This disclosure relates to chewable pouch products comprising nicotine in free base
and salt form, together with methods of making and using the same.
Background
[0002] The health hazards of smoking are well-established. Products which can deliver
nicotine via the oral mucosa rather than via the lungs include snuff, snus, chewing tobacco, nicotine
chewing gums, and oral pouches comprising nicotine. These products face challenges in
manufacturing, shelf stability, efficient nicotine delivery, and consumer acceptance. Nicotine is
readily oxidized, so to enhance shelf stability, nicotine base may be stabilized in a polymer or gum
matrix or provided in salt form. Nicotine free base is believed to be better absorbed through the
oral mucosa than nicotine salts, so products which provide nicotine in salt form may further
comprise pH-adjusting agents to raise the oral pH upon use, thereby releasing the free base. High
pH products may have undesirable bitter or soapy flavors, and/or poor mouthfeel, while products
where nicotine is polymer-stabilized may release nicotine relatively slowly and inefficiently. The
disadvantages of these chewable products may make them unappealing to users as an alternative
to smoking, even though products that deliver nicotine by smoking may present greater danger to
the heart and lungs than chewable products.
[0003] There is a need for chewable nicotine delivery products, which release nicotine
quickly and efficiently, have good flavor and mouthfeel, and which are stable for long-term
storage.
Summary
[0004] The disclosure provides a chewable nicotine product, comprising nicotine base,
nicotine salt, flavor, and binder in a water-permeable, water-insoluble pouch, wherein nicotine and
flavor are released when the pouch is chewed, and wherein the product provides good nicotine
release, flavor, mouthfeel, and shelf-stability.
[0005] For example, in one embodiment, the disclosure provides a chewable nicotine
formulation comprising nicotine, an orally-acceptable nicotine salt, an orally-acceptable alcohol,
flavor components, and binder in a water-permeable, water-insoluble pouch.
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[0006] In another embodiment, the disclosure provides a method for making a pouch
comprising nicotine, nicotine acid addition salt, propylene glycol, flavor, and binder, wherein the
nicotine acid addition salt is formulated in nonaqueous conditions, using propylene glycol as
solvent, and products made thereby.
[0007] In another embodiment, the disclosure provides a method of delivering nicotine,
for example a method of nicotine replacement therapy, comprising administering the abovedescribed chewable pouch to a subject in need thereof.
[0008] Further areas of applicability of the present disclosure will become apparent from
the detailed description provided hereinafter. It should be understood that the detailed description
and specific examples, while indicating certain preferred embodiments of the disclosure, are
intended for purposes of illustration only and are not intended to limit the scope of the disclosure.
Detailed Description
[0009] The formulations of the disclosure are non-aqueous formulations, comprising
nicotine and orally-acceptable acid to form a nicotine acid addition salt in an orally-acceptable
alcohol solvent (e.g., propylene glycol), together with flavor and binder, in a water-permeable,
water-insoluble pouch. Alcohols, such as propylene glycol, have a much lower dielectric constant
than water, so the nicotine and orally-acceptable acid dissolved in the alcohol do not produce ions
to the same extent as they would in water, which has unpredictable effects on salt formation,
relative to salt formation in aqueous solution. It is found that the nicotine acid addition salt
provided thereby is stable relative to nicotine in entirely free base form, but also provides a better
mouth feel and nicotine delivery than a nicotine salt formed in aqueous solution.
[0010] In a first embodiment, the disclosure provides a chewable nicotine formulation
comprising nicotine, an orally-acceptable nicotine salt, an orally-acceptable alcohol, flavor
components, and an orally-acceptable binder in a water-permeable, water-insoluble pouch
(Formulation 1). For example, the disclosure provides the following formulations:
1.1. Formulation 1 wherein the orally-acceptable nicotine salt is selected from nicotine
hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine
sulphate, nicotine zinc chloride monohydrate, nicotine pyruvate, nicotine phosphate, nicotine
salicylate, nicotine malate, nicotine carbonate, nicotine bicarbonate, nicotine acetate, nicotine
3
citrate, nicotine folate, nicotine fumarate, nicotine lactate, and nicotine benzoate.
1.2. Any foregoing formulation wherein the orally-acceptable nicotine salt is a salt of an
orally-acceptable organic acid.
1.3. Any foregoing formulation wherein the orally-acceptable nicotine salt is a salt of an
orally-acceptable monoprotic organic acid.
1.4. Any foregoing formulation wherein the orally-acceptable nicotine salt is nicotine
benzoate.
1.5. Any foregoing formulation wherein the molar ratio between nicotine free base and
orally-acceptable nicotine salt is 1:1 to 1:10.
1.6. Any foregoing formulation wherein the molar ratio between nicotine free base and
nicotine acid addition salt is about 1:2.
1.7. Any foregoing formulation wherein the formulation comprises an orally-acceptable
acid, e.g., selected from hydrochloric acid, tartaric acid, pyruvic acid, phosphoric acid, salicylic
acid, malic acid, carbonic acid, acetic acid, citric acid, tartaric acid, folic acid, fumaric acid, lactic
acid, and benzoic acids; e.g., benzoic acid.
1.8. Any foregoing formulation wherein the orally-acceptable alcohol is propylene glycol.
1.9. Any foregoing formulation wherein the binder is selected from polysaccharides,
polyols, sugars, natural fibers, microcrystalline cellulose, cellulose and cellulose derivatives, and
mixtures thereof.
1.10. Any foregoing formulation wherein the binder is a hydroscopic but insoluble material.
1.11. Any foregoing formulation wherein the binder comprises microcrystalline cellulose.
1.12. Any foregoing formulation wherein the water-permeable, water insoluble pouch is
made of a semi-permeable material which substantially prevents the binder from leaving the bag
but permits saliva and therein dissolved components from the powder in the pouch to freely pass
through said material.
1.13. Any foregoing formulation wherein the water-permeable, water insoluble pouch is
made from one or more polymers or fibers safe for oral use, e.g., selected from polypropylene, low
density polyethylene, polyethylene terephthalate, polyurethane, polyvinyl acetate, polyvinyl
4
alcohol, polystyrene, poly(ethylene-vinyl acetate), rayon, silk, cotton, polyester, cellulosic
materials (e.g., hydroxypropyl cellulose), and combinations thereof.
1.14. Any foregoing formulation further comprising one or more additional components
selected from antioxidants, emulsifiers, preservatives, and solvents.
1.15. Any foregoing formulation further comprising a neutral, orally-acceptable mineral salt,
e.g., selected from sodium chloride, potassium chloride, and mixtures thereof, e.g., comprising
potassium chloride.
1.16. Any foregoing formulation which is substantially free of any basic ingredient other
than nicotine.
1.17. Any foregoing formulation which is substantially free of water.
1.18. Any foregoing formulation which is made under substantially water-free conditions.
1.19. Any foregoing formulation, wherein the contents of the water-permeable, waterinsoluble pouch have a pH of less than 7, e.g., pH 5.5 to pH 6.9, e.g., about pH 6.5, when measured
in a 10% slurry in water.
1.20. Any foregoing formulation, wherein the ratio by weight of (i) binder and (if present)
neutral orally-acceptable mineral salt, e.g., potassium chloride, to (ii) nicotine, orally-acceptable
nicotine salt, orally-acceptable alcohol, and flavor, is from 70:30 from 50:50, e.g., 65:35 to 55:45,
e.g. about 60:40.
1.21. Any foregoing formulation wherein the orally-acceptable nicotine salt is nicotine
benzoate, the orally-acceptable alcohol is propylene glycol, and the orally-acceptable binder is
microcrystalline cellulose.
1.22. Any foregoing formulation wherein the contents of the water-permeable, waterinsoluble pouch consist of nicotine, nicotine benzoate, potassium chloride, propylene glycol,
flavor, and binder.
1.23. Any foregoing formulation wherein the contents of the water-permeable, waterinsoluble pouch consist of nicotine, nicotine benzoate, potassium chloride, propylene glycol,
flavor, and microcrystalline cellulose.
1.24. Any foregoing formulation wherein the flavor components are pH neutral.
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1.25. Any foregoing formulation wherein the flavor components comprises one or more
flavors selected from mint oil, menthol, watermelon, blueberry, pomegranate, strawberry,
blueberry, dragonfruit, and cucumber flavors.
1.26. Any foregoing formulation wherein the flavor components comprise mint oil and/or
menthol.
1.27. Any foregoing formulation wherein the nicotine comprises synthetic nicotine.
1.28. Any foregoing formulation wherein the nicotine comprises nicotine from tobacco.
1.29. Any foregoing formulation wherein the nicotine has an (R):(S) isomeric ratio of greater
than 1.
1.30. Any foregoing formulation wherein the contents of the water-permeable, waterinsoluble pouch are in dry powder form.
1.31. Any foregoing formulation comprising 1% - 9%, e.g. 2-5%, e.g., 2.5 – 3.5%, of nicotine
and orally-acceptable nicotine salts, by weight of the contents of the water-permeable, waterinsoluble pouch.
1.32. Any foregoing formulation comprising 4-20%, e.g., 5% - 15%, e.g., about 5%, or or
about 10%, or about 15%, of orally-acceptable alcohol, e.g. propylene glycol, by weight of the
contents of the water-permeable, water-insoluble pouch.
1.33. Any foregoing formulation comprising 50% – 70%, e.g. 55% - 60%, of binder, e.g.,
microcrystalline cellulose, by weight of the contents of the water-permeable, water-insoluble
pouch.
1.34. Any foregoing formulation comprising 0.5% - 2%, e.g., 1% – 1.5%, of orallyacceptable mineral salt, e.g. potassium chloride, by weight of the contents of the water-permeable,
water-insoluble pouch.
1.35. Any foregoing formulation wherein the contents of the water-permeable, waterinsoluble pouch comprise:
Nicotine: 1% to 6%, e.g. 1% to 3%, e.g., 2%
Benzoic acid: 0.5% to 3%, e.g., 0.5% to 1.5%, e.g., 1%
Propylene glycol: 5% to 20%
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Flavor: 20% to 35%
Microcrystalline cellulose: 55% to 60%
Potassium chloride: 1% to 1.5%
wherein all amounts are by weight of the contents of the pouch,
wherein the nicotine and benzoic acid may be in free or salt form or mixtures
thereof, and
wherein the weight of the nicotine is calculated as the free base equivalent and the
weight of the benzoic acid is calculated as the free acid equivalent, irrespective of
the actual proportions of nicotine and benzoic acid in free or salt form.
1.36. Formulation 1.35 wherein the weight percent of the solid components comprising
microcrystalline cellulose and potassium fluoride is 55% to 65%, e.g., about 60%; and the weight
percent of the liquid components comprising propylene glycol, nicotine, benzoic acid and flavor
is 35% to 45%, e.g., about 40%.
1.37. Formulation 1.35 or 1.36 wherein the weight ratio of nicotine to benzoic acid is 1:1 to
3:1, e.g., about 2:1.
1.38. Formulation 1.35, 1.36 or 1.37 wherein the molar ratio of nicotine to benzoic acid is
3:1 to 1:3, e.g., from 2:1 to 1:1, e.g., is about 3:2.
1.39. Any foregoing formulation wherein each pouch contains a dose of 1 mg to 15 mg
nicotine, e.g., 5-10 mg nicotine, e.g., about 8 mg nicotine, wherein the weight of the nicotine is
calculated as the free base equivalent, irrespective of whether the nicotine is in free base or salt
form.
1.40. Any foregoing formulation wherein the weight of the contents of the pouch is from
0.2g to 1g, e.g. from 0.3g to 0.5g, e.g., about 0.4g.
1.41. Any foregoing formulation when made according to any of Methods 1, et seq.
1.42. Any foregoing formulation for use in a method of delivering nicotine to a subject, e.g.
a person in need of nicotine replacement therapy.
1.43. Any foregoing formulation wherein the formulation has a shelf life of at least 6 months,
7
e.g. at temperatures up to 40ºC.
1.44. Any foregoing formulation wherein the formulation has a pH of less than 7, e.g., pH
5.5 to pH 6.9, e.g., about pH 6.5, when measured in a 10% slurry in water, and exhibits improved
stability, mouth feel, and/or flavor relative to a product having a pH of at least 8 when measured
in a 10% slurry in water.
[0011] In another embodiment, the disclosure provides a method (Method 1) of making a
chewable nicotine formulation, e.g., according to any of Formulation 1 above, comprising the steps
of
a) dissolving nicotine and an orally-acceptable acid in a non-aqueous orally-acceptable
solvent,
b) adding flavor components,
c) mixing with solid orally-acceptable binder and optionally a salt, and
d) filling a water-permeable, water-insoluble pouch with the mixture thus obtained.
For example, Method 1 comprises
1.1. Method 1 wherein the orally-acceptable acid is selected from hydrochloric acid, tartaric
acid, pyruvic acid, phosphoric acid, salicylic acid, malic acid, carbonic acid, acetic acid, citric acid,
tartaric acid, folic acid, fumaric acid, lactic acid, and benzoic acids.
1.2. Any foregoing method wherein the orally-acceptable acid is an organic acid.
1.3. Any foregoing method wherein the orally-acceptable acid is a monoprotic organic acid.
1.4. Any foregoing method wherein the orally-acceptable acid is benzoic acid.
1.5. Any foregoing method wherein the molar ratio between nicotine and orally-acceptable
acid in step a) is from 3:1 to 1:3, e.g., from 2:1 to 1:1.
1.6. Any foregoing method wherein the molar ratio between nicotine and orally-acceptable
acid in step a) is about 3:2.
1.7. Any foregoing method wherein the orally acceptable acid is benzoic acid, and the
weight ratio of weight ratio of nicotine to benzoic acid in step a) is 1:1 to 3:1, e.g., about 2:1.
8
1.8. Any foregoing method wherein the nonaqueous solvent comprises propylene glycol,
e.g. wherein the nonaqueous solvent is propylene glycol.
1.9. Any foregoing method wherein the nonaqueous solvent is heated to facilitate
dissolution of the nicotine and the orally-acceptable acid.
1.10. Any foregoing method wherein the binder is selected from polysaccharides, polyols,
sugars, natural fibers, microcrystalline cellulose, cellulose and cellulose derivatives, and mixtures
thereof.
1.11. Any foregoing method wherein the binder is a hydroscopic but insoluble material.
1.12. Any foregoing method wherein the binder comprises microcrystalline cellulose.
1.13. Any foregoing method wherein the water-permeable, water insoluble pouch is made of
a semi-permeable material which substantially prevents the binder from leaving the bag but
permits saliva and therein dissolved components from the powder in the pouch to freely pass
through said material.
1.14. Any foregoing method wherein the water-permeable, water insoluble pouch is made
from one or more polymers or fibers safe for oral use, e.g., selected from polypropylene, low
density polyethylene, polyethylene terephthalate, polyurethane, polyvinyl acetate, polyvinyl
alcohol, polystyrene, poly(ethylene-vinyl acetate), rayon, silk, cotton, polyester, cellulosic
materials (e.g., hydroxypropyl cellulose), and combinations thereof.
1.15. Any foregoing method further comprising adding one or more additional components
selected from antioxidants, emulsifiers, preservatives, and solvents.
1.16. Any foregoing method further comprising adding to the binder a neutral alkali salt, e.g.,
selected from sodium chloride, potassium chloride, and mixtures thereof, e.g., potassium chloride.
1.17. Any foregoing method wherein no basic ingredient is added other than nicotine.
1.18. Any foregoing method wherein all steps are carried out under substantially water-free
conditions.
1.19. Any foregoing method wherein the product of step b) has an apparent pH of 5 to less
than 7, e.g. about 5.5 - 6.5, when measured using a pH-sensitive glass electrode concentrically
surrounded by a reference electrode filled with reference electrolyte, which measures the H+ ion
9
concentration of the solution.
1.20. Any foregoing method, wherein the product of step c) has a pH of less than 7, e.g., pH
5.5 to pH 6.9, e.g., about pH 6.5, in a 10% slurry in water.
1.21. Any foregoing method, wherein the ratio by weight of (i) binder and (if present) neutral
alkali salt, e.g., potassium chloride, to (ii) nicotine, nicotine benzoate, propylene glycol, and flavor
in the product of step c) is from 70:30 from 50:50, e.g., 65:35 to 55:45, e.g. about 60:40.
1.22. Any foregoing method wherein the product of step c) consists of nicotine, nicotine
benzoate, potassium chloride, propylene glycol, flavor, and binder.
1.23. Any foregoing method wherein the product of step c) consists of nicotine, nicotine
benzoate, potassium chloride, propylene glycol, flavor, and microcrystalline cellulose.
1.24. Any foregoing method wherein the flavor components are pH neutral.
1.25. Any foregoing method wherein the flavor components comprise one or more flavors
selected from mint oil, menthol, watermelon, blueberry, pomegranate, strawberry, blueberry,
dragonfruit, and cucumber flavors.
1.26. Any foregoing method wherein the flavor components comprise mint oil and/or
menthol.
1.27. Any foregoing method wherein the nicotine comprises synthetic nicotine.
1.28. Any foregoing method wherein the nicotine comprises nicotine from tobacco.
1.29. Any foregoing method wherein the nicotine has an (R):(S) isomeric ratio of greater
than 1.
1.30. Any foregoing method wherein the product of step c) in dry powder form.
1.31. Any foregoing method wherein the product of step c) comprises 2-5%, e.g., 2.5 – 3.5%,
of nicotine and nicotine salts, by weight.
1.32. Any foregoing method wherein the product of step c) comprises 4-20%, e.g., 5% - 15%,
e.g., about 5%, or about 10%, or about 15%, of propylene glycol, by weight.
1.33. Any foregoing method wherein the product of step c) comprises 50% – 70%, e.g. 55%
- 60%, of microcrystalline cellulose, by weight.
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1.34. Any foregoing method wherein the product of step c) comprises 0.5% - 2%, e.g., 1% –
1.5%, of potassium chloride, by weight.
1.35. Any foregoing method wherein:
in step a), the amount of nicotine is 1% to 3%, e.g., 2%, the orally-acceptable acid
is benzoic acid in an amount of 0.5% to 1.5%, e.g., 1%, and the non-aqueous
orally-acceptable solvent is propylene glycol, in an amount of 5% to 20%;
in step b), the amount of flavor components is 20% to 35%; and
in step c), the solid binder is microcrystalline cellulose in the amount of 55% to
60% and a salt is present which is potassium chloride in the amount of 1% to
1.5%;
wherein all amounts are given by weight of the product of step c).
1.36. The foregoing method wherein the weight percent of the microcrystalline cellulose plus
the potassium fluoride is 55% to 65% and the weight percent of the propylene glycol plus the
flavor is 35% to 40%.
1.37. Any foregoing method wherein in step d), each pouch is filled with a mixture of the
product of step c) containing 1 mg to 10 mg nicotine (weight given as free base equivalent).
1.38. Any foregoing method, wherein the product is any of Formula 1, et seq.
[0012] In a further embodiment, the disclosure provides a method of delivering nicotine to
a subject comprising administering a chewable nicotine formulation according to any of
Formulation 1, et. seq. to the subject, e.g., a needed, e.g., up to 3x daily, e.g., wherein the subject
is a patient in need of nicotine replacement therapy.
Example 1: Nicotine pouch formulations
[0013] Formulation A – The following components are combined as described above:
11
Name of Material Absolute Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 2.00%
Propylene glycol 14.40%
Flavor Mix 21.60%
MCC 58.84%
Potassium Chloride 1.16%
Total 100%
[0014] The propylene glycol is heated in a heated mixing tank to 70ºC. Benzoic acid is
added and mixed until it completely dissolves. Then nicotine is added and mixed well. Flavor
components are added one by one and mixed to form a liquid premix. Microcrystalline cellulose
(MCC) and potassium chloride are mixed in a ribbon blender, then the liquid premix mixture is
added to the microcrystalline cellulose (MCC) and potassium chloride in the ribbon blender and
all ingredients are mixed well, to form a powder. The powder is then measured to provide the
desired dose of nicotine and placed in pouches.
[0015] Formulation B – The following components are combined as described above:
Name of Material Absolute Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 2.00%
Propylene glycol 4.00%
Flavor Mix 32.00%
MCC 58.84%
Potassium Chloride 1.16%
Total 100%
[0016] Formulation C – The following components are combined:
12
Name of Material Absolute Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 1.00%
Propylene glycol 5.00%
Flavor Mix 32.00%
MCC 58.84%
Potassium Chloride 1.16%
Total 100%
[0017] Formulation D – The following components are combined as described above:
Name of Material Absolute
Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 1.00%
Propylene glycol 15.40%
Flavor
Mix
21.60%
MCC 58.84%
Potassium Chloride 1.16%
Total 100%
[0018] Formulation E – The following components are combined as described above:
Name of Material Absolute Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 1.00%
Propylene glycol 15.40%
Flavor Mix 21.60%
13
MCC 60%
Total 100%
[0019] Formulation F – The following components are combined as described above:
Name of Material Absolute Quantity(%w/w)
Nicotine 2.00%
Benzoic acid 1.00%
Propylene glycol 5.00%
Flavor Mix 32.00%
MCC 60%
Total 100%
Example 2: Nicotine pouch formulation performance
[0020] The liquid premixes for Formulations C, D, E and F have an apparent pH of about
6.5, while the liquid premixes for Formulations A and B have an apparent pH of about 5.5, when
measured using a standard pH sensor (i.e., a pH-sensitive glass electrode concentrically surrounded
by a reference electrode filled with reference electrolyte, which measures the H+ ion concentration
of a solution). Note that while this measurement is not a true pH, as the liquid premixes are nonaqueous, it provides a useful measure of comparative proton activity.
[0021] Formulations A and B, having higher levels of benzoic acid, are tested and found
to have inferior mouth feel relative to Formulations C and D. Formulations C and D provide a
“tingling” sensation, which is preferred by users.
[0022] Formulations C and D, which have potassium chloride, are found to provide a
fresher, cleaner taste compared to Formulations E and F, which do not contain potassium chloride.
[0023] Various solvents are tested, including other alcohols. Propylene glycol is preferred
over other solvents, as it is found to dissolve both the acid and the nicotine efficiently and without
excessive heating, which is important, as heating can cause the nicotine to volatilize and can
generate toxic fumes.

WE CLAIMS:
The following set of claims replaces all previous listings of claims.
1. A chewable nicotine formulation comprising an orally-acceptable nicotine salt, an orallyacceptable alcohol, flavor components, and an orally-acceptable binder in a waterpermeable, water-insoluble pouch.
2. The formulation of claim 1 wherein the orally-acceptable nicotine salt is nicotine
benzoate.
3. The formulation of claim 1, wherein the molar ratio between nicotine free base and orallyacceptable nicotine salt is 1:1 to 1:10, e.g. about 1:2.
4. The formulation of claim 1, wherein the orally-acceptable alcohol is propylene glycol.
5. The formulation of claim 1, wherein the binder comprises microcrystalline cellulose.
6. The formulation of claim 1, further comprising a neutral, orally-acceptable mineral salt.
7. The formulation of claim 1, which is substantially free of any basic ingredient
other than nicotine.
8. The formulation of claim 1, which is made under substantially water-free conditions.
9. The formulation of claim 1, wherein the contents of the water-permeable, water-insoluble
pouch have a pH of less than 7, when measured in a 10% slurry in water.
10. The formulation of claim 1, wherein the ratio by weight of
Application of Patel, N.K.
(i) binder and (if present) neutral orally-acceptable mineral salt, e.g., potassium
chloride, to
(ii) nicotine, orally-acceptable nicotine salt, orally-acceptable alcohol, and flavor,
is from 70:30 from 50:50.
11. The formulation of claim 1, wherein the orally-acceptable nicotine salt is nicotine
benzoate, the orally-acceptable alcohol is propylene glycol, and the orallyacceptable binder is microcrystalline cellulose.
12. The formulation of claim 1, wherein the contents of the water-permeable, waterinsoluble pouch are in dry powder form.
13. The formulation of claim 1 comprising
1% - 9% of nicotine and orally-acceptable nicotine salts;
4% to 20% of orally-acceptable alcohol;
50% – 70% of binder;
0.5% - 2% of orally- acceptable mineral salt,
wherein all percentages are by weight of the contents of the water-permeable, waterinsoluble pouch.
14. The formulation of claim 1, wherein the contents of the water-permeable, waterinsoluble pouch comprise:
a. Nicotine: 1% to 6%
b. Benzoic acid: 0.5% to 3%
c. Propylene glycol: 5% to 20%
Application of Patel, N.K.
d. Flavor: 20% to 35%
e. Microcrystalline cellulose: 55% to 60%
f. Potassium chloride: 1% to 1.5%
wherein all amounts are by weight of the contents of the water-permeable, waterinsoluble pouch, wherein the nicotine and benzoic acid are in free or salt form or
mixtures thereof, and wherein the weight of the nicotine is calculated as the free
base equivalent and the weight of the benzoic acid is calculated as the free acid
equivalent, irrespective of the actual proportions of nicotine and benzoic acid in
free or salt form.
15. The formulation of claim 14 wherein the weight percent of the solid components
comprising microcrystalline cellulose and potassium fluoride is 55% to 65%; and the
weight percent of the liquid components comprising propylene glycol, nicotine, benzoic
acid and flavor is 35% to 45%.
16. The formulation of claim 14 wherein the weight ratio of nicotine to benzoic acid is 1:1 to
3:1.
17. The formulation of claim 1, wherein each pouch contains a dose of 1 mg to 15 mg nicotine,
wherein the weight of the nicotine is calculated as the free base equivalent, irrespective of
whether the nicotine is in free base or salt form.
18. A method of making a chewable nicotine formulation according to claim 1, comprising the
steps of
a) dissolving nicotine and an orally-acceptable acid in a non-aqueous orally-acceptable
solvent,
b) adding flavor components,
c) mixing with solid binder and optionally a salt, and
d) filling a water-permeable, water-insoluble pouch with the mixture thus obtained.
19. A method of delivering nicotine to a subject comprising administering a chewable nicotine
formulation according to claim 1 to the subject, wherein the subject is a patient in need of
nicotine replacement therapy.