CA2384624A1 - Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing - Google Patents

Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing Download PDF

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Publication number
CA2384624A1
CA2384624A1 CA002384624A CA2384624A CA2384624A1 CA 2384624 A1 CA2384624 A1 CA 2384624A1 CA 002384624 A CA002384624 A CA 002384624A CA 2384624 A CA2384624 A CA 2384624A CA 2384624 A1 CA2384624 A1 CA 2384624A1
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CA
Canada
Prior art keywords
reboxetine
dosage form
methods
semipermeable membrane
sustained release
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
Application number
CA002384624A
Other languages
French (fr)
Other versions
CA2384624C (en
Inventor
Sylvia Seroff
Noymi Yam
Atul D. Ayer
Padmanabh Bhatt
Michael A. Desjardin
Andrew C. Lam
David E. Edgren
Phillip R. Nixon
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.)
Alza Corp
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2384624A1 publication Critical patent/CA2384624A1/en
Application granted granted Critical
Publication of CA2384624C publication Critical patent/CA2384624C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61P25/24—Antidepressants
    • 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

Dosage forms and methods for providing sustained release of reboxetine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma reboxetine concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma reboxetine concentration occurrence in each 24 hour period. In addition, the peak plasma reboxetine concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma reboxetine concentration that occurs following administration of reboxetine in an immediate-release dosage form.

Claims (27)

1. A sustained release dosage form adapted to release reboxetine at a uniform rate over a prolonged period of time.
2. The dosage form of Claim 1 wherein the prolonged period of time is four hours or greater.
3. The dosage form of Claim 1 wherein the uniform rate is at least about 0.2 mg/hr.
4. The dosage form of Claim 1 wherein the sustained release dosage form has a T90 of at least about 8 hours.
5. The dosage form of Claim 4 wherein release of reboxetine is achieved through one or more methods associated with the group of methods including osmotic methods, diffusion methods, dissolution methods and ion-exchange methods.
6. The dosage form of Claim 1 wherein the sustained release dosage form is an osmotic composition comprising a reboxetine-containing component admixed with an osmotic agent within an internal compartment, said internal compartment defined by a semipermeable membrane through which reboxetine is delivered via a delivery orifice formed or formable in said semipermeable membrane.
7. The dosage form of Claim 1 wherein the sustained release dosage form is an osmotic composition comprising a reboxetine-containing component and a swellable polymer component within an internal compartment defined by a semipermeable membrane through which reboxetine is delivered via a delivery orifice formed or formable in said semipermeable membrane.
8. The dosage form described in claim 7 wherein the reboxetine-containing component and the swellable polymer component within the internal compartment are configured as adjacent layers and the delivery orifice is formed through the semipermeable membrane at a location adjacent to the reboxetine-containing component.
9. The dosage form described in claim 7 comprising a barrier layer, the reboxetine-containing component and the swellable polymer component being separated by the barrier layer within the internal compartment and the delivery orifice being formed through the semipermeable membrane at a location adjacent to the reboxetine-containing core.
10. The dosage form described in claim 9 comprising an inner wall between the semipermeable membrane and the reboxetine-containing component, the barrier layer and the swellable polymer component, the delivery orifice being formed through the semipermeable membrane and the inner wall at a location adjacent to the reboxetine-containing core.
11. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering to the subject a sustained release dosage form adapted to release reboxetine at a uniform rate over a prolonged period of time.
12. The method of Claim 11 wherein the prolonged period of time is four hours or greater.
13. The method of Claim 11 wherein the uniform rate is at least about 0.2 mg/hr.
14. The method of Claim 11 wherein the sustained release dosage form has a T90 of at least about 8 hours.
15. The method of claim 11 wherein said dosage form is administered once a day.
16. The method of Claim 15 wherein release of reboxetine is achieved through one or more methods associated with the group of methods including osmotic methods, diffusion methods, dissolution methods and ion-exchange methods.
17. A method of treating a condition in a subject responsive to reboxetine, the method comprising administering a reboxetine dose once per day in a sustained release dosage form that produces a therapeutically effective average steady-state plasma reboxetine concentration.
18. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering a reboxetine dosage form that produces a steady-state peak plasma reboxetine concentration at a time at least 4 hours following dose administration.
19. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form to produce one peak plasma reboxetine concentration during each 24-hour period.
20. A method of treating a condition in a subject responsive to reboxetine, the method comprising orally administering reboxetine in a dosage form that provides steady-state C max/dose ratios of less than about 30 and more preferably less than about 25.
21. A dosage form adapted for sustained drug delivery over a prolonged period of time comprising reboxetine and a carbohydrate.
22. The dosage form of claim 21 wherein the carbohydrate is selected from the group consisting of maltodextrin, lactose, dextrose, sucrose, mannitol, and sorbitol.
23. The dosage form of claim 22 comprising reboxetine and maltodextrin having a dextrose equivalence (DE) of 20 or less.
24. The dosage of claim 23 wherein the maltodextrin has a dextrose equivalence (DE) of 9-20.
25. The dosage form of claim 21 formed as a tablet compressed under a force of 3500 newtons or greater.
26. A composition comprising reboxetine and maltodextrin.
27. The composition of claim 25 formed as a compressed composition under a force of 3500 newtons or greater.
CA002384624A 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing Expired - Lifetime CA2384624C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15399799P 1999-09-15 1999-09-15
US60/153,997 1999-09-15
PCT/US2000/025333 WO2001019337A2 (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing

Publications (2)

Publication Number Publication Date
CA2384624A1 true CA2384624A1 (en) 2001-03-22
CA2384624C CA2384624C (en) 2009-12-29

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002384624A Expired - Lifetime CA2384624C (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing

Country Status (13)

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US (2) US6387403B1 (en)
EP (1) EP1216031B1 (en)
JP (1) JP2003509354A (en)
KR (2) KR100831181B1 (en)
AR (1) AR031978A1 (en)
AT (1) ATE356619T1 (en)
AU (1) AU7490700A (en)
CA (1) CA2384624C (en)
CO (1) CO5210862A1 (en)
DE (1) DE60033947T2 (en)
PE (1) PE20010625A1 (en)
TW (1) TWI233809B (en)
WO (1) WO2001019337A2 (en)

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Also Published As

Publication number Publication date
KR20020031424A (en) 2002-05-01
WO2001019337A2 (en) 2001-03-22
JP2003509354A (en) 2003-03-11
PE20010625A1 (en) 2001-06-04
CA2384624C (en) 2009-12-29
AU7490700A (en) 2001-04-17
KR100723850B1 (en) 2007-05-31
ATE356619T1 (en) 2007-04-15
EP1216031B1 (en) 2007-03-14
US6387403B1 (en) 2002-05-14
KR20070007215A (en) 2007-01-12
WO2001019337A3 (en) 2001-08-09
TWI233809B (en) 2005-06-11
AR031978A1 (en) 2003-10-22
US20020146453A1 (en) 2002-10-10
CO5210862A1 (en) 2002-10-30
DE60033947T2 (en) 2007-11-29
DE60033947D1 (en) 2007-04-26
KR100831181B1 (en) 2008-05-21
EP1216031A2 (en) 2002-06-26
US6630165B2 (en) 2003-10-07

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Effective date: 20200915