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WO1997011739A1 - Procede et appareil d'administration de cafeine par pulverisation dans la bouche - Google Patents

Procede et appareil d'administration de cafeine par pulverisation dans la bouche Download PDF

Info

Publication number
WO1997011739A1
WO1997011739A1 PCT/US1995/012249 US9512249W WO9711739A1 WO 1997011739 A1 WO1997011739 A1 WO 1997011739A1 US 9512249 W US9512249 W US 9512249W WO 9711739 A1 WO9711739 A1 WO 9711739A1
Authority
WO
WIPO (PCT)
Prior art keywords
caffeine
person
spray
mixture
liquid
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/US1995/012249
Other languages
English (en)
Inventor
John E. Spector
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
Priority to AU36413/95A priority Critical patent/AU3641395A/en
Priority to PCT/US1995/012249 priority patent/WO1997011739A1/fr
Publication of WO1997011739A1 publication Critical patent/WO1997011739A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A61M35/003—Portable hand-held applicators having means for dispensing or spreading integral media
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised

Definitions

  • the invention herein relates to CNS (central nervous system) stimulants. More particularly, it relates to methods of administering CNS
  • Caffeine ( 1 ,3,7-trimethylxanthine) is well known as a CNS stimulant; Olin (ed.), Drug Facts and Comparisons, ch. 6, pp. 1 1 1 6- 1 1 1 8 ( 1 994) and is found in many common beverages; Olin, supra, p. 1 1 16; Caro et al., in American Pharmaceutical Association (APhA) , Handbook of Nonprescription Drugs, Ch. 1 6, pp. 364-367 (8th Edn.: 1 986) . It is also available as an over-the-counter (OTC) oral medication in tablet and capsule form; Olin et al. , supra, p. 1 1 18; Caro et al. , supra, p. 370.
  • OTC over-the-counter
  • caffeine usage is significantly less than it would be if people could easily and discreetly self-administer caffeine when appropriate stimulation is needed and without concern about the social setting, using a method which would provide for rapid stimulatory effect.
  • the present invention provides the ability to accomplish just that.
  • the invention herein comprises both a method and an apparatus for easily and conveniently self-administering caffeine combined with a breath freshener.
  • the present invention is based on the discovery that a well known CNS stimulant material, caffeine, can be readily, conveniently and effectively administered to humans by a means neither heretofore recognized nor disclosed by the prior art.
  • the caffeine can be absorbed in the human system by swallowing and absorption from the intestinal tract or by absorption through the buccal membranes while the breath freshener provides masking taste to overcome any reluctance that a user might have on the basis of the taste of the caffeine alone.
  • the invention is a unique administration method and device by means of which the stimulatory effect of the caffeine is rapidly realized, and which permits simple and convenient administration of caffeine in a unobtrusive and effective manner, either by self-administration or with the assistance of another person, even in circumstances where the prior art administration methods are inconvenient
  • the invention is a method for administering caffeine to a person which comprises incorporating caffeine in at least a predetermined quantity effective to accomplish CNS stimulation in a human and a breath freshening compound into a physiologically acceptable liquid carrier to form a mixture; placing the mixture into a dispensing device from which the mixture can be ejected as an atomized spray or as a liquid stream: operating the device to eject at least one metered amount of the spray or stream of mixture directly onto the person's tongue; and continuing to convey the spray or steam in metered doses onto the tongue for a period of time sufficient to administer a quantity of caffeine effective to promote CNS stimulation to the person by assimilation into the person's body by oral swallowing or by absorption through buccal membranes.
  • the carrier is preferably purified water; sodium benzoate may also be present to enhance the solubility of the caffeine in the water.
  • the apparatus of the present invention is for oral spray administration of caffeine to a person in at least a predetermined quantity effective to accomplish CNS stimulation in the person, and comprises a reservoir for containing a liquid mixture of caffeine, a breath freshener and a physiologically acceptable liquid carrier, the caffeine being present in a concentration effective on a daily administration basis to promote CNS stimulation to said person by assimilation into said person's body by oral swallowing or by absorption through buccal membranes after administration onto the person's tongue; pump means for generating a metered quantity of a spray or stream of the liquid, having fluid conduit connection to the reservoir; and control means for manipulating the pump means to eject metered quantities of the mixture as the spray or stream directed onto the person's tongue.
  • the apparatus may generate the spray or stream either 1739 PC17US95/12249
  • caffeine In order to be effective, caffeine must be administered at times when a person's central nervous system is depressed and CNS stimulation is needed. The most common instances of such depression are indicated by fatigue, drowsiness, and inability to concentrate, and are often caused by boredom, repetitive work, long unbroken periods of highway driving, etc.
  • the unique administration of the caffeine in spray or stream form directly onto the tongue provides for extremely rapid assimilation of the caffeine into the central nervous system and therefore rapid (substantially immediate, in many cases) stimulation of the central nervous system.
  • the safe and adequate daily quantity of caffeine which can be administered to an adult person is up to 1 600 mg/day, with no more than 200 mg per individual dose.
  • the caffeine will be administered in doses not to exceed an accumulation of 200 mg per four-hour period.
  • Lesser doses should be administered to children and pregnant or lactating women. Excessive doses can cause overstimulation of the central nervous system, resulting in insomnia, dyspnea, headache, restlessness, irritability, mild delirium and tremor. See Olin et al., supra, p. 1 1 1 8 and Caro et al. , supra, p. 364. It is possible to reduce the overall dosage, but the CNS stimulatory effect will be decreased.
  • the actual spray or stream administration is accomplished by first preparing a liquid mixture comprising a predetermined quantity of caffeine, a breath freshener and a physiologically acceptable liquid carrier.
  • the caffeine and breath freshener are dispersed or dissolved in the carrier.
  • the total concentration of caffeine will depend on the number of dose administrations which are contemplated from the device and the amount of caffeine to be administered each day, considering the volume of the device reservoir.
  • Spray/streams valves are designed to dispense a spray or stream with a metered volume in the range of about 0.10-0.20 ml per individual delivery dose, preferably about 0.1 5-0.1 7 ml, and will conveniently have a total capacity of 250-600 individual spray or stream doses, preferably about y v j y ⁇ i i i ⁇ .
  • Caffeine concentrations will be such to provide on the order of about 5-100 mg of caffeine delivered onto the tongue per delivery dose.
  • a device is designed to dispense the caffeine mixture as an atomized spray with purified water as the carrier.
  • the device's total spray capacity is 360 individual metered sprays.
  • the mixture has a caffeine concentration sufficient to provide I 6V3 mg of caffeine per spray, and the recommended usage is three individual spray doses per four- hour period, for a dosage of 50 mg per four-hour period. This may be repeated up to four times per day, for a total daily dosage of 200 mg It will be understood that many other schedules and individual spray or stream quantities are possible and acceptable.
  • the carrier may be any suitable liquid which has the appropriate viscosity to permit effective dispensing in spray or stream form, is inert or at least non-toxic to the user, is physiologically acceptable for human consumption, has the capacity to dissolve or disperse suitable concentrations of caffeine, breath freshener, and (where present) sodium benzoate.
  • the preferred carrier is water, although glycerin, ethanol, fruit juices, edible oils and the like may also be used. All carriers will be in purified form from which foreign matter such as bacteria will have been reduced to a quantity not greater than that approved by applicable governmental regulations or, preferably, eliminated substantially totally
  • sodium benzoate increases the solubility of caffeine in water Consequently it is within the scope of this invention to have sodium benzoate also present in the mixture, so that the concentration of caffeine can be increased in the mixture and greater doses of caffeine can be administered per individual dose.
  • Sodium benzoate is compatible with caffeine and is acceptable for human administration. It does not change the physiological effect of the caffeine, but rather merely permits higher concentrations of caffeine to be present in the mixture in the container and therefore also in each individual dose.
  • breath freshener composition which is incorporated into the mixture with the caffeine provides both breath freshener anti-mouth-odor
  • the tongue requires that the mixture be palatable, or people will simply not use the method . Since the taste of caffeine, sodium benzoate and/or the carrier may be disagreeable to some users, the breath freshener/flavorant is included to overcome any adverse taste.
  • breath freshener materials commercially available which are suitable for administration in liquid form and which are compatible with caffeine and various carriers, and any of these may be used satisfactorily in this invention.
  • the amount of breath freshener which will be administered is not critical, as long as it is sufficient to provide breath freshening and flavorant properties.
  • the overall viscosity of the mixture will be essentially that of the liquid carrier, which must be sufficiently low that the mixture can be readily atomized and sprayed using conventional pump spraying or gas propelled spraying.
  • the latter uses a gas such as CO 2 or a compound which generates a gas, such as nitrogen generation by spontaneous decomposition of azide compounds
  • the gas propellant must be inert with respect to the liquid carrier, the breath freshener and the caffeine and must be nontoxic and otherwise safe for use by a human.
  • the user self-administer the caffeine in intermittent dosages, allowing the stimulatory effect of each individual dose to act for as long as time as possible, before administering the next quantity.
  • the caffeine be administered at at least two separate times during the day, usually spaced apart by the length of time occurring before the symptoms of fatigue, drowsiness, etc. significantly recur.
  • the total cumulative amount of caffeine administered during a four hour period or over the course of a day, regardless of the actual number of administrations, will be no greater than the above-mentioned limits.
  • the device useful herein is a small device comprised of a housing containing the fluid reservoir and onto which is mounted the operating mechanism, which conveniently fits the hand, and which is easily carried and stored in a pocket, purse, pack, briefcase, or the like
  • the reservoir for the caffeine/breath freshener/liquid carrier mixture is connected by a fluid conduit to a dispensing head through which the spray or stream is generated.
  • the dispensing head may contain essentially only a valve and a nozzle.
  • the valve will be a normally-
  • the dispensing head is in the form of a small pump mechanism which draws in ambient air and pumps it into the liquid reservoir, where the increase in pressure forces the liquid mixture out through the nozzle in spray or stream form.
  • the user holds the housing 2 of the device in his or her hand 4 and uses finger 6 to operate dispensing head 8 to cause a metered spray 10 to be sprayed into the user's mouth, and substantially all onto the user's tongue 1 2.
  • the pump mechanism and the nozzle are designed and calibrated such that each stroke of the pump causes metered emission of a predetermined known quantity of liquid mixture and thus of caffeine. This permits the -1 2-
  • the manufacturer to stipulate the specific number of doses to be used to administer the desired daily cumulative quantity of caffeine.
  • the number of daily doses from a given device will of course be dependent upon the volumetric capacity of the dispensing head; the manufacturer may determine beforehand whether the device is to be equipped with a high volume dispensing spray head and used for a few doses per day of individually large volumes, or to be equipped with a small volume dispensing head, and thus requiring a larger number of lesser volumes per day to obtain a large cumulative dosage.
  • the manufacturers will normally prefer the high volume heads with fewer number of doses during the day, since that is most convenient for the user.
  • novel and unique method of administration herein represents a far more convenient and readily acceptable method of administration than those methods described in the prior art.
  • a person may carry a small dispenser device in a pocket, purse, briefcase, etc., from which it can be easily removed and discreetly used to provide the desired or recommended quantity of caffeine at any convenient time.
  • the appearance given will be similarly to that seen with use of commercial spray breath fresheners.
  • One can thus readily and conveniently use the product at any time of choice, and obtain a substantially immediate stimulatory effect, a result particularly important for many activities, such as driving a vehicle, operating machinery, studying, or any other activity which required prompt and continual concentration.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un procédé et un appareil permettant de s'administrer à soi-même, facilement et d'une manière commode, de la caféine en combinaison avec un pulvérisateur buccal. La caféine, qui produit d'importants effets physiologiques en tant que stimulant du système nerveux central, est administrée à des personnes d'une façon qui n'avait été, jusqu'à présent, ni reconnue ni divulguée, et qui assure d'une manière unique le début très rapide de l'effet physiologique stimulant sur l'utilisateur. La caféine, avec un support et en combinaison avec un pulvérisateur buccal, est fournie sous forme de brouillard liquide ou de jet, directement sur la langue de la personne, à partir de laquelle elle est rapidement absorbée par l'organisme, grâce à la déglutition et à l'absorption à partir de l'intestin ou par les membranes buccales. La caféine est administrée au fur et à mesure des besoins, en quantités quotidiennes qui atteignent de préférence jusqu'à 200 mg par période de quatre heures, en une dose, ou de préférence quatre doses mesurées. L'invention fournit un procédé et un appareil d'administration uniques, simples et pratiques de caféine, d'une manière efficace et sans déranger, sur la base des besoins effectifs, avec un effet stimulant qui est rapide et puissant.
PCT/US1995/012249 1995-09-26 1995-09-26 Procede et appareil d'administration de cafeine par pulverisation dans la bouche Ceased WO1997011739A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU36413/95A AU3641395A (en) 1995-09-26 1995-09-26 Method and apparatus for oral spray administration of caffeine
PCT/US1995/012249 WO1997011739A1 (fr) 1995-09-26 1995-09-26 Procede et appareil d'administration de cafeine par pulverisation dans la bouche

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1995/012249 WO1997011739A1 (fr) 1995-09-26 1995-09-26 Procede et appareil d'administration de cafeine par pulverisation dans la bouche

Publications (1)

Publication Number Publication Date
WO1997011739A1 true WO1997011739A1 (fr) 1997-04-03

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Application Number Title Priority Date Filing Date
PCT/US1995/012249 Ceased WO1997011739A1 (fr) 1995-09-26 1995-09-26 Procede et appareil d'administration de cafeine par pulverisation dans la bouche

Country Status (2)

Country Link
AU (1) AU3641395A (fr)
WO (1) WO1997011739A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4236959A4 (fr) * 2020-10-29 2024-04-10 Oye Therapeutics, Inc. Compositions de caféine

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4023712A (en) * 1976-01-27 1977-05-17 Ihor Babiak Portable spray container device
US5078129A (en) * 1987-05-01 1992-01-07 Research Foundation Of State University Of New York Device for stimulating salivation
US5219858A (en) * 1990-03-27 1993-06-15 Parnell Pharmaceuticals, Inc. Method and compositions for effecting withdrawal from drug dependency

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4023712A (en) * 1976-01-27 1977-05-17 Ihor Babiak Portable spray container device
US5078129A (en) * 1987-05-01 1992-01-07 Research Foundation Of State University Of New York Device for stimulating salivation
US5219858A (en) * 1990-03-27 1993-06-15 Parnell Pharmaceuticals, Inc. Method and compositions for effecting withdrawal from drug dependency

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4236959A4 (fr) * 2020-10-29 2024-04-10 Oye Therapeutics, Inc. Compositions de caféine

Also Published As

Publication number Publication date
AU3641395A (en) 1997-04-17

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