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WO2007116915A1 - Préparation médicamenteuse liquide pour administration orale, conditionnée dans un contenant muni d'une unité de distribution - Google Patents

Préparation médicamenteuse liquide pour administration orale, conditionnée dans un contenant muni d'une unité de distribution Download PDF

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Publication number
WO2007116915A1
WO2007116915A1 PCT/JP2007/057594 JP2007057594W WO2007116915A1 WO 2007116915 A1 WO2007116915 A1 WO 2007116915A1 JP 2007057594 W JP2007057594 W JP 2007057594W WO 2007116915 A1 WO2007116915 A1 WO 2007116915A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid pharmaceutical
pharmaceutical preparation
liquid
cylinder
preparation according
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.)
Ceased
Application number
PCT/JP2007/057594
Other languages
English (en)
Japanese (ja)
Inventor
Atsushi Matsuo
Hiroko Iwano
Hiroyuki Matsumura
Takashi Tsuboi
Hiroo Yamasaki
Hironobu Nakagawa
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.)
Kobayashi Pharmaceutical Co Ltd
Original Assignee
Kobayashi Pharmaceutical Co Ltd
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 Kobayashi Pharmaceutical Co Ltd filed Critical Kobayashi Pharmaceutical Co Ltd
Publication of WO2007116915A1 publication Critical patent/WO2007116915A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • A61M11/08—Pocket atomisers of the injector type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1001—Piston pumps
    • B05B11/1004—Piston pumps comprising a movable cylinder and a stationary piston
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/10—Pump arrangements for transferring the contents from the container to a pump chamber by a sucking effect and forcing the contents out through the dispensing nozzle
    • B05B11/1042—Components or details
    • B05B11/1052—Actuation means
    • B05B11/1053—Actuation means combined with means, other than pressure, for automatically opening a valve during actuation; combined with means for automatically removing closures or covers from the discharge nozzle during actuation

Definitions

  • Liquid pharmaceutical preparation for oral administration contained in a container equipped with a discharge device
  • the present invention relates to a liquid pharmaceutical preparation for oral administration contained in a container equipped with a discharge device.
  • liquid preparations are promoted as pharmaceuticals and are actually sold.
  • These liquid preparations include, for example, oral drugs for oral administration (for example, Patent Documents 1 to 4), nasal sprays for nasal administration (for example, Patent Document 5), and external drugs for pharyngeal diseases (for example, Patent Document 6).
  • Liquid pharmaceutical preparations for oral administration are commercially available as "internal liquids” and “syrups”!
  • internal liquids and “syrups”!
  • the dose is inaccurate and a separate measuring cup is required for weighing when taking it immediately.
  • measuring the liquid and washing the cup after use is cumbersome and Speak.
  • Patent Document 1 JP-A-8-193023
  • Patent Document 2 Japanese Patent Laid-Open No. 10-265369
  • Patent Document 3 Japanese Patent Laid-Open No. 2000-273050
  • Patent Document 4 Japanese Patent Laid-Open No. 2003-206242
  • Patent Document 5 Japanese Patent Laid-Open No. 11 171762
  • Patent Document 6 JP-A-10-259124
  • An object of the present invention is to provide a liquid pharmaceutical formulation for oral administration that reduces the burden on patients and reduces the burden on patients and enables safe medication. Means for solving the problem
  • the present invention for oral administration, which is accommodated in a container provided with a discharge device, and is administered by direct non-contact injection of the discharge device force on or around the tongue in the oral cavity.
  • a liquid pharmaceutical preparation wherein the discharge device is energized by an elastic force so as to close the jet outlet of the liquid pharmaceutical preparation, and is moved to pile up the elastic force when the liquid pharmaceutical preparation is discharged.
  • the liquid pharmaceutical preparation is provided, which is a discharge device provided with a valve member.
  • the discharge device includes a pump, and the pump has a cylinder suspended in the container and a cylindrical piston at the lower end, and is biased upward from the inside of the cylinder.
  • the stem is raised, and the pressure of the liquid stored in the internal space between the upper valve on the stem side and the lower valve on the cylinder side is increased by pushing down the stem, and the content liquid is It is configured to pass through the upper valve and be discharged from a jet outlet of a discharge portion provided above the stem, and to raise the stem, suck the liquid in the container through the lower valve and suck it into the cylinder.
  • An already defined liquid pharmaceutical formulation is provided.
  • the medicine is contained in a container provided with a discharge device, and is administered by direct non-contact injection of the discharge device force on or around the tongue in the oral cavity.
  • a liquid pharmaceutical preparation for oral administration wherein the discharge device comprises a pressing head that is attached to a pump with the stem 2 standing upright so as to be able to be pushed in an upward biased state, and the pressing head has an upper end of the stem 2
  • the mounting cylinder 8 fitted to the top plate 9 is suspended from the lower surface of the top plate 9, and the sliding cylinder 10 communicating with the inside of the stem 2 is erected above the top plate 9 and the sliding cylinder 10
  • Provided above the cylinder 16 that is slidably fitted on the outer periphery is provided with a valve chamber having a spout 21 at the tip, and is provided so as to be able to be pressed down against the mounting cylinder member, and the valve chamber
  • the rear outer periphery is slidably fitted to the jet nozzle 2 in the forward biased state.
  • valve member 1 is closed, and the upper end is linked to the valve member 6 and the rear end portion of the valve member 6 that define a flow path from the communication port 19 that communicates with the inside of the cylinder to the jet port 21, and the lower end portion is The valve member is pulled back when the main body is pressed against the mounting cylinder member.
  • An already defined liquid pharmaceutical formulation is provided comprising a heel member 7 pivotally attached to the body so as to be able to swing.
  • Examples of the discharge device in the present invention include a so-called trigger-type discharge device, V, a so-called push pump-type discharge device, and the like.
  • a so-called trigger-type discharge device V
  • a so-called push pump-type discharge device and the like.
  • JP 2002-326054 A JP No. 2001-171764, No. 2004-359242, No. 2004-359241, No. 2004-359238, No. 2004-352343, No. 2004-352333, etc.
  • the discharge device may be attached to the mouth and neck of the container by fitting, and the fitting may be performed in a manner that makes the fitting difficult to remove.
  • the mating mode is considered to contribute to prevention of breakage of the container during transportation and carrying and prevention of accidental ingestion of the liquid pharmaceutical preparation of the present invention.
  • the fitting portion of the container mouth neck portion and the mounting cap of the discharge device includes a first portion in which external teeth are formed on the outer peripheral surface of the container mouth neck portion forming an inner layer of the fitting portion.
  • the ratchet may be an annular fitting portion configured to prevent rotation in a direction in which the container neck and neck portion and the mounting cap are loosened.
  • the inner teeth and the outer teeth have a shape that allows rotation in the direction in which the screwing of the attachment cap and the container mouth neck is tightened but does not allow rotation in the loosening direction.
  • the tooth surface on the side that contacts and presses when the rotational force in the direction in which the screwing between the mounting cap and the container neck is loosened is perpendicular to the rotational force.
  • the tip of the tooth tip side may be inclined to the forward direction in the direction of the rotational force (or the opposite direction) as compared with the tooth base side.
  • Examples of the discharge device in the present invention include a discharge device having a pressing head described in JP-A-2004-834 (see FIGS. 4 to 7).
  • the pressing head is a pressing head that is attached to a pump in which the stem 2 is erected so that it can be pushed in an upward biased state, and a mounting cylinder 8 that is fitted to the upper end of the stem 2 is suspended from the bottom surface of the top plate 9.
  • Stem (2) A sliding cylinder (10) communicating with the inside of the top cylinder (9) is mounted on the top of the mounting cylinder member (3), and the sliding cylinder (10) is slidably fitted to the outer periphery of the cylinder (16) and is jetted to the tip above the cylinder (16).
  • a main body 4 provided with a valve chamber having an outlet 21 open and capable of being pushed down with respect to the mounting cylinder member, and a rear outer periphery slidably fitted to the valve chamber outer periphery, and in a forward biased state
  • the upper end is linked to the rear end of the valve member 6 and the rear end of the valve member 6 which closes the outlet 21 and defines a flow path from the communication port 19 communicating with the inside of the cylinder to the outlet 21.
  • a flange member 7 pivotally attached to the main body so that the valve member can be pulled out rearward when the main body is pressed against the mounting cylinder member.
  • the valve member 6 biased forward by the coil spring 26 always biases the upper portion of the vertical plate portion 28 of the flange member 7 forward, and is mounted by pushing down the main body 4.
  • the top plate 9 of the cylindrical member 3 pushes up the inclined plate portion 29 and rotates the flange member 7, and the valve member portion 6 is pulled out against the front biasing force of the coil spring 26, so that a fluid flow path is secured. It is done.
  • the use of the discharge device including the pressing head described above prevents the chemical liquid from coming into contact with the outside air, prevents deterioration due to the liquid being left in contact with the outside air, and improves the hygiene due to the dripping and the chemical liquid quantification by improving the chemical liquid.
  • the improvement viewpoint power is also preferable.
  • the pressing force of the main body against the stem 2 is configured to be smaller than the pressing force of the stem itself.
  • the pressing head is a pressing head that is mounted on a pump in which the stem 2 is erected so that it can be pushed in an upward biased state, and a mounting cylinder 8 that is fitted to the upper end of the stem 2 is attached to the top plate.
  • a mounting cylinder that is suspended from the bottom surface, and is provided with a sliding cylinder 10 that communicates with the inside of the stem 2 erected above the top plate 9 and a locking plate 12 that extends vertically on both sides of the top plate 9
  • the cylinder 3 fitted to the member 3 and the sliding cylinder 10 so as to be slidable and descendable on the outer periphery of the sliding cylinder 10 is suspended from the lower surface of the horizontal cylinder 15 projecting from the front of the peripheral wall 14a with a front end opened and a space around it.
  • a main body 4 that is engaged with the outer surface of the locking plate so that both sides of the inner surface of the peripheral wall 14a cannot rotate and move up and down, and a cylinder that is fitted to the horizontal cylinder 15 and has an outlet 21 at the tip.
  • the distance between the valve member serving as the flow path and the ejection port is, for example, 0.1 to 1 mm
  • the cross-sectional area of the flow path of the chemical liquid at the time of ejection is, for example, 0.1 to 3.5 mm 2 .
  • the discharge amount of the liquid agent and the cross-sectional area of the flow path can be adjusted, and thereby the flow speed of the discharged chemical liquid and the particle diameter of the droplets can be controlled.
  • the liquid pharmaceutical preparation of the present invention is a liquid preparation having the advantage that it can be used in a simple and accurate dose. Furthermore, the preparation of the present invention does not require water and can be safely taken, and is quickly delivered to the active ingredient absorption site after taking to exhibit a desired medicinal effect.
  • “on or around the tongue” includes, for example, a dentition, gums, heels, and the floor of the mouth. Infiltration of droplets into the trachea and lungs is prevented, and safe oral administration is possible.
  • the liquid pharmaceutical formulation of the present invention is administered by injection onto the tongue.
  • a liquid pharmaceutical formulation as defined above wherein the pressing head has a pressing force of the body against the stem 2 smaller than the pressing force of the stem itself.
  • the pressing head extends vertically on both sides of the top plate 9.
  • the liquid pharmaceutical preparation according to claim 3 or 4 further comprising a mounting cylinder member 3 formed by extending a locking plate 12 to be provided.
  • the variation in the injection amount of the liquid pharmaceutical preparation of the present invention is, for example, ⁇ 15% or less, preferably ⁇ 13% or less, and ⁇ 10% or less.
  • an appropriate amount of the physiologically active substance contained in the liquid pharmaceutical preparation can be easily taken. This is because the valve member that closes the spout just by preventing the dripping by the valve member that closes the spout is energized by the elastic force, so the timing of closing the valve at the end of injection is It is considered that the fact that it is constant and the chemical solution is pushed out by the biasing will also contribute to the improvement of quantitativeness.
  • the liquid pharmaceutical preparation of the present invention is a liquid pharmaceutical composition containing a solvent (for example, water, ethanol, glycerin, propylene glycol) that can be used as a component of the pharmaceutical preparation, and includes a solution, a suspension, It may be an emulsion or dispersion.
  • a solvent for example, water, ethanol, glycerin, propylene glycol
  • the liquid pharmaceutical preparation of the present invention may be an aqueous liquid preparation, for example, an aqueous solution.
  • water that can be used in the present invention include, for example, Japanese Pharmacopoeia purified water, and can be contained at a ratio of, for example, 10 to 99% by weight, preferably 45 to 98% by weight, based on the entire preparation.
  • the injection amount from the discharge device by one injection is, for example, 0.03 to 3 mL, preferably 0.1 to 2 mL, more preferably 0.3 to LmL.
  • the particles of the droplets at the time of ejection have a particle diameter that exceeds a certain level in terms of preventing inflow into the trachea and lungs.
  • the particle diameter of the droplet may be, for example, 100 to 5500 111, preferably 100 to 3600 ⁇ m, more preferably 100 to 1600 ⁇ m.
  • the particle size of the droplets can be adjusted by selecting the nozzle of the discharge device or by configuring the liquid agent flow path near the injection port.
  • the viscosity of the liquid pharmaceutical preparation of the present invention is not particularly limited.
  • the dispensing power of the dispensing device is quantitative, and the viewpoint power for prompt delivery to the absorption site (such as the small intestine) of the active ingredient after the administration is 0. 8 to 500 cP, preferably 0.9 to: LOOcP, more preferably 1.00 to 50.
  • LOOcP more preferably 1.00 to 50.
  • OcP more preferably 1.00 to 25 cP, and even more preferably 1.00 to 2.5 cP (digital viscosity) (Measured with a UL adapter at 25 ° C using a total DV— DV + (Brookfield)).
  • the active ingredient applicable to the liquid pharmaceutical preparation of the present invention is a liquid pharmaceutical preparation for oral administration. If it is, it will not specifically limit.
  • An already defined liquid pharmaceutical formulation comprising one or more is provided.
  • codin phosphate dihydrocodine phosphate, dextromethorphan hydrobromide, dl-methylephedrine hydrochloride, guaifenesin, potassium guaiacol sulfonate, lysozyme chloride, maleic acid
  • an already defined liquid pharmaceutical formulation further comprising chlorfelamin and one or more selected from anhydrous caffeine.
  • a container equipped with a discharge device on the tongue in the oral cavity or A liquid pharmaceutical formulation for oral administration administered by direct injection in a non-contact manner around the discharge device force, wherein the discharge device is elastic so as to close the jet port of the liquid pharmaceutical formulation.
  • An already defined liquid pharmaceutical formulation is provided which is a dispensing device comprising a valve member that is energized and moves against the elastic force during ejection of the liquid pharmaceutical formulation to open the spout.
  • the liquid pharmaceutical preparation of the present invention includes, for example, a bronchodilator, expectorant, antiphlogistic, antipyretic analgesic, antihistamine, antibacterial agent, caffeine, gastric mucosa protective agent as an additional active ingredient.
  • Herbal ingredients and antitussives, vitamins may contain one or more selected ingredients.
  • the liquid pharmaceutical formulation of the present invention comprises, as additional active ingredients, dl-methyl ephedrine hydrochloride, guaifenesin, potassium guaiacol sulfonate, lysozyme chloride, chlorfelamine maleate, and It should also contain one or more types of anhydrous caffeine selected.
  • an already defined liquid pharmaceutical formulation comprising one or more flavoring or sweetening agents.
  • the corrigent or sweetener comprises amatya, reduced maltose starch, glycine, dipotassium glycyrrhizinate, disodium glycyrrhizinate, monoammonium glycyrrhizinate, fructose sugar, glucose water Enter Sucrose spherical granules, honey, simple syrup, lactose, glucose, maltose, maltose, man-toll, starch, sorbitol, caramel, aspartame, stevia extract, licorice, licorice extract, xylitol, brown sugar, liquid sugar, fructose, Fructose dextrose liquid sugar, saccharin
  • Saccharin sodium, sucrose, glycerin power may also be selected.
  • the masking agent is used in the present invention from the viewpoint of masking an unpleasant taste derived from the active ingredient and preventing generation of solids when the preparation is stored for a long period of time.
  • Sweeteners' taste-masking agents are selected, for example, asunameme, saccharin sodium power 1 or more; stevia, caramel, kanzo power 1 or more selected; and sugar alcohols (sorbitol, maltose, maltose, mannitol, xylitol), glycerin One or more combinations selected from may be used.
  • examples of the antitussive include codine phosphate, dihydrocodine phosphate, hydrocodone, hydromorphone, methadone, morphine, oximetebanol, aloclamide hydrochloride, cloperastine hydrochloride, pentoxyberine citrate, ken Tipepidine acid, dibutanato sodium, dextromethorphan hydrobromide, dextromethorphan phenol phthalic acid, tipepidine hibenzate, cloperastine fendizoate, nospin, maou, nantenjit, clofedanol, levopropoxy
  • One or more force-selected ones such as phen, hominoben, oxerazine, pentoxyberine, benproberine, dimemorphane, dibutate, eprazinone, carbetapentane and isoamyl can be used.
  • the antitussive agent is codin phosphate, dihydrocodine phosphate, aloclamide hydrochloride, cloperastine hydrochloride, pentoxyberine citrate, tipepidine citrate, sodium dibutate, dextromethorphan hydrobromide, One or more selected from dextromethorphan phenol phthalic acid, tipepidine hibenzate, cloperastine fendizoate, noss force pin, maou and nantenji can be used.
  • examples of bronchodilators include ex-adrenergic receptor stimulators.
  • ⁇ -adrenergic receptor stimulators e.g., phenol propanolamine, pseudoephedrine, phe-ephedrine, norpinephrine, methoxamine, naphazoline, xylometazoline, clozine, etc.
  • ⁇ -adrenergic receptor stimulators e.g., phenol propanolamine, pseudoephedrine, phe-ephedrine, norpinephrine, methoxamine, naphazoline, xylometazoline, clozine, etc.
  • ⁇ -adrenergic receptor stimulators e.g.
  • bronchodilators include ⁇ -adrenergic receptor stimulants (eg, trimethquinol hydrochloride, methoxyphenamine hydrochloride, methylephedrine hydrochloride) and xanthine derivatives (eg, aminophylline, diprofylline, theophylline, proxyphylline).
  • ⁇ -adrenergic receptor stimulants eg, trimethquinol hydrochloride, methoxyphenamine hydrochloride, methylephedrine hydrochloride
  • xanthine derivatives eg, aminophylline, diprofylline, theophylline, proxyphylline.
  • an expectorant for example, ammonium chloride, 1 menthol, ammonia, wikial, lysozyme chloride, ethyristine hydrochloride, methylcystine hydrochloride, potassium guaiacol sulfonate, guaifenesin, crezo-one
  • One or more selected forces may be used, such as potassium sulfonate, bromhexine hydrochloride, ambroquinol hydrochloride, L carbocystine, and hoodine.
  • the expectorants include salt amylum, 1-menthol, ammonia 'wikial, lysozyme chloride, ethyristine hydrochloride, methylcystine hydrochloride, potassium guaiacol sulfonate, guaifenesin and potassium cresolol sulfonate.
  • salt amylum 1-menthol, ammonia 'wikial, lysozyme chloride, ethyristine hydrochloride, methylcystine hydrochloride, potassium guaiacol sulfonate, guaifenesin and potassium cresolol sulfonate.
  • lysozyme chloride ethyristine hydrochloride
  • methylcystine hydrochloride methylcystine hydrochloride
  • potassium guaiacol sulfonate potassium guaiacol sulfonate
  • the anti-inflammatory agent one or more selected from the group consisting of lysozyme chloride, glycyrrhizic acid, dipotassium glycyrrhizinate and sodium azulene sulfonate can be used.
  • antipyretic analgesic for example, one or more selected from force such as acetaminophen, ibuprofen, aspirin, ethenzamide can be used.
  • examples of the antihistamine include, for example, isothipenzil hydrochloride, iproheptin hydrochloride, dipheterol hydrochloride, diphenylpyrroline hydrochloride, diphenhydramine hydrochloride, salt Triprolysine acid, triberenamine hydrochloride, tondiammine hydrochloride, phenetazine hydrochloride, methazine hydrochloride, diphenhydramine salicylate, carbinoxamine diphenyldisulfonate, alimemazine tartrate, diphenhydramine tannate, phenetazine tannate, diphenylrubin
  • One or more selected from the group such as promethazine methylene disalicylate, carbinoxamin maleate, dl-chlorfelamine maleate, d-chlorfelamine maleate and dipheterol phosphate can be used.
  • fungicide for example, one or more selected from the group consisting of local fungicides such as salt cetylpyridium, decalium chloride and chlorhexidine hydrochloride may be used.
  • caffeine for example, one or more selected from power such as sodium benzoate caffeine, strength fein and anhydrous caffeine can be used.
  • the gastric mucosa protective agent includes, for example, aminoacetic acid, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, dihydroxy aluminum, amino acetate, hydroxyaluminum gel, and dry water.
  • One or more selected from the group consisting of a coprecipitation product of magnesium hydroxide and potassium aluminum sulfate, magnesium carbonate and magnesium aluminate metasilicate may be used.
  • the neurostimulant for example, one or more selected from power such as caffeine, anhydrous caffeine, and caffeine benzoate can be used.
  • antiplasmin drug for example, one or more selected from tranexamic acid, aminocaproic acid and the like can be used.
  • hypnotic sedative one or more selected from, for example, bromide reryl urea, allyl isopropyl acetyl urea, diphenhydramine hydrochloride and the like may be used.
  • the blood circulation improving drug for example, one or more selected from power such as inositol hexanicotinate can be used.
  • the hemostatic agent for example, one or more selected from the group consisting of tranexamic acid and sodium carbazochrome sulfonate can be used.
  • antipruritic agent for example, one or more selected from force such as diphedol hydrochloride and scopolamine hydrobromide can be used.
  • analgesic and antispasmodic agent for example, one or more selected from the group consisting of ethyl aminobenzoate, methylbenactidium bromide, butylscopolamine bromide, funnel extract and the like can be used.
  • stomachic medicine for example, one or more selected from powers such as Keihi, Obata, Shokyo, and sempri can be used.
  • the digestive agent for example, one or more selected from the group consisting of ursodesoxycholic acid, fat digestive enzyme, starch digestive enzyme and the like can be used.
  • the intestinal viable bacteria component for example, one or more kinds selected from lactic acid bacteria powder, bifidobacteria, butyric acid bacteria powder and the like can be used.
  • an antidiarrheal agent for example, one or more selected from oral peramide hydrochloride, albumin tannate, bismuth subgallate and the like can be used.
  • constipation therapeutic agent for example, one or more kinds selected for power such as sennoside, senna, daio, Brantago obata seeds can be used.
  • the vitamin agent for example, one or more selected from the strengths such as tocopherol acetate, ascorbic acid, thiamine, pyridoxine, cyanobalamine may be used.
  • the nourishing tonic for example, one or more selected from power such as taurine, calcium pantothenate, nicotinamide and the like can be used.
  • the circulatory organ agent for example, one or more selected by force such as ubidecarenone, carrot, and agate can be used.
  • the Chinese herbal medicine for example, one or more selected from powers such as Kakchir and Kazuka Detoxin can be used.
  • herbal medicine components include, for example, ziryu, sansoonin, ohhi, onji, licorice, kikiyou, kiyounin, shazenshi, shazensou, sexane, senega, tokon. , Baimo, asenjak, wiki, gon, caronine, kehi, goo, gomin, saishin, zion, jiakou, shajin, shokiyo, sohakuhi, soyou, chiksendin, chimney, carrot, batmondou and roe, nge, etc.
  • One or more can be used.
  • Examples of combinations of active ingredients in the liquid pharmaceutical preparation of the present invention include the following:
  • Dihydrocodeine phosphate, guaifenesin and chlorfelamin maleate codin phosphate, dl-methylephedrine hydrochloride and chlorfelamin maleate; dextromethorphan hydrobromide, guaifenesin and chlorfelamin maleate;
  • Dextromethorphan hydrobromide, guaifenesin and chlorferramine maleate Dextromethorphan hydrobromide, guaifenesin and chlorferramine maleate.
  • the liquid preparation of the present invention is used as a pharmaceutical for oral administration, and includes, for example, general cold medicine, cough, rhinitis, antipyretic analgesics, gastrointestinal drugs, antidiarrheals, motion sickness preventives or palliatives, etc.
  • a pharmaceutical for oral administration includes, for example, general cold medicine, cough, rhinitis, antipyretic analgesics, gastrointestinal drugs, antidiarrheals, motion sickness preventives or palliatives, etc.
  • Table 1 shows examples of active ingredient prescriptions when the present invention is used as a general cold medicine.
  • the active ingredients shown in Table 1 can be used as a solution in an appropriately selected solvent.
  • Tipepidine citrate ⁇ 0.22 That is, according to one aspect of the present invention, there is provided an already defined liquid pharmaceutical preparation comprising the components shown in Table 1 as an active ingredient.
  • the liquid pharmaceutical composition of the present invention includes, as optional ingredients, a flavoring agent, sweetening agent, preservative, flavoring agent, diluent, solubilizer, PH regulator, viscosity modifier, colorant, stabilizer, It may contain additives such as surfactants, suspension agents, antioxidants, cooling agents, flavoring agents, and fragrances.
  • a liquid pharmaceutical formulation as defined above comprising one or more flavoring or sweetening agents.
  • the corrigent and sweetener used in the present invention are not particularly limited, and for example, the corrigent and sweetener usually used in pharmaceutical preparations can be used.
  • flavoring and sweetening agents include fructose, glucose liquid sugar, sucrose, strength lamella, aspartame, neotame, stevia extract, licorice extract, brown sugar, saccharin sodium, sorbitol, and sugar alcohols (e.g., mantol, xylo , Xylitol, erythritol, maltitol and latathitol) and glycerin.
  • one or more, preferably two or more selected from aspartame, neotame, stevia extract, licorice extract, brown sugar, sodium saccharin, caramel and sorbitol can be used as a corrigent or sweetener.
  • the blending amount of the sweetener and the flavoring agent contained in the liquid pharmaceutical preparation of the present invention is, for example, 2 to 95% by weight, preferably 2 to 50% by weight, more preferably 2 to 23% by weight.
  • the daily dose in the liquid preparation of the present invention is not particularly limited, and may be appropriately determined according to the daily dose of the active ingredient contained in the liquid preparation. From the viewpoint of the number of administrations per day and convenience at the time of administration, the daily dose may be, for example, 1.5 to 18 mL, preferably 3.0 to 15 mL, more preferably 6.0 to 9 mL. Good.
  • the single dose in the liquid preparation of the present invention is not particularly limited, and can be appropriately determined according to the daily dose of the active ingredient contained in the liquid preparation, the number of daily doses, and the like. From the viewpoint of the number of administrations per day and safety at the time of taking, it may be, for example, 0.5 to 5 mL, preferably 0.75 to 3 mL, and more preferably 1.0 to 2 mL. According to the present invention, since the ingestion is performed safely and reliably, the necessary amount of the active ingredient can be ingested in a small amount compared with a normal oral liquid pharmaceutical preparation.
  • the liquid pharmaceutical formulation of the present invention eliminates complications during administration, and causes negative effects on patients during frequent administration. Since it has the effect of reducing the burden, the present invention is suitable for a drug whose daily dose is 2 times or more.
  • the number of doses of the liquid pharmaceutical preparation of the present invention may be, for example, 1 to 6 times a day, preferably 4 to 6 times a day.
  • the container used in the present invention is not particularly limited as long as it is normally used as a container for a liquid pharmaceutical preparation, and for example, a brown light-shielding glass container or the like may be used.
  • a liquid pharmaceutical preparation was prepared based on the following prescription and filled into a container with a push pump type discharge device (with a spout valve on the spout, SP500LR shutoff nozzle, purchased from Yoshino Kogyo Co., Ltd.).
  • the discharge volume was measured as the volume of chemical liquid (g) discharged at one time, and the volume (mL) of the chemical liquid discharged from the specific gravity (1.05) of the chemical liquid was converted. The results are shown in Table 3.
  • Fig. 1 is a graph showing an example of test results for confirming the drug efficacy of the drug of the present invention as an internal cough solution.
  • FIG. 2 is a graph showing an example of test results for confirming the efficacy of the drug of the present invention as a cough medication solution.
  • FIG. 3 is a cross-sectional view showing a structure for preventing removal of a fitting portion (screwing portion) of a container mouth neck portion and a mounting cap of a discharge device used in the present invention.
  • FIG. 4 is a longitudinal sectional view showing an example of a pressing head used in a discharge device used in the pharmaceutical composition of the present invention.
  • FIG. 5 is a longitudinal sectional view taken along line AA in FIG. 6 is a cross-sectional view taken along line BB in FIG.
  • FIG. 7 is a perspective view of a flange member used in the pressing head.
  • FIG. 8 is a longitudinal sectional view showing another example of the pressing head of the discharge device used in the pharmaceutical composition of the present invention.
  • FIG. 9 is a longitudinal sectional view of FIG.

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Abstract

L'invention vise à fournir une préparation médicamenteuse liquide pour administration orale, qui permette de réduire l'effort de prise de médicament afin de ménager le patient et de rendre la prise de médicament sûre. A cet effet, une préparation médicamenteuse liquide pour administration orale est conditionnée dans un contenant muni d'une unité de distribution et est administrée par passage direct de l'unité de distribution sur la langue ou à proximité de la langue dans la cavité buccale, et ce sans aucun contact. L'unité de distribution comprend un élément valve qui est précontraint élastiquement de manière à fermer l'orifice de distribution de la préparation médicamenteuse liquide et qui se déplace à l'encontre de la force élastique à l'instant de distribution de la préparation médicamenteuse liquide de manière à ouvrir l'orifice de distribution.
PCT/JP2007/057594 2006-04-04 2007-04-04 Préparation médicamenteuse liquide pour administration orale, conditionnée dans un contenant muni d'une unité de distribution Ceased WO2007116915A1 (fr)

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JP2006103539A JP5155524B2 (ja) 2006-04-04 2006-04-04 吐出装置を備えた容器に収容される経口投与用液体医薬製剤
JP2006-103539 2006-04-04

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2942781A1 (fr) * 2009-03-03 2010-09-10 Toly Korea Inc Dispositif pour ouvrir et fermer une buse de boitier cosmetique
US10036574B2 (en) 2013-06-28 2018-07-31 British American Tobacco (Investments) Limited Devices comprising a heat source material and activation chambers for the same
US10542777B2 (en) 2014-06-27 2020-01-28 British American Tobacco (Investments) Limited Apparatus for heating or cooling a material contained therein
US11064725B2 (en) 2015-08-31 2021-07-20 British American Tobacco (Investments) Limited Material for use with apparatus for heating smokable material
US11241042B2 (en) 2012-09-25 2022-02-08 Nicoventures Trading Limited Heating smokeable material
US11452313B2 (en) 2015-10-30 2022-09-27 Nicoventures Trading Limited Apparatus for heating smokable material
US11659863B2 (en) 2015-08-31 2023-05-30 Nicoventures Trading Limited Article for use with apparatus for heating smokable material
US11672279B2 (en) 2011-09-06 2023-06-13 Nicoventures Trading Limited Heating smokeable material
US11825870B2 (en) 2015-10-30 2023-11-28 Nicoventures Trading Limited Article for use with apparatus for heating smokable material
US11924930B2 (en) 2015-08-31 2024-03-05 Nicoventures Trading Limited Article for use with apparatus for heating smokable material

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JP5752625B2 (ja) * 2012-03-13 2015-07-22 サッポロビール株式会社 麦芽非発酵飲料およびその製造方法、ならびに不快な香味のマスキング方法
JP5928968B2 (ja) * 2015-04-09 2016-06-01 サッポロビール株式会社 麦芽飲料およびその製造方法、ならびに不快な香味のマスキング方法
EP3405174A4 (fr) 2016-01-12 2019-10-30 Nortic Holdings Inc. Formulation de bêtaméthasone destinée à une pulvérisation par voie orale et méthode d'utilisation associée pour le traitement de l'ataxie

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JPH10265369A (ja) * 1997-03-25 1998-10-06 Taisho Pharmaceut Co Ltd 風味の改善された内服液剤
JP2003206242A (ja) * 2001-12-28 2003-07-22 Lion Corp 内服液剤組成物
JP2004000834A (ja) * 2002-05-31 2004-01-08 Yoshino Kogyosho Co Ltd ポンプの押下ヘッド
JP2004344784A (ja) * 2003-05-22 2004-12-09 Yoshino Kogyosho Co Ltd 液体噴出器
JP2005022664A (ja) * 2003-06-30 2005-01-27 Yoshino Kogyosho Co Ltd ポンプ式スプレー容器

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JP2570042Y2 (ja) * 1992-03-31 1998-04-28 日本化薬株式会社 医薬用容器
JP3072680U (ja) * 2000-04-20 2000-10-24 洋司 信長 噴霧器
DE10210122A1 (de) * 2002-03-08 2003-09-18 Vwu Kanzlei Fuer Vermoegens Wi Aufnahme- und Abgabevorrichtung für flüssige und gasförmige Stoffe in pädagogischer Form

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JPH10265369A (ja) * 1997-03-25 1998-10-06 Taisho Pharmaceut Co Ltd 風味の改善された内服液剤
JP2003206242A (ja) * 2001-12-28 2003-07-22 Lion Corp 内服液剤組成物
JP2004000834A (ja) * 2002-05-31 2004-01-08 Yoshino Kogyosho Co Ltd ポンプの押下ヘッド
JP2004344784A (ja) * 2003-05-22 2004-12-09 Yoshino Kogyosho Co Ltd 液体噴出器
JP2005022664A (ja) * 2003-06-30 2005-01-27 Yoshino Kogyosho Co Ltd ポンプ式スプレー容器

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2942781A1 (fr) * 2009-03-03 2010-09-10 Toly Korea Inc Dispositif pour ouvrir et fermer une buse de boitier cosmetique
US12041968B2 (en) 2011-09-06 2024-07-23 Nicoventures Trading Limited Heating smokeable material
US11672279B2 (en) 2011-09-06 2023-06-13 Nicoventures Trading Limited Heating smokeable material
US11241042B2 (en) 2012-09-25 2022-02-08 Nicoventures Trading Limited Heating smokeable material
US10036574B2 (en) 2013-06-28 2018-07-31 British American Tobacco (Investments) Limited Devices comprising a heat source material and activation chambers for the same
US10542777B2 (en) 2014-06-27 2020-01-28 British American Tobacco (Investments) Limited Apparatus for heating or cooling a material contained therein
US11659863B2 (en) 2015-08-31 2023-05-30 Nicoventures Trading Limited Article for use with apparatus for heating smokable material
US11924930B2 (en) 2015-08-31 2024-03-05 Nicoventures Trading Limited Article for use with apparatus for heating smokable material
US11064725B2 (en) 2015-08-31 2021-07-20 British American Tobacco (Investments) Limited Material for use with apparatus for heating smokable material
US11452313B2 (en) 2015-10-30 2022-09-27 Nicoventures Trading Limited Apparatus for heating smokable material
US11825870B2 (en) 2015-10-30 2023-11-28 Nicoventures Trading Limited Article for use with apparatus for heating smokable material
US12016393B2 (en) 2015-10-30 2024-06-25 Nicoventures Trading Limited Apparatus for heating smokable material
US12219986B2 (en) 2015-10-30 2025-02-11 Nicoventures Trading Limited Article for use with apparatus for heating smokable material

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