title: A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation.
abstract: BACKGROUND
  The oral administration of the gum resin extracts of Indian frankincense (Boswellia serrata Roxb. ex Colebr) results in very low plasma concentrations of boswellic acids (BAs), being far below the pharmacologically active concentrations required in vitro for anti-inflammatory activity. For that reason the use of Indian frankincense in clinical practice and pharmaceutical development has substantially lagged behind. Recently the application of new formulation technologies resulted in a formulation of frankincense extract with lecithin, which revealed improved absorption and tissue penetration of BAs in a rodent study, leading for the first time to plasma concentrations of BAs in the range of their anti-inflammatory activity.
  
  
  OBJECTIVE
  In order to verify these encouraging results in humans, the absorption of a standardized Boswellia serrata extract (BE) and its lecithin formulation (CSP) was comparatively investigated in healthy volunteers.
  
  
  METHODS
  According to a randomized cross-over design with two treatments, two sequences and two periods, 12 volunteers alternatively received the lecithin-formulated Boswellia extract (CSP) or the non-formulated Boswellia extract (BE) at a dosage of 2×250mg capsules.
  
  
  METHODS
  The plasma concentrations of the six major BAs (KBA, AKBA, βBA, αBA, AβBA, AαBA) were determined using LC/MS.
  
  
  RESULTS
  With the exception of KBA, a significantly higher (both in terms of weight-to-weight and molar comparison) and quicker absorption of BAs from the lecithin formulation was observed, leading to Cmaxin the range required for the interaction with their molecular targets.
  
  
  CONCLUSIONS
  These findings pave the way to further studies evaluating the clinical potential of BAs, and verify the beneficial effect of lecithin formulation to improve the absorption of poorly soluble phytochemicals.
authors.affiliation: Indena S.p.A., Viale Ortles 12, Milano, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Riva
authors.affiliation: Indena S.p.A., Viale Ortles 12, Milano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Morazzoni
authors.affiliation: Indena S.p.A., Viale Ortles 12, Milano, Italy.
authors.forename: Christian
authors.initials: C
authors.lastname: Artaria
authors.affiliation: Indena S.p.A., Viale Ortles 12, Milano, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Allegrini
authors.affiliation: Central Laboratory of German Pharmacists, Carl-Mannich-Str. 20, 65760 Eschborn, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Meins
authors.affiliation: R&D Solution s.r.l., Via Luigi Perna, 51 00142 Roma, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Savio
authors.affiliation: Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Via Bovio 6, 28100, Novara, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Appendino
authors.affiliation: Department of Pharmaceutical Chemistry, Goethe-University Frankfurt, Max-von-Laue Strasse 9, 60438 Frankfurt am Main, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Schubert-Zsilavecz
authors.affiliation: Central Laboratory of German Pharmacists, Carl-Mannich-Str. 20, 65760 Eschborn, Germany. Electronic address: m.tawab@zentrallabor.com.
authors.forename: Mona
authors.initials: M
authors.lastname: Abdel-Tawab
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000097:blood / Q000493:pharmacokinetics; D029743:Boswellia / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D004339:Drug Compounding / Q000379:methods*; D005260:Female; D006801:Humans; D007155:Immunologic Factors; D007408:Intestinal Absorption; D054709:Lecithins; D008297:Male; D013058:Mass Spectrometry; D008875:Middle Aged; D010936:Plant Extracts / Q000097:blood / Q000493:pharmacokinetics*; D012116:Resins, Plant; D014315:Triterpenes / Q000097:blood / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D007155:Immunologic Factors; D054709:Lecithins; D010936:Plant Extracts; D012116:Resins, Plant; D014315:Triterpenes; C054625:boswellic acid
keywords: Absorption; Boswellia serrata; Boswellic acids; Frankincense; Lecithin; Triterpenoids