US2868691A - Self-propelling compositions for inhalation therapy containing a salt of isoproterenol or epinephrine - Google Patents

Self-propelling compositions for inhalation therapy containing a salt of isoproterenol or epinephrine Download PDF

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Publication number
US2868691A
US2868691A US572788A US57278856A US2868691A US 2868691 A US2868691 A US 2868691A US 572788 A US572788 A US 572788A US 57278856 A US57278856 A US 57278856A US 2868691 A US2868691 A US 2868691A
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United States
Prior art keywords
medicament
composition
freon
self
isoproterenol
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Expired - Lifetime
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US572788A
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English (en)
Inventor
Porush Irving
George L Maison
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Riker Laboratories Inc
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Riker Laboratories Inc
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Priority to BE555319D priority Critical patent/BE555319A/xx
Application filed by Riker Laboratories Inc filed Critical Riker Laboratories Inc
Priority to US572788A priority patent/US2868691A/en
Priority to GB7565/57A priority patent/GB830426A/en
Application granted granted Critical
Publication of US2868691A publication Critical patent/US2868691A/en
Anticipated expiration legal-status Critical
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • a number of previous eflorts have been directed to the preparation of medicament-containing, pharmaceutical preparations for use in inhalation therapy.
  • Thes'e preparations suffer from one or more shortcomings. In many cases they require cumbersome mechanical devices to dispense the medicament. Some of these devices employ a rubber airbulb to aspirate the medicament. This often requires substantial physical effort on the "part of the user. In other cases the vehicle for the medicament may possess irritating properties which mitigate against the use of the compositions for inhalation therapy where delicate mucous membranes may be aflected. In some cases Where a fixed dosage is required these'compositions are not conveniently dispensed in measured, constant amounts. For these reasons, as well as others, the benefits of inhalation therapy have not'been fully realized and progress in this mode of medication has lagged.
  • compositions invide a self-propelling therapeutic composition for inhalation therapy which maybe packaged with safety in suitable low pressure containers,;such as frangible containers, or in containers having a dispensing valve construction which will permit dispensing jmeasui'ed, constant doses of "the medicament.
  • Still another object of the present invention is to provide a stable therapeutic composition containing a liquified non-toxic propellent material which is not subject to erratic pressure variations and which imparts easily controlled pressures at room or ambient temperatures to the container in which the composition is stored and dispensed from.
  • compositions of the present invention comprise a medicament dissolved in a non-toxic
  • liquid propellant in thenature of a fluorinated or fluorochlorinated lower aliphatic hydrocarbon, preferably with the aid of a co-solvent for both the medicament and the a medicament in aerosol form for inhalation therapy.
  • the non-toxic, liquid propellant shall be a fluorinated or a fluorochlorinated lower saturated aliphatic hydrocarbon, and preferably a halogenated alkane containing not more than 2 carbon atoms and at least 1 fluorine atom, or mixtures thereof.
  • the propellants shall possess a boiling point of less than F. at 760 mm. pressure.
  • propellants examples include dichlorodifiuoromethane (Freon 12), dichlorotetrafluoroethane (Freon 114) CCIF CClF trichloromonofluoromethane (Freon 11), dichloromonofiuoromethane (Freon 21), and Propellants with improved vapor pressure characteristics may be obtained by using certain mixtures of these compounds, e.
  • Freon 11 and Freon 12, or Freon 12 and Freon 114 For example, dichlorodifluoromethane, which has a vapor pressure of about 70 pounds per square inch .gauge and 1,2-dichloro-1,1,2,2-tetrafluoroethane (Freon 114), with a vapor pressure of about -13 pounds per square inch. gauge at 70 F., may be mixed in various proportions to form a propellant having an intermediate vapor pressure which is well suited for use in relatively low pressure containers.
  • the vapor pressure of the propellant employed shall itself be between about 25 and 65 pounds per square inch gauge at 70 F., and preferably between about 30 and 40 pounds per square inch gauge at that temperature.
  • a one-component propellant defined'for use in thecomposition was found to give a'composition with gaugepressures in the rangeof 55to 65 pounds per square inch at 70 F., which are usable safely with metal containers.
  • the two-component propellants such as equalweight mixtures of Freon 12 and "Freon 11, were found to give gauge pressures in the range of 2 0 to 40 pounds per square inch at 70 F., which are usable safely with specially reinforced glass containers.
  • the medicament employed in a composition according to this invention can be one which is therapeutically ef fective when administered'by inhalation and which may be brought into stable solution in any of the above defined liquified propellants, if necessary, with the aid of a cosolvent and/ or stabilizing substance.
  • One type of medicament which can be employed satisfactorily is the vasoconstrictive amines and their acid-addition salts.
  • other types of medicaments such :as hormones, enzymes, alkaloids, steroids, analgesics, broncho-dilators,. antihistamines, 'antitussives, anginal preparations, antibiotics and sulfonamides and synergistic combinations of these,v
  • Examples of the medicaments which may be employed in producing the compositions of this invention are: isoproterenol hydrochloride [u-(isopropylaminomethyl) protocatechuyl alcohol], phenylephrine, epinephrine, ephedrine, narcotine, codeine, atropine, ergotamine, scopolamine, colchicine, cortisone and alkyl nitrites, such'as amyl nitrite or octyl nitrite.
  • the co-solvent maybe any liquid substance which assists in. dissolving the medicament in the liquified propellant and which is chemically inert to the medicament in the sense that it does not promote the decomposition of this substance.
  • Suitable co-solvents are intermediate in polarity between the propellant and the medicament.
  • the co-solvents have the property of being a solvent for the medicament and soluble in the propellants prescribed for use in this invention.
  • the co-solvent beside being chemically inert toward the medicament, should benontoxic andwithout undesirable effects on inhalation in the amount present in the aersol produced.
  • the co-solvent shall have as low a boiling point as possible and prefer-. ably not higher than 212 F. at atmospheric pressure. Examples of satisfactory co-solvents include non-toxic loweralcohols and eth ers, e. g., ethanol, diethyl ether, chloroform, mixtures of ethanol and wate r, and mixtures of chloroform and ethanol.
  • the stabilizers or anti-oxidants which .may be employed are stronger reducing agents than the medicament and which are non-toxic, such as the alkali-metal bisu'lfites (sodium bisulfite), alkali-metal ascorbates (sodium ascorbate), ascorbic acid, nordihydroguaiaretic acid, 2- tertiarybutyl-4-hyd'roxy anisole, 3-tertiarybutyl-4-hydroxy anisole, butylated hydroxytoluene' (sold under the trademark Tenox BHT), ethylhydro-caffeate, etc. It is normallynot necessary to employ -a stabilizer in an amount in excess'of 0.25% by-weight ofthe composition.
  • Spray pattern involves the delivery rate, the particle size distribution and the spray angle.
  • the spray pattern is affected by mechanical factors, e. g., valve construction and orifice size and shape, and by the characteristics of the composition, e. g., viscosity, vapor pressure, type and percentage of propellant.
  • thecomposition lack-suificient propellent force and consequently the'inadequate aerosolization of the medicament results in a particle size distribution which is not efiiciently absorbed in-the' bronchioles and alveoli.
  • the composition may become unstable during storage and-the medicament may precipitate from the composition.
  • thecompositions may develop undesirably high pressures.
  • the open container and its contents are then cooled, preferably to a temperature below the boiling point of the propellant to be employed. A temperature of 25 F. is usually satisfactory.
  • a measured quantity of the liquified propellant which also has been cooled below its boiling point is then introduced into the container and mixed with the solution already present. The quantities of the components introduced into the container are calculated to provide the desired concentration of each in the final composition.
  • the container is sealed with a closure equipped with asuitable dispensing valve arrangement. Upon warming to room temperature the Q mnts of the container are mixed by agitation of the containerto insure complete solution of the medicament.
  • the liquid propellant constitute at least about 50% by weight of the total composition upward to about 90%. It is preferred that the propellant constitute between about 55% or 60% and 80% by weight of the total composition.
  • the amount and constitution of the co-solvent is largely dependent upon the solubility characteristics of the medicament employed. In most cases it has been found that satisfactory results are obtained where the co-solvent constitutes between about 5% or 10% and 40%, and preferably between abont 20% and 40%'-- v we hto the t a .cQmP s t Qn- .lf to!
  • the amout of medicament shall generally constitute from about 0.1% to 20%, and preferably from about 0.1% to 2% by weight of the'composition.
  • the propellant makes-upthe difference 'betwen the proportions of medicamennco-solvent, stabilizer and 100%.
  • novel compositions of the-invention maybe-prepared and containers filled with them by-means of-the following process:
  • Asuitable measured quantity-of the medicament- is mixed with, and dissolved in, a measured amountof the co-solvent. .A stabilizer, if desired,- is added.
  • A- measured quantity-zof the resultingsolution isythea ntra used percentages bysweight of the total composition.
  • Example 3 I Percent Isoproterenol l ICl ate Ethan We Trichloromonotiuoromethane (Freon 1-1)
  • Example 6 g 1 V H Percent Narcotine v 1 Water 0.65 Ethanol (absolute) a 12.35 Chloroform 20.6
  • Dichlorodifiuorornethane (Freon 12) i f-'3 4.8
  • Example 10 I I I P ercent Atropine 0.1 Ethanol 95% a 9.9 Dichlorodifluoromethane (Freon 12) 45 Dichlorotetrafluoroethane (Freon 114) 45 1 100
  • Example 11 i t Percent Octyl nitrite 0.1 Ethanol 95 9.9 Dichlorotetrafiuoroethane .(Freon 114) 55.4 Dichlorodifiuoromethane (Freon 12) 34.6
  • colchicine cortisone, amyl nitrite, etc.
  • compositions in accordance with this invention are characterized by a clear, sparkling appearancewith the advantage that it is easy to observe when the'container is nearly empty. It is recommended for added safety that the glass bottles be coated with a plastic film, preferably clear.
  • 'Aldip-tube of suitable material may be connected with the opening containing the valve arrangement and extendingfto the bottom of the container or an inverted system without a dip-tube may be'-used.
  • the composition is expelled through the opening in the form of a fine stream to form an aerosol of the medicament.
  • the opening is desirably constructed to provide a small orifice so as to expel a fine spray of the composition.
  • a self-propelling pharmaceutical composition capable of providing a medicament in aerosol formsuitable for inhalation therapy, comprising as the medicament a water-soluble acid-addition salt of a bronchodi lator amine selected from the class consisting of isoproterenol and epinephrine, said medicament comprising between about 0.1% and 2% of the composition, as a co solvent for said medicament, an aqueous ethanol mixture in an amount comprising between about 20% to 40% of the composition, the water in said cosolvent comprising between about 1.5% and 2% 'of the total com'-' position, and as a liquefied non-toxic propellant componut 21 halogenated lower alkane containing at least 1 fluorine atom and not more than 2 carbon atoms and having a vapor pressure of between about 20 and 65 pounds per square inch gauge at F., said liquefied propellantfcomponent comprising substantially the re mainder of the composition.
  • a self-propelling pharmaceutical composition as defined by claim .1 containing about 0.25% ,isoprotera enol hydrochloride, about-1.5% water, about 33.25%- ethanol, and the remainder being a liquefied'non-toxie propellant as ,defi ne d by claim 1.
  • a package comprising a pressure-tight container having a valve-controlled opening and containing a selfpropelling pharmaceutical composition capable of providing a medicament in aerosol form suitable forinhal-ation therapy, comprising as a medicament a water-soluble acid-addition salt ofa bronchodilator' amine selected from the. class consisting of. isoproterenol and epinephrine,- said medicament comprising between about 0.1% and 2% of the composition, as. a .cosolvent-for said medicament an aqueous ethanol mixture. in an. amount comprising- -betwee about 20%. and 40% of the composition, the waterin said cosolvent comprising between about 1.5% and 2% of the total.
  • a selfpropelling pharmaceutical composition capable of providing a medicament in aerosol form suitable forinhal-ation therapy, comprising as a medicament a water-soluble acid-addition salt ofa bronchodilator' amine selected from the. class consisting of. isoproterenol and
  • said liquefied propellant component comprising substantia l lythe remainder of the composition.
  • a method oi producing a measured dose ofimedicament in aerosol form suitable for inhalation therapy whi omprise f rm n a q d mposition oira' msdis mentqnthetorm o a atqrs luhleaci d ition altof abronchodilatoramine selected from the class consisting otisoproterenol and epinephrine, said medicamom.
  • composition comprising between about 0.1% and 2% of the composition, said medicament being dissolved ina mixture of a co-solvent and a liquefied non-toxic propellant component, said co-solvent comprising an aqueous ethanol gniggtpre i n an amount comprising between about 2 1 and 49% oi the total.
  • nqns9lve n t comprising between about l.5'%.wand'2%' or the total composition, said liquefied non-toxic; propellant component comprising a halogenated lower alkane containing at least 1 fluorine atom and not more than 2 carbon atoms and having a--.v-ap,or pressure of between ab9u-t'20 and pounds per square inch gauge at F., said liquefied propellant component comprising substan-v a ly e .remainder ofthe. composition,v .and dispensing he. l iq isl .qq l position. from. a. pressure-tight. container through a control valve for-self-propelled delivery in the f rm of an. a lQS01' l'QSU1l1l1g from the rapidvaporization of...the propellant.
  • propellant component comprising a halogenated lower alkane containing at least 1 fluorine atom

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Otolaryngology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
US572788A 1956-03-21 1956-03-21 Self-propelling compositions for inhalation therapy containing a salt of isoproterenol or epinephrine Expired - Lifetime US2868691A (en)

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Application Number Priority Date Filing Date Title
BE555319D BE555319A (e) 1956-03-21
US572788A US2868691A (en) 1956-03-21 1956-03-21 Self-propelling compositions for inhalation therapy containing a salt of isoproterenol or epinephrine
GB7565/57A GB830426A (en) 1956-03-21 1957-03-07 Self-propelling pharmaceutical compositions

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US572788A US2868691A (en) 1956-03-21 1956-03-21 Self-propelling compositions for inhalation therapy containing a salt of isoproterenol or epinephrine

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