Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2002-11-07
2011-11-22
Vu, Jake M. (Department: 1618)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C514S522000
Reexamination Certificate
active
08062666
ABSTRACT:
The present invention relates to an extended release composition comprising as active compound Venlafaxine Hydrochloride, in which Venlafaxine Hydrochloride is coated on a non pareil inert core, which coated core is then coated with polymeric layer which enables the controlled release of the Venlafaxine Hydrochloride.
REFERENCES:
patent: 4389393 (1983-06-01), Schor et al.
patent: 4521401 (1985-06-01), Dunn
patent: 4786505 (1988-11-01), Lovgren et al.
patent: 4966768 (1990-10-01), Michelucci et al.
patent: 5232706 (1993-08-01), Palomo Coll
patent: 5472712 (1995-12-01), Oshlack et al.
patent: 5505983 (1996-04-01), Kamada
patent: 6149943 (2000-11-01), McTeigue et al.
patent: 6274171 (2001-08-01), Sherman et al.
patent: 6403120 (2002-06-01), Sherman et al.
patent: 6419958 (2002-07-01), Sherman et al.
patent: 6451350 (2002-09-01), Bartholomaeus et al.
patent: 6660300 (2003-12-01), Timmins et al.
patent: 6703044 (2004-03-01), Pinhasi et al.
patent: 7563456 (2009-07-01), Rafael De Souza et al.
patent: 7807195 (2010-10-01), Bhattacharya et al.
patent: 2003/0190354 (2003-10-01), Sela
patent: 2005/0169985 (2005-08-01), Bhattacharya et al.
patent: 2006/0121114 (2006-06-01), Antarkar et al.
patent: 2006/0182797 (2006-08-01), Karavas et al.
patent: 2009/0081286 (2009-03-01), Dixit et al.
patent: 2529393 (2010-08-01), None
patent: 0797991 (1997-10-01), None
patent: 0797991 (1997-10-01), None
patent: 0919236 (1999-02-01), None
patent: 0 919 236 (1999-06-01), None
patent: 94 27589 (1994-12-01), None
patent: EP 0919236 (1998-05-01), None
patent: WO 99/22724 (1999-05-01), None
patent: WO 9922724 (1999-05-01), None
patent: WO 00/71099 (2000-11-01), None
patent: WO 0071099 (2000-11-01), None
patent: 01/19901 (2001-03-01), None
patent: 02 102129 (2002-12-01), None
patent: 03 041692 (2003-05-01), None
patent: 2004/047718 (2004-06-01), None
patent: 2004/091580 (2004-10-01), None
patent: 2005/009414 (2005-02-01), None
patent: 2005/034930 (2005-04-01), None
patent: 2005/074895 (2005-08-01), None
FDA (Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products—General considerations (2002).
Dorland's Illustrated Medical Dictionary, 29th ed., Philadelphia, PA, W.B. Saunders Co, p. 599 (2000).
Dorland's Illustrated Medical Dictionary, 29th ed., Philadelphia, PA, W.B. Saunders Co, p. 636 (2000).
Ghebre-Sellassie “Multiparticulate oral drug delivery”, Drugs and the pharmaceutical sciences; v. 65 Chapters 5 and 10, pp. 78-111 and 218-283 (1994).
Colorcon publication “Surelease” (1990).
Porter et al. “Use of Opadry, Sureteric, and Surelease for the Aqueous Film Coating of Pharmaceutical Oral Dosage Forms” Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms / Drugs and the pharmaceutical sciences, Second Edition, Revised and Expanded, Marcel Dekker, Inc. v. 79, Chapter 9, pp. 327-372 (1997).
Ethocel Ethylcellulose Polymers Technical Handbook, Dow Cellulosics (2004).
Methocel Cellulose Ethers resources, Chemistry, Typical Chemical Structures of METHOCEL Products, Dow, http://www.dow.com/methocel/resource/chem.htm (downloaded Aug. 18, 2010).
Eudragit RL 30 D Online Publication, Evonik Industries, http://eudragit.evonik.com/product/eudragit/en/products-services/eudragit-products/sustained-release-formulations/rl-30-d/pages/default.aspx (downloaded Aug. 17, 2010).
Eudragit RS 30 D Online Publication, Evonik Industries, http://eudragit.evonik.com/product/eudragit/en/products-services/eudragit-products/sustained-release-formulations/rs-30-d/pages/default.aspx (downloaded Aug. 17, 2010).
(GMS) Mono-And Diglycerides, Prepared at the 17th JECFA (1973), published in FNP 4 (1978) and in FNP 52 (1992). Metals and arsenic specifications revised at the 55th JECFA (2000).
Orange Book: Approved Drug Products with Therapeutic Equivalent Evaluations., (Venlafaxine Hydrochloride) FDA online book: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm (downloaded Aug. 18, 2010).
Non-Final Office Action of Aug. 22, 2005, in U.S. Appl. No. 10/406,777.
Final Office Action of Apr. 11, 2006, in U.S. Appl. No. 10/406,777.
Non-Final Office Action of Dec. 28, 2006, in U.S. Appl. No. 10/406,777.
Non-Final Office Action of Sep. 20, 2007, in U.S. Appl. No. 10/406,777.
Dias et al., Investigation of a Venlafaxine HCI (37.5 mg) Extended Release Formulation Using Hypromellose (HPMC) Matrices, Methocel Application Data, http://www.colorcon.com [Online] (2006).
Gohel et al., “Advanced formulation design of venlafaxine hydrochloride coated and triple-layer tablets containing hypromellose”, Pharmaceutical Development and Technology; 14(6): 650-658 (2009).
Madhavi et al., “Formulation and Evaluation of Venlafaxine HCL Enclosed in Alginate Microbeads Prepared by Iontophoretic Gellation Method” International Journal of Pharma Research and Development, pp. 1-11, Publication Ref No. IJPRD/2009/PUB/ARTI/VOL-8/OCT/006 [Online], (2009).
Makhija et al., Once daily sustained release tablets of venlafaxine, a novel antidepressant. Eur J. Pharm Biopharm, 54(1):9-15 (2002).
Park et al., “Formulation of Sustained Release Granule for Venlafaxine-HCI Using Water-Insoluble Polymer” J. Kor. Pharm, Sci., vol. 37, No. 2, 101-106 (2007).
Public Assessment Report, Decentralised Procedure, “Ranfaxiran XL 37.5 mg, 75 mg and 150 mgprolonged release capsules, hard,” “RanfaxineXL 37.5 mg, 75 mg and 150 mg prolonged release, capsules, hard” PL 14894/0519-24, UK/H/1129/01-03DC, UK/H/1130/01-03DC, Medicines and Healthcare Products Regulatory Agency, Ranbaxy (UK) Limited, pp. 1-3, and 19-21 (2008).
Trixat XL 75 MG Prolonged Release Capsules, PL 10622/0280, Trixat XL 150 MG Prolonged Release Capsules, PL 10622/0281, Ukpar, Medicines and Healthcare Products Regulatory Agency, pp. 1-2, 5, 6 and 30-32 (2008).
Browdy and Neimark PLLC
Lycored Bio Ltd.
Vu Jake M.
LandOfFree
Extended release compositions comprising as active compound... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Extended release compositions comprising as active compound..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Extended release compositions comprising as active compound... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4269317