Modified release formulations of memantine oral dosage forms

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form

Reexamination Certificate

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C514S766000

Reexamination Certificate

active

08039009

ABSTRACT:
The present invention provides pharmaceutical compositions given once daily containing at least one therapeutically active ingredient selected from the group consisting of memantine and a pharmaceutically acceptable salt of memantine, and a pharmaceutically acceptable polymeric matrix carrier. The dosage forms of the invention sustain the release of the therapeutically active agent from about 4 to about 24 hours when said dosage form is exposed to aqueous solutions. following entry of said form into a use environment, wherein said dosage form has a dissolution rate of more than about 80% after passage of about 6 hours to about 12 hours following said entry into said use environment.

REFERENCES:
patent: 4122193 (1978-10-01), Scherm et al.
patent: 4273774 (1981-06-01), Scherm
patent: 5007790 (1991-04-01), Shell
patent: 5061703 (1991-10-01), Bormann et al.
patent: 5334618 (1994-08-01), Lipton
patent: 5382601 (1995-01-01), Nürnberg et al.
patent: 5506231 (1996-04-01), Lipton
patent: 5582837 (1996-12-01), Shell
patent: 5614560 (1997-03-01), Lipton
patent: 5972389 (1999-10-01), Shell et al.
patent: 6034134 (2000-03-01), Gold et al.
patent: 6071966 (2000-06-01), Gold et al.
patent: 6194000 (2001-02-01), Smith et al.
patent: 6413556 (2002-07-01), Bathurst et al.
patent: 6444702 (2002-09-01), Wang et al.
patent: 6479553 (2002-11-01), McCarthy
patent: 2004/0102525 (2004-05-01), Kozachuk
patent: 2005/0245617 (2005-11-01), Meyerson et al.
patent: 2006/0002999 (2006-01-01), Yang et al.
patent: 2006/0142398 (2006-06-01), Went et al.
patent: 2007/0065512 (2007-03-01), Dedhiya et al.
patent: 2009/0247644 (2009-10-01), Dedhiya et al.
patent: 0284849 (1988-10-01), None
patent: WO-96/26718 (1996-09-01), None
patent: WO-98/55107 (1998-12-01), None
patent: WO 02/45710 (2002-06-01), None
Hartmann et al ‘Tolerability of memantine in combination with cholinesterase inhibitors in dementia therapy’ International Clinical Psychopharmacology, 18(2), p. 81-85, 2003.
Tariot et al ‘Memantine Treatment in Patients with Moderate to Severe Alzheimer's Disease Already Receiving Donepezil’ JAMA, 291(3), p. 317-324, Jan. 2004.
International Search Report mailed on Oct. 6, 2005 for corresponding Application No. PCT/US2005/021260.
Parsons et al.,Neuropharmacology; 38(6):735-767 (1999).
FDA Guidelines (Dissolution Testing of Immediate Release Solid Oral Dosage Forms, issued, Section IV-A) (Aug. 1997).
Guidance for Industry, “Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations”, Food and Drug Administration, CDER, p. 17, (Sep. 1997).
Guidance for Industry, “Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations,” Food and Drug Administration, CDER, p. 4 (Sep. 1997).
Guidance for Industry,: “Modified Release Solid Oral Dosage Forms,” Food and Drug Administration, CDER, p. 6, (Sep. 1997).
Multisource Pharmaceutical Products: Guidelines on Registration Requirements to establish Interchangeability, Quality Assurance and Safety: Medicines, Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland, pp. 11-12 (2004).
U.S. Pharmacopoeia and National Formulary, USP XXIV / NF 19, Chapter 1088, pp. 2051-2056 (2000).
U.S. Pharmacopoeia and National Formulary, USP XXIV / NF 19, Chapter 711, pp. 1941-1943 (2000).
Reisberg Barry et al: “Memantine in moderate-to-severe Alzheimer's disease.” The New England Jouunal of Medicine. Apr. 3, 2003, vol. 348, No. 14, Apr. 3, 2003, pp. 1333-1341, XP009054230, ISSN: 1533-4406, abstract.
Suzuki Rie et al: “Comparison of the effects of MK-801, ketamine and memantine on responses of spinal dorsal horn neurones in a rat model of mononeuropathy”, PAIN, vol. 91, No. 1-2, Mar. 2001, pp. 101-109, XP002346013, ISSN: 0304-3959, abstract, p. 107, col. 2, paragraph 2 & p. 108, col. 1, paragraph 3.
First Action Interview Pilot Program Pre-Interview Communication for U.S. Appl. No. 11/424,024 mailed Dec. 17, 2009.
Response to Pre-Interview Communication for U.S. Appl. No. 11/424,024, filed Jan. 6, 2010.
Interview Summary, date of interview Jan. 22, 2010 for U.S. Appl. No. 11/424,024 mailed Feb. 1, 2010.
First Action Interview Office Action Summary for U.S. Appl. No. 11/424,024 mailed Feb. 1, 2010.
Interview Summary, date of interview Feb. 16, 2010 for U.S. Appl. No. 11/424,024 mailed Feb. 24, 2010.
Response to First Action Interview Office Action Summary for U.S. Appl. No. 11/424,024, filed Feb. 16, 2010.
Final Office Action for U.S. Appl. No. 11/424,024 mailed Jun. 3, 2010.
Response to Final Office Action for U.S. Appl. No. 11/424,024, filed Aug. 18, 2010.
International Search Report mailed on Oct. 19, 2006 for PCT/US2006/022841 corresponding to U.S. Appl. No. 11/424,024.

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