CA2599156A1 - Dosage form containing oxycodone and naloxone - Google Patents
Dosage form containing oxycodone and naloxone Download PDFInfo
- Publication number
- CA2599156A1 CA2599156A1 CA002599156A CA2599156A CA2599156A1 CA 2599156 A1 CA2599156 A1 CA 2599156A1 CA 002599156 A CA002599156 A CA 002599156A CA 2599156 A CA2599156 A CA 2599156A CA 2599156 A1 CA2599156 A1 CA 2599156A1
- Authority
- CA
- Canada
- Prior art keywords
- dosage form
- form according
- oxycodone
- pharmaceutically acceptable
- acceptable salt
- 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.)
- Granted
Links
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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- 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
-
- 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
The present invention concerns a dosage form comprising oxycodone and naloxone which is characterized by specific in vivo parameters such as tmax, Cmax,AUCt value, mean bowel function score and/or duration of analgesic efficacy.
Claims (26)
1. A dosage form comprising oxycodone and/or a pharmaceutically acceptable salt thereof and naloxone and/or a pharmaceutically acceptable salt thereof, which provides a t max for oxycodone or a pharmaceutically acceptable salt at about 1 to about 17 hours, at about 2 to about 15 hours, at about 3 to about 8 hours or at about 4 to about 5 hours after single dose administration to healthy human subjects.
2. The dosage form according to claim 1, which provides an improvement of bowel function during pain therapy, in particular an improvement of the mean bowel function score of at least about 5, at least about 8, at least about 10 or at least about 15 after steady state administration to human patients, wherein the mean bowel function score is measured with a numerical analog scale ranging from 0 to 100.
3. The dosage form according to claim 1 or 2, which provides an analgesic effect for at least about 12 hours or at least about 24 hours after steady state administration to human patients or healthy human subjects.
4. The dosage form according to any of the preceding claims, which provides an AUCt value for oxycodone of about 100 ng.cndot.h/mL to about ng.cndot.h/mL, about 400 ng.cndot.h/mL to about 550 ng.cndot.h/mL, or about 450 to about 510 ng.cndot.h/mL after single dose administration to healthy human subjects.
5. The dosage form according to any of the preceding claims, which provides a C max for oxycodone of about 5 ng/mL to about 50 ng/mL, about ng/mL to about 40 ng/mL or about 35 ng/mL after single dose administration to healthy human subjects.
6. The dosage form according to any of the preceding claims, which in terms of efficacy is ranked good or very good by more than 50% of patients and preferably by more than 70% of patients.
7. The dosage form according to any of the preceding claims, which in terms of tolerability is ranked good or very good by more than 60% of patients and preferably by more than 70 or even 80% of patients.
8. The dosage form according to any of the preceding claims, which provides a reduction of days with laxative intake by at least 10%, preferably by at least 20%, more preferably by at least 25% and even more preferably by at least 30%.
9. The dosage form according to any of the preceding claims, which provides an improved side effect profile.
10. The dosage form according to any of the preceding claims, which shows no food effect.
11. The dosage form according to any of the preceding claims, which precipitates withdrawal symptoms in opioid dependent human subjects.
12. The dosage form according to any of the preceding claims, wherein oxycodone and/or naloxone are present in the form of a hydrochloride.
13. The dosage form according to any of the preceding claims, wherein oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof are present in a weight ratio range of 2:1.
14. The dosage form according to any of the preceding claims, wherein naloxone or a pharmaceutically acceptable salt thereof is present in an amount of about 10 to about 40 mg, and preferably of about 20 mg and wherein oxycodone or a pharmaceutically acceptable salt thereof is present in an amount of about 10 to about 160 mg, and preferably of about 80 mg or of about 40 mg.
15. The dosage form according to any of the preceding claims, wherein oxycodone and/or naloxone are released from the preparation in a sustained, invariant and/or independent manner.
16. The dosage form according to any of the preceding claims, wherein the preparation comprises a non-swellable and non-erosive diffusion matrix.
17. The dosage form according to claim 16, wherein the diffusion matrix comprises at least one ethylcellulose component and at least one fatty alcohol.
18. The dosage form according to claim 17, wherein the fatty alcohol is selected from lauryl, myrestyl, stearyl, cetostearyl, ceryl and/or cetyl alcohol, and is preferably stearyl alcohol.
19. The dosage form according to claims 17 or 18, wherein the ethylcellulose component is a polymer mixture containing ethylcellulose.
20. The dosage form according to any of the preceding claims, wherein the dosage form has been formulated for oral, nasal, rectal application and/or for application by inhalation.
21. The dosage form according to any of the preceding claims, wherein the dosage form or precursors thereof are produced by extrusion.
22. The dosage form according to any of the preceding claims, which is suitable for stable storage over a period of at least 2 years under standard conditions (60% relative humidity, 25 C) in accordance with admission guidelines by the FDA or EMEA.
23. Use of any of the dosage forms according to claims 1 to 22 for the preparation of a pharmaceutical preparation for pain treatment.
24. Use according to claim 23 for the preparation of a pharmaceutical preparation for the treatment of pain and constipation during pain therapy.
25. Use according claims 23 or 24 for the preparation of a pharmaceutical preparation for the treatment of pain while preventing or reducing also abuse.
26. Use according to any of claims 23 to 25, wherein the dosage form is suitable for once-a-day or twice-a-day administration at steady state or of a single dose to human patients.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2768075A CA2768075A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP05004377.7 | 2005-02-28 | ||
EP05004377A EP1695700A1 (en) | 2005-02-28 | 2005-02-28 | Dosage form containing oxycodone and naloxone |
PCT/EP2006/060341 WO2006089973A2 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2768075A Division CA2768075A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2599156A1 true CA2599156A1 (en) | 2006-08-31 |
CA2599156C CA2599156C (en) | 2012-05-01 |
Family
ID=34933990
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2599156A Active CA2599156C (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
CA2960011A Abandoned CA2960011A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
CA2768075A Abandoned CA2768075A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2960011A Abandoned CA2960011A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
CA2768075A Abandoned CA2768075A1 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Country Status (27)
Country | Link |
---|---|
US (5) | US20080145429A1 (en) |
EP (5) | EP1695700A1 (en) |
JP (2) | JP2008531650A (en) |
KR (1) | KR20070107805A (en) |
CN (2) | CN101128191A (en) |
AT (1) | ATE517611T1 (en) |
AU (2) | AU2006217870B2 (en) |
BR (1) | BRPI0607975A2 (en) |
CA (3) | CA2599156C (en) |
CY (1) | CY1111967T1 (en) |
DE (2) | DE202006020095U1 (en) |
DK (2) | DK1855657T3 (en) |
ES (1) | ES2370409T3 (en) |
FI (1) | FI7750U1 (en) |
HK (1) | HK1111604A1 (en) |
HR (1) | HRP20110775T1 (en) |
IL (2) | IL185514A0 (en) |
ME (1) | ME01262B (en) |
MX (1) | MX2007010494A (en) |
NZ (1) | NZ588875A (en) |
PL (1) | PL1855657T3 (en) |
PT (1) | PT1855657E (en) |
RS (1) | RS51984B (en) |
RU (1) | RU2428985C2 (en) |
SI (1) | SI1855657T1 (en) |
UA (1) | UA93543C2 (en) |
WO (1) | WO2006089973A2 (en) |
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