DE05011213T1 - Analgetisch wirksame Zusammensetzung mit verzögerter Wirkstoffabgabe von Buprenorphin - Google Patents
Analgetisch wirksame Zusammensetzung mit verzögerter Wirkstoffabgabe von Buprenorphin Download PDFInfo
- Publication number
- DE05011213T1 DE05011213T1 DE05011213T DE05011213T DE05011213T1 DE 05011213 T1 DE05011213 T1 DE 05011213T1 DE 05011213 T DE05011213 T DE 05011213T DE 05011213 T DE05011213 T DE 05011213T DE 05011213 T1 DE05011213 T1 DE 05011213T1
- Authority
- DE
- Germany
- Prior art keywords
- dosing interval
- beginning
- buprenorphine
- hours
- release rate
- 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.)
- Pending
Links
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 title claims abstract 19
- 229960001736 buprenorphine Drugs 0.000 title claims abstract 19
- 230000000202 analgesic effect Effects 0.000 title 1
- 230000003111 delayed effect Effects 0.000 title 1
- 230000037317 transdermal delivery Effects 0.000 claims abstract 13
- 230000036470 plasma concentration Effects 0.000 claims abstract 6
- 238000007726 management method Methods 0.000 claims abstract 3
- 239000000463 material Substances 0.000 claims abstract 2
- 239000011159 matrix material Substances 0.000 claims abstract 2
- 229920000642 polymer Polymers 0.000 claims abstract 2
- 150000003839 salts Chemical class 0.000 claims abstract 2
- 238000004519 manufacturing process Methods 0.000 claims 1
Classifications
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4748—Quinolines; Isoquinolines forming part of bridged ring systems
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
Verwendung
einer Polymermatrixschicht, umfassend Buprenorphin oder ein pharmazeutisch akzeptables
Salz davon, und eine Stützschicht,
die aus einem pharmazeutisch akzeptablen Material gefertigt ist,
und welche für
Buprenorphin undurchlässig
ist, bei der Herstellung eines transdermalen Abgabesystems für Buprenorphin,
welches für
die Behandlung von Schmerzen in einem menschlichen Patienten für ein Dosierintervall
von mindestens vier Tagen wirksam ist, wobei das transdermale Abgabesystem
durch Aufbringen des transdermalen Abgabesystems auf die Haut eines
Patienten eine Freisetzungsrate an Buprenorphin über ungefähr ein 72 Stunden Dosierintervall
bereitstellt, so dass eine maximale Plasmakonzentration von 20 pg/ml
bis 850 pg/ml erreicht wird und die transdermale Abgabeeinheit,
wenn sie auf der Haut des Patienten für ein zusätzliches 24 Stunden Intervall
beibehalten wird, Plasmakonzentrationen an Buprenorphin in den Patienten
oberhalb der minimalen wirksamen Konzentrationen an Buprenorphin
bereitstellt, so dass die Patienten während dieses zusätzlichen
Dosierintervalls weiterhin wirksames Schmerzmanagement erfahren.
Claims (8)
- Verwendung einer Polymermatrixschicht, umfassend Buprenorphin oder ein pharmazeutisch akzeptables Salz davon, und eine Stützschicht, die aus einem pharmazeutisch akzeptablen Material gefertigt ist, und welche für Buprenorphin undurchlässig ist, bei der Herstellung eines transdermalen Abgabesystems für Buprenorphin, welches für die Behandlung von Schmerzen in einem menschlichen Patienten für ein Dosierintervall von mindestens vier Tagen wirksam ist, wobei das transdermale Abgabesystem durch Aufbringen des transdermalen Abgabesystems auf die Haut eines Patienten eine Freisetzungsrate an Buprenorphin über ungefähr ein 72 Stunden Dosierintervall bereitstellt, so dass eine maximale Plasmakonzentration von 20 pg/ml bis 850 pg/ml erreicht wird und die transdermale Abgabeeinheit, wenn sie auf der Haut des Patienten für ein zusätzliches 24 Stunden Intervall beibehalten wird, Plasmakonzentrationen an Buprenorphin in den Patienten oberhalb der minimalen wirksamen Konzentrationen an Buprenorphin bereitstellt, so dass die Patienten während dieses zusätzlichen Dosierintervalls weiterhin wirksames Schmerzmanagement erfahren.
- Verwendung eines transdermalen Abgabesystems für Buprenorphin, das vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls eine mittlere Freisetzungsrate von 3 μg/Std. bis 86 μg/Std. an Buprenorphin bereitstellt und, basierend auf einem transdermalen Abgabesystem mit 10 mg Buprenorphin, von 72 Stunden nach dem Beginn des Dosierintervalls bis mindestens 96 Stunden nach dem Beginn des Dosierintervalls eine mittlere Freisetzungsrate von 0,3 μg/Std. bis 9 μg/Std. bereitstellt, bei der Herstellung eines transdermalen Abgabesystems für Buprenorphin, das für die Behandlung von Schmerzen bei einem menschlichen Patienten für ein Dosierintervall von mindestens vier Tagen wirksam ist, wobei das transdermale Abgabesystem durch Aufbringung des transdermalen Abgabesystems auf die Haut eines Patienten über ein 72 Stunden Dosierintervall eine maximale Plasmakonzentration von 20 pg/ml bis 850 pg/ml bereitstellt, und, wenn es für ein zusätzliches 24 Stundenintervall auf der Haut des Patienten beibehalten wird, Plasmakonzentrationen an Buprenorphin oberhalb den minimalen wirksamen Konzentrationen an Buprenorphin bereitstellt, so dass die Patienten während dieses zusätzlichen Dosierintervalls weiterhin wirksames ein Schmerzmanagement erfahren.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 3 μg/Std. bis 5 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 0,3 μg/Std. bis 0,6 μg/Std. von 72 Stunden nach Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 6 μg/Std. bis 11 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 0,7 μg/Std. bis 1 μg/Std. bis 72 Stunden nach dem Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 13 μg/Std. bis 21 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 1 μg/Std. bis 2 μg/Std. von 72 Stunden nach dem Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 26 μg/Std. bis 43 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 3 μg/Std. bis 4 μg/Std. von 72 Stunden nach dem Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 39 μg/Std. bis 64 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 4 μg/Std. bis 7 μg/Std. von 72 Stunden nach dem Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
- Verwendung gemäß Anspruch 1 oder 2, wobei die mittleren relativen Freisetzungsraten, die über das Dosierintervall erreicht werden, wie folgt sind: eine mittlere relative Freisetzungsrate von 51 μg/Std. bis 86 μg/Std. vom Beginn des Dosierintervalls bis 72 Stunden nach dem Beginn des Dosierintervalls, und eine mittlere relative Freisetzungsrate von 5 μg/Std. bis 9 μg/Std. von 72 Stunden nach dem Beginn des Dosierintervalls bis zum Ende des Dosierintervalls.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3891997P | 1997-02-24 | 1997-02-24 | |
US38919P | 1997-02-24 | ||
US08/939,068 US5968547A (en) | 1997-02-24 | 1997-09-29 | Method of providing sustained analgesia with buprenorphine |
US939068 | 1997-09-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
DE05011213T1 true DE05011213T1 (de) | 2007-09-06 |
Family
ID=26715643
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE05011213T Pending DE05011213T1 (de) | 1997-02-24 | 1998-02-24 | Analgetisch wirksame Zusammensetzung mit verzögerter Wirkstoffabgabe von Buprenorphin |
DE69835584T Expired - Lifetime DE69835584T2 (de) | 1997-02-24 | 1998-02-24 | Verzögerte analgesie erreicht mit transdermaler verabreichung von buprenorphin |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69835584T Expired - Lifetime DE69835584T2 (de) | 1997-02-24 | 1998-02-24 | Verzögerte analgesie erreicht mit transdermaler verabreichung von buprenorphin |
Country Status (22)
Country | Link |
---|---|
US (15) | US5968547A (de) |
EP (9) | EP2305193A1 (de) |
JP (1) | JP2000511936A (de) |
KR (1) | KR100703101B1 (de) |
CN (2) | CN1252705A (de) |
AT (3) | ATE336212T1 (de) |
AU (2) | AU2004218685B2 (de) |
BR (1) | BR9815439A (de) |
CA (1) | CA2276170C (de) |
CZ (2) | CZ2015477A3 (de) |
DE (2) | DE05011213T1 (de) |
DK (4) | DK1731152T3 (de) |
ES (4) | ES2271988T3 (de) |
HK (3) | HK1096847A1 (de) |
HU (3) | HU230374B1 (de) |
IL (4) | IL131561A0 (de) |
NO (11) | NO322515B1 (de) |
NZ (1) | NZ337386A (de) |
PL (1) | PL196086B1 (de) |
PT (4) | PT1570823E (de) |
SI (3) | SI1570823T1 (de) |
WO (1) | WO1998036728A2 (de) |
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