BOSWELLIN® CG: CHEMISTRY,  TOXICOLOGY & CLINICAL   9 CLINICAL EVALUATION OF A TOPICAL ANALGESIC  FORMULATION CONTAINING BOSWELLIN®     Authors: Muhammed Majeed, Ph.D., Lakshmi Prakash, Ph.D. 

           

 

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INTRODUCTION Boswellia serrata (N.O. Burseraceae) is a large, much branched, deciduous tree that grows abundantly in the dry, hilly parts of India. It is known as “Dhup”, Indian Frankincense or Indian Olibanum. Since ancient times, resins have been important in the preparation of incense, medicines, cosmetics and perfumes. The Egyptians, Hindus, Persians, Israelites, Greek, Romans and the Europeans of Queen Victoria’s times greatly valued these materials. Olibanum, the resin from the Boswellia species has been used as incense for centuries. However, its major use today is as a fixative in perfumes, soaps, creams lotions and detergents. In India, the gum resin exudates of Boswellia serrata, known in the vernacular as “Salai guggal”, has been used in the Ayurvedic system of medicine in the managements of several inflammatory conditions and as a topical anti-inflammatory agent. The major use of Boswellia serrata in contemporary medicine is as an anti-arthritic and anti-inflammatory pharmacological agent1. The anti-inflammatory properties of the gum resin are attributed to the presence of “boswellic acids”. Boswellic acids were found to inhibit two pro-inflammatory enzymes, 5-lipoxygenase (which generates inflammatory leukotrienes) and Human Leukocyte Elastase (HLE). HLE is a serine protease that initiates injury to the tissue, which in turn triggers the inflammatory process2. This dual inhibitory action on the inflammatory process is unique to boswellic acids. Sabinsa Corporation pioneers Boswellin® (a standardized extract containing boswellic acids isolated from the oleogum resin of Boswellia serrata) and introduced it to the US and European markets in 1991. Recently, Sabinsa Corporation has redefined the standards of Boswellin® based on the recent research findings. CHEMISTRY OF BOSWELLIN® The gum resin of Boswellia serrata is known to contain3: 9 9 9 9 9 9

Monoterpenes (α thujene) Diterpenes (macrocyclic diterpenoids such as incensole, incensole oxide, inoincencole oxide, a diterpene alcohol (serrtol)) Triterpenes (such as α- and β-amyrins) Pentacyclic triterpenic acids (boswellic acids) Tetracyclic triterpenic acids (tirucall-8, 24-dien-21-oic acids)

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The four major pentacyclic triterpenic acids present in the acidic extract of Boswellia serrata gum resin (Boswellin®) are: 9 9 9 9

Β-Boswellic Acid (I) Acetyl-β-Boswellic Acid (II) 11-keto-β-Boswellic Acid (III) Acetyl-11-keto-β-Boswellic Acid (IV)

These compounds are reported to be responsible for the anti-inflammatory action of Boswellin®. Of these, acetyl-11-keto-β-boswellic acid is reported to be the most potent anti-inflammatory fraction4. CLINICAL EVALUATION OF A TOPICAL ANALGESIC FORMULATION CONTAINING BOSWELLIN® In an open field study, a topical cream Chilisin®, (consisting of boswellic acids, capsaicin and methyl salicylate) was evaluated in twelve volunteers monitored by several independently working chiropractors. The study was coordinated by Synergy Wellness Clinics, DeSoto, Texas2. The criteria for admission to the study group included a long standing arthritic condition manifested by one or all of the following symptoms: chronic joint pain, diminished joint mobility, joint swelling, heat sensation over the involved joint and morning stiffness. All willing and qualified participants were asked © 2007 Sabinsa Corporation Boswellin® CG– Product Insight Paper

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to sign the informed consent, previously approved by the chiropractor that supervised the study. Each patient was provided with a two weeks supply of Chilisin® cream, and asked to apply the cream daily as needed. In addition, each patient agreed to fill up the self-evaluation questionnaire before the treatment started and again after the completion of two weeks treatment. Based on the information obtained from 12 patients in the study, seven women and five men, middleaged to elderly, Chilisin® cream applied regularly on a daily basis for at least two weeks resulted in significant improvement in all parameters tested, with pain sore being diminished by half as a result of the treatment (Fig.1). Of the twelve participants, five evaluated the therapeutic effects of Chilisin® as very good, three as good, three as modest and one as not satisfactory. The person who claimed the “not satisfactory” result of the treatment was an 83-year old woman who preferred “Blue Ice” to Chilisin®. None of the participants reported any side effects of the treatment. Two patients complained about a specific odor of the cream (due to the presence of methyl salicylate).

Fig. 1. Mean scores of arthritic symptoms as evaluated in an open field study of boswellic acids – containing topical analgesic, Chilisin®

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TOXICOLOGY OF BOSWELLIC ACIDS (TOPICAL APPLICATION) A patch test was performed to assess the safety of Boswellin® CG for topical applications.5 An ointment preparation containing 5% Boswellin® CG was found to be free from dermal toxicity. In this study, 15 healthy volunteers in the 23-41 year age group were subjected to patch tests on five healthy forearm skin areas each. Finn chambers, a patch test device that provides good occlusion because of the chamber design, were used. The ointment was applied onto a vaseline album and also introduced into empty Finn chambers. No skin reaction in terms of erythema, papule, blisters, dryness, itching, burning or odor was reported by any of the volunteers after 24 and 48 hours. Objective evaluation by the examining doctors also revealed no untoward reactions, with identical results being recorded for the vaseline album and testing in an empty Finn chamber. The preparation containing Boswellin® was thus well-tolerated by all the volunteers. It was therefore concluded that Boswellin® is a safe topical agent that does not sensitize the skin or manifest dermal toxicity. Boswellin® is thus a safe and effective anti-inflammatory agent.

It can be conveniently used in

formulations for soaps, lotions and cosmetic creams as an anti-inflammatory ingredient.

The

characteristic aroma of frankincense is acceptable in most topical formulations. The products may contain up to 5% of Boswellin®.

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References: 1. Majeed, M. et. al. (1996). Boswellin® The Anti-inflammatory Phytonutrient. Nutriscience Publishers, NJ. 2. Safayhi, H. et. al. (1997). Inhibition by boswellic acids of human leukocyte elastase. J. Pharmacol. Exp. Ther. 281:460-463. 3. Majeed, M. et. al. (1999). Redefining our standards Boswellin® The only natural leukotriene and HLE inhibitor™ Information brochure from Sabinsa Corporation. 4. Safayhi, H. et. al. (1992). Boswellic acids: novel, specific, non-redox, inhibitors of lipoxygenase. J. Pharmacol. Exp. Ther. 261: 1143-6. 5.

Research Report, Sabinsa Corporation, February 2000.

Protocols of studies on cosmeceutical products performed /sponsored by Sabinsa Corporation are based on alternatives to animal testing. Any references to animal tests appearing in product informational materials are related to information from published scientific literature compiled therein.

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