Classifications

• • 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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2833—Organic macromolecular compounds
  • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
  • A61K9/2866—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
• • 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
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • 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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2813—Inorganic compounds
• • 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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2833—Organic macromolecular compounds
  • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
  • A61K9/2846—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
  • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
  • A61K9/2806—Coating materials
  • A61K9/2833—Organic macromolecular compounds
  • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/04—Centrally acting analgesics, e.g. opioids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/16—Otologicals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
  • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Definitions

• the invention relates to controlled-release pharmaceutical preparations in the form of microtablets containing flupirtine or one of its physiologically acceptable salts as active ingredient, and to processes for their preparation.
• Flupirtine (Katadolon TM) is a centrally acting, non-opiate analgesic.
• CONFIRMATION COPY Flupirtin is usually administered orally, rectally or parenterally.
• the daily dosages are usually 300-600 mg when given orally. To ensure optimal pain management, it is desirable to release the drug evenly over an extended period of time to reduce daily doses.
• multiparticulate dosage forms consist of sustained-release film-coated individual particles, granules or pellets which have been compressed into tablets. If these film-coated particles, granules or pellets are compressed into a tablet with or without further excipients, it is possible that the film will be damaged by the deformation.
• the present invention is therefore based on the object, a flupirtine containing multiple unit - drug form with sustained release drug
• microtablets based on granules obtained by granulation, preferably dry granulation, which has a high proportion of active ingredient. At least a portion of the microtablets are subsequently coated with a retarding film and optionally filled into a capsule, a sachet, a stick, a bag or a single-dose dispenser.
• the microtablets have a smaller volume with the same amount of active ingredient, and thus the compliance is significantly increased. In addition, they are variable in dosage and therefore as well
• Micro-tablets can be pressed, even if the active ingredient content is very high and is dispensed with the conventionally necessary excipients. Thus, one is
• the microtablets thus obtained have a more uniform geometry, more uniform weight and lower porosity (defined surface area) in comparison to granules, active ingredient particles and pellets.
• a reproducible Befilmungsprozeß is possible.
• Granules or pellets, on the other hand, are often uneven in shape and have a rough and uneven surface, which makes subsequent filming difficult.
• microtablets In addition, almost complete processing into microtablets is possible, during which, in the case of conventional pelletizing of pellets and granules, grain size selection (screening) has to be carried out. Otherwise, the fluctuations in the surface to be coated are too great, with the same quantity application, release fluctuations are the result. Due to the standardized surface of the microtablets, the amount of film application is uniformly dosed, resulting in a more uniform layer thickness of the film, the drug release is reproducible.
• the retarding coating is hardly damaged during the dosing process. This ensures a more uniform drug release, drug release tips are avoided (dose dumping).
• a big advantage over multiple unit tablets is that drug release of the microtablets is independent of the disintegration time of a tablet in the stomach into the single retard particles.
• the food influences are lower, i. the rate of gastric and pyrolus passage of the microtablets for
• Absorption site (small intestine) is independent of the filling state of the stomach.
• microtablets to be produced allow a large variability in the design of the single-dose unit, eg the combination of microtablets with different drug release profiles (fast and delayed release) or the combination of microtablets with various, even mutually chemically incompatible, active ingredients in a capsule, a sachet, a stick, a bag or a Einzeldosierspender is possible.
• microtablets have the advantage of being at
• Dysphagia can be better applied than large tablets.
• the filling of the micro-tablets from a capsule, a sachet, a stick, a bag or a single dosing dispenser and the intake with food is easily possible, the administration with a nasogastric tube is possible.
• the sustained release effect is not affected.
• the preparation of the dosage forms according to the invention is carried out by the active ingredient flupirtine or one of its pharmaceutically acceptable salts, preferably
• Dry granulator (roller compactor) is granulated. The entire granulate is processed further.
• the resulting granules are optionally mixed with other excipients, preferably with magnesium stearate, highly disperse silica, cross-carmellose sodium and optionally microcrystalline cellulose and mixed in a container mixer.
• This tablettable mixture is added to a rotary tablet press
• Microtablets in a filming apparatus are coated with an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), talc, yellow iron oxide, polysorbate 80 and hydroxypropylmethylcellulose.
• the required drug release profile is achieved by mixing the appropriate proportions of sustained-release and immediate-release micro-tablets.
• the single dose of micro-tablets is filled into a capsule, a sachet, a stick, a bag or a single-dose dispenser.
• the proportion of excipients in the microtablets is between 0.1 and 25% (w / w), preferably between 1 and 20% (w / w), more preferably between 3.5 and 5.5% (w / w) or between 11 and 16% (w / w).
• the sustained-release coating is between 0.01 and 25% (w / w), between 1 and 15% (w / w), preferably between 4 and 9% (w / w), particularly preferably between 5.5% (w / w ) and 7.5% (w / w) of the delayed release microtablets.
• the sustained release coating is between 1 and 25% (w / w), between 5 and 10% (w / w), between 10 and 15% (w / w), between 15 and 20% (w / w), between 20 and 25% (w / w), between 5 and 6% (w / w), between 6 and 7% (w / w), between 7 and 8% (w / w), between 8 and 9% ( w / w), between 9 and 10% (w / w), between 10 and 11% (w / w), between 11 and 12% (w / w), between 12 and 13% (w / w), between 13 and 14% (w / w), between 14 and 15% (w / w), between 15 and 16% (w / w), between 16 and 17% (w / w), between 17 and 18% (w / w), between 18 and 19% (w / w), between 19 and 20% (w / w), between 20 and 21% (w / w),
• the sustained-release coating achieves a uniform in vitro release of active ingredient from the dosage form according to the invention of between 30 and 80% within 4 hours.
• a uniform in vitro release of active ingredient from the dosage form according to the invention of between 30 and 80% within 4 hours.
• the proportion of immediate-release flupirtine microtablets at which the drug release rate is at least 80% in 45 minutes one can vary the proportion of immediate-release flupirtine microtablets at which the drug release rate is at least 80% in 45 minutes.
• Release can be achieved within 15 minutes between 15 and 35%, or in another embodiment within 4 hours between 50 and 75%. After a period of 10 hours, the release of the active ingredient is at least 75% of the flupirtin or its physiologically acceptable salts. Thus, even drug levels are achieved in vivo.
• the in vitro release rate of the active substance from the pharmaceutical preparation is carried out at 100 rpm in a buffer according to Ph. Eur. At pH 6.8 at 37 ° C. using the Ph. Eur. Paddle method Measurement determined with a UV spectrophotometer. Further constituents may be all auxiliaries known to the person skilled in the art.
• Binders preferably cellulose derivatives such as methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, carboxymethylcellulose and salts thereof, alginic acid and its salts, propylene glycol alginate, xanthans, starch, carboxymethyl starch, can be used. It can also simultaneously
• binders for example different cellulose derivatives
• flow control agents may preferably silicas, silified
• microcrystalline cellulose microcrystalline cellulose
• the disintegrating agents used are preferably croscarmellose, starch, cellulose, pectins, alginates, carboxymethylcellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone, ultraamylopectin.
• Magnesium stearate, stearic acid, talc, calcium stearate, glyceryl behenate, glyceryl monostearate, glyceryl palmitostearate, sodium stearyl fumarate, polyethylene glycols are preferably used as molding / release agents.
• Preferred fillers are starch (e.g., potato starch, corn starch, modified starch), cellulose (e.g., microcrystalline, silicified microcrystalline),
• Preferred coatings for the retardation are:
• Carboxymethyl cellulose polyvinyl acetate, methyl cellulose phthalate,
• Methacrylic acid and methacrylic esters (Eudragit® L, Eudragit® S), copolymers of acrylic and methacrylic acid esters with a low content of
• Trimethylammonium methacrylate (Eudragit® RL; Eudragt® RS), copolymer of acrylic acid, methacrylic acid and their esters (ratio of free carboxyl groups to ester groups eg 1: 1) (Eudragit® L30 D, Eudragit® L100), copolymers of ethyl acrylate and methyl methacrylate ( Eudragit® NE 30D, Eudragit NM 30 D), polyvinyl acetate dispersion (Kollicoat® SR 30D), methacrylic acid ethyl acrylate copolymer (Kollicoat® MAE 30 DP, Kollicoat® MAE 100 P).
• Preferred plasticizers are e.g. Dibutyl sebacate, citric and tartaric acid esters, glycerol and glycerol esters, phthalic acid esters.
• Preferred release agents and pigments are talc, magnesium stearate, iron oxides, glycerol monostearate, calcium arachinate, glycerol palmitostearate, stearic acid and triglycerides.
• the daily dosages are between 20 and 800 mg, between 50 and 600 mg, between 100 and 600 mg, preferably between 300 and 600 mg, more preferably 400 mg, and 200 to 300 mg in children.
• a single dose is between 20 and 600 mg, preferably 400 mg or 75 mg in children.
• compositions according to the invention are for example for
• Impairment of the haemopoietic cell system against neurodegenerative diseases, against Creutzfeldt-Jacob disease, as
• Antiphlogisticum or used as muscle relaxant are examples of Antiphlogisticum or used as muscle relaxant.
• the medicament formulations according to the invention may be used in combination with other active substances, in particular from the group of opioids, such as, for example, sufentanil, remifentanil, fentanyl, alfentanil, buprenorphine, hydromorphone,
• opioids such as, for example, sufentanil, remifentanil, fentanyl, alfentanil, buprenorphine, hydromorphone
• Levomethadone oxycodone, diacetylmorphine, methadone, hydrocodone, morphine, piritramide, nalbuphine, pentazocine, codeine, dihydrocodeine, pethidine, tramadol, tilidine, naloxone, naltrexone, loperamide, apomorphine or their pharmaceutically acceptable salts.
• a dosing unit is at all
• Drug combinations any combination of fast-release and delayed-release micro-tablets possible.
• the active ingredient flupirtine maleate is granulated in a dry granulator (roller compactor). The resulting entire granulate is processed further.
• 0.96 kg of the granules thus obtained are admixed with 0.012 kg of magnesium stearate, 0.01 kg of fumed silica and 0.02 kg of cross-carmellose sodium and mixed in a container mixer.
• This tablettable mixture is added to a rotary tablet press
• Micro-tablets with a diameter of 2 mm are pressed.
• Befilmungsapparatur (Trommelcoater, fluidized bed apparatus) with 58 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 17 g of talc, 1, 8 g of iron oxide yellow, 1, 7 g of polysorbate 80 and 1, 7 g of hydroxypropylmethylcellulose befilmt.
• Example 3
• the active ingredient flupirtine maleate is granulated in a dry granulator (roller compactor). The resulting entire granulate is processed further.
• 0.87 kg of the granules thus obtained are mixed with 0.10 kg of microcrystalline cellulose, 0.012 kg of magnesium stearate, 0.01 kg of fumed silica and 0.01 kg of cross-carmellose sodium and mixed in a container mixer.
• This tablettable mixture is added to a rotary tablet press
• Micro-tablets with a diameter of 2 mm are pressed.
• Befilmungsapparatur (Trommelcoater, fluidized bed apparatus) with 58 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 17 g of talc, 1, 8 g of iron oxide yellow, 1, 7 g of polysorbate 80 and 1, 7 g of hydroxypropylmethylcellulose befilmt.
• the active ingredient tramadol hydrochloride is in a dry granulator
• 0.96 kg of the granules thus obtained are admixed with 0.012 kg of magnesium stearate, 0.01 kg of fumed silica and 0.02 kg of cross-carmellose sodium and mixed in a container mixer.
• This tablettable mixture is added to a rotary tablet press
• Micro-tablets with a diameter of 2 mm are pressed.
• Filming apparatus drum coater, fluidized bed apparatus
• 58 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D)
• 17 g of talc 17 g
• 1, 7 g of polysorbate 80 1, 7 g of hydroxypropylmethylcellulose befilmt.
• the required drug release profile is obtained by mixing or dosing the appropriate proportions of microtablets from Examples 1 and 2, 1 and 4, 1 and 9, 1 and 11, 1 and 13, 1 and 15, 2 and 3, 3 and 4, 3 and 10, 3 and 12, 3 and 14, 3 and 16 achieved.
• the individual single dose of microtablets is filled into a capsule, a sachet, a stick, a bag or a single dosing dispenser.
• the required drug release profile is achieved by mixing or dosing the appropriate proportions of microtablets from Examples 1 and 5, 1 and 6, 2 and 5 or 2 and 6.
• the individual single dose of microtablets is filled into a capsule, a sachet, a stick, a bag or a single dosing dispenser.
• Filming apparatus drum coater, fluidized bed apparatus
• 116 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D)
• 17 g of talc 17 g
• 1, 8 g of iron oxide yellow 17 g
• polysorbate 80 3.5 g
• silica filmed 3.5 g
• Filming apparatus drum coater, fluidized bed apparatus
• 116 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D)
• 17 g of talc 17 g
• 1, 8 g of iron oxide yellow 17 g
• polysorbate 80 3.5 g
• silica filmed 3.5 g
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 1 in a
• Filming apparatus drum coater, fluidized bed apparatus
• 232 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D)
• 1.8 g of iron oxide yellow 7 g of polysorbate 80
• 20.9 g of silica film-coated 20.9 g
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 3 in one
• Filming apparatus drum coater, fluidized bed apparatus
• 232 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 1, 8 g of iron oxide yellow, 7 g of polysorbate 80 and 20.9 g of silica film-coated.
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 1 in one
• Foilmungsapparatur (Trommelcoater, fluidized bed apparatus) with 348 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 1, 8 g of iron oxide yellow, 10.5 g of polysorbate 80 and 31, 3 g of silica filmed.
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 3 in one
• Foilmungsapparatur (Trommelcoater, fluidized bed apparatus) with 348 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 1, 8 g of iron oxide yellow, 10.5 g of polysorbate 80 and 31, 3 g of silica filmed.
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 1 in one
• Foilmungsapparatur drum coater, fluidized bed apparatus
• 464 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 1, 8 g of iron oxide yellow, 14 g of polysorbate 80 and 41, 8 g of silica befilmt.
• Modified drug-release microtablets containing flupirtine maleate 600 g of the microtablets are prepared as in Example 3 in one
• Foilmungsapparatur drum coater, fluidized bed apparatus
• 464 g of an aqueous suspension of polyacrylate dispersion 30% (Eudragit NM 30 D), 1, 8 g of iron oxide yellow, 14 g of polysorbate 80 and 41, 8 g of silica befilmt.

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