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(12) United States Patent (10) Patent No.: US 9,283,192 B2 Mullen Et Al

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(12) United States Patent (10) Patent No.: US 9,283,192 B2 Mullen Et Al US009283192B2 (12) United States Patent (10) Patent No.: US 9,283,192 B2 Mullen et al. (45) Date of Patent: Mar. 15, 2016 (54) DELAYED PROLONGED DRUG DELIVERY 2009. O1553.58 A1 6/2009 Diaz et al. 2009,02976O1 A1 12/2009 Vergnault et al. 2010.0040557 A1 2/2010 Keet al. (75) Inventors: Alexander Mullen, Glasgow (GB); 2013, OO17262 A1 1/2013 Mullen et al. Howard Stevens, Glasgow (GB); Sarah 2013/0022676 A1 1/2013 Mullen et al. Eccleston, Scotstoun (GB) FOREIGN PATENT DOCUMENTS (73) Assignee: UNIVERSITY OF STRATHCLYDE, Glasgow (GB) EP O 546593 A1 6, 1993 EP 1064937 1, 2001 EP 1607 O92 A1 12/2005 (*) Notice: Subject to any disclaimer, the term of this EP 2098 250 A1 9, 2009 patent is extended or adjusted under 35 JP HO5-194188 A 8, 1993 U.S.C. 154(b) by 0 days. JP 2001-515854. A 9, 2001 JP 2001-322927 A 11, 2001 JP 2003-503340 A 1, 2003 (21) Appl. No.: 131582,926 JP 2004-300148 A 10, 2004 JP 2005-508326 A 3, 2005 (22) PCT Filed: Mar. 4, 2011 JP 2005-508327 A 3, 2005 JP 2005-508328 A 3, 2005 (86). PCT No.: PCT/GB2O11AOOO3O7 JP 2005-510477 A 4/2005 JP 2008-517970 A 5, 2008 JP 2009-514989 4/2009 S371 (c)(1), WO WO99,12524 A1 3, 1999 (2), (4) Date: Oct. 2, 2012 WO WOO1 OO181 A2 1, 2001 WO WOO3,O266.15 A2 4/2003 (87) PCT Pub. No.: WO2011/107750 WO WOO3,O26625 A1 4/2003 WO WO 03/026626 A2 4/2003 PCT Pub. Date: Sep. 9, 2011 WO WOO3/030920 A1 4/2003 WO WO 2006/045618 A1 5, 2006 (65) Prior Publication Data WO WO 2008/07.9102 A1 T 2008 WO WO 2008/081891 A1 T 2008 US 2013/OO22677 A1 Jan. 24, 2013 (Continued) (30) Foreign Application Priority Data OTHER PUBLICATIONS Mar. 5, 2010 (GB) ................................... 10O3734.9 Ghimire et al., “In-vitro/In-vivo Correlation of Pulsatile Drug Release from Press-Coated Tablet Formulations: A (51) Int. Cl. Pharmacoscintigraphic Study in the Beagle Dog”. European Journal A6 IK9/20 (2006.01) of Pharmaceutics and Biopharmaceutics, 2007, vol. 67, pp. 515 A6 IK 9/22 (2006.01) 523.: A6 IK9/24 (2006.01) Ghimire, M. et al. "In-vitro/In-vivo Correlation of Pulsatile Drug (52) U.S. Cl. Release from Press-Coated Tablet Formulations: A CPC ............... A61K9/209 (2013.01); A61 K9/2013 Pharmacoscintigraphic Study in the Beagle Dog. European Journal (2013.01); A61 K9/2054 (2013.01) of Pharmaceutics and Biopharmaceutics, 2007, vol. 67, No. 2, 515 (58) Field of Classification Search 523. None Written Opinion of the International Searching Authority (Form See application file for complete search history. PCT/ISA/237) mailed Mar. 12, 2012, for International Application No. PCT/GB2011/000307, 14 pages. (56) References Cited (Continued) U.S. PATENT DOCUMENTS Primary Examiner — Michael B Pallay 4,832,958 A 5, 1989 Baudier et al. 4,871,549 A 10, 1989 Ueda et al. (74) Attorney, Agent, or Firm — Hoxie & Associates LLC 5,145,644 A 9, 1992 Park et al. 5,508,044 A 4, 1996 Buxton et al. (57) ABSTRACT 5,558,879 A 9, 1996 Chen et al. 5,614,220 A 3, 1997 Hirakawa et al. In one aspect, the present invention is concerned with a treat 5,788,987 A 8, 1998 Busetti et al. 6,312,724 B1 1 1/2001 Odidi et al. ment where it is desired that an active agent is designed to be 6,610,323 B1 8/2003 Lundberg et al. released in a prolonged manner at a time point sometime after 6,632,451 B2 10/2003 Penhasi et al. administration of the active agent. The present invention is 6,740,339 B1 5, 2004 Ohkouchi et al. particularly Suited to administering an agent which may be 8, 168,218 B2 5/2012 Vergnault et al. released whilst a Subject is sleeping, shortly before waking 2004.0062804 A1* 4/2004 Lee et al. ...................... 424/471 2004/0241100 A1 12/2004 Kramer et al. and continues to administer the drug during the early waking 2005/O152974 A1 7/2005 Boehm et al. hours. As well as treating certain conditions by a particular 2005/022O877 A1 10/2005 Patel et al. regime, the invention also provides novel formulations for a 2006/0177506 A1* 8/2006 Yanai et al. ................... 424/468 delayed, followed by a prolonged release of drug. 2006, O2574.82 A1 11/2006 Kumar et al. 2007/OO98788 A1 5, 2007 Gore et al. 2009.0053308 A1 2/2009 Ishida et al. 24 Claims, 5 Drawing Sheets US 9,283,192 B2 Page 2 (56) References Cited Alvarez-Lorenzo, C. et al., “Evaluation of Low-substituted Hydroxypropylceulluloses (LHPCs) as Filler-Binders for Direct Compression.” International Journal of Pharmaceutics, 2000, 197, FOREIGN PATENT DOCUMENTS 107-116. English-language abstract of JP 2001-322927. Date of publication of WO WO 2008, 129517 A2 10/2008 application Nov. 20, 2001, 1 page. WO WO 2009,154810 A2 12/2009 English-language machine translation of JP 2001-322927, retrieved from the Japanese Patent Office website on May 2, 2015, 15 pages. Fukui, E. et al., “Studies on Applicability of Press-coated Tablets OTHER PUBLICATIONS Using Hydroxypropylcellulose (HPC) in the Outer Shell for Timed Stevens, H.N.E., "Chronopharmaceutical Drug Delivery,” Journal of release Preparations,” Journal of Controlled Release, 2000, 68,215 Pharmacy and Pharmacology, 1998, 50 (Supplement 9), 5. 223. Written Opinion of the International Searching Authority (Form Kleinebudde, P. "Application of Low Substituted Hydroxypropycel PCT/ISA/237) mailed Mar. 12, 2012, for International Application lulose (L-HPC) in the Production of Pellets. Using Extrusion / No. PCT/GB2011/000306, 15 pages. Spheronization” International Journal of Pharmaceutics, 96, pp. 119 128, (1993). Written Opinion of the International Searching Authority (Form Shin-Etsu Guide on Low Substituted Hydroxypropyl Cellulose NF, PCT/ISA/237) mailed Mar. 12, 2012, for International Application cited in U.S. Appl. No. 13/582.913 in which Examiner listed publi No. PCT/GB2011/000314, 14 pages. cation date as 2008. Rowe, R. et al., Eds. Handbook of Pharmaceutical Excipients, Sixth Edition, Pharmaceutical Press, London, 2009, pp. 317-324. * cited by examiner U.S. Patent Mar. 15, 2016 Sheet 1 of 5 US 9,283,192 B2 28 m 8 2.8 8 2 . 1?t 20 3in 4to 5th) so to ado Time (min) FG. U.S. Patent Mar. 15, 2016 Sheet 2 of 5 US 9.283,192 B2 100 80 50 - to 2 so do so at to ado Time mir) FG, 2 U.S. Patent Mar. 15, 2016 Sheet 3 of 5 US 9.283,192 B2 : xxx 8 * :...it * x *:::::. 3 x FG 3 U.S. Patent Mar. 15, 2016 Sheet 4 of 5 US 9.283,192 B2 00°00z000\00800900z0 oz. do??eu?uepuoO U.S. Patent Mar. 15, 2016 Sheet 5 of 5 US 9.283,192 B2 Werapai PK study - orverapani concentration 8 60 - 1:0 Coicetratio 2 -- subject overapai (0. -S-subject 2 gii. as a 80 --subject 3 8. --subject 4 a -- subject 5 subject 6 2 O 3. OO SOO. inte (ins F.G. 5 US 9,283,192 B2 1. 2 DELAYED PROLONGED DRUG DELVERY It is amongst the objects of the present invention to provide a formulation which may be easily and/or cheaply manufac CROSS REFERENCE TO RELATED tured and which allows for an active agent to be administered APPLICATIONS in a prolonged manner, following a period of delay following administration. This application is a U.S. application under 35 U.S.C. 371 claiming benefit of PCT application No. PCT/GB2012/ SUMMARY OF INVENTION 000307, filed on Mar. 4, 2011, which claims the benefit of GB application No. 1003734.9, filed on Mar. 5, 2010, the contents The present inventors recognised a need to be able to of each of which are incorporated herein by reference. 10 administer, for example, a pharmaceutically active agent to a Subject in a manner Such that a delayed release of the phar FIELD OF INVENTION maceutically active ingredient could be achieved, followed by a prolonged delivery of the agent. Although this may have In one aspect, the present invention is concerned with a been possible using prior device/methods known in the art, treatment where it is desired that an active agent is designed 15 many such devices/methods do not result in a desired physi to be released in a prolonged manner at a time point some time cochemical and/or physicomechanical profile and many are after administration of the active agent. The present invention highly complex. As such there is therefore a distinct advan is particularly Suited to administering an agent which may be tage in providing a simpler press-coated tablet formulation released whilst a Subject is sleeping, shortly before waking and method of treatment. and continues to administer the drug during the early waking One particularly preferred embodiment relates to treating hours. As well as treating certain conditions by a particular Subjects who suffer from cardiovascular conditions. In a pre regime, the invention also provides novel formulations for a ferred embodiment therefore, the formulations of the present delayed, followed by a prolonged release of drug. invention are for treating cardiovascular conditions such as hypertension, angina pectoris, cardiac failure, pulmonary BACKGROUND TO THE INVENTION 25 hypertension, the primary or secondary prevention of cardio vascular disease, peripheral vascular disease, stroke, oedema, Time-dependent release mechanisms of drugs have been arrhythmias. Such formulations therefore comprise a phar described in the literature for tablet, pellet and capsule for maceutically active agent for treating Such cardiovascular mulation utilising a wide range of physicochemical and conditions.
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