known that p the presence of a substance such as sucrose, sorbitol or glycerol in aqueous compositions i of salbutamol or one of its physiologically acceptable salts is -associated with an accelerated deterioration%! 25 of the stability of salbutamol in the composition.
; ; - A présent, de façon étonnante, la Demanderesse ^ a trouvé que l’on pouvait améliorer nettement la sta- I bilité du salbutamol dans des formulations aqueuses par la présence d’un dérivé de cellulose formant une 30 dispersion colloïdale dans l’eau.; ; Now, surprisingly, the Applicant has found that the stability of salbutamol in aqueous formulations can be markedly improved by the presence of a cellulose derivative forming a colloidal dispersion in water.
Dès lors, la présente invention fournit une 1 composition pharmaceutique améliorée comprenant une dispersion aqueuse d’un ou de plusieurs dérivés ce la cellulose,contenant du salbutamol et/ou un ou plu— r 35 sieurs de ses sels phvsxoloffiauement acceptables.Therefore, the present invention provides an improved pharmaceutical composition comprising an aqueous dispersion of one or more cellulose derivatives, containing salbutamol and / or one or more of its generally acceptable salts.
6 / ' / ! * ο6 / '/! * ο
Suivant une forme de réalisation préférée de 3 · l'invention, la composition pharmaceutique est formu lée sous forme d'une préparation liquide appropriée pour une administration par voie orale, préparation 5 dans laquelle on utilise avantageusement le dérivé de la cellulose comme agent épaississant.According to a preferred embodiment of the invention, the pharmaceutical composition is formulated in the form of a liquid preparation suitable for oral administration, preparation 5 in which the cellulose derivative is advantageously used as a thickening agent.
Des dérivés de cellulose appropriés sont ceux formant une dispersion optiquement transparente ou opalescente dans l'eau, de préférence, une dispersion 10 colloïdale optiquement transparente.Suitable cellulose derivatives are those forming an optically transparent or opalescent dispersion in water, preferably an optically transparent colloidal dispersion.
Parmi les dérivés préférés de la cellulose, il y a les dérivés non ioniques tels que les éthers i alkyliques et/ou hvdroxy—alkyliques de la cellulose, ! en particulier, les éthers alkyliques en C^ —et/ou 15 les éthers hydroxyalkyliques en C^—de la cellulose, par exemple, l'éthyl-cellulose, la méthvl-cellulose, 11éthyl-méthyl-cellulose, 1'hydroxyméthyl-cellulose, 1'hydroxyéthyl-cellulose, l'hydroxypropyl-cellulose, l'hydroxy éthyl-méthyl-cellulose, l'hydroxypr-opyl-20 méthyl-cellulose et l'hydroxyéthyléthyl-cellulose.Among the preferred cellulose derivatives are non-ionic derivatives such as alkyl and / or hydroxyalkyl ethers of cellulose,! in particular, C ^-alkyl ethers and / or C ^-hydroxyalkyl ethers of cellulose, for example, ethyl cellulose, methyl cellulose, ethyl methyl cellulose, hydroxymethyl cellulose , Hydroxyethyl-cellulose, hydroxypropyl-cellulose, hydroxyethyl-methyl-cellulose, hydroxypr-opyl-methyl-cellulose and hydroxyethylethyl-cellulose.
Parmi les dérivés ioniques appropriés de la f cellulose, il y a la carboxyméthyl—cellulose et ses sels tels que ses sels de calcium ou de sodium, i - Des dérivés particulièrement préférés de la 25 cellulose sont 1'hydroxyéthyl-cellulose et, plus spécialement , 1'hydroxypropyl-méthyl-cellulose.Among the suitable ionic derivatives of cellulose are carboxymethyl cellulose and its salts such as its calcium or sodium salts. Particularly preferred derivatives of cellulose are hydroxyethyl cellulose and, more particularly , Hydroxypropyl-methyl-cellulose.
tin sel préféré de salbutamol que l'on utilise dans la composition pharmaceutique suivant l'invention, est le sulfate.A preferred salt of salbutamol which is used in the pharmaceutical composition according to the invention is sulfate.
30 La quantité totale des dérives dispersables de la cellulose qui sont présents dans la composition pharmaceutique suivant l'invention, est calculée de telle sorte que la dispersion colloïdale obt errje ait la stabilité améliorée désirée, ainsi qu'une vis-35 cosité appropriée oour son mode d'administration pro- / 3 posé. De préférence, la composition pharmaceutique » contient au moins 031% en poids/volume des dérivés de la cellulose.The total amount of the dispersible cellulose derivatives which are present in the pharmaceutical composition according to the invention is calculated so that the colloidal dispersion obtained err has the desired improved stability, as well as an appropriate viscosity for its proposed method of administration. Preferably, the pharmaceutical composition "contains at least 031% w / v of the cellulose derivatives.
Pour des préparations liquides appropriées pour 5 une administration par voie orale, la quantité totale des dérivés de la cellulose sera déterminée principalement par le fait qu’il convient d’obtenir une solution ayant une viscosité appropriée pour une administration par voie orale et se situant, de préférence, 10 dans l’intervalle de 5 à 10.000 centipoises, mieux encore, dans l1intervalle de 10 à 100 centipoises.For liquid preparations suitable for oral administration, the total amount of cellulose derivatives will be determined mainly by the fact that a solution having a viscosity suitable for oral administration and lying in the range should be obtained. preferably 10 in the range of 5 to 10,000 centipoise, more preferably in the range of 10 to 100 centipoise.
La concentration du salbutamol ou de ses sels dans la formulation peut être réglée pour l’adapter à l’utilisation à laquelle la formulation est destinée, 15 et/ou selon les conditions qu’exige le patient. Par exemple, pour une utilisation par voie orale, la concentration est avantageusement égale à 1—4 mg, de préférence, à 2 mg de salbutamol (exprimé en base libre de salbutamol) pour 5 ml du liquide.The concentration of salbutamol or its salts in the formulation can be adjusted to suit the use for which the formulation is intended, and / or as required by the patient. For example, for oral use, the concentration is advantageously equal to 1—4 mg, preferably 2 mg of salbutamol (expressed as free base of salbutamol) per 5 ml of the liquid.
20 De préférence, le pH de la composition phar maceutique se situe dans l’intervalle allant de 2,5 à 7 et ü est plus particulièrement de 3*53 ce pH étant avantageusement obtenu en utilisant un tampon.Preferably, the pH of the pharmaceutical composition is in the range from 2.5 to 7 and more particularly 3 * 53, this pH being advantageously obtained by using a buffer.
- Pour des compositions destinées à une administration 25 par voie orale, parmi les tampons appropriés, il y a un tampon de citrate ce sodium/acide citrique.- For compositions intended for oral administration, among the appropriate buffers, there is a citrate, sodium / citric acid buffer.
La composition pharmaceutique suivant l’invention peut également contenir un agent de conservation antimicrobien tel que 1 ’acide benzoi'cue ou un 30 de ses sels engendrant l’acide in situ, ou encore un hydroxybenzoate de méthyle, d’éthyle, de propyle ou de butyle. Pour une utilisation par voie orale, de préférence, la composition contient également un agent aromatisant, un agent édulcorant r-el que la saccharine 35 de sodium ou le cvclamate de sodium et/ou un agent / ; 4 colorant.The pharmaceutical composition according to the invention may also contain an antimicrobial preservative such as benzoyl acid or a salt thereof generating the acid in situ, or alternatively a methyl, ethyl, propyl or hydroxybenzoate. butyl. For oral use, preferably, the composition also contains a flavoring agent, a sweetening agent such as sodium saccharin or sodium clamate and / or an agent /; 4 dye.
* On peut préparer la composition pharmaceutique suivant l’invention en dispersant un ou plusieurs dérivés de la cellulose dans l’eau, puis en ajoutant 5 ou en mélangeant la dispersion obtenue respectivement à ou avec le salbutamol ou un de ses sels physiologiquement acceptables, avantageusement dissous dans l’eau, conjointement avec l’un ou l’autre composant facultatif de la composition.* The pharmaceutical composition according to the invention can be prepared by dispersing one or more cellulose derivatives in water, then adding 5 or mixing the dispersion obtained respectively with or with salbutamol or one of its physiologically acceptable salts, advantageously dissolved in water, together with either optional component of the composition.
10 On donnera ci-après, à titre d'1 illustration, des exemples de formulations (exprimées sous forme d’une dose de 5 ml pour administration par voie orale) suivant l’invention :10 Below are given, by way of illustration, examples of formulations (expressed in the form of a dose of 5 ml for oral administration) according to the invention:
Exemple 1 15 Sulfate de salbutamol 2,40 mgExample 1 15 Salbutamol sulfate 2.40 mg
Hydroxyéthyl-cellulose ("Natrosol 250H”) 22,5 mg * Eau distillée, pour compléter à 5 mlHydroxyethyl cellulose ("Natrosol 250H”) 22.5 mg * Distilled water, to make up to 5 ml
Pour préparer cette formulation, on disperse 11hydroxyéthyl-cellulose dans l’eau, puis on la mélange 20 avec une solution de sulfate de salbutamol dans l’eau. Exemple 2To prepare this formulation, the hydroxyethyl cellulose is dispersed in water and then mixed with a solution of salbutamol sulfate in water. Example 2
Sulfate de salbutamol - 2,40 mgSalbutamol sulfate - 2.40 mg
Citrate de sodium à deux molécules d’eau 9,60 mgSodium citrate two molecules of water 9.60 mg
Acide citrique à une molécule d’eau 15,15 mg 25 "Natrosol 250H” 15,0 mgCitric acid in one molecule of water 15.15 mg 25 "Natrosol 250H” 15.0 mg
Eau distillée, pour compléter à 5,0 ml.Distilled water, to make up to 5.0 ml.
Pour préparer cette formulation, on disperse l’hydroxyéthyl—cellulose dans l’eau, puis on mélange la dispersion obtenue avec une solution de salbutamol 30 et des sels tampons dans l’eau.To prepare this formulation, the hydroxyethyl cellulose is dispersed in water, then the dispersion obtained is mixed with a solution of salbutamol 30 and buffer salts in water.
! ' 5! '5
Exemple 3Example 3
Sulfate de salbutamol 2,40 mgSalbutamol sulfate 2.40 mg
Citrate de sodium à deux molécules d'eau 9*60 ragSodium citrate with two molecules of water 9 * 60 rag
Acide citrique à une molécule d'eau 15*25 mg 5 Hydroxypropyl-méthvl-cellulose (viscosité, type 4000) 22,5 mgCitric acid in one molecule of water 15 * 25 mg 5 Hydroxypropyl-methvl-cellulose (viscosity, type 4000) 22.5 mg
Eau distillée, pour compléter à 5 mlDistilled water, to make up to 5 ml
Exemple 4Example 4
Sulfate de salbutamol (Pharmacopée 10 Britannique) 2,40 mgSalbutamol sulfate (British Pharmacopoeia 10) 2.40 mg
Citrate de sodium (Pharmacopée Britannique) 7*5 mg Acide citrique à une molécule d'eau (Pharmacopée Britannique) 25,0 mgSodium citrate (British Pharmacopoeia) 7 * 5 mg Citric acid to one molecule of water (British Pharmacopoeia) 25.0 mg
Hydroxypropyl-méthyl-cellulose 15 (viscosité, type 4000) 22,5 mgHydroxypropyl-methyl-cellulose 15 (viscosity, type 4000) 22.5 mg
Benzoate de sodium (Pharmacopée Britan— ; nique) 10,0 mg ! Saccharine de sodium (pharmacopée B ri— j tannique) 2,5 mg j 20 Agent aromatisant quantité suffisante I Eau purifiée, pour compléter à 5 ml.Sodium benzoate (British Pharmacopoeia) 10.0 mg! Sodium saccharin (British pharmacopoeia) 2.5 mg d 20 Flavoring agent sufficient quantity I Purified water, to make up to 5 ml.
! Pour préparer les formulations des exemples 3 et 4* on disperse 1 ' hydroxypropyl-méthyl-cellulos e j * dans de l'eau chaude, on refroidit la dispersion ; 25 obtenue, puis on la mélange avec une solution aqueuse ji contenant le sulfate de salbuvamol et les autres coir.- [ posants de la formulation.! To prepare the formulations of Examples 3 and 4 *, the hydroxypropyl methylcellulos and j * are dispersed in hot water, the dispersion is cooled; 25 obtained, and then mixed with an aqueous solution containing salbuvamol sulfate and the other coir.- [formants.
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Claims (10)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB8215502 | 1982-05-27 | ||
| GB8215502 | 1982-05-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| LU84828A1 true LU84828A1 (en) | 1985-03-21 |
Family
ID=10530673
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| LU84828A LU84828A1 (en) | 1982-05-27 | 1983-05-27 | PHARMACEUTICAL COMPOSITIONS |
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 FR FR8308722A patent/FR2527442B1/en not_active Expired
- 1983-05-26 NO NO831875A patent/NO163166C/en not_active IP Right Cessation
- 1983-05-27 IE IE1267/83A patent/IE55139B1/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
- 1983-05-27 AT AT0195283A patent/AT390191B/en not_active IP Right Cessation
- 1983-05-27 IT IT48384/83A patent/IT1174759B/en active Protection Beyond IP Right Term
- 1983-05-27 ZW ZW118/83A patent/ZW11883A1/en unknown
- 1983-05-27 NL NL8301900A patent/NL192663C/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 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 IL IL68805A patent/IL68805A0/en not_active IP Right Cessation
- 1983-05-27 BE BE0/210866A patent/BE896870A/en not_active IP Right Cessation
- 1983-05-27 LU LU84828A patent/LU84828A1/en unknown
- 1983-05-27 CA CA000429095A patent/CA1203176A/en not_active Expired
- 1983-05-27 DK DK241783A patent/DK167558B1/en not_active IP Right Cessation
- 1983-05-27 PH PH28974A patent/PH19601A/en unknown
- 1983-05-27 NZ NZ204385A patent/NZ204385A/en unknown
- 1983-05-27 FI FI831893A patent/FI81257C/en not_active IP Right Cessation
- 1983-05-27 PT PT76773A patent/PT76773B/en unknown
-
1987
- 1987-12-30 MY MY275/87A patent/MY8700275A/en unknown
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