US009750778B2 (12 ) United States Patent ( 10 ) Patent No. : US 9 , 750 ,778 B2 Kalidindi (45 ) Date of Patent : Sep . 5 , 2017 ( 54 ) TERMINALIA CHEBULA AND TERMINALIA FOREIGN PATENT DOCUMENTS BELLIRICA EXTRACTS FOR INHIBITION OF XANTHINE OXIDASE CN 102309681 A 1 / 2012 CN 102441081 A 5 / 2012 JP H11116497 A 4 / 1999 (71 ) Applicant : Natreon , Inc ., New Brunswick , NJ WO 2007 /057924 Al 5 / 2007 (US ) WO 2010 / 093191 A2 8 / 2010 WO 2011/ 119592 Al 9 /2011 ( 72 ) Inventor: Sanyasi R . Kalidindi, Monroe , NJ WO 2013 / 155175 A1 10 / 2013 (US ) ( 73 ) Assignee : Natreon , Inc. , New Brunswick , NJ OTHER PUBLICATIONS (US ) Caraka Sa + /4hit¢ — Edited & translated by P . V Sharma, vol . II : Chaukhamba Orientalia , Varanasi , Edn . 5th , 2000 . [ Time of origin ( * ) Notice : Subject to any disclaimer, the term of this 1000 BC - 4th century ] ( one page print -out from Traditional patent is extended or adjusted under 35 Knowledge Digital Library ( TKDL ). * U . S . C . 154 ( b ) by 27 days . Cheng et al . Antioxidant and Free Radical Scavenging Activities of Terminalia Chebula ; Biol . Pharm . Bull . 26 ( 9 ) 1331- 1335 ( 2003 ) .* (21 ) Appl. No .: 14 /459 , 046 Gupta , P . C . Biological and Pharmacological Properties of @ Terminalia Chebula Retz . (Haritaki ) — An Overview ; Int. J . of (22 ) Filed : Aug. 13 , 2014 Pharmacy and Pharmaceutical Sciences; vol. 4 , Sup . 3 , 2012 , pp . 62 -68 . * Latha et al . Influence of Terminalia bellerica Roxb . Fruit Extracts on (65 ) Prior Publication Data Biochemical Paramters in Streptozotocin Diabetic Rats ; Int. J . of Pharmacology 6 ( 2 ) : 89 - 96 ( 2010 ). * US 2015 /0050369 A1 Feb . 19 , 2015 Naik et al . Free Radical Scavenging Reactions and Phytochemcial Related U . S . Application Data Analysis of Triphala , an Ayurvedic Formulation ; Current Science , vol. 90 , No. 8 , Apr . 25 , 2006 . * (60 ) Provisional application No . 61/ 865 , 233 , filed on Aug . Shen et al . Tannins and Related Compounds Isolated From 13, 2013 . Terminalia Bellerica ; Planta Med 2010 ; 76 - P56 , 7 pages. * Wikipedia : Hyperuricemia ; Online , URL : <https : // web .archive .org / (51 ) Int. CI. web / 20120203161708 /http : / /en .wikipedia .org /wiki / A61K 36 /61 ( 2006 .01 ) Hyperuricemia > , Feb . 3 , 2012 , 3 pages. * A61K 36 / 185 ( 2006 .01 ) Naik ,GH ; Priyadarsini, KI; Mohan , H “ Free radical scavenging U . S . CI. reactions and phytochemical analysis of triphala , an ayurvedic formulation ” Current Science , Apr . 25 , 2006 , 90 ( 8 ) , 1100 - 1105 . * CPC .. .. .. A61K 36 / 185 ( 2013 .01 ) ; A61K 36 /61 Gao , et al ., “ Inhibitory effect on alpha - glucosidase by the fruits of ( 2013 .01 ) Terminalia chebula Retz ., ” Food Chem . (2007 ) 105 :628 -634 . ( 58 ) Field of Classification Search H - S . Lee , et al. , " Antioxidant Effects of Aqueous Extract of None Terminalia chebula in Vivo and in Vitro , " Biol. Pharm . Bull . ( 2005 ) See application file for complete search history. 28 ( 9 ) : 1639 - 1644 . Mahesh , et al. , “ Effect of Terminalia chebula aqueous extract on oxidative stress and antioxidant status in the liver and kidney of (56 ) References Cited young and aged rats ,” Cell Biochem . Funct . ( 2009 ) 27 : 358 - 363 . Pfundstein , et al. , “ Polyphenolic compounds in the fruits of Egyp U . S . PATENT DOCUMENTS tian medicinal plants ( Terminalia bellerica , Terminalia chebula and 6 ,730 , 332 B25 /2004 Agarwal et al . Terminalia horrida ) : Characterization , quantitation and determina 7 ,618 ,663 B2 11/ 2009 Palpu et al. tion of antioxidant capacities ,” Phytochemistry ( 2010 ) 71 : 1132 8 ,445 ,033 B2 * 5 / 2013 Vaidya .. .. .. .. A61K 36 / 185 1148 . 424 / 725 Saraswathi Motamarri et al . , “ Terminalia belerica Roxb - A 9 , 155 ,768 B2 * 10 / 2015 Gutmann . .. A61K 45 / 06 Phytopharmacological Review , ” Intl. J . of Research in Pharmaceu 2002 /0022060 A1 * 2 / 2002 Mathur .. .. .. .. .. .. A61K 36 / 185 tical and Biomedical Sciences , vol . 3 ( 1 ) Jan . -Mar . 2012 96 - 99 424 / 725 (2012 ) . 2004 /0258775 A1* 12/ 2004 Patel A61K 36 / 185 Soni et al . , “ Febuxostat : The New Generation novel xanthine 424 / 745 oxidase Inhibitors , " Internationale Pharmaceutica Sciencia , vol. 1 , 2005 / 0008710 A1 * 1/ 2005 Subbiah .. .. A61K 36 / 00 issue 1 , Jan .- Mar . 2011 107 - 115 . 424 /725 2005 /0084547 A1 * 4 / 2005 Subbiah .. .. .. .. .. A61K 31 / 704 (Continued ) 424 / 740 2005/ 0227910 A1 * 10 / 2005 Yang . .. .. .. .. .. A61K 9 / 0024 Primary Examiner — Chris R Tate 424 /422 2006 /0147555 A1 * 7 / 2006 Tripathi . .. A61K 36 / 185 Assistant Examiner — Aaron J Kosar 424 / 725 (74 ) Attorney, Agent, or Firm — Amin Talati Upadhye 2006 /0280698 A1* 12 / 2006 Gupta .. * .* .* .* . A61K 8 / 97 LLP ; Adam D . Sussman ; George M . Carrera , Jr . 424 / 50 2007/ 0065456 A1* 3 / 2007 Woods . .. .. .. A61K 31 /045 (57 ) ABSTRACT 424 / 195 . 17 2010 /0202980 A1 * 8 / 2010 Fogel . .. A61K 36 /605 Compositions containing extracts of Terminalia chebula and 424 /48 Terminalia bellerica , or combinations thereof and methods 2010 /0203178 A1 * 8 / 2010 Gupta .. A61K 9 /08 for treatment of uricemia , hyperuricemia , and gout in a 424 / 769 human subject are provided . 2012 / 0034325 A1 * 2 / 2012 Vaidya .. A61K 36 / 185 424 / 734 11 Claims, No Drawings US 9 , 750 ,778 B2 Page 2 ( 56 ) References Cited Latha , R . C . , et al. , Influence of Terminalia bellerica Roxb . Fruit Extracts on Biochemical Parameters in Streptozotocin Diabetic Rats. International Journal of Pharmacology . 2010 ; 6 ( 2 ) : 89 - 96 . OTHER PUBLICATIONS Naik , G . H ., et al . , Studies on the aqueous extract of Terminalia chebula as a potent antioxidant and a probable radioprotector . Hazra et al. , “ Comparative study of the antioxidant and reactive Phytomedicine II . ( 2004 ) ;530 - 538 . oxygen species scavenging properties in the extracts of the fruits of Juang , L . J. , et al. , Determination of hydrolyzable tannins in the fruit Terminalia chebula , Terminalia belerica and Emblica officinalis, " of Terminalia chebula Retz . by high -performance liquid chroma BMC Complementary and Alternative Medicine (2010 ) 10 : 20 . tography and capillary electrophoresis . J . Sep . Sci . 2004 ; 27 , Khan , “ The effect of regular intake of Terminalia chebula on 718 -724 oxidative stress in mice originated from Salmonella typhmurium , " Park , J . O . , et al ., Effect of Terminalia chebula on Physiological EurAsia J . BioSci . ( 2009 ) 3 : 113 - 21 . Ballabh et al. , “ Traditional medicinal plants of cold desert Ladakh Activity in Mice . Korean Society of Life Science ( F ) Pusan Life Used against kidney and urinary disorders , " Jul. 23 , 2008 , vol. 118 , Science Society . Feb . 28 , 2004 ; 14 ( 1 ) , 148 - 153 . Abstract Only . issue 2 , pp . 331 -339 ( abstract ). Sodhala ; Gadanigrahah ed , Ganga Sahaya Pandeya & Com . Soni et al. , “ Febuxostat : The New Generation novel xanthine Indradeva Tripathi, Part 2 ( Kaya cikitsa Khanda ) Cahaukhamba oxidase Inhibitors, ” Internationale Pharmaceutica Science , vol. 1 , Sanskrit Sansthan (Varanasi ) Ed . 3rd 1997, p . 527 - 528 . issue 1 , Jan . -Mar . 2011 107 - 115 . Mohammad Akbar Arzani; Qaraabaadeen Qaadri ( 17th century Latha , R . C ., et al ., Therapeutic potential of octyl gallate isolated AD ), Ahmadi Publication . Delhi, 1968 AD , p . 337 . from fruits of Terminalia bellerica in streptozotocin - induced dia Ali Ibn e Abbaas Majoosi; Kaamil al Sena ' ah , Part II ( 10th century ) betic rats . Pharm Biol . Jun . 2013 ;51 ( 6 ) :798 -805 . AD ) . Central Council for Research in Unani Medicine , 61 65 Bag, A . , et al. , Therapeutic potential of Terminalia chebula Retz . Institutional Area , Janak Puri, New Delhi 58 , 2005 AD p . 558 . Asian Pac J Trop Biomed . Mar . 2013 ; 3 ( 3 ) : 244 -52 . Ayurveda Sarasamgrahah Shri Baidyanath Ayurveda Bhavan Lim Baliga , M . S . et al. Scientific Validation of the Ethnomedicinal ited , Calcutta . Edn . 2003 , p . 523 - 524 . Properties of the Ayurvedic Drug Triphala : A Review . Chin J Integr Susruta ; Susruta Samhita Edited & translated by P . V Sharma. vol. Med . Dec . 18 , 2012 ; ( 12 ) : 946 -954 . II : Chaukhamba Visvabharati , Varanasi. Edn . 1st . 2000 . [ Time of Chauhan , V . , Treatment of Gout Pain With Effective Herbal Medi origin 1000 BC 5th century ] p . 318 . cines. https : / /web .archive . org /web / 20120918011905 / http : / /www . Ayurveda Sarasamgrahah Shri Baidyanath Ayurveda Bhavan Lim drvikram . com / gout. php . May 28 , 2012 . ited , Calcutta , Edn . 2003 , p . 561. Sarkar , R . , et al. , Hydroalcoholic extracts of Indian medicinal plants Bhavamisra ; Bhavaprakasa Edited & translated by Brahmasankara can help in amelioration from oxidative stress through antioxidant Misra , Part II : Chaukhamba Sanskrit Sansthan , Varanasi, Edn . 7th , properties. J Complement Integr Med . 2012 ; 9 : Article 7 . 2000 . [ Time of origin 16th century ] p . 307 . Babita , Y ., et al. , A Perspective Study of Haritaki . IJRAP . 2011 ; 2 ( 5 ) Bharata Bhaisajya Ratnakara Compiled by Nagmadasa Chaganalala 1466 - 1470 . Saha , Translated by Gopinath Gupta vol. IV : B . Jain Publishers . Hazra , B . , et al. , Comparative study of the antioxidant and reactive New Delhi, Edn . 2nd . Reprint, Aug . 1999 . [ This book containsback oxygen species scavenging properties in the extracts of the fruits of references from 1000 B . C . to 20th century ] p . 19 . Terminalia chebula , Terminalia belerica and Emblica officinalis . BMC Complement Altern Med . May 13 , 2010 ; 10 : 20 . * cited by examiner US 9 ,750 ,778 B2 TERMINALIA CHEBULA