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WO1988009605A2 - Traumatic and ischemic brain injury treatment with opiate-receptor antagonists - Google Patents

Traumatic and ischemic brain injury treatment with opiate-receptor antagonists Download PDF

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Publication number
WO1988009605A2
WO1988009605A2 PCT/US1988/001839 US8801839W WO8809605A2 WO 1988009605 A2 WO1988009605 A2 WO 1988009605A2 US 8801839 W US8801839 W US 8801839W WO 8809605 A2 WO8809605 A2 WO 8809605A2
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WO
WIPO (PCT)
Prior art keywords
opiate
receptor
traumatic
brain injury
receptor antagonist
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US1988/001839
Other languages
French (fr)
Inventor
Alan I. Faden
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medicis Corp
Original Assignee
Medicis Corp
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 Medicis Corp filed Critical Medicis Corp
Publication of WO1988009605A2 publication Critical patent/WO1988009605A2/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • Endogenous opioids may be released following traumatic or ischemic injury of the central nervous system. These opioids may serve as secondary pathophy ⁇ iologic factors contributing to the neurological disorder which stems fro"m the injury to the central nervous system.
  • Opiate receptor antagonists such as naloxone, has been used to treat brain or spinal cord injury at dosages in the range of 1 to 10 g/kg of body weight of the patient.
  • naloxone is not completely selective nor a pure opiate antagonist in all situations. At low dosages, naloxone has considerable selectivity for the mu-opiate receptor. At higher dosages, naloxone acts on other opiate receptors, including the delta and kappa receptors. Further at higher dosages, naloxone may have effects that are not mediated by opiate receptors.
  • opiate receptor antagonists v/hich exhibit a high degree of specificity for or enhanced activity at a specific opiate receptor are being sought. Also, opiate receptor antagonists which act exclusively as such without producing any undesirable side reactions within the body are preferred.
  • the present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury which comprises administering to said patient an effective amount of an opiate-receptor antagonist having enhanced activity at the kappa-opiate receptor suitable to permit the induction of opiate-receptor antagonistic activity.
  • an opiate-receptor antagonist of the present invention there is contemplated any pharmaceutically acceptable compound or salt thereof having enhanced activity at the kappa-opiate receptor capable of inducing opiate receptor antagonistic activity.
  • an effective amount of the opiate-receptor antagonist of the present invention there is contemplated an amount of antagonist which is sufficient to induce opiate receptor antagonistic activity.
  • An effective amount of the opiate receptor antagonist of the present invention is from about 0.01 to about 10 mg/kg body weight of the patient daily.
  • a preferred embodiment of the present invention involves an effective amount of the opiate receptor antagonist from about 0.1 to 1 mg/kg body weight of the patient daily.
  • the opiate receptor antagonist of the present invention may be administered to the patient in any dosage form convenient under the patient's specific circumstances. Usually, parenteral administration is preferred.
  • a dosage unit suitable for intravenous administration which comprises (i) an effective amount of an opiate receptor antagonist having enhanced activity at or specificity for the kappa opiate receptor and (ii) a pharmaceutically acceptable solution.
  • a pharmaceutically acceptable solution there is contemplated any solution which is safe for injection and which is biologically inert and hence does not interfere with, the active ingredient.
  • a pharmaceuti ally acceptable solution may be mentioned an i ⁇ otonic solution suitable for injection into a patient.
  • the isotonic solution may contain water, salt and conventional ingredients such as glucose.
  • a preferred embodiment of the present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein the opiate receptor antagonist administered to the patient is 3- (2-alpha, 6-alpha , US*) - (-) -1- cyclopentyl-5-(l,2,3,4,5, 6-hexahydro-8-hydroxy-3 ,6,11- trimethyl-2 , 6-methano-3-benzazocin-ll-yl) -3-pentanone methane sulfonate.
  • a further preferred embodiment of the present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein said opiate-receptor antagonist is administered in a dosage of from about 0.04 to about 4 mg/kg 3-4 times daily.
  • a more preferred embodiment of the present invention provides a method of inducing opiate- receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein said opiate- receptor antagonist is administered in a dosage of from about 0.1 to about 1 mg/kg 3-4 times daily.
  • EXAMPLE 3 Induction of opiate receptor antagonistic activity in a patient suffering from traumatic or ischemic brain injury is accomplished through injection of 0.1 mg/kg of the pharmaceutical preparation of Example 1 4 times daily for 1 day.
  • EXAMPLE 4 Induction of opiate receptor antagonistic activity in a patient suffering from traumatic or ischemic brain injuiy is accomplished through injection of 0.5 of the pharmaceutical preparation of Example 2 3 times daily for 1 day.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Other In-Based Heterocyclic Compounds (AREA)

Description

1
TRAUMATIC AND ISCHEMIC BRAIN INJURY TREATMENT WITH OPIATE- RECEPTOR ANTAGONISTS BACKGROUND OF THE INVENTION Endogenous opioids may be released following traumatic or ischemic injury of the central nervous system. These opioids may serve as secondary pathophyεiologic factors contributing to the neurological disorder which stems fro"m the injury to the central nervous system. Opiate receptor antagonists, such as naloxone, has been used to treat brain or spinal cord injury at dosages in the range of 1 to 10 g/kg of body weight of the patient.
However, naloxone is not completely selective nor a pure opiate antagonist in all situations. At low dosages, naloxone has considerable selectivity for the mu-opiate receptor. At higher dosages, naloxone acts on other opiate receptors, including the delta and kappa receptors. Further at higher dosages, naloxone may have effects that are not mediated by opiate receptors.
In order to simplify and enhance the safety of central nervous system protocols, opiate receptor antagonists v/hich exhibit a high degree of specificity for or enhanced activity at a specific opiate receptor are being sought. Also, opiate receptor antagonists which act exclusively as such without producing any undesirable side reactions within the body are preferred.
DETAILED DESCRIPTION OF THE INVENTION The present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury which comprises administering to said patient an effective amount of an opiate-receptor antagonist having enhanced activity at the kappa-opiate receptor suitable to permit the induction of opiate-receptor antagonistic activity.
As an opiate-receptor antagonist of the present invention there is contemplated any pharmaceutically acceptable compound or salt thereof having enhanced activity at the kappa-opiate receptor capable of inducing opiate receptor antagonistic activity.
As an effective amount of the opiate-receptor antagonist of the present invention there is contemplated an amount of antagonist which is sufficient to induce opiate receptor antagonistic activity. An effective amount of the opiate receptor antagonist of the present invention is from about 0.01 to about 10 mg/kg body weight of the patient daily. A preferred embodiment of the present invention involves an effective amount of the opiate receptor antagonist from about 0.1 to 1 mg/kg body weight of the patient daily.
The opiate receptor antagonist of the present invention may be administered to the patient in any dosage form convenient under the patient's specific circumstances. Usually, parenteral administration is preferred.
As a parenteral dosage form there is contemplated a dosage unit suitable for intravenous administration which comprises (i) an effective amount of an opiate receptor antagonist having enhanced activity at or specificity for the kappa opiate receptor and (ii) a pharmaceutically acceptable solution.
As a pharmaceutically acceptable solution there is contemplated any solution which is safe for injection and which is biologically inert and hence does not interfere with, the active ingredient. As such a pharmaceuti ally acceptable solution may be mentioned an iεotonic solution suitable for injection into a patient. The isotonic solution may contain water, salt and conventional ingredients such as glucose.
A preferred embodiment of the present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein the opiate receptor antagonist administered to the patient is 3- (2-alpha, 6-alpha , US*) - (-) -1- cyclopentyl-5-(l,2,3,4,5, 6-hexahydro-8-hydroxy-3 ,6,11- trimethyl-2 , 6-methano-3-benzazocin-ll-yl) -3-pentanone methane sulfonate. A further preferred embodiment of the present invention provides a method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein said opiate-receptor antagonist is administered in a dosage of from about 0.04 to about 4 mg/kg 3-4 times daily. A more preferred embodiment of the present invention provides a method of inducing opiate- receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury, wherein said opiate- receptor antagonist is administered in a dosage of from about 0.1 to about 1 mg/kg 3-4 times daily. The following illustrate the invention.
EXAMPLE 1
3- (2-alpha , 6-alpha, IIS*) - (-) - -cyclopentyl-5-
(1,2,3,4,5, 6-hexahydro-8-hydroxy-3 , 6 , ll-trimethyl-2 , 6- methano-3-benzazocin-ll-yl) -3-pentanone methane sulfonate is admixed with 10 cc isotonic solution to obtain a final concentration of active ingredient in the solution of 5 mg/cc.
EXAMPLE 2 3- (2-alpha, 6-alpha, US*) -(-) -l-cyclopentyl-5-
(1,2,3,4,5, 6-hexahydro-8-hydroxy-3 ,6,1 l-trimethy1-2 , 6- methano-3-benzazocin-ll-yl) -3-pentanone methane sulfonate is admixed with 10 cc isotonic solution to obtain a final concentration of active ingredient in the solution of 1 mg/cc.
EXAMPLE 3 Induction of opiate receptor antagonistic activity in a patient suffering from traumatic or ischemic brain injury is accomplished through injection of 0.1 mg/kg of the pharmaceutical preparation of Example 1 4 times daily for 1 day.
EXAMPLE 4 Induction of opiate receptor antagonistic activity in a patient suffering from traumatic or ischemic brain injuiy is accomplished through injection of 0.5 of the pharmaceutical preparation of Example 2 3 times daily for 1 day.

Claims

WHAT IS CLAIMED IS:
1. A method of inducing opiate-receptor antagonistic activity in a patient suffering from ischemic or traumatic brain injury which comprises administering to said patient an effective amount of an opiate-receptor antagonist having enhanced activity at the kappa-opiate receptor sxitable to permit the induction of opiate-receptor antagonistic activity.
2. A method of claim 1, wherein said opiate-receptor antagonist is 3-(2-alpha, 6-alpha,IIS*)-(-)-l-cyclopentyl-5- (1,2,3,4,5, 6-hexahydro-8-hydroxy-3, 6, ll-trimethyl-2, 6- methano-3-benzazocin-ll-yl)-3-pentanone methane sulfonate.
3. A method of claim 1, wherein said opiate-receptor antagonist is administered in a dosage of from about 0.01 mg/kg to about 4 mg/kg 3-4 times daily.
4. A method of claim 1, wherein said opiate-receptor antagonist is administered in a dosage of from about 0.1 mg/kg to about 1 mg/kg 3-4 times daily.
PCT/US1988/001839 1987-06-05 1988-06-06 Traumatic and ischemic brain injury treatment with opiate-receptor antagonists Ceased WO1988009605A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5833787A 1987-06-05 1987-06-05
US058,337 1987-06-05

Publications (1)

Publication Number Publication Date
WO1988009605A2 true WO1988009605A2 (en) 1988-12-15

Family

ID=22016198

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1988/001839 Ceased WO1988009605A2 (en) 1987-06-05 1988-06-06 Traumatic and ischemic brain injury treatment with opiate-receptor antagonists

Country Status (4)

Country Link
EP (1) EP0348440A1 (en)
JP (1) JPH02500439A (en)
CA (1) CA1322522C (en)
WO (1) WO1988009605A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994013641A1 (en) * 1992-12-16 1994-06-23 Japan Tobacco Inc. Benzomorphan useful as nmda receptor antagonist

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994013641A1 (en) * 1992-12-16 1994-06-23 Japan Tobacco Inc. Benzomorphan useful as nmda receptor antagonist

Also Published As

Publication number Publication date
JPH02500439A (en) 1990-02-15
EP0348440A1 (en) 1990-01-03
CA1322522C (en) 1993-09-28

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