Source: http://www.google.com/patents/US8216604?ie=ISO-8859-1
Timestamp: 2015-07-30 12:11:31
Document Index: 18030944

Matched Legal Cases: ['Application No. 19995021', 'Application No. 98917414', 'Application No. 200507799', 'art 4', 'Application No. 98917414', 'Application No. 10', 'Application No. 541018', 'Application No. 10', 'Application No. 2', 'Application No. 70647', 'Application No. 541018', 'Application No. 337289', 'Application No. 70647', 'Application No. 2', 'Application No. 19995021', 'Application No. 337289', 'Application No. 10', 'Application No. 2', 'Application No. 337289', 'Application No. 541018', 'Application No. 200507799', 'Application No. 19995021', 'Application No. 169480', 'Application No. 10', 'Application No. 2', 'Application No. 2', 'Application No. 2991', 'Application No. 541018', 'Application No. 200501105', 'Application No. 10', 'Application No. 10', 'Application No. 2008', 'Application No. 2006', 'Application No. 2008', 'Application No. 337289', 'Application No. 2991', 'Application No. 2', 'Application No. 2004204381', 'Application No. 200507799', 'Application No. 70647', 'Application No. 2004204381', 'Application No. 2008', 'Application No. 2', 'Application No. 337289', 'Application No. 200480002000', 'Application No. 200480002000', 'Application No. 04701381', 'Application No. 2004204381', 'Application No. 98917414', 'Application No. 10', 'Application No. 10']

Patent US8216604 - Method of managing or treating pain - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan...http://www.google.com/patents/US8216604?utm_source=gb-gplus-sharePatent US8216604 - Method of managing or treating painAdvanced Patent SearchPublication numberUS8216604 B2Publication typeGrantApplication numberUS 12/047,388Publication dateJul 10, 2012Filing dateMar 13, 2008Priority dateJan 10, 2003Also published asCA2511974A1, CA2511974C, CN1723012A, CN100423709C, EP1635783A2, EP1635783B1, EP2436375A1, US8889176, US9078814, US20040166067, US20080153879, US20120270903, US20120277267, WO2004062561A2, WO2004062561A3Publication number047388, 12047388, US 8216604 B2, US 8216604B2, US-B2-8216604, US8216604 B2, US8216604B2InventorsPeter James Watts, Jonathan David Castile, William Columbus Ian Lafferty, Alan SmithOriginal AssigneeArchimedes Development LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (85), Non-Patent Citations (220), Referenced by (2), Classifications (13), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetMethod of managing or treating pain
US 8216604 B2Abstract
1. A method of treating or managing pain by intranasally administering to an animal in need thereof in a single dosage regimen having a practical dose volume to provide rapid absorption in combination with a lower peak plasma concentration than that provided using a simple aqueous solution and in an amount to effectively treat or manage pain, a pharmaceutical composition comprising an aqueous solution of
fentanyl or a pharmaceutically acceptable salt thereof in an amount to effectively treat or manage pain that is from 0.1 to 30 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base) and
wherein the animal administered the composition in the single dosage regimen is provided with a peak plasma concentration of fentanyl (Cmax) that is from 20 to 75% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose; and
2. A method according to claim 1, wherein the animal administered the composition by the single dosage regimen is provided with a peak plasma concentration of fentanyl (Cmax) that is from 30 to 70% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose.
3. A method according to claim 1, wherein the pectin has a DE value of from 7 to 30%.
4. A method according to claim 3, wherein the pectin has a DE value of from 10 to 25%.
5. A method according to claim 1, wherein the pectin has a DE value of from 5 to 25%.
6. A method according to claim 1, wherein the animal administered the composition by the single dosage regimen is provided with a peak plasma concentration of fentanyl (Cmax) that is from 30 to 70% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose, and wherein the pectin has a DE value of from 5 to 25%.
7. A method according to claim 1, wherein the composition comprises a pharmaceutically acceptable salt of fentanyl.
8. A method according to claim 7, wherein the pharmaceutically acceptable salt of fentanyl is fentanyl citrate.
9. A method according to claim 1, wherein the composition has a concentration of pectin from 5 to 25 mg/ml of the composition.
10. A method according to claim 1, wherein the composition is at least 99% free of divalent metal ions.
11. A method according to claim 1, wherein the composition has an osmolality of from 0.25 to 0.35 osmol/kg.
12. A method according to claim 1, wherein the composition has a pH of from 3.4 to 5.0.
13. A method according to claim 1, wherein the composition is administered by the single dosage regimen in the form of drops or as a spray.
14. A method according to claim 1 for treating acute or chronic pain.
15. A method according to claim 1, wherein the animal is a human.
16. A method according to claim 1, wherein the composition comprises from 0.1 to 20 mg/ml of the composition of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base).
17. A method according to claim 16, wherein the composition comprises from 0.2 to 16 mg/ml of the composition of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base) of the composition.
18. A method of treating or managing pain by intranasally administering to an animal in need thereof in a single dosage regimen having a practical dose volume to provide rapid absorption in combination with a lower peak plasma concentration than that provided using a simple aqueous solution and in an amount to effectively treat or manage pain, a pharmaceutical composition comprising an aqueous solution of
0.2 to 16 mg/ml (expressed as fentanyl base) of fentanyl or a pharmaceutically acceptable salt thereof and
so as to provide in the animal administered the composition a peak plasma concentration of fentanyl (Cmax) that is from 20 to 75% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose and a time to achieve peak plasma concentration (Tmax), of fentanyl in the animal's plasma of 5 to 30 minutes.
19. A method according to claim 18, wherein the animal is a human.
20. A method according to claim 19, wherein the single dosage regimen of the method further comprises administering the composition to the human via a maximum of two intranasal sprays to each nostril of the human where the maximum volume of each spray is 0.15 ml of the composition.
21. A method according to claim 15, wherein the single dosage regimen of the method further comprises administering the composition to the human via a maximum of two intranasal sprays to each nostril of the human where the maximum volume of each spray is 0.15 ml of the composition.
22. A method of treating or managing pain by intranasally administering to an animal in need thereof in a single dosage regimen having a practical dose volume to provide rapid absorption in combination with a lower peak plasma concentration than that provided using a simple aqueous solution and in an amount to effectively treat or manage pain, a pharmaceutical composition comprising an aqueous solution of
fentanyl or a pharmaceutically acceptable salt thereof in an amount to effectively treat or manage pain that is from 0.1 to 30 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base);
23. The method of claim 22, wherein the non-metal ion osmolality adjusting agent is selected from one or more in the group consisting of mannitol, sorbitol, dextrose, sucrose and trehalose.
24. The method of claim 22, wherein the osmolality of the composition is from 0.2 to 0.4 osmol/kg.
25. The method of claim 24, wherein the osmolality of the composition is from 0.25 to 0.35 osmol/kg.
26. The method of claim 18, wherein the osmolality of the composition is from 0.25 to 0.35 osmol/kg.
This application is a division of U.S. patent application Ser. No. 10/753,628, filed Jan. 8, 2004, now abandoned, the disclosure of which is hereby incorporated herein by reference in its entirety.
It has been reported that fentanyl is rapidly and well absorbed from the nasal cavity (Striebel et al., Brit. J. Anaesthesia, 96, suppl 1, 108, 1993). In addition, the effectiveness of intranasal fentanyl in providing analgesia in patients has been demonstrated in a number of studies (for example Striebel et al., Brit. J. Anaesthesia, 96, suppl 1, 108 and 109, 1993; Striebel et al., Anaesthesia, 48, 753-757, 1993; Majushree et al., Can. J. Anesth., 49, 190-193, 2002; Toussaint et al, Can. J. Anesth., 47, 299-302, 2000). In all of these studies the intranasal administration of fentanyl appears to have been achieved by dropping or spraying a commercially available injection formulation into the nose (SUBLIMAZE�, from Janssen). The commercially available injection formulation of fentanyl contains 0.05 mg of fentanyl, in the form of the citrate salt, in 1 ml of sodium chloride solution and necessitates the intranasal administration of a large volume of liquid in order to provide a therapeutically effective dose of drug.
Fentanyl is also currently available in a transdermal patch and a transmucosal lozenge. The transdermal patch (for example DUROGESIC� from Janssen) provides a steady concentration of fentanyl in plasma over a prolonged period and is not suitable for the rapid relief of severe pain, such as breakthrough pain associated with terminal illness or acute pain associated with trauma or following surgery. The transmucosal lozenge (ACTIQ�, Cephalon Inc) is used in the treatment of breakthrough pain and is available in a number of dose strengths ranging from 0.2 to 1.6 mg. The absorption of fentanyl from the transmucosal formulation is relatively slow. Times to achieve the peak plasma concentration (Tmax) of from 20 to 480 minutes have been reported (pp. 405-409, Physician's Desk Reference, 54th edition, Medical Economics Company, Montvale, N.J., 2000).
Low DE pectins may be purchased commercially. An example of a low DE pectin which may be used in the present invention is SLENDID� 100, supplied by CP Kelco (Lille Skensved, Denmark) which has a degree of esterification of about 15 to 25%.
Solution Containing 1.57 mg/ml Fentanyl Citrate (Equivalent to 1 mg/ml Fentanyl Base) and 10 mg/ml Pectin
Solution Containing 1.57 mg/ml Fentanyl Citrate and 20 mg/ml Pectin
Solution Containing 1.57 mg/ml Fentanyl Citrate, 100 mg/ml Poloxamer 188 and 5 mg/ml Chitosan Glutamate
Solution Containing 6.28 mg/ml Fentanyl Citrate (Equivalent to 4 mg/ml Fentanyl Base) and 10 mg/ml Pectin
Preparation of Solution Containing 1.57 mg/ml Fentanyl Citrate
Preparation of Solution Containing 1.57 mg/ml Fentanyl Citrate and 5 mg/ml Chitosan Glutamate
Pharmacokinetic Performance of Fentanyl Intranasal Formulations in the Sheep
Pharmacokinetic Performance of Fentanyl Intranasal and Oral Transmucosal Formulations in Human Volunteers
A clinical study was performed to evaluate the pharmacokinetic performance of three intranasal fentanyl formulations and a transmucosal lozenge formulation (ACTIQ�, Elan Pharmaceuticals, United Kingdom).
The study was a randomized four-way complete cross-over trial in a group of 18 healthy adult volunteers. Intranasal doses were administered using Pfeiffer Unitdose devices. Each subject received a single spray into one nostril to provide a fentanyl dose of 0.1 mg. The ACTIQ� dose was provided as a lozenge containing 200 μg (0.2 mg) of fentanyl. The lozenge was administered by dissolving in the mouth over a period of approximately 15 minutes. Plasma samples were collected from the subjects and analyzed for fentanyl content using a LC-MS-MS assay. Pharmacokinetic parameters were calculated from the plasma data.
Cmax Bioavailability
Tmax (pg/
(pg/ml � h)
to ACTIQ � (%)
Nasal chitosan solution
Nasal pectin solution
Nasal poloxamer + chitosan
ACTIQ � (oral
transmucosal)
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