WO2007007182A2 - Formes galeniques solides d'agent antiepileptique - Google Patents

Formes galeniques solides d'agent antiepileptique Download PDF

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Publication number
WO2007007182A2
WO2007007182A2 PCT/IB2006/001949 IB2006001949W WO2007007182A2 WO 2007007182 A2 WO2007007182 A2 WO 2007007182A2 IB 2006001949 W IB2006001949 W IB 2006001949W WO 2007007182 A2 WO2007007182 A2 WO 2007007182A2
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WO
WIPO (PCT)
Prior art keywords
oxcarbazepine
dosage form
solid
sodium
range
Prior art date
Application number
PCT/IB2006/001949
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English (en)
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WO2007007182A3 (fr
Inventor
Umesh Setty
Mohinder Paul Pakhetra
Ashish Gogia
Kishor Deo
Uttam Kumar Ray
Srikanth Guntupalli
Sivakumaran Meenakshisunderam
Original Assignee
Aurobindo Pharma Limited
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Application filed by Aurobindo Pharma Limited filed Critical Aurobindo Pharma Limited
Publication of WO2007007182A2 publication Critical patent/WO2007007182A2/fr
Publication of WO2007007182A3 publication Critical patent/WO2007007182A3/fr

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    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Definitions

  • the present invention relates to oral dosage forms of an antiepileptic agent. More particularly, the present invention relates to oral dosage forms of oxcarbazepine or its pharmaceutically acceptable salts.
  • the present invention also relates to a process for the preparation of oral dosage forms of oxcarbazepine or its pharmaceutically acceptable salts.
  • Oxcarbazepine 10,11 -Dihydro- 10-oxo-5H-dibenz[b,/]azepine-5- carboxamide, acts as a central nervous system depressant.
  • TRILEPTAL Currently it is being marketed as TRILEPTAL, for treatment of epilepsy.
  • TRILEPTAL the pharmacological benefit of oxcarbazepine is primarily exerted through the 10-hydroxy metabolite of oxcarbazepine. It is known in the art that low-solubility drugs often show poor bioavailability or irregular absorption, the degree of irregularity being affected by factors such as dose level, fed state of the patient, and form of the drug.
  • Oxcarbazepine a class of antiepileptic drug widely used for the treatment of convulsions is slightly soluble in solvents such as chloroform, dichloromethane, acetone and methanol, and practically insoluble in solvents such as ethanol, ether and water.
  • WO 02/094774 discloses uncoated dosage form for oral administration comprising oxcarbazepine and a wetting agent. It is further disclosed that wetting agent may be useful in improving the bioavailability and when used with oxcarbazepine having a median particle size of about 20 ⁇ m to about 50 ⁇ m with a maximum residue of about 10% on a 45 ⁇ m to 100 ⁇ m sieve gives the best results.
  • U.S. Pat. Nos. 3,716,640; 4,452,738; 4,559,174 and 5,808,058 disclose processes for preparing oxcarbazepine.
  • Factors such as chemical activity, adsorption, dissolution, and bioavailability of the drug may depend on the surface of the solid (E L Parrott, in Pharmaceutical Technology: Fundamental Pharmaceutics, Burgess, Minneapolis, Minn., 1970, pp 1-36, E L Parrott, Pharm. Manuf., 2, 30-37 (1985)).
  • the surface area of a solid material provides information about the void spaces on the surfaces of individual particles or aggregates of particles.
  • the adsorption of inert gases onto solid materials represents the most widely used method for the determination of SSA, although other methods are available.
  • the BET method S. Brunauer, P H Emmett and E Teller, J. Am. Chem. Soc, 60, 309 (1938)
  • Oxcarbazepine being commercially potent antiepileptic drug, still there is need for dosage forms of oxcarbazepine manufacture without using special equipment/machines.
  • the inventors of the present invention during their continuous efforts to develop improved formulations of oxcarbazepine dosage forms discovered that the specific surface area of oxcarbazepine used in formulating final dosage forms is critical on the bioavailability.
  • the stability and bioavailability can be maintained through out the shelf life of the dosage form by using the median particle size in the range of about 15 to 50 ⁇ m and without wetting agent by using particle specific surface area of at least 0.8 m 2 /g and applying a single layer film coating on the resulted dosage forms to ensure the external homogeneity thereby avoiding the costly double layer.
  • Yet another objective of the present invention is to provide oral dosage forms of oxcarbazepine, which comply with the reference product in terms of in vzvo parameters like bioequivalence and in vitro parameters like dissolution, disintegration.
  • Another objective of the present invention is to provide simple, cost effective and efficient process for preparing pharmaceutically elegant oxcarbazepine oral dosage forms on a commercial scale.
  • the present invention provides oral dosage forms comprising oxcarbazepine having specific surface area in the range of 0.8 to 8 m 2 /g.
  • solid oral dosage forms comprising oxcarbazepine having median particle size in the range of 15 to 30 ⁇ m, wherein the composition comprises no wetting agent.
  • the solid dosage form is in the form of tablet wherein the tablets are uncoated tablets or monolayered film coated tablets, capsule, powder for suspension and the like.
  • the particles of oxcarbazepine are in regular shape when observed under microscope (magnification 10X) and hence have more surface area.
  • Figure IA depicts the crystal morphology of oxcarbazepine having surface area more than 0.8 m 2 /g and figure IB depicts the oxcarbazepine having surface area less than 0.8 m /g.
  • the tablet and capsule dosage form comprising oxcarbazepine of the present invention further comprises one or more pharmaceutically acceptable excipients such as diluents, disintegrants, binder, solubilizing agents, glidants, lubricants, and the like.
  • the oxcarbazepine is in the form of crystalline or amorphous or mixture of both.
  • the amorphous oxcarbazepine of the present invention may be prepared by lyophilization, solvent crystallization, spray drying and freeze drying techniques or any other suitable technique.
  • the oxcarbazepine has a specific surface area in the range of 0.8 to 8 m /g, preferably 0.9 to 4 m Ig.
  • the solid dosage form comprises oxcarbazepine having median particle size in the range of 15 to 30 ⁇ m and specific surface area in the range of 0.8 to 8 m 2 /g.
  • the solid dosage forms comprising oxcarbazepine have particles, wherein 90% of the particles are in the range of 15 to 30 ⁇ m and 100 % of the particles are less than 80 ⁇ m.
  • the median particle size of oxcarbazepine of the present invention means
  • (d50) in the range of 15 to 30 ⁇ m as measured by Malvern particle size analyzer.
  • the diluents used according to the present invention are selected from calcium phosphate-dibasic, calcium carbonate, lactose, sucrose, cellulose- microcrystalline, cellulose powdered, calcium silicate, kaolin, starch, starch pregelatinized, polyols such as mannitol, sorbitol, lactitol, xylitol, maltitol, sucrose and combinations thereof.
  • Suitable disintegrants of the present invention are selected from croscarmellose sodium, crospovidone, sodium starch glycolate, sodium carboxymethylcellulose, hydroxypropylcellulose, xanthan gum, alginic acid, alginates, carbopols and the like or combination thereof.
  • Suitable binders of the invention are selected from methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, gelatin, gum arabic, ethyl cellulose, polyvinyl alcohol, starch, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol, alginate, plasdone and the like.
  • Suitable lubricants according to the present invention are selected from sodium lauryl sulfate, talc, magnesium stearate, sodium stearyl fumarate, stearic acid, glyceryl behenate, hydrogenated vegetable oil, zinc stearate and suitable glidants include colloidal silicon dioxide and talc.
  • Solubilizing agents may be used according to the present invention, for increasing the solubility of poorly soluble oxcarbazepine, such as polyethylene glycol, propylene glycol and the like.
  • a stable oral liquid suspension of oxcarbazepine or its pharmaceutically acceptable salts comprising a mixture of suspending agents, which mixture is devoid of microcrystalline cellulose.
  • the oral liquid suspension further comprises one or more excipients such as sweeteners, pH adjusting agents, preservatives, buffering systems, antioxidants, chelating agents, wetting agents, flavouring aids, colouring aids and the like or mixtures thereof.
  • excipients such as sweeteners, pH adjusting agents, preservatives, buffering systems, antioxidants, chelating agents, wetting agents, flavouring aids, colouring aids and the like or mixtures thereof.
  • the flow of oral liquid suspension is not less than 4.1 ml/sec.
  • the oral liquid suspension imparts low viscosity with good pourability having free from lump formation there by stable during storage.
  • the mixture of suspending agent is selected from the group consisting of carragenan, sodium carboxymethylcellulose, colloidal silicon dioxide, sodium starch glycolate, xanthan gum, guar gum, hydroxypropylcellulose, hydroxypropylmethylcellulose, starch, polyvinylpyrrolidine, croslinked carboxymethylcellulose, magnesium aluminium silicate.
  • the suspending agent used is a mixture of carragenan, sodium carboxymethylcellulose, colloidal silicon dioxide, and sodium starch glycolate.
  • Suitable antioxidants used according to the present invention are selected from butylated hydroxy toluene (BHT), butylated hydroxy anisole, (BHA), ascorbic acid, cysteine hydrochloride ascorbic acid, citric acid, sorbic acid, sodium methanesulphite with / without nitrogen purging.
  • BHT butylated hydroxy toluene
  • BHA butylated hydroxy anisole
  • ascorbic acid cysteine hydrochloride ascorbic acid
  • citric acid citric acid
  • sorbic acid sodium methanesulphite with / without nitrogen purging.
  • Suitable wetting agents used according to the present invention are selected from polyethylene glycol stearate, polysorbates and the like.
  • Suitable preservatives used according to the present invention are selected from methyl paraben, propyl paraben, alkyl hydroxybenzoates, sorbic acid or a salt thereof, benzoic acid or a salt thereof, and mixtures thereof.
  • Suitable buffering systems are selected from combinations of citric acid and salts and solvates thereof, such as citric acid (anhydrous or monohydrate) combined with sodium citrate dihydrate.
  • Suitable chelating agents according to the present invention are selected from edetic acid and their salts.
  • Suitable flavouring aids according to the present invention are selected from yellow plum lemon aroma, strawberry, cherry, grape, and vanillin.
  • Suitable sweeteners according to the present invention are selected from fructose, acesulfame, aspartame, prosweet and the like or mixture thereof.
  • Suitable liquid carriers according to the present invention are selected from water, alcohol, propylene glycol, glycerin and mixtures thereof.
  • Suitable pH adjusting agents according to the present invention are selected from amino acids such as glutamic acid, aspartic acid, cysteine hydrochloride and the like or inorganic acid such as hydrochloric acid.
  • the oral liquid compositions of the present invention have a viscosity not more than 5 cps.
  • the viscosity may be measured, by using a Haake VT 550 viscometer (Searle-principle). For example, the sample is vigorously shaken, by hand, prior to filling into the measuring beaker and the measurement then is carried out directly after Filling.
  • the suspension may be stirred 5 minutes at 1000 s "1 before a reading is taken.
  • the measuring temperature is 2O 0 C.
  • the suspension achieved with this cost effective materials is stable and bioequivalent to the marketed product, has less viscosity, improved ease of swallowing, no coating on tongue, better taste and mouthfeelness.
  • the suspension of the present invention besides having less viscosity and more flowability has a flocculated structure, which forms loose sediment with clear solution on top during storage. This flocculated loose sediment is very easy to re-dispense on even gentle shaking, therefore has improved pourability, syringeability and does not stick to inner walls of syringe thus ensuring complete and uniform dosing of oxcarbazepine. Further, there is ease of handling during manufacture too.
  • the pharmaceutically acceptable salts of oxcarbazepine are selected from hydrochloride, hydrobromide, and the like.
  • a process for the preparation of oxcarbazepine having specific surface area in the range of 0.8 to 8 m 2 /g which comprises the steps of : i). suspending oxcarbazepine having a median particle size of about less than 250 ⁇ m with specific surface area less than 0.8 m 2 /g in a mixture of solvent and refluxing to obtain a clear solution; ii). filtering the solution; iii). adding DM water with high agitation and stirring the solution, iv). filtering the solid and washing the solid with water and v). drying the solid to obtain oxcarbazepine with specific surface area of 0.8 to 8 m 2 /g.
  • the solvent used in step (i) may be selected from water, methanol, ethanol, propanol, isopropanol, butanol, isobutanol and mixtures thereof, preferably a mixture of water and methanol.
  • a process for the preparation of solid dosage forms comprising oxcarbazepine having median particle size in the range of 15 to 30 ⁇ m, wherein the composition comprises no wetting agent, which comprises the steps of: i) mixing oxcarbazepine, diluents, disintegrants, ii) granulating the blend of step (i) with binder solution and drying the granules obtained, iii) passing the dried granules through multimill, iv) blending the dried granules with extragranular ingredients, v) lubricating the blend of step (iv) and compressing the lubricated blend into tablets or filling into capsules and if desired, vi) film coating the compressed tablets with coating suspension to form monolayered film coated dosage form of oxcarbazepine.
  • the specific surface area of the particles is measured by the gas adsorption method (BET method; see S. Brunauer: The adsorption of Gases and
  • Oxcarbazepine (2Og) was suspended into the mixture of methanol (1200 ml) and water (20 ml) and the suspension was refluxed for 30 minutes at 60-62 0 C to obtain a clear solution.
  • the resulting solution was filtered at 55 ⁇ 2 0 C and the filtrate was added very fast into the DM water (3000 ml) at 25-3O 0 C with high agitation.
  • the slurry was stirred at 40-45 0 C for lhr with high agitation and the slurry was filtered and solid was washed with DM water (100 ml) at a temperature of about 25-3O 0 C.
  • the product was dried at 40-50 0 C under reduced pressure ( ⁇ 5mmHg) to obtain the compound (15.0gm).
  • Oxcarbazepine Monolayered film coated tablets
  • Oxcarbazepine Median Particle size - 36.9 ⁇ m and SSA - 0.95.
  • Oxcarbazepine Median Particle size - 21 ⁇ m and SSA - 0.79.
  • the processing steps involved are : i) oxcarbazepine, microcrystalline cellulose and crospovidone were mixed in Rapid mixture granulator, ii) the above mixture was granulated with a binder solution of HPMC in water and the wet granules were dried in fluidized bed drier, iii) the dried granules were sifted and retentions were passed through multimill at fast speed and blended with microcrystalline cellulose and colloidal silicon dioxide, iv) lubricated the blend obtained in step (iii) with magnesium stearate, v) compressed the lubricated blend to obtain core tablets and vi) coated the core tablets using opadry dispersion of 15 % w/w in purified water to obtain monolayered film coated tablets of oxcarbazepine.
  • step (i) dissolved sorbic acid, methyl paraben and propyl paraben in hot water, (ii) sodium carboxymethyl cellulose and carragenan were dispersed in solution of step (i),
  • step (iii) added colloidal silicon dioxide and sodium starch glycolate and stirred, (iv) dispersed poly ethylene glycol stearate in hot water and added to the solution of step (iii), (v) oxcarbazepine was added with continuous stirring to the solution of step
  • step (vi) saccharin sodium and ascorbic acid were added to the solution of step (v), (vii) propylene glycol, sorbitol solution and flavour were added to the solution of step (vi) and stirred, and finally (viii) made up the volume and passed through colloidal mill.

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Abstract

L'invention concerne des formes galéniques orales d'un agent antiépileptique. Plus particulièrement, l'invention concerne des formes galéniques orales d'oxcarbazépine ou les sels d'oxcarbazépine acceptables sur le plan pharmaceutique. Par ailleurs, l'invention concerne un procédé de préparation des formes galéniques orales d'oxcarbazépine ou des sels d'oxcarbazépine acceptables sur le plan pharmaceutique.
PCT/IB2006/001949 2005-07-08 2006-07-05 Formes galeniques solides d'agent antiepileptique WO2007007182A2 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
IN905/CHE/2005 2005-07-08
IN905CH2005 2005-07-08
IN995/CHE/2005 2005-07-25
IN995CH2005 2005-07-25
IN1935CH2005 2005-12-27
IN1935/CHE/2005 2005-12-27
IN311/CHE/2006 2006-02-24
IN311CH2006 2006-02-24

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WO2007007182A2 true WO2007007182A2 (fr) 2007-01-18
WO2007007182A3 WO2007007182A3 (fr) 2007-08-23

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007089926A2 (fr) * 2006-01-31 2007-08-09 Teva Pharmaceutical Industries Ltd. Preparations pharmaceutiques de l'oxcarbazepine et procedes pour sa preparation
WO2007121523A1 (fr) * 2006-04-21 2007-11-01 Alphapharm Pty Ltd Composition pharmaceutique d'oxcarbazépine À PARTICULES DE 15 À 30 microns EN moyenne
WO2008037044A1 (fr) * 2006-09-27 2008-04-03 Medley S.A. Indústria Farmacêutica Formulation orale contenant oxcarbazépine et son procédé de production
WO2011031176A1 (fr) * 2009-09-10 2011-03-17 Bial - Portela & C.A., S.A. Formulations de suspension orales d’acétate d’eslicarbazépine
WO2022250499A1 (fr) * 2021-05-28 2022-12-01 Sk Biopharmaceuticals Co., Ltd. Formulations de suspension aqueuse orale comprenant un composé carbamate
CN115487145A (zh) * 2022-10-10 2022-12-20 上海奥科达生物医药科技有限公司 一种奥卡西平口服混悬液及其制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160051478A1 (en) * 2013-03-29 2016-02-25 Roquette Freres Film-forming compostions for the film-coating of solid forms

Citations (5)

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Publication number Priority date Publication date Assignee Title
EP0435826A1 (fr) * 1989-12-27 1991-07-03 Ciba-Geigy Ag Solutions intraveineuses pour l'épilepsie
WO2002094774A2 (fr) * 2001-05-18 2002-11-28 Ranbaxy Laboratories Limited Formes galeniques d'oxcarbazepine
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WO2007089926A3 (fr) * 2006-01-31 2008-12-24 Teva Pharma Preparations pharmaceutiques de l'oxcarbazepine et procedes pour sa preparation
WO2007121523A1 (fr) * 2006-04-21 2007-11-01 Alphapharm Pty Ltd Composition pharmaceutique d'oxcarbazépine À PARTICULES DE 15 À 30 microns EN moyenne
WO2008037044A1 (fr) * 2006-09-27 2008-04-03 Medley S.A. Indústria Farmacêutica Formulation orale contenant oxcarbazépine et son procédé de production
WO2011031176A1 (fr) * 2009-09-10 2011-03-17 Bial - Portela & C.A., S.A. Formulations de suspension orales d’acétate d’eslicarbazépine
WO2022250499A1 (fr) * 2021-05-28 2022-12-01 Sk Biopharmaceuticals Co., Ltd. Formulations de suspension aqueuse orale comprenant un composé carbamate
CN115487145A (zh) * 2022-10-10 2022-12-20 上海奥科达生物医药科技有限公司 一种奥卡西平口服混悬液及其制备方法
CN115487145B (zh) * 2022-10-10 2023-09-01 上海奥科达医药科技股份有限公司 一种奥卡西平口服混悬液及其制备方法

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