US20230270154A1 - Aerosolisable formulation - Google Patents

Aerosolisable formulation Download PDF

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Publication number
US20230270154A1
US20230270154A1 US17/290,652 US201917290652A US2023270154A1 US 20230270154 A1 US20230270154 A1 US 20230270154A1 US 201917290652 A US201917290652 A US 201917290652A US 2023270154 A1 US2023270154 A1 US 2023270154A1
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Prior art keywords
formulation
nicotine
aerosolizable
acid
aerosolizable formulation
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English (en)
Inventor
Ross Cabot
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Nicoventures Trading Ltd
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Nicoventures Trading Ltd
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Assigned to Nicoventures Trading Limited reassignment Nicoventures Trading Limited ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BRITISH AMERICAN TOBACCO (INVESTMENTS) LIMITED, CABOT, Ross
Publication of US20230270154A1 publication Critical patent/US20230270154A1/en
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    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A24B15/167—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes in liquid or vaporisable form, e.g. liquid compositions for electronic cigarettes
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/24—Treatment of tobacco products or tobacco substitutes by extraction; Tobacco extracts
    • A24B15/241—Extraction of specific substances
    • A24B15/243—Nicotine
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/10—Devices using liquid inhalable precursors

Definitions

  • the present disclosure relates to an aerosolizable formulation, a method of forming the same, a container containing the same, a device containing the same and processes and uses of the same.
  • Electronic aerosol provision systems such as e-cigarettes generally contain a reservoir of liquid which is to be vaporized, typically containing nicotine.
  • a heater is activated to vaporize a small amount of liquid, which is therefore inhaled by the user.
  • Aerosols from e-cigarettes and smoke from tobacco products such as cigarettes provides to the user a complex chain of flavor in the mouth, nicotine absorption in the mouth and throat, followed by nicotine absorption in the lungs.
  • Nicotine contributes to a number of these factors, and is strongly associated with factors such as impact, irritation and smoothness; these are readily perceived by consumers, and e-cigarettes may offer too much or too little of these parameters for consumers, depending upon individual preferences. Nicotine reward is particularly complex as it results from both the amount of and speed with which nicotine is absorbed from the lining of the mouth, this is typically nicotine in the vapor phase, and from the amount and speed nicotine that is absorbed from the lungs, this is typically nicotine in the particulate phase of the aerosol which is inhaled. Each of these factors, and their balance, can strongly contribute to consumer acceptability of an e-cigarette. Providing means to optimize the overall vaping experience is therefore desirable to e-cigarette manufacturers.
  • Harm from cigarette and e-cigarette devices primarily comes from toxicants. Therefore, there is a desire to reduce the components present in the system which may form toxicants.
  • an aerosolizable formulation comprising
  • a process for forming an aerosol comprising aerosolizing an aerosolizable formulation comprising
  • a contained aerosolizable formulation comprising
  • an electronic aerosol provision system comprising:
  • FIG. 1 shows a graph illustrating variation of p s K a2 with nicotine concentration.
  • an aerosolizable formulation comprising
  • an advantageous system which contains water and in which an acid which is at least partially dissolved.
  • the inclusion of the an acid such that at least 5 wt% of the nicotine present in the formulation is in protonated form and such that the formulation has a pH of from 4 to 6 both protonates the nicotine and inhibits microbial growth in the water containing system.
  • the number of components present may be reduced leading to less chance of forming breakdown products/toxicants.
  • the use of water allows for the replacement of some or all of the glycerol, propylene glycol, 1,3-propane diol and mixtures thereof typically used in e-cigarettes.
  • the use of an acid as a multi-functional component also allows for a reduction in the number of components in the formulation.
  • nicotine may exist in unprotonated form, monoprotonated form or diprotonated form.
  • the structures of each of these forms are given below.
  • references in the specification to protonated form means both monoprotonated nicotine and diprotonated nicotine. Reference in the specification to amounts in the protonated form means the combined amount of monoprotonated nicotine and diprotonated nicotine. Furthermore, when reference is made to a fully protonated formulation it will be understood that at any one time there may be very minor amounts of unprotonated nicotine present, e.g. less than 1% unprotonated.
  • the aerosolizable formulation comprises water in an amount of at least 20 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 25 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 30 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 35 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 40 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 45 wt.% based on the aerosolizable formulation.
  • water is present in an amount of at least 50 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 55 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 60 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 65 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 70 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 75 wt.% based on the aerosolizable formulation.
  • water is present in an amount of at least 80 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 85 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 90 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 95 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of at least 99 wt.% based on the aerosolizable formulation.
  • water is present in an amount of from 20 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 25 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 30 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 35 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 40 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 45 to 99 wt.% based on the aerosolizable formulation.
  • water is present in an amount of from 50 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 55 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 60 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 65 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 70 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 75 to 99 wt.% based on the aerosolizable formulation.
  • water is present in an amount of from 80 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 85 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 90 to 99 wt.% based on the aerosolizable formulation. In one aspect water is present in an amount of from 95 to 99 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 8 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 1 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.1 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.01 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains no glycerol, propylene glycol, 1,3-propane diol and mixtures thereof.
  • the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 8 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 5 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.5 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.01 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains no glycerol, propylene glycol, and mixtures thereof.
  • the aerosolizable formulation contains glycerol in an amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 8 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 2 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains glycerol in an amount of no greater than 1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 0.5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 0.2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 0.1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains glycerol in an amount of no greater than 0.01 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains no glycerol.
  • the aerosolizable formulation contains propylene glycol in an amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 8 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 2 wt.% based on the aerosolizable formulation.
  • the aerosolizable formulation contains propylene glycol in an amount of no greater than 1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 0.5 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 0.2 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 0.1 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains propylene glycol in an amount of no greater than 0.01 wt.% based on the aerosolizable formulation. In one aspect the aerosolizable formulation contains no propylene glycol.
  • the formulation comprises nicotine in protonated form.
  • the formulation may comprise nicotine in unprotonated form.
  • the formulation comprises nicotine in unprotonated form and nicotine in monoprotonated form.
  • the formulation comprises nicotine in unprotonated form and nicotine in diprotonated form.
  • the formulation comprises nicotine in unprotonated form, nicotine in monoprotonated form and nicotine in diprotonated form.
  • the one or more acids protonate at least 5% of the nicotine.
  • at least 10 wt% of the nicotine present in the formulation is in protonated form.
  • at least 15 wt% of the nicotine present in the formulation is in protonated form.
  • at least 20 wt% of the nicotine present in the formulation is in protonated form.
  • at least 25 wt% of the nicotine present in the formulation is in protonated form.
  • at least 30 wt% of the nicotine present in the formulation is in protonated form.
  • at least 35 wt% of the nicotine present in the formulation is in protonated form.
  • at least 40 wt% of the nicotine present in the formulation is in protonated form.
  • At least 45 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 50 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 55 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 60 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 65 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 70 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 75 wt% of the nicotine present in the formulation is in protonated form.
  • At least 80 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 85 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 90 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 99 wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 99.9 wt% of the nicotine present in the formulation is in protonated form.
  • the nicotine present in the formulation is in protonated form. In one aspect from 10 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 15 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 20 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 25 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 30 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 35 to 95 wt% of the nicotine present in the formulation is in protonated form.
  • the nicotine present in the formulation is in protonated form. In one aspect from 45 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 50 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 55 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 60 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 65 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 70 to 95 wt% of the nicotine present in the formulation is in protonated form.
  • the nicotine present in the formulation is in protonated form. In one aspect from 80 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 85 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 90 to 95 wt% of the nicotine present in the formulation is in protonated form.
  • Nicotine 3-(1-methylpyrrolidin-2-yl) pyridine
  • pKa 3.12 for the pyridine ring
  • 8.02 for the pyrrolidine ring
  • It can exist in pH-dependent protonated (mono- and di-) and non-protonated (free base) forms which have different bioavailability.
  • the fraction of non-protonated nicotine will be predominant at high pH levels whilst a decrease in the pH will see an increase of the fraction of protonated nicotine (mono- or di- depending on the pH). If the relative fraction of protonated nicotine and the total amount of nicotine in the sample are known, the absolute amount of protonated nicotine can be calculated.
  • the relative fraction of protonated nicotine in formulation can be calculated by using the Henderson-Hasselbalch equation, which describes the pH as a derivation of the acid dissociation constant equation, and it is extensively employed in chemical and biological systems.
  • [B] is the amount of non-protonated nicotine (i.e. free base)
  • [BH+] the amount of protonated nicotine (i.e. conjugate acid)
  • the relative fraction of protonated nicotine can be derived from the alpha value of the non-protonated nicotine calculated from the Henderson-Hasselbalch equation as:
  • the one or more acids provide a formulation having a pH of from 4 to 6. In one aspect the one or more acids provide a formulation having a pH of from 4.5 to 6. In one aspect the one or more acids provide a formulation having a pH of from 4 to 5.5. In one aspect the one or more acids provide a formulation having a pH of from 4.5 to 5.5. In one aspect the one or more acids provide a formulation having a pH of from 4.5 to 5. In one aspect the one or more acids provide a formulation having a pH of from 5 to 6. In one aspect the one or more acids provide a formulation having a pH of from 5 to 5.5. In one aspect the one or more acids provide a formulation having a pH of from 5.5 to 6.
  • Nicotine formulations may be provided having desirable properties of flavor, impact, irritation, smoothness and/or nicotine reward for the user.
  • nicotine is present in an amount of no greater than 6 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.01 to 6 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.02 to 6 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.05 to 6 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.08 to 6 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 5 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of no greater than 4 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 4 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 4 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 4 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 4 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of no greater than 3 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 3 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 3 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 3 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 3 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of no greater than 2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 2 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of no greater than 1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 1 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.1 to 1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of no greater than 0.5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.5 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.08 to 0.5 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of no greater than 0.2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.2 wt% based on the total weight of the aerosolizable formulation.
  • nicotine is present in an amount of from 0.08 to 0.2 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of no greater than 0.1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.1 wt% based on the total weight of the aerosolizable formulation. In one aspect nicotine is present in an amount of from 0.08 to 0.1 wt% based on the total weight of the aerosolizable formulation.
  • the aerosolizable formulation contains an acid which is at least partially water soluble.
  • the acid has a solubility in water of at least 2 g/L at 20° C.
  • the acid has a solubility in water of at least 5 g/L at 20° C.
  • the acid has a solubility in water of at least 10 g/L at 20° C.
  • the acid has a solubility in water of at least 20 g/L at 20° C.
  • the acid has a solubility in water of at least 50 g/L at 20° C.
  • the acid has a solubility in water of at least 100 g/L at 20° C.
  • the acid has a solubility in water of at least 200 g/L at 20° C. In one aspect the acid has a solubility in water of at least 300 g/L at 20° C. In one aspect the acid has a solubility in water of at least 400 g/L at 20° C. In one aspect the acid has a solubility in water of at least 500 g/L at 20° C. In one aspect the acid has a solubility in water of at least 600 g/L at 20° C. In one aspect the acid has a solubility in water of at least 700 g/L at 20° C. In one aspect the acid has a solubility in water of at least 800 g/L at 20° C.
  • the acid has a solubility in water of at least 900 g/L at 20° C. In one aspect the acid has a solubility in water of at least 1000 g/L at 20° C. In one aspect the acid has a solubility in water of at least 1100 g/L at 20° C.
  • the acid may be any suitable acid provided of course the acid at least 5 wt% of the nicotine present in the formulation is in protonated form; and wherein the formulation has a pH of from 4 to 6.
  • the acid is an organic acid. In one aspect the acid is a carboxylic acid. In one aspect the acid is an organic carboxylic acid. In one aspect the acid has a bitter or sour taste. In one aspect the acid has a bitter taste. In one aspect the acid has a sour taste.
  • the acid is selected from the group consisting of citric acid, maleic acid, malic acid, lactic acid, levulinic acid, benzoic acid, sorbic acid, acetic acid and mixtures thereof. In one aspect the acid is selected from the group consisting of citric acid, maleic acid, lactic acid, levulinic acid, benzoic acid, and mixtures thereof. In one aspect the acid is selected from the group consisting of citric acid, benzoic acid, sorbic acid, acetic acid and mixtures thereof. In one aspect the acid is selected from the group consisting of benzoic acid, sorbic acid, acetic acid and mixtures thereof. In one aspect the acid is at least sorbic acid. In one aspect the acid consists of sorbic acid.
  • the acid is at least acetic acid. In one aspect the acid consists of acetic acid. In one aspect the acid is at least benzoic acid. In one aspect the acid consists of benzoic acid. In one aspect the acid is at least citric acid. In one aspect the acid consists of citric acid.
  • the acid is selected from acids having a pKa of from 2 to 5. In one aspect the acid is a weak acid. In one aspect the acid is a weak organic acid.
  • the molar ratio of acid to nicotine may be selected as desired. In one aspect the molar ratio of acid to nicotine is from 5:1 to 1:5. In one aspect the molar ratio of acid to nicotine is from 4:1 to 1:4. In one aspect the molar ratio of acid to nicotine is from 3:1 to 1:3. In one aspect the molar ratio of acid to nicotine is from 2:1 to 1:2. In one aspect the molar ratio of acid to nicotine is from 1.5:1 to 1:1.5. In one aspect the molar ratio of acid to nicotine is from 1.2:1 to 1:1.2. In one aspect the molar ratio of acid to nicotine is from 5:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 4:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 3:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 2:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 1.5:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 1.2:1 to 1:1.
  • the total content of acid present in the formulation is no greater than 5 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 4 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 3 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 2 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 1 mole equivalents based on the nicotine.
  • the total content of acid present in the formulation is no less than 0.01 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.05 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.1 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.2 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.3 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.4 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.5 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.7 mole equivalents based on the nicotine.
  • the acid may be present in any suitable amount. In one aspect the acid is present in an amount of no greater than 6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 6 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.01 to 5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 4 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 4 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.02 to 4 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 4 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 4 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 3 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 3 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 3 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.05 to 3 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 3 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 2 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.08 to 2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 1 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.1 to 1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 0.6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.6 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.1 to 0.6 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 0.5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.5 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.5 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of no greater than 0.2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.2 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of no greater than 0.1 wt% based on the aerosolizable formulation.
  • the acid is present in an amount of from 0.01 to 0.1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.1 wt% based on the aerosolizable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.1 wt% based on the aerosolizable formulation.
  • the amount of acid and the solubility of the acid may be selected such that a given amount of the acid will dissolve in the water.
  • the amount of acid and the solubility of the acid may be selected such that a given amount of the acid will dissolve in the water.
  • at 20° C. at least 20% of the acid dissolves in the water.
  • at 25° C. at least 20% of the acid dissolves in the water.
  • at 30° C. at least 20% of the acid dissolves in the water.
  • at 20° C. at least 35% of the acid dissolves in the water.
  • at 20° C. at least 40% of the acid dissolves in the water.
  • In one aspect at 20° C. at least 45% of the acid dissolves in the water.
  • at 20° C. at least 50% of the acid dissolves in the water.
  • At least 55% of the acid dissolves in the water In one aspect at 20° C. at least 60% of the acid dissolves in the water. In one aspect at 20° C. at least 65% of the acid dissolves in the water. In one aspect at 20° C. at least 70% of the acid dissolves in the water. In one aspect at 20° C. at least 75% of the acid dissolves in the water. In one aspect at 20° C. at least 80% of the acid dissolves in the water.
  • the aerosolizable formulation further comprises one or more flavors or flavoring components.
  • flavors and “flavorant” refer to materials which, where local regulations permit, may be used to create a desired taste or aroma in a product for adult consumers. They may include extracts (e.g.
  • the one or more flavors may be selected from the group consisting of (4-(para-)methoxyphenyl)-2-butanone, vanillin, ⁇ -undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8-thiol-3-one and mixtures thereof.
  • the flavor is at least menthol.
  • the one or more flavors may be present in any suitable amount. In one aspect the one or more flavors are present in a total amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of no greater than 7 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of no greater than 5 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of no greater than 4 wt.% based on the aerosolizable formulation.
  • the one or more flavors are present in a total amount of no greater than 3 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of no greater than 2 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of no greater than 1 wt.% based on the aerosolizable formulation.
  • the one or more flavors are present in a total amount of from 0.01 to 5 wt. % based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of from 0.01 to 4 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of from 0.01 to 3 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of from 0.01 to 2 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of from 0.01 to 1 wt.% based on the aerosolizable formulation. In one aspect the one or more flavors are present in a total amount of from 0.01 to 0.5 wt.% based on the aerosolizable formulation.
  • an aerosolizable formulation as described herein consisting of (i) water; (ii) nicotine; (iii) the acid; and (iv) optionally one or more flavors.
  • an aerosolizable formulation as described herein consisting of (i) water; (ii) nicotine; (iii) the acid; and (iv) one or more flavors.
  • an aerosolizable formulation as described herein consisting of (i) water; (ii) nicotine; and (iii) the acid.
  • One or more cyclodextrins may or may not be present in any suitable amount in the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 12 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 10 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 9 wt.% based on the aerosolizable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 8 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 7 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 6 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 5 wt.% based on the aerosolizable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 4 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 3 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 2 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 1 wt.% based on the aerosolizable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 0.1 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 0.01 wt.% based on the aerosolizable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 0.001 wt.% based on the aerosolizable formulation.
  • the one or more cyclodextrins may be selected from the group consisting of unsubstituted cyclodextrins, substituted cyclodextrins and mixtures thereof. In one aspect at least one cyclodextrin is an unsubstituted cyclodextrin. In one aspect the one or more cyclodextrins are selected from the group consisting of unsubstituted cyclodextrins. In one aspect at least one cyclodextrin is a substituted cyclodextrin. In one aspect the one or more cyclodextrins are selected from the group consisting of substituted cyclodextrins.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, unsubstituted (y)-cyclodextrin, substituted (y)-cyclodextrin, and mixtures thereof.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, and mixtures thereof.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, unsubstituted (y)-cyclodextrin, and mixtures thereof. In one aspect the one or more cyclodextrins is selected from unsubstituted (P)-cyclodextrin.
  • the one or more cyclodextrins are selected from the group consisting of substituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, substituted (y)-cyclodextrin, and mixtures thereof. In one aspect the one or more cyclodextrins is selected from substituted ( ⁇ )-cyclodextrins. Chemical substitutions at the 2-, 3-, and 6-hydroxyl sites are envisaged, and in particular substitution at the 2-position.
  • the one or more cyclodextrins are selected from the group consisting of 2-hydroxy-propyl- ⁇ -cyclodextrin, 2-hydroxy-propyl- ⁇ -cyclodextrin, 2-hydroxy-propyl- ⁇ -cyclodextrin and mixtures thereof. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin.
  • 2-hydroxy-propyl derivatives of cyclodextrins such as 2-hydroxy-propyl- ⁇ -cyclodextrin have increased solubility in water when compared to base cyclodextrins such as ⁇ -cyclodextrin.
  • the aerosolizable formulation is in liquid form. In one aspect the aerosolizable formulation is not in liquid form. In one aspect if the aerosolizable formulation is in the form of a gel or paste.
  • the aerosolizable formulation contains one or more cyclodextrins, then the aerosolizable formulation contains no flavors that can be encapsulated by the one or more cyclodextrins.
  • a process for forming an aerosol comprising aerosolizing an aerosolizable formulation comprising
  • the aerosol may be formed by a process performed at a temperature below 60° C.In the process the aerosol may be formed by a process performed at a temperature below 50° C. In the process the aerosol may be formed by a process performed at a temperature below 40° C. In the process the aerosol may be formed by a process performed at a temperature below 30° C. In the process the aerosol may be formed by a process performed at a temperature below 25° C. In the process the aerosol may be formed by a process which does not involve heating.
  • the aerosol may be formed by applying ultrasonic energy to the aerosolizable formulation.
  • the aerosol of the aerosolized formulation has a D50 of from 2 to 6 ⁇ m.
  • D50, D10 or D90 refer to values measured in accordance with British and European Pharmacopoeia, 2.9.31 Particle Size Analysis By Laser Light Diffraction (see BRITISH PHARMACOPOEIA COMMISSION. (2014), British Pharmacopoeia. London, England: Stationery Office and COUNCIL OF EUROPE. (2013). European Pharmacopoeia. France: Council of Europe).
  • the terms D50, Dv50 and Dx50 are interchangeable.
  • D10, Dv10 and Dx10 are interchangeable.
  • D90, Dv90 and Dx90 are interchangeable.
  • the aerosol has a D50 of from 2.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 3 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 3.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 4 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 4.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 2.5 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 3 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 3.5 to 5.5 ⁇ m.
  • the aerosol has a D50 of from 4 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 4.5 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 5 to 5.5 ⁇ m.
  • the aerosol has a D10 of at least 0.5 ⁇ m. In one aspect the aerosol has a D10 of at least 1 ⁇ m. In one aspect the aerosol has a D10 of at least 2 ⁇ m.
  • the aerosol has a D90 of no greater than 15 ⁇ m. In one aspect the aerosol has a D90 of no greater than 12 ⁇ m. In one aspect the aerosol has a D90 of no greater than 10 ⁇ m.
  • D50 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • D10 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • D90 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • the formulation may be contained or delivered by any means.
  • the present disclosure provides a contained aerosolizable formulation comprising (a) one or more containers; and (b) an aerosolizable formulation as defined herein.
  • the container may be any suitable container, for example to allow for the storage or delivery of the formulation.
  • the container is configured for engagement with an electronic aerosol provision system.
  • the container may be configured to become fluidly in communication with an electronic aerosol provision system so that formulation may be delivered to the electronic aerosol provision system.
  • the present disclosure relates to container which may be used in an electronic aerosol provision system, such as an e-cigarette. Throughout the following description the term “e-cigarette” is used; however, this term may be used interchangeably with electronic aerosol provision system.
  • the container of the present disclosure is typically provided for the delivery of aerosolizable formulation to or within an e-cigarette.
  • the aerosolizable formulation may be held within an e-cigarette or may be sold as a separate container for subsequent use with or in an e-cigarette.
  • e-cigarettes may contain a unit known as a detachable cartomizer which typically comprises a reservoir of aerosolizable formulation, and an aerosolizer such as a wick material and a heating element for vaporising the aerosolizable formulation.
  • the cartomizer is part of a single-piece device and is not detachable.
  • the container is a cartomizer or is part of a cartomizer. In one aspect the container is not a cartomizer or part of a cartomizer and is a container, such as a tank, which may be used to deliver nicotine formulation to or within an e-cigarette.
  • the container is part of an e-cigarette. Therefore in a further aspect the present disclosure provides an electronic aerosol provision system comprising: an aerosolizable formulation as defined herein; an aerosolizer for aerosolizing formulation for inhalation by a user of the electronic aerosol provision system; and a power supply comprising a cell or battery for supplying power to the aerosolizer.
  • the present disclosure provides a process for improving the sensory properties of an aerosolized nicotine.
  • the disclosure provides a process for improving the storage stability of an aerosolized nicotine formulation.
  • Reference to an improvement in the sensory properties of a vaporized nicotine solution refer may include an improvement in the smoothness of the vaporized nicotine solution as perceived by a user.
  • the process of the present disclosure may comprises additional steps either before the steps listed, after the steps listed or between one or more of the steps listed.
  • the viable micro-organisms are fungal: Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus brasiliensis, Candida albicans and Escherichia coli ,
  • Acceptance criteria for the efficacy of antimicrobial preservation may be based on those published in the literature for similar aerosol products (European Pharmacopoeia 2011). Suitable statistical models are also recommended but not mandatory to contextualise any resulting data. An example includes Analysis of Variance (ANOVA) and at a suitable confidence interval - e.g. 95%.
  • ANOVA Analysis of Variance
  • Formulations with different acids at a range of pHs (4 to 6) were tested for 14 and 28 days at 20° C. for microbial growth.
  • the acids tested were benzoic acid, sorbic acid and acetic acid.
  • a 1 in 10 dilution was prepared using Neutralizer as a diluent. Further dilutions were performed to create 1/100 and 1/1000 dilutions.
  • a 1 ⁇ 10, 1/100 & 1/1000 dilution of the test sample in Neutralizer was prepared. The sample was pour plated and incubated. For the product, the initial bioburden was determined.
  • TAMC Total Aerobic Microbial Count
  • TYMC Total Yeasts and Mold Count
  • test product in diluent (Neutralizer), the test product and a positive control (diluent without product) were inoculated with test microorganisms.
  • the test microorganisms were Aspergillus brasiliensis, Candida albicans, Staphylococcus aureus, Escherichia col i and Pseudomonas aeruginosa .
  • the method tested duplicate plates of test product and positive controls (diluent without product) inoculated with test organisms. Duplicate plates of test product in diluent (Neutralizer) were also included. All samples were incubated.
  • microorganism counts were also identified as follows in Tables 2-4.

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