Global Patent Index - EP 1765287 A2

EP 1765287 A2 20070328 - DRINKABLE IMMEDIATE RELEASE TABLET MADE WITH DIRECT COMPRESSION OF MEMANTINE OR NERAMEXANE

Title (en)

DRINKABLE IMMEDIATE RELEASE TABLET MADE WITH DIRECT COMPRESSION OF MEMANTINE OR NERAMEXANE

Title (de)

FORMULIERUNGEN FÜR DIE SOFORTIGE FREISETZUNG ORALER MEMANTIN-DARREICHUNGSFORMEN

Title (fr)

FORMULATIONS A LIBERATION IMMEDIATE DE FORMES DE DOSAGE ORAL DE MEMANTINE

Publication

EP 1765287 A2 20070328 (EN)

Application

EP 05857458 A 20050616

Priority

  • US 2005021284 W 20050616
  • US 58124404 P 20040617

Abstract (en)

[origin: WO2006096194A2] The present invention relates to an immediate release solid oral dosage form containing 1-aminocyclohexanes, preferably memantine or neramexane, and optionally a pharmaceutically acceptable coating, wherein the active ingredient exhibits dose proportionality and is released at a dissolution rate of more than about 80% within about the first 60 minutes following entry of said form into a use environment. The dosage form is direct compressed and has a hardness with the range of between about 3 and 40Kp, exhibits and average T <SUB>max </SUB>within the range of about 2 to about 8 hours with an active ingredient load within the range of about 2.5 to about 150 mg. The formulation allows for dose-proportional compositions for once daily or b.i.d. dosing, while maintaining a steady average of T <SUB>max</SUB>.

IPC 8 full level

A61K 9/20 (2006.01); A61K 31/13 (2006.01)

CPC (source: EP KR)

A61K 9/0095 (2013.01 - EP); A61K 9/20 (2013.01 - KR); A61K 9/2013 (2013.01 - EP); A61K 9/2054 (2013.01 - EP); A61K 9/2095 (2013.01 - EP); A61K 9/28 (2013.01 - KR); A61K 31/13 (2013.01 - EP KR); A61K 31/40 (2013.01 - EP); A61P 25/00 (2017.12 - EP); A61P 25/28 (2017.12 - EP); Y02A 50/30 (2017.12 - EP)

Citation (search report)

See references of WO 2006096194A2

Citation (examination)

  • DE 4014672 A1 19911114 - MUELLER WERNER E G PROF DR [DE], et al
  • USPTO document for application number US11/457,182 - Mail Date: 28.11.2008
  • WIRTH D D ET AL: "Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine.", JOURNAL OF PHARMACEUTICAL SCIENCES JAN 1998, vol. 87, no. 1, January 1998 (1998-01-01), pages 31 - 39, ISSN: 0022-3549
  • EYJOLFSSON R: "Lisinopril-lactose incompatibility.", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY AUG 1998, vol. 24, no. 8, August 1998 (1998-08-01), pages 797 - 798, ISSN: 0363-9045
  • CASTELLO R A ET AL: "Discoloration of tablets containing amines and lactose.", JOURNAL OF PHARMACEUTICAL SCIENCES FEB 1962, vol. 51, February 1962 (1962-02-01), pages 106 - 108, ISSN: 0022-3549
  • ABDOH A ET AL: "Amlodipine besylate-excipients interaction in solid dosage form.", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 2004, vol. 9, no. 1, 2004, pages 15 - 24, ISSN: 1083-7450
  • HARMON P A ET AL: "Liquid chromatography-mass spectrometry and proton nuclear magnetic resonance characterization of trace level condensation products formed between lactose and the amine-containing diuretic hydrochlorothiazide.", JOURNAL OF PHARMACEUTICAL SCIENCES JUL 2000, vol. 89, no. 7, July 2000 (2000-07-01), pages 920 - 929, ISSN: 0022-3549
  • Center for Drug Evaluation and Research; Approval Package for: Application Number 21-487; Clinical and Pharmacology and Biopharmaceutics Review
  • Guidance for Industry; Waiver for In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based in a Biopharmaceutics Classification System
  • "Scientific Discussion for the Approval of Axura", 21 October 2005 (2005-10-21), Retrieved from the Internet <URL:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000378/WC500029674.pdf> [retrieved on 20121112]

Citation (third parties)

Third party :

  • DE 4014672 A1 19911114 - MUELLER WERNER E G PROF DR [DE], et al
  • WIRTH D.D. ET AL: "Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine.", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 87, no. 1, 1 January 1998 (1998-01-01), AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US, pages 31 - 39, XP002248910, DOI: 10.1021/js9702067
  • ABDOH A. ET AL: "AMLODIPINE BESYLATE-EXCIPIENTS INTERACTION IN SOLID DOSAGE FORM", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 9, no. 1, 1 January 2004 (2004-01-01), NEW YORK, NY, US., pages 15 - 24, XP008034356, DOI: 10.1081/PDT-120027414
  • CASTELLO R.A. ET AL: "Discoloration of tablets containing amines and lactose", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 51, no. 2, 1 February 1962 (1962-02-01), AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US., pages 106 - 108, XP002987850, DOI: 10.1002/jps.2600510204
  • HARMON P.A. ET AL: "Liquid Chromatography-Mass Spectrometry and Proton Nuclear Magnetic Resonance Characterization of Trace Level Condensation Products Formed Between Lactose and the Amine-Containing Diuretic Hydrochlorothiazide.", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 89, no. 7, July 2000 (2000-07-01), pages 920 - 929, XP003030856
  • EYJOLFSSON R.: "Lisinopril-Lactose Incompatibility.", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, vol. 24, no. 8, 1998, pages 797 - 798, XP003030857
  • Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid oral Dosage Forms Based on a Bopharmaceutics Classification System. August 2000 (FDA)
  • Scientific Discussion 2004 (Emea)

Designated contracting state (EPC)

AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR

Designated extension state (EPC)

AL BA HR LV MK YU

DOCDB simple family (publication)

WO 2006096194 A2 20060914; WO 2006096194 A3 20071122; WO 2006096194 A8 20061116; WO 2006096194 A8 20070111; AU 2005328701 A1 20060914; AU 2005328701 B2 20090813; BR PI0512263 A 20080226; CA 2568445 A1 20060914; CA 2568445 C 20110524; CN 101389315 A 20090318; EA 011290 B1 20090227; EA 200700055 A1 20071026; EP 1765287 A2 20070328; EP 2397122 A2 20111221; EP 2397122 A3 20120125; EP 2397122 B1 20140514; EP 2601937 A1 20130612; ES 2483126 T3 20140805; IL 179992 A0 20070515; IL 179992 A 20120229; JP 2008509089 A 20080327; JP 5025468 B2 20120912; KR 20090033410 A 20090402

DOCDB simple family (application)

US 2005021284 W 20050616; AU 2005328701 A 20050616; BR PI0512263 A 20050616; CA 2568445 A 20050616; CN 200580019878 A 20050616; EA 200700055 A 20050616; EP 05857458 A 20050616; EP 11179637 A 20050616; EP 13153135 A 20050616; ES 11179637 T 20050616; IL 17999206 A 20061211; JP 2007516731 A 20050616; KR 20097005872 A 20090323