Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reissue Patent
1999-10-20
2010-02-23
Wang, Shengjun (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S458000, C424S468000, C424S469000, C424S470000, C424S471000, C424S472000, C514S649000
Reissue Patent
active
RE041148
ABSTRACT:
A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.
REFERENCES:
patent: 2099402 (1937-11-01), Keller
patent: 2738303 (1956-03-01), Blythe
patent: 3048526 (1962-08-01), Boswell
patent: 3365365 (1968-01-01), Butler et al.
patent: 3979349 (1976-09-01), Fink
patent: 4049791 (1977-09-01), Cohen
patent: 4723958 (1988-02-01), Pope et al.
patent: 4728512 (1988-03-01), Mehta et al.
patent: 4765989 (1988-08-01), Wong et al.
patent: 4794001 (1988-12-01), Mehta et al.
patent: 4871549 (1989-10-01), Veda et al.
patent: 4891230 (1990-01-01), Geoghegan et al.
patent: 4894240 (1990-01-01), Geoghegan et al.
patent: 4902516 (1990-02-01), Korsatko et al.
patent: 4917899 (1990-04-01), Geoghegan et al.
patent: 5002776 (1991-03-01), Geoghegan et al.
patent: 5011692 (1991-04-01), Fujioka et al.
patent: 5011694 (1991-04-01), Nuernberg et al.
patent: 5051262 (1991-09-01), Panoz et al.
patent: 5093200 (1992-03-01), Watanabe et al.
patent: 5137733 (1992-08-01), Noda et al.
patent: 5202159 (1993-04-01), Chen et al.
patent: 5226902 (1993-07-01), Bae et al.
patent: 5229131 (1993-07-01), Amidon et al.
patent: 5260068 (1993-11-01), Chen
patent: 5260069 (1993-11-01), Chen
patent: 5275819 (1994-01-01), Amer et al.
patent: 5312388 (1994-05-01), Wong et al.
patent: 5364620 (1994-11-01), Geoghegan et al.
patent: 5378474 (1995-01-01), Morella et al.
patent: 5395628 (1995-03-01), Noda et al.
patent: 5407686 (1995-04-01), Patel et al.
patent: 5411745 (1995-05-01), Oshlack et al.
patent: 5422121 (1995-06-01), Lehmann et al.
patent: 5474786 (1995-12-01), Kotwal et al.
patent: 5496561 (1996-03-01), Okada et al.
patent: 5541170 (1996-07-01), Rhodes et al.
patent: 5616345 (1997-04-01), Geoghegan et al.
patent: 5618559 (1997-04-01), Desai et al.
patent: 5733575 (1998-03-01), Mehra et al.
patent: 5800836 (1998-09-01), Morella et al.
patent: 5824341 (1998-10-01), Seth et al.
patent: 5824342 (1998-10-01), Cherukuri et al.
patent: 5824343 (1998-10-01), Ng et al.
patent: 5837284 (1998-11-01), Mehta et al.
patent: 5840329 (1998-11-01), Bai
patent: 5885616 (1999-03-01), Hsiao et al.
patent: 5885998 (1999-03-01), Bencherif et al.
patent: 5891474 (1999-04-01), Busetti et al.
patent: 6322819 (2001-11-01), Burnside et al.
patent: 6605300 (2003-08-01), Burnside et al.
patent: 6749867 (2004-06-01), Robinson et al.
patent: 6764696 (2004-07-01), Pather et al.
patent: 2004/0059002 (2004-03-01), Couch et al.
patent: 109438 (1940-01-01), None
patent: 640 337 (1995-03-01), None
patent: 59-082311 (1984-05-01), None
patent: 03-148215 (1991-06-01), None
patent: 07-061922 (1995-03-01), None
patent: 09-249557 (1997-09-01), None
patent: 09-267035 (1997-10-01), None
patent: 10-081634 (1998-03-01), None
patent: WO87/00044 (1987-01-01), None
patent: WO90/09168 (1990-08-01), None
patent: WO-97/03673 (1997-02-01), None
patent: WO-98/14168 (1998-04-01), None
patent: WO-99/03471 (1999-01-01), None
patent: WO-00/25752 (2000-05-01), None
patent: WO-00/35450 (2000-06-01), None
US 6,034,101, 3/2000, Gupta et al. (withdrawn)
Complaint for Declaratory Judgment,Impax Laboratories, Inc.v.Shire International Laboratories, Inc.(Civ. Action No. 05772) and Exhibits attached thereto.
Fukumori, Coating of Multiparticulates Using Polymeric Dispersions, Multiparticulate Oral Drug Delivery (Swarbrick and Selassie eds. 1994), 79-110.
Bodmeier et al., The Influence of Buffer Species and Strength on Dittiazem HCl Release from Beads Coated with the Aqueous Cationic Polmer Dispersions, Eudraglt RS, RL 30D, Pharmaceutical Research vol. 13, No. 1, 1996, 52-56.
Shire Laboratories Inc.'s Opposition to Barr Laboratories' Motion to Amend Its Answers and Counterclaims, Sep. 15, 2004.
Chan, Materials Used for Effective Sustained-Release Products, Proceedings of the International Symposium held on Jan. 29-31, 1987 (The Bombay College of Pharmacy 1988), 69-84.
PDR Drug Information for Ritalin LA Capsules, Apr. (2004).
Greenhill et al., A Pharmacokinetic/Pharmacodynamic Study Comparing a Single Morning Dose of Adderall to Twice-Daily Dosing in Children with ADHD. J. Am. Acad. Adolesc. Psychiatry, 42:10, Oct. 2003.
Teva Notice letter: Feb. 21, 2005.
Bauer, et al., Cellulose Acetate Phthalate (CAP) and Trimellitate (CAT), Coated Pharmaceutical Dosage Forms (1998), 102-104.
Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms (1997).
Treatise on Controlled Drug Delivery, pp. 285-299 (Agis Kydonieus ed. 1992).
Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (1997).
Wouessidjewe, Aqueous polymethacrylate Dispersions as Coating Materials for Sustained and Enteric Release Systems, S.T.P. Pharma Sciences 7(6) 469-475 (1997).
Adderall XR Package Inset, Sep. (2004).
Marcotte et al., Kinetics of Protein Diffusion from a Poly(D,L-Lactide) Reservoir System, Journal of Pharmaceutical Sciences, vol. 79, No. 5, May 1990.
Guo Deposition Transcript, Jan. 24, 2005.
Watano, et al., Evaluation of Aqueous Enteric Coated Granules prepared by Moisture Control Method in Tumbling Fluidized Bed Process, Chem. Pharm. Bull. 42(3) 663-667 (1994).
Schaffer Deposition Transcript, Aug. 17, 2005.
Rambali, et al., Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale, International Journal of Pharmaceutics 220 (2001) 149-160.
Treacy Deposition Transcript, Aug. 31, 2004.
Tulloch, et al., SL1381 (Adderall XR), a Two-component, Extended-Release Formulation of Mixed Amphetamine Salts: Bioavailability of Three Test formulatons and Comparison of Fasted, Fed, and Sprinkled Administration, PHARMACOTHERAPY vol. 22, No. 11. (2002), 1405-1415.
Chang Deposition Transcript, Sep. 8, 2004.
Edward Stempel, Prolonged Drug Action, HUSA's Pharmaceutical Dispensing, Sixth Edition, 1966, 464, 481-485.
McGuiness Deposition Transcript, Aug. 6, 2004.
Remington's Pharmaceutical Sciences, RPS XIV, 1700-1714.
Fiske Deposition Transcript, Sep. 17, 2004.
Vasilevska, et al., Preparation and Dissolution Characteristics of Controlled Release Diltiazem Pellets, Drug Development and Industrial Pharmacy, 18(15), 1649-1661 (1992).
Opening Expert Report of Dr. Walter Chambliss and exhibits thereto, Mar. 15, 2005.
Agyilirah GA and Bauker SB, Polymers for Enteric Coating Applications, Polymers for Controlled Drug Delivery (Peter J. Tarcha ed. 1991) 39-66.
Impax Laboratories, Inc.'s First Amended Answer and Affirmative Defenses.
Moller, Dissolution Testing of Delayed Release Preparations, Proceedings of the International Symposium held on Jan. 29-31, 1987 (The Bombay College of Pharmacy 1988), 85-111.
Impax Laboratories, Inc.'s Reply Memorandum in Support of the Motion to Amend its Answer dated Mar. 18, 2005 and exhibits thereto.
Stevens, et al., Controlled, Multidose, Pharmacokinetic Evaluation of Two Extended-Release Carbamazepine Formulations (Carbatrol and Tegretol-XR), Journal of Pharmaceutical Sciences vol. 87, No. 12, Dec. 1998, 1531-1534.
Deposition transcript of Honorable Gerald J. Mossinghoff and exhibits thereto.
Physicians' Desk Reference: Adderall, 51st Ed. (1997).
Expert Report of Dr. Joseph R. Robinson and exhibits thereto, Feb. 28, 2005.
Sriamornsak, et al., Development of sustained release theophylline pellets coated with calcium pectinate, Journal of Controlled Release 47 (1997) 221-232.
Answering Expert Report of Dr. Alexander Klibanov, Apr. 25, 2005.
Sprowls' American Pharmacy: An Introduction to Pharmaceutical Techniques and Dosage Forms, 7th Ed. (1974), 387-388.
Barr Laboratories' Objections and Responses to Plaintiff Shire Laboratories
Burnside Beth A.
Chang Rong-Kun
Couch Richard A.
Fiske Kimberly
Guo Xiaodi
McDermott Will & Emery LLP
Shire Laboratories Inc.
Wang Shengjun
LandOfFree
Oral pulsed dose drug delivery system does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Oral pulsed dose drug delivery system, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Oral pulsed dose drug delivery system will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4190074