Details for Patent: 8,975,273

Title:	Controlled release hydrocodone formulations
Abstract:	A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C.sub.12/C.sub.max ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.
Inventor(s):	Oshlack; Benjamin (New York, NY), Huang; Hua-Pin (Englewood Cliffs, NJ), Masselink; John (Old Tappan, NJ), Tonelli; Alfred P. (Congers, NY)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Filing Date:	Sep 11, 2014
Application Number:	14/483,395
Claims:	1. cited by applicant . Drugs Jan. 1999; 57(1 ):93-9. cited by applicant . Johnson, Sarah J., "Opioid Safety in Patients With Renal or Hepatic Dysfunction" Pain Treatment Topics pp. 1-9 (Release date Jun. 2007; updated Nov. 30, 2007). cited by applicant . Emami, J. et al, "In vitro-In vivo Correlation: From Theory to Applications", J. Pharm Pharmaceut Sci, (www.cspsCanada.org) 9 (2), 169-189, 2006. cited by applicant . Lippold, B. C., Constant or Pulsed Delivery of Active Substance?, Pharmacie in uns Zeit, Jan. 1990, 13-31, No. 1. cited by applicant . Clin. Neuropharmacol Jan.-Feb. 1999; 22 (1):33-9). cited by applicant . Clin. Phannacokinet Sep. 1998; 35(3):173-90. cited by applicant . Conte. et al., Drug Del.. Ind. Pharm. (1989) 15:2583-2596. cited by applicant . J. Control Release Aug. 5, 1999; 60(2-3):391-7. cited by applicant . J. Pharm. Pharmacol Dec. 1996; 48(12):1276-84. cited by applicant . J. Pharm. Sci. Feb. 1993; 82(2):113-26. cited by applicant . Zimm et al., Pharmaceutical Development and Technology, 1(1), 37-42 (1996) "Drug Release from a Multiparticulate Pallet System". cited by applicant . Thomsen, L. Juul, "Prolonged Release Matrix Pellets Prepared by Melt Pelletization. Part IV: Drug Particles Size, and Binder Composition," Pharmaceutical Technology Europa, pp. 19-24 (Oct. 1994). cited by applicant . Gourlay, et al., "Once A Day (i.e. 24 Hourly) Kapanol.TM., A New Sustained Release Morphine Formulation, In the Treatment of Cancer Pain: Pharmacokinetic Aspects," European Journal of Cancer; Part A General Topics 1995:31 (S5) Suppl: S187 Abs 897, European Conference on Clinical Oncology and Cancer Nursing, Paris, Oct. 29-Nov. 2, 1995. cited by applicant . Applicant-Initiated Interview Summary issued in connection with U.S. Appl. No. 13/833,263 on Nov. 3, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 13/833,263 on Oct. 7, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 13/833,263 on Jun. 23, 2014. cited by applicant . Applicant-Initiated Interview Summary issued in connection with U.S. Appl. No. 13/833,263 on May 12, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 13/833,263 on Feb. 6, 2014. cited by applicant . Advisory Action issued in connection with U.S. Appl. No. 12/982,386 on Oct. 9, 2014. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Aug. 13, 2014. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Feb. 26, 2014. cited by applicant . Advisory Action issued in connection with U.S. Appl. No. 12/982,386 on Dec. 19, 2014. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Sep. 4, 2014. cited by applicant . Claims pending in U.S. Appl. No. 14/094,968 on Nov. 17, 2014. cited by applicant . Claims pending in U.S. Appl. No. 13/833,263 on Nov. 17, 2014. cited by applicant . Claims pending in U.S. Appl. No. 12/982,386 on Nov. 17, 2014. cited by applicant . Claims pending in U.S. Appl. No. 14/520,032 on Nov. 17, 2014. cited by applicant . Decision to refuse a European Patent application issued in connection with European patent application No. 01992565.0-1464 on Jun. 27, 2014. cited by applicant . Decision to refuse a European Patent application issued in connection with European patent application No. 10 180 984.6-1464 on Jul. 9, 2014. cited by applicant . Office Action issued in connection with Japanese patent application No. 2013-168584 on Sep. 16, 2014. cited by applicant . Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/ In Vivo Correlations; US Dept. of Health and Human Services Food and Drug Administration; Center for Drug Evaluation and Research (CDER), Sep. 1997, pp. 1-24. cited by applicant . Giunchedi et al., J. Pharm. (1991) 77:177-181. cited by applicant . Eur. J. Pharm. Sci. Jul. 1999; 8(3):157-9. cited by applicant . Shah et al., J. Cont. Rel. (1989) 9:169-175. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Apr. 30, 2013. cited by applicant . Applicant-Initiated Interview Summary issued in connection with U.S. Appl. No. 12/982,386 on Apr. 18, 2013. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Nov. 5, 2012. cited by applicant . Office Action issued in in connection with U.S. Appl. No. 12/982,386 on Apr. 10, 2012. cited by applicant . Applicant-Initiated Interview Summary issued in connection with U.S. Appl. No. 14/094,968 on Nov. 5, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 14/094,968 on Oct. 3, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 14/094,968 on Jun. 24, 2014. cited by applicant . Applicant-Initiated Interview Summary issued in connection with U.S. Appl. No. 14/094,968 on May 9, 2014. cited by applicant . Office Action issued in connection with U.S. Appl. No. 14/094,968 on Feb. 6, 2014. cited by applicant . Brendenberg "New Concepts in Administration of Drugs in Tablet Form: Formulation and Evaluation of a Sublingual Tablet for Rapid Absorption and Presentation of an Individualized Dose Administration System Acta Universitiatis Upsaliensis." Comprehensive Summaries of Uppsa/a Dissertations from the Faculty of Pharmacy 287 83 pp. Uppsala ISBN 91-554-5600-6 (2003). cited by applicant . Frohof-Hulsmann et al., "Aqueous Ethyl Cellulose Dispersion Containing Plasticizers of Different Water Solubility and Hydroxypropyl Methyl-Cellulose as Coating Material for Diffusion Pellets II: Properties of Sprayed Films", European Journ. of Pharma and Biopharma., vol. 48, pp. 67-75, 1999. cited by applicant . Gustafsson et al., "Characterisation of Particle Properties and Compaction Behaviour of Hydroxypropyl Methylcellulose with Different Degrees of Methoxy/Hydroxypropyl Substitution", EP Journ of Pharmaceutical Sci. 9, pp. 171-184, 1999. cited by applicant . Hyppola et al.,"Evaluation of Physical Properties of Plasticized Ethyl Cellulose Films Cast From Ethanol Solution Part 1", International Journ. of Pharma., vol. 133, pp. 161-170, 1996. cited by applicant . Physician's Desk Reference 57th ed. 2003 p. 1184-1185 (package insert information for ACTIQ). cited by applicant . Portenoy et al. "Fentanyl Buccal Tablet (FBT) for Relief of Breakthrough Pain in Opioid-Treated Patients with Chronic Low Back Pain: A Randomized, Placebo- Controlled Study", ASRA 06, Final Abstract, Submitted Aug. 4, 2007. cited by applicant . Portenoy et al. "Fentanyl Buccal Tablet (FBT) for Relief of Breakthrough Pain in Opioid-Treated Patients with Chronic Low Back Pain", Current Medical Research and Opinion, vol. 23(7), pp. 223-233, 2007. cited by applicant . Siepmann et al., "A New Model Describing the Swelling and Drug Release Kinetics from Hydroxypropyl Methylcellulose Tablets", Journ. of Pharmaceutical Sciences, vol. 88, No. 1, pp. 65-72, Jan. 1999. cited by applicant . Sung et al., "Effect of Formulation Variables on Drug and Polymer Release from HPMC-Based Matrix Tablets", International Journ. of Pharmaceutics vol. 142, pp. 53-60, 1996. cited by applicant . Vashi et al., "Clinical Pharmacology and Pharmacokinetics of Once-Daily Hydromorphone Hydrochloride Extended-Release Capsules", J. Clin. Pharmacal, vol. 45, pp. 547-554, 2005. cited by applicant . Viriden et al., "Investigation of Critical Polymer Properties for Polymer Release and Swelling of HPMC Matrix Tablets", EP Journal of Pharmaceutical Sciences 36, pp. 297-309, 2009. cited by applicant . Webster, PTI-821: Sustained-Release Oxycodon Investig. Drugs, vol. 16, (3), pp. 1-8, 2007. cited by applicant . International Preliminary Report on Patentability and Written Opinion re: PCT/US2011/035767 dated Nov. 13, 2012. cited by applicant . International Preliminary Report on Patentability and Written Opinion re: PCT/US2011/035768 dated Nov. 13, 2012. cited by applicant . International Preliminary Report on Patentability and Written Opinion re: PCT/US2011/035770 dated Nov. 13, 2012. cited by applicant . International Preliminary Report on Patentability and Written Opinion re: PCT/US2011/025914 dated Aug. 28, 2012. cited by applicant . International Search Report and Written Opinion for PCT/US2007/020041, dated Feb. 25, 2008. cited by applicant . An English translation of the Notice on Reexamination issued in connection with Chinese patent application No. 200810125922.X on Dec. 3, 2014. cited by applicant . Claims pending in U.S. Appl. No. 12/982,386 on Jan. 13, 2015. cited by applicant . Claims pending in U.S. Appl. No. 14/094,968 on Jan. 5, 2015. cited by applicant . Claims pending in U.S. Appl. No. 13/833,263 on Jan. 5, 2015. cited by applicant . Claims pending in U.S. Appl. No. 14/581,175 on Jan. 5, 2015. cited by applicant.

Primary Examiner: Basquill; Sean
Attorney, Agent or Firm: Davidson, Davidson, & Kappel LLC