Compositions and dosage forms for gastric delivery of...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

Reexamination Certificate

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C424S464000, C424S451000, C424S452000, C424S457000

Reexamination Certificate

active

06881420

ABSTRACT:
The present invention provides oral dosage forms and compositions for administering antineoplastic agents, such as irinotecan, etoposide, paclitaxel, doxorubicin and vincristine, whose oral effectiveness is limited by pre-systemic and systemic deactivation in the GI tract. Gelling of the gastric retention vehicle composition, and in the case of solid forms concomitant expansion of the composition, retains the antineoplastic drug in the patient's stomach, minimizing pre-systemic and/or systemic deactivation of the drug.

REFERENCES:
patent: 2996431 (1961-08-01), Barry
patent: 3139383 (1964-06-01), Neville
patent: 3995058 (1976-11-01), Hammond et al.
patent: 4140755 (1979-02-01), Sheth et al.
patent: 4167558 (1979-09-01), Sheth et al.
patent: 4190672 (1980-02-01), Fahn
patent: 4434153 (1984-02-01), Urquhart et al.
patent: 4557925 (1985-12-01), Lindahl et al.
patent: 4704285 (1987-11-01), Alderman
patent: 4705651 (1987-11-01), Staibano
patent: 4721613 (1988-01-01), Urquhart et al.
patent: 4752470 (1988-06-01), Mehta
patent: 4756911 (1988-07-01), Drost et al.
patent: 4758436 (1988-07-01), Caldwell et al.
patent: 4764380 (1988-08-01), Urquhart et al.
patent: 4767627 (1988-08-01), Caldwell et al.
patent: 4853229 (1989-08-01), Theeuwes
patent: 4919938 (1990-04-01), Lovegrove et al.
patent: 4983398 (1991-01-01), Gaylord et al.
patent: 5007790 (1991-04-01), Shell
patent: 5051262 (1991-09-01), Panoz et al.
patent: 5198229 (1993-03-01), Wong et al.
patent: 5232704 (1993-08-01), Franz et al.
patent: 5560933 (1996-10-01), Soon-Shiong et al.
patent: 5599534 (1997-02-01), Himmelstein et al.
patent: 5674874 (1997-10-01), Hausheer et al.
patent: 5780057 (1998-07-01), Conte et al.
patent: 5837284 (1998-11-01), Mehta et al.
patent: 5840756 (1998-11-01), Cohen et al.
patent: 5958443 (1999-09-01), Viegas et al.
patent: 6120803 (2000-09-01), Wong et al.
patent: 6143326 (2000-11-01), Möckel et al.
patent: 6207197 (2001-03-01), Illum et al.
patent: 6261601 (2001-07-01), Talwar et al.
patent: 6271278 (2001-08-01), Park et al.
patent: 6340475 (2002-01-01), Shell et al.
patent: 20020136744 (2002-09-01), McGlynn et al.
patent: 0 761 209 (1997-03-01), None
patent: H4-346919 (1992-12-01), None
patent: WO 9811879 (1998-03-01), None
patent: WO 9904764 (1999-02-01), None
patent: WO 9932151 (1999-07-01), None
US 6,034,101, 3/2000, Gupta et al. (withdrawn)
John G. Kuhn, “Pharmacology of Irinotecan,” Oncology, vol. 12, No. 8, supplement No. 6, Aug. 1998, pp. 39-42.*
Hwang, Sung-Joo; Park, Haesun; Park, Kinam, “Gastric Retentive Drug-Delivery Systems”, Critical Reviews in Therapeutic Drug Carrier Systems, 1998, vol. 15, Issue 3, pp. 243-284.
Chen, Jun; Park Kinam, “Synthesis and characterization of superporous hydrogel composites”, Journal of Controlled Release 65, 2000, pp. 73-82.
The United States Pharmacopeia and The National Formulary, Jan. 1, 2000, 24/19, p. 2235 (1999).
Chen, Jun; Blevins, William E.; Park, Haesun; Park, Kinam, “Gastric retention properties of superporous hydrogel composites”, Journal of Controlled Release 64, 2000, pp. 39-51.
Thompson et al., “Efficacy of oral irinotecan against neuroblastoma xenografts,” Anti-Cancer Drugs, vol. 8, 1997, Rapid Science Publishers, pp. 313-322.
Stewart et al., “Disposition of irinotecan and SN-38 following oral and intravenous irinotecan dosing in mice,” Cancer Chemother Pharmacol (1997) 40, pp. 259-265.
Rothenberg et al., “Alternative Dosing Schedules for Irinotecan,” Oncology, vol. 12, No. 8, supplement No. 6, Aug. 1998, pp. 68-71.
Drengler et al., “Phase J and Pharmacokinetic Trial of Oral Irinotecan Administered Daily for 5 Days Every 3 Weeks in Patients With Solid Tumors,” Journal of Clinical Oncology, vol. 17, No. 2, Feb. 1999, pp. 685-696.
Bissery et al., “Experimental antitumor activity and pharmacokinetics of the camptothecin analog irinotecan (CPT-11) in mice,” Anti-Cancer Drugs, vol. 7, 1996, Rapid Science Publishers, pp. 437-460.
John G. Kuhn, “Pharmacology of Irinotecan,” Oncology, vol. 12, No. 8, supplement No. 6, Aug. 1998, pp. 39-42.
Choi et al., “Oral versus intraperitoneal administration of irinotecan in the treatment of human neuroblastoma in nude mice,” Cancer Letters 124, 1998; pp. 15-21.
Zamboni et al., “Altered Irinotecan and SN-38 Disposition after Intravenous and Oral Administration of Irinotecan in Mice Bearing Human Neuroblastoma Xenografts,” Clinical Cancer Reseach, vol. 4, Feb. 1998, pp. 455-462.
Beaulieu et al., “Comparative Assessment of P-Glycoprotein Expression in Mammalian Tissues by Immunoblotting,” IJBC, 1999, vol. 4, pp. 253-268.
Zamboni et al., “Studies of the Efficacy and Pharmacology of Irinotecan against Human Colon Tumor Zenograft Models,” Clinical Cancer Research, vol. 4, Mar. 1998, pp. 743-753.
Lowe et al. “Dependent Apoptosis Modulations the Cytotoxicity of Anticancer Agents,” Cell, vol. 74, Sep. 24, 1993, pp. 957-967.
Yusuke Tanigawara, “Role of P-Glycoprotein in Drug Disposition,” Therapeutic Drug Monitoring, 22: 137-140, 2000, Lippincott Williams & Williams, Inc.
Fisher et al., “MDR Expression in Normal Tissues,” Hematology/Onocology Clinics of North America, Drug Resistance in Clinical Oncology and Hematology, vol. 9, No. 2, Apr. 1995, pp. 319-337.
Hung Liang Tai, “Technology evalution: Valspodar, Novartis AG,” Current-Opinion in Molecular Therapeutics, 2000; 2/4 (459-467).
M.F. Fromm, “P-glycoprotein: a defense mechanism limiting oral bioavailability and CNS accumulation of drugs,” International Journal of Clinical Pharmacology and Therapeutics, vol. 38, No. 2/2000 (69-74).
DeMario et al., “Oral Chemotherapy: Rationale and Future Directions,” Journal of Clinical Oncology, vol. 16, No. 7 (Jul.), 1998: pp. 2557-2567.
Sparreboom et al., “Limited oral bioavailability and active epithelial excretion of paclitaxel (Taxol) caused by P-glycoprotein in the intestine,” Proc. Natl. Acad. Sci. USA, vol. 94, pp. 2031-2035, Mar. 1997 Pharacology, pp. 2031-2035.
Takehiko Kunimoto et al., “Antitumor Activity of 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxy-camptothecin, a Novel Water-soluble Derivative of Camptothecin, Against Murine Tumors,” Cancer Research, vol. 47, No. 22, Nov. 15, 1987, pp. 5944-5947.

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