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WO2003017932B1 - Compositions and methods for targeting cerebral circulation and treatment of headache - Google Patents

Compositions and methods for targeting cerebral circulation and treatment of headache

Info

Publication number
WO2003017932B1
WO2003017932B1 PCT/US2002/026613 US0226613W WO03017932B1 WO 2003017932 B1 WO2003017932 B1 WO 2003017932B1 US 0226613 W US0226613 W US 0226613W WO 03017932 B1 WO03017932 B1 WO 03017932B1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
headache
active substance
person
formulation
Prior art date
Application number
PCT/US2002/026613
Other languages
French (fr)
Other versions
WO2003017932A3 (en
WO2003017932A2 (en
Inventor
Bruce Frome
Original Assignee
Epitome Pharmaceuticals Ltd
Bruce Frome
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Epitome Pharmaceuticals Ltd, Bruce Frome filed Critical Epitome Pharmaceuticals Ltd
Priority to AU2002313785A priority Critical patent/AU2002313785A1/en
Priority to EP02753504A priority patent/EP1418918A4/en
Priority to US10/483,509 priority patent/US7981901B2/en
Publication of WO2003017932A2 publication Critical patent/WO2003017932A2/en
Publication of WO2003017932A3 publication Critical patent/WO2003017932A3/en
Publication of WO2003017932B1 publication Critical patent/WO2003017932B1/en

Links

Classifications

    • 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
    • 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
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Methods and compositions for targeting cerebral circulation and treatment of headache include formulations comprising a pharmacologically active substance in a transdermal formulation, which is topically applied to an area of skin superficial to a carotid artery, a temporal artery, a vertebral artery, or to a tender spot associated with a headache. Particularly preferred formulations include a xanthine derivative (e.g., theophylline, caffeine, aminophylline), and may further comprise ketoprofen. Contemplated methods further include methods of advertising use of contemplated compositions.

Claims

AMENDED CLAIMS[Received by the International Bureau on 27 March 2003 ( 27.03.03): original claimsl-46 replaced by amended claims 1-46]
1. A method of directing a pharmacologically active substance to a cerebral circulation, comprising: providing a composition that includes a pharmacologically active substance; including the composition in a transdeπnal formulation; and topically applying the transdermal formulation to at least one area of skin superficial to a carotid artery, a temporal artery, and a vertebral artery, wherein the transdermal formulation is applied in an amount effective to deliver the pharmacologically active substance to the cerebral circulation.
2. The method of claim 1 wherein the composition comprises a skin penetration enhancer selected from the group consisting of an azone derivative, a synthetic terpene, oleic acid, N-methyl-2-pyrrolidone, an epsilon-aminocaproic acid ester, a lecithin organogel, a pluronic-lecithin-organogel, and an aromatic S,S-dimethyl- iminosulfurane.
3. The method of claim 1 wherein the composition comprises a skin penetration enhancer selected from the group consisting of natural terpenes, Padimate O, oil- water emulsions with sub-micron droplets, and capsaicin.
4. The method of claim 1 wherein the pharmacologically active substance comprises a xanthine derivative.
5. The method of claim 4 wherein the xanthine derivative comprises caffeine.
6. The method of claim 4 wherein the xanthine derivative comprises theophylline.
7. The method of claim 4 wherein the xanthine derivative comprises aminophylline.
8. The method of claim 4 wherein the xanthine derivative has a concentration of at least 2%(wt).
9. The method of claim 4 wherein the xanthine derivative has a concentration of at least 4%(wt).
28
10. The method of claim 1 wherein the pharmacologically active substance comprises ketoprofen.
11. The method of claim 10 wherein ketoprofen has a concentration of at least 0.5%(wt).
12. The method of claim 10 wherein ketoprofen has a concentration of at least 4%(wt).
13. The method of claim 1 wherein the step of topically applying is undertaken to lessen a headache.
14. A method of treating a person having a headache, comprising: providing a composition that includes a pharmacologically active substance; identifying at least one tender spot associated with the headache on a body surface of the person; and topically applying the composition to the tender spot in an amount effective to reduce the headache.
15. The method of claim 14 wherein the composition comprises a skin penetration enhancer.
16. The method of claim 15 wherein the skin penetration enhancer is selected from the group consisting of an azone derivative, a synthetic terpene, oleic acid, N-methyl-2- pyrrolidone, an epsilon-aminocaproic acid ester, a pluronic-lecithin-organogel, and an aromatic S,S-dimethyliminosulfurane.
17. The method of claim 14 wherein the composition comprises lecithin.
18. The method of claim 14 wherein the pharmacologically active substance comprises a vaso-active substance.
19. The method of claim 18 wherein the vaso-active substance comprises a xanthine derivative.
20. The method of claim 18 wherein the pharmacologically active substance further comprises a muscular-active compound.
21. The method of claim 20 wherein the muscular-active compound comprises ketoprofen.
22. A composition comprising: at least one xanthine derivative and ketoprofen.
23. The composition of claim 22 wherein the xanthine derivative comprises a substance selected from the group consisting of aminophylline, theophylline, and caffeine.
24. The composition of claim 23 wherein the xanthme derivative and the ketoprofen are formulated in a lecithin-containing formulation.
25. The composition of claim 23 wherein the xanthine derivative and the ketoprofen are formulated in a pluronic-lecithin-organogel formulation.
26. A method of treating a person having a headache, comprising: providing a composition according to claim 22; identifying at least one tender spot associated with the headache on a body surface of the person having the headache; and topically applying the composition to the tender spot in an amount effective to reduce the headache.
27. The method of claim 26 wherein the composition is in a skin penetration formulation.
28. The method of claim 27 wherein the skin penetration formulation comprises a pluronic-lecithin-organogel formulation.
29. The method of claim 26 wherein the xanthine derivative comprises a substance selected from the group consisting of aminophylline, theophylline, and caffeine.
30. A method of marketing a product, comprising: including a skin penetration enhancer and a pharmacologically active substance as a component of the product; instructing a person to identify at least one tender spot associated with a headache on a body surface of the person; and instructing the person to topically apply the product to the tender spot in an amount effective to reduce the headache.
31. The method of claim 30 wherein the product comprises a xanthine derivative and ketoprofen.
32. The method of claim 30 wherein at least one of the steps of instructing comprises providing printed information.
33. The method of claim 32 wherein the printed information comprises at least one of a pictogram, graph, and photographic image.
34. A method of marketing a product, comprising: including a skin penetration enhancer and a pharmacological active substance as a component of the product; instructing a person to identify at least one area of skin superficial to at least one of a carotid artery, a temporal artery, and a vertebral artery; and instructing the person to topically apply the product to the area in an amount effective to direct the pharmacological active substance to a cerebral circulation of the person.
35. The method of claim 34 wherein the skin penetration enhancer is selected from the group consisting of an azone derivative, a synthetic terpene, oleic acid, N-methyl-2- pyrrolidone, an epsilon-aminocaproic acid ester, a pluronic-lecithin-organogel, and an aromatic S,S-dimethyliminosulfurane.
36. The method of claim 34 wherein the pharmacological active substance is selected from the group consisting of aminophylline, theophylline, and caffeine.
37. The method of claim 34 wherein the product comprises a pluronic-lecithin-organogel and aminophylline.
38. The method of claim 34 wherein the product further comprises ketoprofen.
39. A method of prophylactic treatment of a patient to avoid a headache, comprising: providing a composition that includes a pharmacologically active substance; including the composition in a transdermal formulation; and topically applying the transdermal formulation to at least one area of skin superficial to a carotid artery, a temporal artery, and a vertebral artery, wherein the transdermal formulation is applied in an amount effective to prevent onset of the headache.
31
40. A method of prophylactic treatment of a patient to avoid a headache, comprising: providing a composition that includes a pharmacologically active substance; identifying at least one tender spot associated with onset of the headache on a body surface of the person; and topically applying the composition to the tender spot in an amount effective to reduce the headache.
41. A method of treatment of a patient having an ischemic stroke, comprising: providing a composition having at least one of a vasodilatory agent and an anticoagulant; including the composition in a transdermal formulation; topically applying the transdermal formulation to at least one area of skin superficial to a carotid artery, a temporal artery, and a vertebral artery; and wherein the transdermal formulation is applied in an amount effective to deliver the at least one of the vasodilatory agent and anticoagulant to a cerebral circulation of the patient, thereby improving blood flow in an area affected by reduction of blood flow.
42. The method of claim 1 wherein the vasodilatory agent is selected from the group consisting of niacin, nitroglycerin, a nitrate, and hydralazine.
43. The method of claim 43 wherein the vasodilatory agent is niacin and present in the transdermal formulation at a concentration of 5 % (by weight).
44. A method of reducing fever in a patient, comprising: providing a composition that includes a fever reducing agent; including the composition in a transdermal formulation; topically applying the transdermal formulation to at least one area of skin superficial to a carotid artery, a temporal artery, and a vertebral artery; and wherein the transdermal formulation is applied in an amount effective to deliver the fever reducing agent to a cerebral circulation, thereby reducing an elevated body temperature of the patient.
45. The method of claim 44 wherein the fever reducing agent is a non-steroid anti- inflammatory agent.
32 The method of claim 45 wherein the non-steroid anti-inflammatory agent is acetaminophen, dipyrone, or aspirin.
33
PCT/US2002/026613 2001-08-23 2002-08-20 Compositions and methods for targeting cerebral circulation and treatment of headache WO2003017932A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2002313785A AU2002313785A1 (en) 2001-08-23 2002-08-20 Compositions and methods for targeting cerebral circulation and treatment of headache
EP02753504A EP1418918A4 (en) 2001-08-23 2002-08-20 Compositions and methods for targeting cerebral circulation and treatment of headache
US10/483,509 US7981901B2 (en) 2001-08-23 2002-08-20 Compositions and methods for targeting cerebral circulation and treatment of headache

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US2001/026459 WO2003018023A1 (en) 2001-08-23 2001-08-23 Compositions and methods for targeting cerebral circulation and treatment of headache
USPCT/US01/26459 2001-08-23

Publications (3)

Publication Number Publication Date
WO2003017932A2 WO2003017932A2 (en) 2003-03-06
WO2003017932A3 WO2003017932A3 (en) 2003-07-10
WO2003017932B1 true WO2003017932B1 (en) 2003-09-12

Family

ID=21742800

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2001/026459 WO2003018023A1 (en) 2001-08-23 2001-08-23 Compositions and methods for targeting cerebral circulation and treatment of headache
PCT/US2002/026613 WO2003017932A2 (en) 2001-08-23 2002-08-20 Compositions and methods for targeting cerebral circulation and treatment of headache

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2001/026459 WO2003018023A1 (en) 2001-08-23 2001-08-23 Compositions and methods for targeting cerebral circulation and treatment of headache

Country Status (3)

Country Link
EP (1) EP1418918A4 (en)
AU (1) AU2002313785A1 (en)
WO (2) WO2003018023A1 (en)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4777174A (en) * 1982-07-22 1988-10-11 Analgesic Associates Analgesic and anti-inflammatory compositions comprising caffeine and methods of using same
US4532244A (en) 1984-09-06 1985-07-30 Innes Margaret N Method of treating migraine headaches
US4777147A (en) 1987-01-28 1988-10-11 Texas Instruments Incorporated Forming a split-level CMOS device
US5250529A (en) * 1990-02-08 1993-10-05 Kos Pharmaceuticals, Inc. Method alleviating migraine headache with mast cell degranulation blocking agents
HRP921157A2 (en) * 1991-12-20 1994-10-31 Lohmann Therapie Syst Lts Transdermal system of applying acetilsalicilyc acid in antithrombosys therapy
US5552406A (en) * 1994-06-17 1996-09-03 The Mclean Hospital Corporation Method for treating pain and brain perfusion abnormalities using mixed opioid agonist-antagonists
AUPN814496A0 (en) 1996-02-19 1996-03-14 Monash University Dermal penetration enhancer
US5885597A (en) * 1997-10-01 1999-03-23 Medical Research Industries,Inc. Topical composition for the relief of pain
DE10025644A1 (en) * 2000-05-24 2001-12-06 Lohmann Therapie Syst Lts Narrow band-shaped transdermal therapeutic system for the application of active substances directly over the arterial or venous vascular system

Also Published As

Publication number Publication date
AU2002313785A1 (en) 2003-03-10
WO2003017932A3 (en) 2003-07-10
WO2003018023A1 (en) 2003-03-06
EP1418918A2 (en) 2004-05-19
WO2003017932A2 (en) 2003-03-06
EP1418918A4 (en) 2006-11-29

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