EP2934422A1 - Gellangummiträger für ein medikament, mittel und verfahren - Google Patents

Gellangummiträger für ein medikament, mittel und verfahren

Info

Publication number
EP2934422A1
EP2934422A1 EP13864604.7A EP13864604A EP2934422A1 EP 2934422 A1 EP2934422 A1 EP 2934422A1 EP 13864604 A EP13864604 A EP 13864604A EP 2934422 A1 EP2934422 A1 EP 2934422A1
Authority
EP
European Patent Office
Prior art keywords
medicament
chamber
gel
sodium
dosage form
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13864604.7A
Other languages
English (en)
French (fr)
Other versions
EP2934422A4 (de
Inventor
Vadim ZELIKMAN
Zarema Zelikman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP2934422A1 publication Critical patent/EP2934422A1/de
Publication of EP2934422A4 publication Critical patent/EP2934422A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/042—Force radial
    • F04C2270/0421—Controlled or regulated

Definitions

  • a Gellan gum carrier for a medicament means and method
  • the present invention pertains to compositions comprising a gel material such as Gellan gum, Pregellatinized starch or Modified Starch adapted as a carrier for a pharmaceutical drug or the like.
  • a gel material such as Gellan gum, Pregellatinized starch or Modified Starch adapted as a carrier for a pharmaceutical drug or the like.
  • the invention further relates to an apparatus, kit and method for compounding an orally administered dosage form of a medicament.
  • one or more coatings is desired for drug administration forms such as tablets, pills caplets and the like in order to obtain one or more of gloss, better appearance, identification, mouth feel, stability, color, swallowability, improved taste and the like.
  • coating material are used for medicaments especially gel materials as gellan gum.
  • US patent application No.2008299199 describes a dosage form which before oral ingestion the particulate material is subjected to an aqueous medium, whereby it is converted to a semi-solid form by swelling or geling of one or more of the components, especially of a gellan gum, of the particulate matter.
  • the invention also relates to a vehicle for oral administration of one or more active substances, the vehicle comprising a gellan gum arranged in a configuration allowing optimal water diffusion so that upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less swells and/or gels and the texture of the swelled vehicle being similar to that of a soft pudding and having a viscosity of at least about 10,000 cps .
  • EP patent No. 0662320 further discloses a dry gel composition containing 40 wt. % or less of an orally administrable medicine, 3 wt. % or more of a geling agent and 5 wt.. When mixed with a given amount of water, the composition gives a homogeneous aqueous gel composition having a viscosity of around 100 to 500 cP and preferably a thixotropy.
  • the aqueous gel composition can be readily swallowed even by the aged having a reduced swallowing function without being aspirated into the trachea, so that it is useful for the pharmacotherapy of the aged.
  • 2004033261 describes a film coated tablet wherein the tablet is film coated with a gellan gum coating composition containing gellan gum, a plasticizer, and a disintegration aid. Optionally a slip enhancer is added to the composition.
  • a method for coating a tablet with the gellan gum composition wherein the composition is applied as a solution.
  • It is an object of the present invention to disclose an apparatus for compounding an orally administered dosage form of at least one medicament comprising: a container for mixing a crushed medicament with a gel-based carrier; the container comprises at least one chamber and at least one membrane as a separating element;
  • the membrane when removed , provides a mixture of a defined dosage form of the medicament comprising the crushed medicament and the gel- based carrier; the membrane is further configured to prevent contamination, overdosing and non sanctioned abuse of active ingredient of the medicament.
  • It is an object of the present invention to disclose an apparatus for compounding an orally administered dosage form of at least one medicament comprising :a container for mixing a crushed medicament with a gel-based carrier the container comprising at least one first chamber for accommodating a solution and at least one second chamber for accommodating a gel- based carrier ; the at least one first chamber and at least one second chamber are connected with each other via a membrane for separating the first and second chambers;
  • the membranee when removed , provides a mixture of a defined dosage form of the medicament comprising the crushed medicament and the gel- based carrier, the first chamber and second chamber have a surface tension allowing the user to extract the mixture by pressing the lower chamber.
  • It is an object of the present invention to disclose an apparatus for compounding an orally administered dosage form of at least one medicament comprising: a container for mixing a crushed medicament with a gel- based carrier, the container comprising at least one first chamber for accommodating a solution and at least one second chamber for accommodating the gel- based carrier ; the at least one first chamber and at least one second chamber are connected with each other via a membrane for separating the first and second chambers; and,
  • the membrane is partially broken by rotating the first chamber at least a half- turn therefore, providing a defined dosage form of the medicament comprising the crushed medicament and the gel- based carrier, the membrane is further configured to prevent contamination, overdosing and non sanctioned abuse of active ingredient of the medicament. It is another object of the present invention to provide the apparatus as defined above, wherein additionally comprising a collecting device selected from the group consisting of a spoon, a cup and a combination thereof.
  • the membrane is a composed of a flexible material selected from the group consisting of polymer, cellulose, metal, metal alloys, metal oxides and any combination thereof.
  • the at least one first chamber is adapted for accommodating the gel-based carrier whilst the second chamber is adapted for accommodating water and salt.
  • the salt is selected from the group consisting of: calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chloride, tripotassium phosphate, sodium borate, potassium bromide, potassium fluoride, sodium bicarbonate, calcium chloride, magnesium chloride, sodium citrate, sodium acetate, calcium lactate, magnesium sulfate, alkali metal chlorides, sodium fluoride, organic acids such s citric, succinic, fumaric, malic, maleic, glutaric, lactic and the like; alkali metal sulfates such as sodium sulfate; dihydrogen sodium phosphate, monohydrogen sodium phosphate, disodium hydrogen phosphate, and mixtures thereof, and multivalent metal cations.
  • a dosage form selected from the group consisting of: tablet, caplet, particle, micronized particle, particulate, pellet, pill, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles or any combination thereof.
  • the gel-based carrier is further elected from the group consisting of Pionil 1500 , GENU GEL SWG-J, Primojel, GENU pectin, guaiacol, L-HPC(LH-31) L- HPC(LH-21) , Avicel RC-591NF , alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, propane- 1 ,2-diol alginate, agar, carrageenan, processed eucheuma seaweed, locust bean gum, guar gum, tragacanth, acacia gum, xanthan gum, karaya gum, tara gum, konjac, pectins, cellulose derivatives such as: methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, sodium carboxy
  • It is one object of the present invention to provide a kit for oral administration of at least one medicament comprising:
  • a container for mixing a crushed medicament with a carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating the first and second chambers;
  • a medicament d. a medicament; and, e. a gel-based carrier selected from the group consisting of gellan gum, pregellatinized starch ,modified starch and a combination thereof; wherein the membrane ,when removed, the content of each of the chambers is mixed thereby, forming a mixture of a defined dosage form of a defined medicament comprising the crushed medicament and the gel- based; the first chamber and second chamber have a surface tension allowing the user to extract the mixture by pressing the lower chamber.
  • a gel-based carrier selected from the group consisting of gellan gum, pregellatinized starch ,modified starch and a combination thereof
  • It is one object of the present invention to provide a kit for oral administration of at least one medicament comprising:
  • an apparatus for compounding an orally administered dosage form of a medicament comprising:
  • a container for mixing a crushed medicament with a carrier comprising at least first chamber and at least second chamber connected with each other via a membrane for separating the chambers;
  • a gel based carrier selected from the group consisting of gellan gum, pregellatinized starch, modified starch and a combination thereof; wherein the membrane is partially broken by rotating the first chamber at least a half- turn therefore, providing a mixture of defined dosage form of a defined medicament comprising the crushed medicament and the gel- based carrier, so as to prevent contamination, overdosing and non sanctioned abuse of active ingredient of the medicament.
  • the dosage form is selected from the group consisting of: tablet, caplet, particle, micronized particle, particulate, pellet, pill, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles or any combination thereof.
  • the first chamber is an upper chamber comprising at least one mold adjusted to a structure of the dosage form of at least one medicament. It is another object of the present invention to provide the kit as defined above, wherein the membrane is partially broken by tapping, knocking , raping or hitting the first chamber thereby forming an aperture within a portion of the membrane.
  • the mold is a replaceable element which can be removed and/or replaced. It is another object of the present invention to provide the kit as defined above, wherein the collecting device is selected from the group consisting of spoon, cup and any combination thereof.
  • kit is suitable for customizing a tailor made prescription to fit individual requirements in a dosage form that insures efficacy, swallowability, safety and compliance.
  • the salt is selected from the group consisting of: calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chloride, tripotassium phosphate, sodium borate, potassium bromide, potassium fluoride, sodium bicarbonate, calcium chloride, magnesium chloride, sodium citrate, sodium acetate, calcium lactate, magnesium sulfate, alkali metal chlorides, sodium fluoride, organic acids such s citric, succinic, fumaric, malic, maleic, glutaric, lactic and the like; alkali metal sulfates such as sodium sulfate; dihydrogen sodium phosphate, monohydrogen sodium phosphate, disodium hydrogen phosphate, and mixtures thereof, and multivalent metal cations.
  • the gel-based carrier is further selected from the group consisting of Pionil 1500 , GENU GEL SWG-J, Primojel, GENU pectin, guaiacol, L-HPC(LH-31) L- HPC(LH-21) , Avicel RC-591NF , alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, propane- 1 ,2-diol alginate, agar, carrageenan, processed eucheuma seaweed, locust bean gum, guar gum, tragacanth, acacia gum, xanthan gum, karaya gum, tara gum, konjac, pectins, cellulose derivatives such as: methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, sodium carboxy
  • the gel-based carrier is selected from the group consisting of: gellan gum, pregellatinized starch ,modified starch and a combination thereof;
  • a container for mixing a crushed medicament with a gel- based carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating said first chamber and said second chamber;
  • a crushing apparatus for crushing a medicament ii. a crushing apparatus for crushing a medicament
  • a collecting device iii. a collecting device
  • a gel-based carrier adapted for mixing with an orally administrated medicine;
  • the carrier is selected from the group consisting of: gellan gum, pregellatinized starch , modified Starch and a combination thereof;
  • a container for mixing a crushed medicament with a gel-based carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating the first and the second chambers;
  • step of admixing the content is by additionally rotating the first chamber at least a half- turn membrane such that the membrane is partially broken therefore, providing a mixture of defined dosage form of a defined medicament comprising the crushed medicament and the gel- based carrier, so as to prevent contamination, overdosing and non sanctioned abuse of active ingredient of the medicament.
  • compositions as defined above wherein further comprising additives as a palatability improving agents. It is another object of the present invention to provide the composition as defined above, wherein the solid composition further comprising an effective amount of a plasticizer, a disintegration aid, or an effective amount of a slip enhancer.
  • compositions as defined above wherein the dosage form is selected from the group consisting of: aliquot, tablet, caplet, capsule, pill , bolus, particle, micronized particle, particulate, pellet, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles or any combination thereof.
  • a salt selected from the group consisting of: calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chloride
  • compositions as defined above, wherein the composition further comprises binders selected from the group consisting of: hydro xypropyl cellulose, hydroxypropyl methylcellulose and polyvinylpyrrolidone.
  • compositions as defined above, wherein the composition further comprises ingredients selected from the group consisting of: flavor(s), sweetener(s), mint(s), fragrance(s), active ingredient(s) and mixtures thereof
  • sweeteners is selected from the group consisting of corn syrup solids, sucrose, aspartame, neotame, maltilol, maltilol syrup, neosorb, xylitol, acesulfame, Sweet Am, fructose, brown sugar, Stevia, saccharin and a combination thereof .
  • flavour is selected from the group consisting of cherry, mint, spearmint, peppermint, wintergreen, banana, coconut, wild cherry, grape, tooti fruiti, cinnamon, strawberry, orange, root beer, bubble gum, chocolate and any combination thereof.
  • the gel-based carrier is selected from the group consisting of Pionil 1500 , GENU GEL SWG-J; Primojel, GENU pectin, guaiacol; L-HPC(LH-31) L-HPC(LH- 21) , Avicel RC-591NF , alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, propane- 1 ,2-diol alginate, agar, carrageenan, processed eucheuma seaweed, locust bean gum, guar gum, tragacanth, acacia gum, xanthan gum, karaya gum, tara gum, konjac, pectins, cellulose derivatives such as: methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, sodium carboxy methyl cellulose, crosslinked sodium carboxy methyl cellulose, en
  • kits for oral administration of a medicament comprising:
  • a container for mixing a crushed medicament with a gel- based carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating the chambers a crushing apparatus for crushing a medicament;
  • a gel-based carrier selected from the group consisting of gellan gum, pregellatinized starch , modified starch and a combination thereof ; b. crushing the medicament using a crushing apparatus;
  • kits for oral administration of a medicament comprising:
  • a container for mixing a crushed medicament with a gel- based carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating the chambers;
  • a gel- based carrier selected from the group consisting of gellan gum, pregellatinized starch , modified starch and a combination thereof ; b. crushing the medicament using a crushing apparatus; c. applying the gel- based carrier and the medicament to the first chamber of the container whilst the second chamber comprises water;
  • a salt selected from the group consisting of: calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chlor
  • Fig 1 presents a device having a configuration for mixing a medicament with a gel- based carrier of the present invention
  • Fig 2 presents a device having a configuration for mixing a medicament with a gel- based carrier of the present invention
  • Fig 3 presents a device having a configuration for mixing a medicament with a gel- based carrier of the present invention
  • Fig 4 presents a device having a configuration for mixing a medicament with a gel- based carrier of the present invention
  • Fig. 5 presents a graph of Acetaminophen release profile of the present invention
  • Fig. 6 presents a release profile graph of Acetaminophen incorporated with starch gel of the present invention ;
  • Fig. 7 presents a release profile graph of Acetaminophen incorporated with Gellan Gum Gel of the present invention
  • the term "Gellan Gum” includes gellan gum and/or compositions of gellan gum.
  • the composition may further comprise polymers.
  • the Gellan gum is a water-soluble polysaccharide solution which is used without limitation ,as a thickener, emulsifier, and stabilizer .
  • the gellan gum composition may further be prepared in tap water, deionized water, or other aqueous media containing salts or other components such as colorants, flavoring agents, active ingredients such as deodorants, foods, preservatives, etc.
  • Dosage Form includes without limitation, : aliquot, tablet, caplet, capsule, pill , bolus, particle, micronized particle, particulate, pellet, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles , mixtures thereof and the like.
  • the preferred dosage form will be in a form sufficiently stable physically and chemically to be effectively mixed in a system which involves some movement of the dosage form. Virtually any tablet, placebo, the latter typically lactose or sugar or mixtures thereof and the like.
  • the invention relates to an apparatus for preparing a swallowable pharmaceutical composition for oral administration comprising at least one pharmaceutically active compound in an effective amount and further comprising a carrier consisting of gellan gum, pregellatinized starch, various kinds of native and modified starches, maltodextrin, dextrins, and a kit and a process for production thereof.
  • a carrier consisting of gellan gum, pregellatinized starch, various kinds of native and modified starches, maltodextrin, dextrins, and a kit and a process for production thereof.
  • the term "about X” or “approximately X” or “substantially X” usually refers to a range 25% less than to 25% more than of X (X +- 25%), at times X +- 20%, X +- 15% and preferably X +- 10%.
  • the present invention provides an apparatus for compounding an orally administered dosage form of at least medicament comprising: a container for mixing a crushed medicament with a carrier.
  • the container comprises at least one chamber and a separating element.
  • the container may additionally comprise a collecting device for collecting the prepared composition.
  • the apparatus is adapted to provide a defined dosage form of the medicament comprising the crushed medicament and carrier such as a gel-based carrier.
  • the apparatus is further adapted to prevent contamination, overdosing and non sanctioned abuse of active ingredients.
  • the container may comprise a separating element such as a membrane or any divider element such that the container is divided to at least two portions or chambers.
  • the separating element may be a mobile part such that when it is removed the content of each section within the container is mixed.
  • the membrane has a film-like structure for separating at least two fluid and/or solid materials. It may act as a separating structure or a selective barrier allowing some particles or chemicals to pass through, but not others.
  • the membrane may comprises at least one pore having a diameter size for allowing medicament particles to transform from the first chamber to the second chamber.
  • the membrane pores size is selected from the group consisting of microporous (dp ⁇ 2 nm), mesoporous (2 nm ⁇ dp ⁇ 50 nm) , macroporous (dp > 50 nm) and any combination thereof.
  • the e can be neutral or charged, and particles which transport can be active or passive. The latter can be facilitated by pressure, concentration, chemical or electrical gradients of the membrane process.
  • the container may further comprise at least two separated chambers which may be located one upon the other or one parallel to another.
  • the chambers are connected with each other via the separating element such as membrane or a divider for separating the chambers.
  • the apparatus may be use for multiple uses and applications or for one time use respectively.
  • the dispensing unit 1 is a container configured for mixing gellan gum with a crushed medicament.
  • the apparatus is adapted for compounding an orally administered dosage form of a medicament comprising: (a)a container for mixing a crushed medicament with a gel- based carrier, comprising at least one first chamber 20 (B) and at least one second chamber 10( A) connected with each other via a separation element 30 for separating the chambers( A, B), the appartus further comprises a crushing apparatus for crushing the medicament.
  • the membrane is configured , when removed, to provide a defined dosage form of a defined medicament so as to prevent contamination, overdosing and non sanctioned abuse of active ingredients of the medicament.
  • the upper chamber 10 may comprise at least one mold adjusted to a structure of the dosage form of at least one medicament.
  • the mold has a cavity shape selected from the group consisting of: tablet, caplet, particle, micronized particle, particulate, pellet, pill, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles or any combination thereof.
  • the mold may further be a replaceable element which can be removed and/or replaced.
  • the medicament mold plate may be of metal or metal alloys.
  • the medicament triturate molds is a cavity plate which has holes.
  • the volume of the cavities always remains constant, but the weight of the medicament dosage form will be depended upon the nature of the material. Different medicament dosage form will have different densities and so the cavity capacity must be determined for each medicament dosage form.
  • the mold is further calibrated.
  • the container is adapted for customizing tamper proof production of swallowable aliquots.
  • the separation element is a flexible membrane which separates the two chamber such that when it is removed the content of each of the chambers is mixed. The removing of the membrane allows mixing a variety of components in order to prepare a product suitable to be consumed as a pharmaceutical/cosmoceutical /veterinary.
  • the chambers of the container have a surface tension allowing the user to extract the mixed composition to a built-in spoon by pressing the chamber.
  • the composition can be further molded into a desired shape or pressed onto a dispensing unit, a build in collecting element 40 selected from the group consisting of a spoon or a cap like element.
  • the apparatus may further comprise an instruction leaflet which describes the manner and way for using the apparatus its elements.
  • the apparatus is a container configured for mixing carrier with a crushed medicament.
  • the dispenser may be adapted for multiple uses.
  • the dispenser comprises at least two chambers 100a and 100b, which comprises a carrier such as modified starch, pregellatinized starch or gellan gum , a crushing apparatus 110 comprising the medicament , and a mechanical handle 150 which controls and allows the crushing of the medicament and transferring of the carrier from at least one of the chambers to a mixing container 120.
  • the container also comprises the crushed medicament.
  • the handle further allows and controls the mixing process of the carrier together with the crushed medicament.
  • the apparatus further comprises a pressing button 160 for releasing the prepared mixture composition into a collecting device such as cup 140, located within a cubical 130 of the apparatus.
  • the crushing device may further comprise a mold having a cavity shape adjusted to the dosage form of the medicament.
  • the dispensing unit is a container 200 configured for mixing carrier with a crushed medicament.
  • the container comprises a non removable membrane 230.
  • the membrane is with a flexibility such that when rotating, spinning or turning the upper chamber 210 at least half-turn, the membrane is partially broken resulting a pore or an aperture having a diameter of about 0.1mm to about 10mm such that the content of the upper chamber 210 falls directly to the lower chamber 220 .
  • the membrane may further partially brake by tapping, knocking , raping or hitting the upper chamber thereby forming an aperture within a portion of the membrane.
  • the appartus may be composed of rigid or semi-rigid material selected from a group consisting of polymers ,metals, metal oxides, metal alloys, wood, cellulose and any combination thereof.
  • the apparatus and more particularly the membrane is composed of a flexible ,semi rigid material selected from the group consisting of Acrylic and modified acrylic plastics, Acrylonitrile/butadiene/styrene co-polymer,
  • Polyethylene fluorinated, Polyethylene, oxidized, Polyethylene phthalate polymers, Poly(phenyleneterephthalamide) resins, Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene), Poly(oxy- 1 ,2-ethanediyloxycarbonyl-2,6- naphthalenediylcarbonyl) resins, Polystyrene and rubber-modified polystyrene, Polysulfide polymer-polyepoxy resins, Polysulfone resins, Poly (tetramethylene terephthalate), Polyvinyl alcohol film, Polyurethane resins, Styrene block polymers, Styrene-maleic anhydride copolymers, Styrene-methyl methacrylate copolymers, Textryls, Urea-formaldehyde resins in molded articles, Melamine- formaldehyde resins in molded articles, Vinyl chloride-ethylene copolymers, Vinyl chlor
  • the membrane may further be partially broken by rotation of the upper chamber relative to the lower chamber or by pushing, pressing or/ and clicking the upper chamber.
  • the membrane is partially broken to enable to content of the upper chamber to be transferred to the lower chamber.
  • the container further comprises an upper chamber for containing water and a lower portion for accommodating the gellan gum and/or additional additives.
  • the medicament may be located in the lower chamber with the gellan gum or added and dissolved in the water located in to the upper chamber of the container.
  • Fig.4 illustrates an additional configuration of an apparatus for preparing a pharmaceutical composition for oral administration.
  • the apparatus comprises an opening for medicament entrance 310.
  • the opening may further comprise a medicament identifier for medicament type identification.
  • the medicament is transferred to a crushing apparatus 330 using a pressing button 340.
  • the appartus further comprises at least one chamber 360 for mixing the crushed medicament, the gel based carrier, water and salts.
  • the appartus additionally comprises two separated containers 390, 380 which are connected to the mixing chamber using lines 380A, 390B for supplying a sufficient amount of gel based carrier and solutions to the mixing chamber 360.
  • the appartus is mechanically operated using a handle 330 which activates the appartus.
  • the prepared mixture is transferred to a cup 350.
  • the present invention further provides a kit comprising a device for mixing a crushed medicament with a carrier consisting of gellan gum, pregellatinized starch or modified starch, using water and/or salt solutions.
  • the kit for oral administration of a medicament comprises: (a)a container for mixing a crushed medicament with a carrier comprising at least one first chamber and at least one second chamber connected with each other via a membrane for separating the chambers , (b)at least one additive, (c)a crushing apparatus for crushing a medicament,(d)a collecting device and (e)a medicament.
  • the kit is configured to the dosage form of the medicament to prevent contamination, overdosing and non sanctioned abuse of active ingredients.
  • the present invention may further comprise a kit for oral administration of a medicament comprising: (a) an apparatus for compounding an orally administered dosage form of a medicament comprising: (i)a container for mixing a crushed medicament with a carrier the container comprising a lower chamber and an upper chamber connected with each other via a membrane for separating the chambers; (ii)a crushing apparatus for crushing a medicament; and, (iii)a collecting device; (b)a medicament, and (c)a gel-based carrier consisting of gellan gum, pregellatinized starch or modified starch;
  • the kit is configured to provide a defined dosage form of a defined medicament so as to prevent contamination, overdosing and non sanctioned abuse of active ingredients.
  • the kit comprises a container having at least two flexible chambers whilst the upper chamber comprises a gel-based carrier, additional additives and the crushed medicament; the lower chamber comprises water and salt solution. Furthermore the carrier may be located in the lower chamber and the water and salt solution may be located in the upper chamber respectively. The medicament may be further added to the upper chamber or the lower chamber.
  • the container comprises a flexible membrane for separating the two chambers such that when the membrane is removed the content of each of the chambers is mixed.
  • the chambers have a surface tension allowing the user to extract the mixed composition to a built-in spoon by pressing the chamber.
  • the membrane may be a flexible membrane such that when rotating the first chamber at least a half- turn,the membrane is partially broken therefore forming an aperture allowing the content of the first chamber to pass to the second chamber.
  • the membrane may further partially brake by tapping, knocking , raping or hitting the upper chamber thereby forming an aperture within a portion of the membrane.
  • a defined dosage form of a defined medicament is formed so as to prevent contamination, overdosing and non sanctioned abuse of active ingredient of the medicament.
  • the kit may further comprise an instruction leaflet which describes the manner and way for using its elements and further mixing a desired medicament with a carrier.
  • the kit of the present invention comprises a home use or doctor's office device which, by it's specific features, provides a means of taking a tablet for example, converting it to powder (by a built-in crushing apparatus or the like), mixing it with gellan gum or another carrier, to provide a swallowable and safer bolus or aliquot, all the while protecting the active ingredient.
  • the kit of the present invention is with the ability to produce the customized aliquots, and furthermore is with the ability to ensure that only medically sanctioned dosages can be prepared.
  • the present invention is suitable and designed with drug administration and anti tampering and safety standards in mind.
  • the chamber that comprises the medicament will be adjusted to the dosage , aliquot, tablet, caplet, capsule, pill , bolus, particle, micronized particle, particulate, pellet, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, nanoparticles, agglomerates, of a specific medicament to prevent contamination, overdosing and non sanctioned abuse of active ingredients.
  • This kit leverages a unique Home compounding approach.
  • a lab bench and retail pharmacy scale compounding kit suitable for customizing a tailor made prescription to fit individual requirements in a dosage form that insures efficacy, swallowability, safety and compliance.
  • the invention relates to an easy to swallow pharmaceutical composition for oral administration comprising at least one pharmaceutically active compound in an effective amount and comprising a gel agent.
  • the mixed composition of the present invention may be in a solid form, a gel form or a liquid form.
  • the present invention proposes an improvement over the art by providing a substantially water free dosage form, containing particulate materials which are further designed for the purpose of masking the taste of drug substances and/or to provide controlled release of a drug substance or drug substances
  • the present invention further provides a pharmaceutical composition for improving palatability of medicaments.
  • the invention may further provides a taste masking formulation comprising a blend of a lipid(s) in combination with an acid soluble or swellable polymer, which enables delivery of substantial amount of drug immediately, while ensuring improved palatability.
  • a taste masking formulation comprising a blend of a lipid(s) in combination with an acid soluble or swellable polymer, which enables delivery of substantial amount of drug immediately, while ensuring improved palatability.
  • the amount of polymer required for imparting palatability will vary.
  • Palatability of the active pharmaceutical ingredient is a very significant technical obstacle to develop a patient friendly formulation. Organoleptic properties such as taste, mouth feel, smell and the like are considerable factors in distinguishing different products and medicament for same active pharmaceutical index.
  • the medicament palatability is influenced by a combination of sensory perceptions including taste and smell, and to a lesser extent texture, appearance, and temperature of the product undesirable taste of most drugs is one of the important factors to affect the patient compliance.
  • taste of the drug product is one f the important criteria when designing the product. Therefore taste masking of bitter drugs is required in order to improve the patient's acceptance and adherence to the particular drug therapy.
  • Various techniques known in the field may be adapted for concealing the objectionable taste of the drug.
  • the present invention improves the medicament palatability by optimizing these factors. Since there is often a correlation between the chemical structure of a compound and its taste, the present invention provides an optimized composition which is adjusted to the chemical structure and dosage form of the medicament.
  • the present invention presents a novel technology using geling agent consisting of gellan gum, pregellatinized starch or modified Starch as a carrier and water for a pharmaceutical drug or the like whilst protecting the drug and its function.
  • geling agent consisting of gellan gum, pregellatinized starch or modified Starch as a carrier and water for a pharmaceutical drug or the like whilst protecting the drug and its function.
  • the gellan gum, pregellatinized starch or modified Starch is in a pH range of about 1-7.5.
  • the present invention provides a composition, a kit and a method configured for converting a prescribed drug into a swallowable drug bolus by using a carrier gel consisting of gellan gum, pregellatinized starch or modified starch for an orally administrated medicine.
  • the carrier is adjusted to the dosage form and amount of the medicament and further to protect the active ingredient of the medicament especially when digestion occurs.
  • the carrier is further adjusted to the dosage, aliquot, tablet, caplet, capsule, pill , bolus, particle, micronized particle, particulate, pellet, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles of a specific medicament to prevent
  • the carrier is designed to hold the medicament together such that it acts as an 'enteric coating' or a 'gastro -resistant' of the active ingredient within the digestive system without adding any liquid or any other substrate.
  • the composition of the present invention provides a better swallowing form, better smell and taste of the medicament it comprises. Such a composition can be swallowed by even aged people having a weakened swallowing function without causing the improper suction in the trachea.
  • the gel composition can be easily prepared from a dry gel composition containing a gelling agent capable of rapidly forming a gel upon mixing with water at an ambient temperature in a range of about 20 to 30 °C .
  • the gel composition can be formed without the need of heating or cooling the composition .
  • composition comprising the gellan gum carrier may further comprise an effective amount of a plasticizer, a disintegration aid, and optionally an effective amount of a slip enhancer.
  • the plasticizer is selected from the group consisting of propylene glycol, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, glycerol triacetate, polysorbate 80, triethyl citrate, PLAS 2, and acetylated monoglycerides.
  • the disintegration aid is selected from the group consisting of lecithin, pregelatinized modified corn starch,pregellatinized starch, glyceryl carpylate, sorbitan oleate, and sodium lauryl sulfate.
  • the gellan gum may further comprise a color or colorants or color systems for application to a colored or non colored coated or uncoated dosage form.
  • Illustrative colors and colorants useful herein include without limitation, pigments, dyes, lakes, and oxides (including titanium dioxide) and the like, may be optionally employed with gellan gum used in practicing this invention.
  • the composition may further comprise binders selected from the group consisting of: hydroxypropyl cellulose, hydro xypropyl methylcellulose and polyvinylpyrrolidone.
  • binders selected from the group consisting of: hydroxypropyl cellulose, hydro xypropyl methylcellulose and polyvinylpyrrolidone.
  • various other ingredients may be employed in the gellan gum composition including any ingredient which is compatible or can be made compatible with the gellan gum composition useful to be mixed with dosage forms presented in this invention. Such other ingredients include, but not limited to, flavor(s), sweetener(s), mint(s), fragrance(s), active ingredient(s) and mixtures thereof and the like.
  • Suitable sweeteners include, but are not limited to, corn syrup solids, sucrose, aspartame, neotame, maltilol, maltilol syrup, neosorb, xylitol, acesulfame, Sweet Am, fructose, brown sugar, Stevia (Butterfly Brand & wisdom of the Ancients.)
  • Flavors include, but are not limited to, cherry, mint, spearmint, peppermint, wintergreen, banana, coconut, wild cherry, grape, tooti fruiti, cinnamon, strawberry, orange, root beer, bubble gum, chocolate, saccharin and any combination thereof.
  • the gellan gum may be further used as a primary coating, a secondary coating, or a tertiary coating.
  • the gellan gum composition may be coated onto dosage forms which are uncoated or have been coated with one or more prior coatings (overcoating) of an acceptable coating composition which allows adherency with gellan gum.
  • an initial coating may comprise one or more polymers consisting of: cellulosics, dextrins, acrylics, colors, or other pharmaceutical coating material.
  • this amount of gellan gum is that amount which is necessary to provide an effective or desired coating.
  • the amount of gellan gum which may be added to a dosage form such as tablets in practicing this invention is that amount which provides a gellan gum having a weight gain from about 0.025% to about 10% weight percent of the total medicament weight and preferably from about 0.05% to about 5% weight percent of the total tablet weight although larger and smaller weight percents may be employed if desired
  • gelling agents may be used in the present invention such as, Pionil 1500 (a product of Matsutani Chemical
  • GENU GEL SWG-J a product of Copenhagen Pectin Factory
  • Primojel a product of Matsutani Chemical Industries Co., Ltd.
  • GENU pectin is used as the LM pectin
  • guaiacol is used as the guar gum
  • L-HPC(LH- 31) and L-HPC(LH-21) are used as the low substituted hydroxypropyl cellulose
  • Avicel RC-591NF is used as the mixture of crystalline cellulose and sodium carboxymethyl cellulose.
  • the composition of the present invention may further comprise other suitable gelling and/or swelling a vehicle and/or compositions selected from the group consisting of: hydrocolloids and hydrogelling agents such as alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, propane- 1, 2 -diol alginate, agar, carrageenan, processed Vietnameseeuma seaweed, locust bean gum, guar gum, tragacanth, acacia gum, xanthan gum, karaya gum, tara gum, konjac, pectins, cellulose derivatives such as: methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, sodium carboxy methyl cellulose, crosslinked sodium carboxy methyl cellulose, enzymatically hydrolysed carboxy methyl cellulose, gelatine, or mixtures thereof.
  • hydrocolloids and hydrogelling agents such as al
  • the composition may further comprise sequestrants for facilitating the dissolution of the gellan gum composition.
  • sequestrants which may be used in the present invention include trisodium orthophosphate (TSP), ethylenediaminetetraacetic acid (EDTA), sodium citrate, tetrasodium pyrophosphate (TSPP), sodium hexametaphosphate (Calgon) and the like.
  • TSP trisodium orthophosphate
  • EDTA ethylenediaminetetraacetic acid
  • TSPP tetrasodium pyrophosphate
  • Calgon sodium hexametaphosphate
  • the sequestrants can be added to the aqueous media before or after introduction of the gum. Alternatively, they can be added concomitantly, for example, by preparing dry blends of gum and sequestrant.
  • the amount of sequestrant required to completely dissolve the gum at ambient temperature is a function of the amount of gum, the number of free polyvalent cations in solution, and the particular sequestrant used.
  • the amount of gellan gum which can be used for forming gels ranges from about 0.05-3% (wt./wt.). For many applications levels of 0.05-1 % (wt./wt.) are recommended.
  • the gums can be used singly or in combination depending on the properties of the gel which are desired.
  • the composition may further comprise a salt selected from the group consisting of: calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chloride, tripotassium phosphate, sodium borate, potassium bromide, potassium fluoride, sodium
  • bicarbonate calcium chloride, magnesium chloride, sodium citrate, sodium acetate, calcium lactate, magnesium sulfate, alkali metal chlorides, sodium fluoride, organic acids such s citric, succinic, fumaric, malic, maleic, glutaric, lactic and the like; alkali metal sulfates such as sodium sulfate; dihydrogen sodium phosphate, monohydrogen sodium phosphate, disodium hydrogen phosphate, and mixtures thereof, and multivalent metal cations.
  • the composition can be prepared in a short time in a simplified manner just before the use.
  • the present invention further provides a method for preparing a composition for oral administration of a medicament, comprising the steps of: (a) providing a kit for oral administration of a medicament comprising:(i)a container for mixing a crushed medicament with a carrier comprising a lower chamber and an upper chamber connected with each other and a membrane for separating the chambers ,(ii)at least one additive, (iii)a crushing apparatus for crushing a medicament, (iv)a collecting device, (v)a medicament and, (vi) a carrier consisting of gellan gum, pregellatinized starch or modified starch.
  • composition of the present invention may be in a solid form, a gel form or a liquid form.
  • the method as described above wherein the gel-based carrier is adapted as an enteric coating of the medicament
  • the enteric coating is adjusted to the dosage form of the medicament in order to prevent contamination, overdosing and non sanctioned abuse of active ingredients.
  • bolus particle, micronized particle, particulate, pellet, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, nanoparticles or any combination thereof.
  • the method as described above wherein further comprises an effective amount of a plasticizer, a disintegration aid, or an effective amount of a slip enhancer.
  • the method as described above wherein the gellan gum has a weight of about 0.025% to about 10% weight percent of the total medicament dosage form weight.
  • the method as described above wherein the gellan gum has a weight of preferably from about 0.05% to about 5% weight percent of the total dosage form weight.
  • Starch gel preparation from a dosage form without protective coating and without sustained/extended release matrix using the following:
  • Pregellatinized starch 800 mg
  • Maltodextrine 300 mg
  • Sweetener Sucrazit
  • Strawberry flavoring Pink coloring
  • Dexamol Purified water (10 ml).
  • the tablet was crushed using a crushed apparatus and added to the upper chamber of the container at a room temperature and standard conditions. After admixing by rotating and shaking the upper chamber at least half-turn (relatively to the lower chamber ) the membrane (separating the upper and lower chamber) is broken forming an aperture in the middle of the membrane.
  • the appartus is of a semi rigid material such that when tapping, knocking , raping or just hitting the upper chamber the membrane will brake in the middle forming an aperture.
  • the formed aperture allows the content of the upper chamber to be transferred to the lower chamber.
  • the apparatus comprising the mixture was mixed again forming a homogeneous medicament composition .
  • the prepared medicament composition was extruded by removing the upper chamber.
  • the prepared medicament composition had a taste with pudding consistency and was further easy to swallow.
  • Fig. 5 further presents a release profile graph of acetaminophen (Paracetamol) as a blank measurement.
  • a tablet of Acetaminophen (Dexamol, 500 mg, Dexcel Pharma) was grinded to fine powder using mortar and pestle.
  • the powder was introduced to a beaker with 100 ml of simulated gastric fluid (SGF, 37° C, pH 1.2) and were mixed slowly and gently at least 6 rounds per minute ,using magnetic stirrer. 100 ⁇ . of the mixture was sampled and methanol was added up to whole content of 1 ml.
  • the prepared sample was filtered and used for absorbance measurement (Cole-Parmer Scanning Double Beam UV/Visible Spectrophotometer). An absorbance of the prepared sample was observed at 243.5 nm.
  • Fig. 6 further illustrates a release profile graph of acetaminophen admixed with starch gel.
  • the gel prepared as described in Example 1 was used.
  • the measurement technique and dissolution medium type were identical to those of the blank measurement.
  • An absorbance was observed at 243.5 nm.
  • Starch gel preparation from a dosage form without protective coating and without sustained/extended release matrix using the following:
  • Modified starch (acetylated distarch phosphate) 800 mg, Maltodextrine 500 mg Sweetener (Sucrazit) 82 mg, Strawberry flavoring, Pink coloring,CaCi 2, Dexamol (Paracetamol) 500 mg , Purified water (10 ml).
  • the procedure of the gel preparation is identical to this of the Example 1.
  • the prepared gel was tasty and easy to swallow.
  • Starch gel preparation from a dosage form without protective coating and without sustained/extended release matrix using the following:
  • the procedure of the gel preparation is identical to this of the Example 1.
  • the prepared gel was tasty and easy for swallowing.
  • the procedure of the gel preparation is identical to Example 1 except than the nature of the gellation agent.
  • Fig. 7 further illustrates the release profile of acetaminophen admixed with Gellan Gum gel as described in Example 4.
  • the measurement technique was identical to the Blank measurement. An absorbance was observed at 243.5 nm.
  • the gel that contains the medicine was introduced to a beaker with 100 mL SGF equipped with magnetic stirrer.
  • the gel particles immediately changed their texture to more solid and hard in this medium.
  • a monobasic potassium phosphate (0.68 g) was added and the pH was adjusted to 6.8 by addition of 0.2 N sodium hydroxide (simulated intestinal fluid (SIF) sine pancreatin).
  • SIF simulated intestinal fluid
  • the gel particles changed their texture with a time to more soft.
  • Each 5 min a 100 ⁇ of the fluid were sampled and a methanol was added up to whole volume of 1 mL. Then, the sample was filtered and an absorbance value was observed at 243.5 nm. After lh of the measurement, the fluid was sampled each 15 min.
  • the results show very low release rate within 120 min (up to 6% in the SGF). After the 120 min interval (SIF), a gradual elevation of the acetaminophen release occurs. During 7.5 hours of the test, the release level reached 78%, as compared with the blank measurement. Thus, a medicine gets a protection in the stomach by the formation of a more hard gel and by critically decreased release of the medicine. After a passing along the intestine, the pH is increase and the gel swelling and releases the medicine. The release rate depends on the gel composition, the amount of the gel agents, the medicine nature, the temperature, and the pH.
  • Each sample was prepared from pregellatinized starch (800 mg), maltodextrin (300 mg), and distilled water (10 mL). 30 sec after the preparation, each sample was placed to vial comprising aqueous media with specific pH value. A pH values were achieved by addition of HCl/NaOH to purified water and measured using a pH meter .
  • the dissolution was determined by visual test of each vial and by filtration of each sample via filtration paper and examining the solids.
  • a time of gel dissolution was 8-11 min. So, after swallowing of the gel, it's structure destroyed within this time interval and, thus, it can't influence a medicine release.

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US5431915A (en) * 1993-12-20 1995-07-11 Harvey; Bryce M. Frozen oral medication delivery system and method
US6709678B2 (en) * 1996-08-15 2004-03-23 Losan Pharma Gmbh Easy to swallow oral medicament composition
AU2002306629A1 (en) * 2001-03-02 2002-09-19 Euro-Celtique, S.A. Method and apparatus for compounding individualized dosage forms
EP1758557B1 (de) * 2004-05-11 2011-07-13 Egalet Ltd. Quellbare dosierform mit gellan-gummit
US20070128251A1 (en) * 2005-12-07 2007-06-07 Piedmont Pharmaceuticals, Inc. Process for manufacturing chewable dosage forms for drug delivery and products thereof
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