ZA200409793B - A buffered, liquid nicotine composition for pulmonary administration - Google Patents
A buffered, liquid nicotine composition for pulmonary administration Download PDFInfo
- Publication number
- ZA200409793B ZA200409793B ZA200409793A ZA200409793A ZA200409793B ZA 200409793 B ZA200409793 B ZA 200409793B ZA 200409793 A ZA200409793 A ZA 200409793A ZA 200409793 A ZA200409793 A ZA 200409793A ZA 200409793 B ZA200409793 B ZA 200409793B
- Authority
- ZA
- South Africa
- Prior art keywords
- nicotine
- pharmaceutical formulation
- subject
- liquid pharmaceutical
- methods
- Prior art date
Links
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 title claims description 279
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 title claims description 276
- 229960002715 nicotine Drugs 0.000 title claims description 274
- 239000007788 liquid Substances 0.000 title claims description 97
- 239000000203 mixture Substances 0.000 title claims description 69
- 230000002685 pulmonary effect Effects 0.000 title claims description 16
- 238000000034 method Methods 0.000 claims description 106
- 239000008194 pharmaceutical composition Substances 0.000 claims description 92
- 235000002637 Nicotiana tabacum Nutrition 0.000 claims description 83
- 241000208125 Nicotiana Species 0.000 claims description 82
- 230000000391 smoking effect Effects 0.000 claims description 78
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 58
- 210000004369 blood Anatomy 0.000 claims description 38
- 239000008280 blood Substances 0.000 claims description 38
- 239000000779 smoke Substances 0.000 claims description 38
- 230000009467 reduction Effects 0.000 claims description 36
- 210000004072 lung Anatomy 0.000 claims description 32
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 30
- 238000009472 formulation Methods 0.000 claims description 30
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 24
- 239000000126 substance Substances 0.000 claims description 21
- 238000011282 treatment Methods 0.000 claims description 20
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 18
- 238000010521 absorption reaction Methods 0.000 claims description 18
- 238000004519 manufacturing process Methods 0.000 claims description 18
- 239000000463 material Substances 0.000 claims description 18
- 210000000214 mouth Anatomy 0.000 claims description 16
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- 239000000443 aerosol Substances 0.000 claims description 15
- 150000003839 salts Chemical group 0.000 claims description 14
- 239000012458 free base Substances 0.000 claims description 13
- 239000006172 buffering agent Substances 0.000 claims description 12
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- 239000007921 spray Substances 0.000 claims description 11
- 239000003826 tablet Substances 0.000 claims description 11
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- 235000015218 chewing gum Nutrition 0.000 claims description 10
- 230000001105 regulatory effect Effects 0.000 claims description 10
- 238000002560 therapeutic procedure Methods 0.000 claims description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
- 239000011780 sodium chloride Substances 0.000 claims description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 8
- 230000029219 regulation of pH Effects 0.000 claims description 8
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 7
- 239000000654 additive Substances 0.000 claims description 7
- 201000010099 disease Diseases 0.000 claims description 7
- -1 mono-carbonate Chemical compound 0.000 claims description 7
- 239000007922 nasal spray Substances 0.000 claims description 7
- 239000001117 sulphuric acid Substances 0.000 claims description 7
- 235000011149 sulphuric acid Nutrition 0.000 claims description 7
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 6
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 6
- 238000001990 intravenous administration Methods 0.000 claims description 6
- 239000007791 liquid phase Substances 0.000 claims description 6
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- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 4
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- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 claims description 3
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- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 claims description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 2
- RGHNJXZEOKUKBD-SQOUGZDYSA-M D-gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O RGHNJXZEOKUKBD-SQOUGZDYSA-M 0.000 claims description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-M L-tartrate(1-) Chemical compound OC(=O)[C@H](O)[C@@H](O)C([O-])=O FEWJPZIEWOKRBE-JCYAYHJZSA-M 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 2
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- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 claims description 2
- 239000000920 calcium hydroxide Substances 0.000 claims description 2
- 229910001861 calcium hydroxide Inorganic materials 0.000 claims description 2
- BRPQOXSCLDDYGP-UHFFFAOYSA-N calcium oxide Chemical compound [O-2].[Ca+2] BRPQOXSCLDDYGP-UHFFFAOYSA-N 0.000 claims description 2
- 239000000292 calcium oxide Substances 0.000 claims description 2
- ODINCKMPIJJUCX-UHFFFAOYSA-N calcium oxide Inorganic materials [Ca]=O ODINCKMPIJJUCX-UHFFFAOYSA-N 0.000 claims description 2
- 125000002091 cationic group Chemical group 0.000 claims description 2
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- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 2
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- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
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- AWUCVROLDVIAJX-GSVOUGTGSA-N sn-glycerol 3-phosphate Chemical compound OC[C@@H](O)COP(O)(O)=O AWUCVROLDVIAJX-GSVOUGTGSA-N 0.000 claims description 2
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- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- 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
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/465—Nicotine; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A61P25/00—Drugs for disorders of the nervous system
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- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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SE0201669A SE0201669D0 (sv) | 2002-06-03 | 2002-06-03 | New formulation and use thereof |
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2002
- 2002-06-03 SE SE0201669A patent/SE0201669D0/sv unknown
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- 2003-05-30 BR BR0311451-1A patent/BR0311451A/pt not_active Application Discontinuation
- 2003-05-30 DE DE60329592T patent/DE60329592D1/de not_active Expired - Lifetime
- 2003-05-30 JP JP2004508811A patent/JP4745658B2/ja not_active Expired - Lifetime
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- 2003-05-30 RU RU2004139067/15A patent/RU2283111C2/ru active
- 2003-05-30 CA CA2487699A patent/CA2487699C/en not_active Expired - Lifetime
- 2003-05-30 CN CNB038128098A patent/CN100500148C/zh not_active Expired - Lifetime
- 2003-05-30 AT AT03756140T patent/ATE444753T1/de not_active IP Right Cessation
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- 2003-05-30 EP EP03756140A patent/EP1509227B9/en not_active Expired - Lifetime
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CA2487699C (en) | 2012-04-17 |
ES2332405T3 (es) | 2010-02-04 |
RU2004139067A (ru) | 2005-08-10 |
JP4745658B2 (ja) | 2011-08-10 |
CN1658876A (zh) | 2005-08-24 |
ATE444753T1 (de) | 2009-10-15 |
BR0311451A (pt) | 2005-03-15 |
EP1509227B9 (en) | 2010-05-19 |
WO2003101454A1 (en) | 2003-12-11 |
CA2487699A1 (en) | 2003-12-11 |
TW200407142A (en) | 2004-05-16 |
EP1509227B1 (en) | 2009-10-07 |
EP1509227A1 (en) | 2005-03-02 |
AR039947A1 (es) | 2005-03-09 |
DE60329592D1 (de) | 2009-11-19 |
AU2003243074A1 (en) | 2003-12-19 |
IL165195A0 (en) | 2005-12-18 |
JP5430525B2 (ja) | 2014-03-05 |
SE0201669D0 (sv) | 2002-06-03 |
JP2005533770A (ja) | 2005-11-10 |
DK1509227T3 (da) | 2010-02-01 |
RU2283111C2 (ru) | 2006-09-10 |
MXPA04012041A (es) | 2005-08-16 |
AU2003243074B2 (en) | 2008-11-20 |
CN100500148C (zh) | 2009-06-17 |
JP2010280721A (ja) | 2010-12-16 |
NZ536863A (en) | 2007-05-31 |
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