Compositions Comprising Boswellia Serrata and Aegle Marmelos

Compositions Comprising Boswellia Serrata and Aegle Marmelos

(19) TZZ ¥Z¥ _T (11) EP 2 303 298 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 36/324 (2006.01) A61K 36/75 (2006.01) 16.12.2015 Bulletin 2015/51 A61K 36/9068 (2006.01) A61K 36/38 (2006.01) A61K 31/19 (2006.01) A61P 11/00 (2006.01) (2006.01) (21) Application number: 09769808.8 A61K 45/06 (22) Date of filing: 02.06.2009 (86) International application number: PCT/IN2009/000318 (87) International publication number: WO 2009/157016 (30.12.2009 Gazette 2009/53) (54) Compositions comprising Boswellia serrata and Aegle marmelos extracts for use in the treatment of asthma and similar diseases Zusammensetzungen enthaltend Boswellia serrata und Aegle marmelos Extrakte zur Verwendung in der Behandlung von Asthma und ähnlichen Erkrankungen Compositions comprenant des extraits de Boswellia serrata et d’Aegle marmelos pour l’utilisation dans le traitement d’asthme et des maladies similaires (84) Designated Contracting States: • GOKARAJU, Ganga Raju AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Vijayawada 520 010 HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL Andhra Pradesh (IN) PT RO SE SI SK TR (74) Representative: Rees, Kerry et al (30) Priority: 03.06.2008 US 58271 P WP Thompson 55 Drury Lane (43) Date of publication of application: London WC2B 5SQ (GB) 06.04.2011 Bulletin 2011/14 (56) References cited: (73) Proprietor: M/s Laila Nutraceuticals JP-A- 10 072 357 US-A1- 2006 040 000 Vijayawada 520 010 AP (IN) • DATABASE TKDL [Online] 1995, "Nasika Rogahara Yoga-2", XP002671003, Database (72) Inventors: accession no. AK14/315B & Arkaprakasah: In: • GOKARAJU, Rama, Raju Indradeva Tripathi: "Lankapatiravana", 1995, Vijayawada 520 010 Krishnadas Academy, Varanasis, India page 117, Andhra Pradesh (IN) * the whole document * • GOLAKOTI, Trimurtulu • DATABASE TKDL [Online] 1990, Vijayawada 520 008 "Pänalaverädikasäyah", XP002671004, Database Andhra Pradesh (IN) accession no. VS/2964 & D. V. Panditarao: 1990, • CHILLARA, Sivaramakrishna Govt of India: Sahastrayoga, New Delhi page 63, Vijayawada 520 008 * the whole document * Andhra Pradesh (IN) • SENGUPTA, Krishanu Vijayawada 520 008 Andhra Pradesh (IN) • BHUPATHIRAJU, Kiran Vijayawada 520 008 Andhra Pradesh (IN) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 303 298 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 2 303 298 B1 • AMMON H P T: "BOSWELLIASAEUREN • ARUL, V. ET AL.: ’Mechanisms of the contractile (INHALTSSTOFFE DES WEIHRAUCHS) ALS effect of the alcoholic extract of Aegle marmelos WORKSAME PRINZIPIEN ZUR BEHANDLUNG Corr. on isolated guinea pig ileum and tracheal CHRONISCH ENTZUENDLICHER chain.’ PHYTOMEDICINE vol. 11, 2004, pages 679 ERKRANKUNGEN//Boswellic acids - 683, XP004956773 (components of frankincense) as the active • SAVITHRAMMA, N. ET AL.: ’Ethnobotanical principle in treatment of chronic inflammatory survey of plants used to treat asthma in Andhra diseases", WIENER MEDIZINISCHE Pradesh’ JOUMAL OF ETHNOPHARMACOLOGY WOCHENSCHRIFT, vol. 152, no. 15-16, 1 January vol. 113, 2007, INDIA., pages 54 - 61, XP022162817 2002 (2002-01-01), pages 373-378, XP009096034, • ULBRICHT, C.: ’Boswellia: An Evidence-Based SPRINGER WIEN, AT ISSN: 0043-5341, DOI: Systematic Review by the Naturasl Standard 10.1046/J.1563-258X.2002.02056.X Research Collaboration.’ JOURNAL OF HERBAL • CHEMICAL ABSTRACTS, 27 November 2009, PHARMACOTHERAPY vol. 4, no. ISS.3, April Columbus, Ohio, US; abstract no. 147:533852, 2005, pages 63 - 83, XP009067501 SHARMA, A. ET AL.: ’Phytochemical profile of • JAINAND SUMITA SRIVASTAVA S K: "Traditional Boswellia serrata: an overview.’ XP008144679 & uses of some Indian plants among islanders of PHARMACOGNOSY REVIEWS vol. 1, no. 1, 2007, the Indian Ocean", INDIAN JOURNAL OF pages 137 - 142 TRADITIONAL KNOWLEDGE, RESOURCES, • CHEMICAL ABSTRACTS, 27 November 2009, NEW DELHI, NEW DELHI - INDIA, vol. 4, no. 4, 1 Columbus, Ohio, US; abstract no. 146:350251, October 2005 (2005-10-01) , pages 345-357, WADA, K. ET AL.: ’Bioactivities of Boswellia gum XP018021348, ISSN: 0972-5938 resin.’ XP008144680 & AROMA RESEARCH vol. 7, no. 3, 2006, pages 234 - 241 2 1 EP 2 303 298 B1 2 Description hypersensitivity. [0005] The enriched Boswellia composition (5-Loxin) Field of the invention used in the present inventive composition for use con- tains unique blend of triterpenes, selectively enriched [0001] The invention relates to anti-adipocyte fatty ac- 5 with the most active boswellic acid called 3-O-acetyl-11- id-binding protein (aP2), anti-5-lipoxygenase-activating keto-β-boswellic acid (AKBA) and characterized by the protein (FLAP) and anti-Cysteinyl Leukotriene (CysLT)- lack of significant quantities of the components present 1 receptor expression herbal compositions comprising in regular Boswellia serrata extracts except AKBA, which 3-O-acetyl-11-keto-β-boswellic acid (AKBA) enriched is a minor component in regular extracts and a major extract of Boswellia serrata and Aegle mannelos Bael 10 component in present invention. The components fruit ethanol extract for use in the treatment of disorders present in regular extracts are 1) β-boswellic acid, 2) 3- selected from asthma, allergic rhinitis, hay fever, type-1 O-acetyl-β-boswellic acid, 3) 11-keto- β-boswellic acid, 4) hypersensitivity and mild allergies, eczema, and psoria- 3-O-acetyl-11-keto-β-boswellic acid,5) 9-ene- β-boswell- sis, and optionally in combination with extracts/frac- ic acid, 6) α3-hydroxyurs-9,11-diene-24-oic acid, 7) tions/pure isolates of Zingiber officinale and Garcinia 15 2α,3α-hydroxyurs-12-ene-24-oic acid. The components mangostana. The compositions can take the form of Di- of unique Boswellia enriched product used in the inven- etary supplements or Pharmaceutical tive composition for use are 1) 3-O-acetyl-11-keto-β- boswellic acid, 2) 3-O-acetyl-9(11)-dehydro-β-boswellic Back ground of the invention acid, 3) 3-O-acetyl-11-keto-β-amirin, 4) 3-O-acetyl-11- 20 keto-α-boswellic acid. An enriched extract containing [0002] The inflammatory processes are known to be more than 30% 3-O-acetyl-11-keto-β-boswellic acid is triggered by increased metabolic activity of arachidonic used in the present invention (5-Loxin). Extracts enriched acid. Arachidonic acid diverges down into two main path- to higher concentration of AKBA may also be used. ways during this process, the cyclooxygenase (COX) and [0006] Aegle marmelos (Bael) is a medium sized tree lipoxygenase (LOX) pathways. The COX pathways lead 25 that grows up to 40 ft. It is native to Central and Southern to prostaglandins and thromboxane production and the India, Pakistan, Bangladesh, and Burma. The flesh of LOX pathways leads to leukotrienes (LTS) and hydroxyl the Aegle marmelos fruit is eaten raw or processed into eicosatetraenoic acid (HETEs). These classes of inflam- drinks or flavoring. Unripe pulp is used to treat diarrhea matory molecules exert profound biological effects, and dysentery. All other parts of the plant are used for a which enhance the development and progression of hu- 30 wide variety of medicinal purposes. The fruit or leaf or man cancers. Inhibition of 5-lipoxygenase indirectly re- root or bark extract or the mixed is used in the present duces the expression of TNF-α. Both 5-Lipoxygenase invention. and TNF-α therefore, are the target enzymes useful for [0007] Zingiber officinale (Ginger) has been used as a identifying inhibitors, which have the potential to cope treatment for nausea, diarrhea and epigastric and joint with a variety of inflammations and hypersensitivity-35 pains inAyurvedic and traditional Chinese medicine. Gin- based human diseases including asthma, arthritis, bowel ger has antihistaminic activity. Ginger’s oleoresin con- diseases such as ulcerative colitis and circulatory disor- stituents have potent inhibitory effect on the biosynthesis ders such as shock and ischemia. of pro inflammatory prostaglandins and leukotrienes. [0003] Asthma is the most common disease of diffuse Shogaol and Paradol inhibit COX-2 activity and Gingerol airway inflammation caused by variety of stimuli and40 inhibits 5-LOX enzyme activity (Tjendraputra, E., et al., characterized by reversible and recurrent attacks of Bioorg. Chem., 29, 156-163,2001; Srivastava, K. C., et breathlessness and wheezing (Murali P M, et. al., Res- al., Med. Hypoth, 39, 342-348, 1992). In an uncontrolled piration 2006; 73:457-463). US Census Bureau; Popu- trial, all seven arthritis patients treated with half gram of lation Estimates and International Data Base, 2004 esti- powdered ginger per day reported pain relief and de- mated that globally 373,847,408 people suffer from Asth- 45 creased signs of inflammation (Srivastava, K. C., et al., ma. An approximate 30.2 million American citizens have Med. Hypoth, 39, 342-348, 1992). Ginger root extracts been diagnosed with asthma. Children / teenagers age standardized to 5 - 15% gingerols are used to prepare 5-17 years have the highest prevalence rates. In 2004, this composition. Extracts standardized to other concen- 14.01% children were diagnosed with asthma. trations and other components could also be used for [0004] The pathophysiology of asthma consists of50 making the present inventive compositions for use chronic inflammation of airways accompanied by a de- [0008] Garcinia mangostana L belongs to Guttiferae gree of airway remodeling, which results in decreased family. It is commonly known as Mangosteen. Mangos- airway caliber. Accumulation of inflammatory cells in to teen is a slow-growing topical, evergreen tree and can the airway lining, together with inflammatory cascade attain 6 -25 m in height with leathery glabrous leaves (B.

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