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Extracts of frankincense, the gum resin of Boswellia species, have been extensively used in traditional folk medicine since ancient times and are still of great interest as promising anti-inflammatory remedies in Western countries. Despite their common therapeutic use and the intensive pharmacological research including studies on active ingredients, modes of action, bioavailability, pharmacokinetics, and clinical efficacy, frankincense preparations are available as nutraceuticals but have not yet approved as a drug on the market. A major issue of commercially available frankincense nutraceuticals is the striking differences in their composition and quality, especially related to the content of boswellic acids (BAs) as active ingredients, mainly due to the use of material from divergent Boswellia species but also because of different work-up and extraction procedures. Here, we assessed three frequently used frankincense-based preparations for their BA content and the interference with prominent pro-inflammatory actions and targets that have been proposed, that is, 5-lipoxygenase and leukotriene formation in human neutrophils, microsomal prostaglandin E2 synthase-1, and inflammatory cytokine secretion in human blood monocytes. Our data reveal striking differences in the pharmacological efficiencies of these preparations in inflammation-related bioassays which obviously correlate with the amounts of BAs they contain. In summary, high-quality frankincense extracts display powerful anti-inflammatory effectiveness against multiple targets which can be traced back to BAs as bioactive ingredients.
Friedemann Börner; Markus Werner; Johannes Ertelt; Jürgen Meins; Mona Abdel-Tawab; Oliver Werz. Analysis of Boswellic Acid Contents and Related Pharmacological Activities of Frankincense-Based Remedies That Modulate Inflammation. Pharmaceuticals 2021, 14, 660 .
AMA StyleFriedemann Börner, Markus Werner, Johannes Ertelt, Jürgen Meins, Mona Abdel-Tawab, Oliver Werz. Analysis of Boswellic Acid Contents and Related Pharmacological Activities of Frankincense-Based Remedies That Modulate Inflammation. Pharmaceuticals. 2021; 14 (7):660.
Chicago/Turabian StyleFriedemann Börner; Markus Werner; Johannes Ertelt; Jürgen Meins; Mona Abdel-Tawab; Oliver Werz. 2021. "Analysis of Boswellic Acid Contents and Related Pharmacological Activities of Frankincense-Based Remedies That Modulate Inflammation." Pharmaceuticals 14, no. 7: 660.
Medicinal plants represent a big reservoir for discovering new drugs against all kinds of diseases including inflammation. In spite the large number of promising anti-inflammatory plant extracts and isolated components, research on medicinal plants proves to be very difficult. Based on that background this review aims to provide a summarized insight into the hitherto known pharmacologically active concentrations, bioavailability, and clinical efficacy of boswellic acids, curcumin, quercetin and resveratrol. These examples have in common that the achieved plasma concentrations were found to be often far below the determined IC50 values in vitro. On the other hand demonstrated therapeutic effects suggest a necessity of rethinking our pharmacokinetic understanding. In this light this review discusses the value of plasma levels as pharmacokinetic surrogates in comparison to the more informative value of tissue concentrations. Furthermore the need for new methodological approaches is addressed like the application of combinatorial approaches for identifying and pharmacokinetic investigations of active multi-components. Also the physiological relevance of exemplary in vitro assays and absorption studies in cell-line based models is discussed. All these topics should be ideally considered to avoid inaccurate predictions for the efficacy of herbal components in vivo and to unlock the “black box” of herbal mixtures.
Mona Abdel-Tawab. Considerations to Be Taken When Carrying Out Medicinal Plant Research—What We Learn from an Insight into the IC50 Values, Bioavailability and Clinical Efficacy of Exemplary Anti-Inflammatory Herbal Components. Pharmaceuticals 2021, 14, 437 .
AMA StyleMona Abdel-Tawab. Considerations to Be Taken When Carrying Out Medicinal Plant Research—What We Learn from an Insight into the IC50 Values, Bioavailability and Clinical Efficacy of Exemplary Anti-Inflammatory Herbal Components. Pharmaceuticals. 2021; 14 (5):437.
Chicago/Turabian StyleMona Abdel-Tawab. 2021. "Considerations to Be Taken When Carrying Out Medicinal Plant Research—What We Learn from an Insight into the IC50 Values, Bioavailability and Clinical Efficacy of Exemplary Anti-Inflammatory Herbal Components." Pharmaceuticals 14, no. 5: 437.
Xanthohumol is known to exert anti-inflammatory properties but has poor oral bioavailability. Using advanced micellization technology, it has been possible to markedly enhance its bioavailability. In the present study, we compared the chronic anti-inflammatory activities of native and micellar xanthohumol in the rat adjuvant arthritis model, using diclofenac as a reference drug. Adjuvant arthritis was induced by injecting Freund's complete adjuvant into the right hind paw of rats and monitoring paw volume over 3 weeks. The drugs were given daily for 3 weeks, starting from the day of adjuvant inoculation. Serum was collected at the end of the experiment to measure inflammatory and oxidative stress parameters. Statistical comparisons between different groups were carried out by one-way analysis of variance followed by Tukey-Kramer multiple comparison test. Micellar solubilized xanthohumol showed a better anti-inflammatory activity than its native form. The reduction in paw volume was reflected in corresponding changes in relevant mediators of inflammation like tumor necrosis factor-α, interleukin-6 and C-reactive protein, myloperoxidase and lipid peroxidation markers. The findings confirm that micellar solubilization of xanthohumol enhances its anti-inflammatory activity, probably as a result of improving its bioavailabilty. The solubilized xanthohumol may prove to be a promising adjuvant tool for anti-inflammatory treatment and a potential anti-inflammatory alternative to synthetic drugs.
Mohamed T. Khayyal; Rania M. El-Hazek; Walaa A. El-Sabbagh; Jan Frank; Dariush Behnam; Mona Abdel-Tawab. Micellar solubilization enhances the anti-inflammatory effect of xanthohumol. Phytomedicine 2020, 71, 153233 .
AMA StyleMohamed T. Khayyal, Rania M. El-Hazek, Walaa A. El-Sabbagh, Jan Frank, Dariush Behnam, Mona Abdel-Tawab. Micellar solubilization enhances the anti-inflammatory effect of xanthohumol. Phytomedicine. 2020; 71 ():153233.
Chicago/Turabian StyleMohamed T. Khayyal; Rania M. El-Hazek; Walaa A. El-Sabbagh; Jan Frank; Dariush Behnam; Mona Abdel-Tawab. 2020. "Micellar solubilization enhances the anti-inflammatory effect of xanthohumol." Phytomedicine 71, no. : 153233.
Pyrrolizidine alkaloids (PAs) are distributed in plant families of Asteraceae, Boraginaceae, and Fabaceae and serve in the chemical defense mechanism against herbivores. However, they became a matter of concern due to their toxicity associated with the high risk of intake within herbal preparations, e.g., phytopharmaceutical formulations, medicinal teas, or other plant-derived drug products. In 1992, the German Federal Ministry of Health established the first limits of PA content for fourteen medicinal plants. Because of the toxic effects of PAs, the Federal Institute of Risk Assessment (BfR) established more stringent limits in 2011, whereby a daily intake
Thomas Kopp; Mona Abdel-Tawab; Boris Mizaikoff. Extracting and Analyzing Pyrrolizidine Alkaloids in Medicinal Plants: A Review. Toxins 2020, 12, 320 .
AMA StyleThomas Kopp, Mona Abdel-Tawab, Boris Mizaikoff. Extracting and Analyzing Pyrrolizidine Alkaloids in Medicinal Plants: A Review. Toxins. 2020; 12 (5):320.
Chicago/Turabian StyleThomas Kopp; Mona Abdel-Tawab; Boris Mizaikoff. 2020. "Extracting and Analyzing Pyrrolizidine Alkaloids in Medicinal Plants: A Review." Toxins 12, no. 5: 320.
Xanthohumol (XN), a prenylated chalcone from hops, has been reported to exhibit a variety of health-beneficial effects. However, poor bioavailability may limit its application in the prevention and therapy of diseases. The objective of this study was to determine whether a micellar solubilization of xanthohumol could enhance the bioavailability and biological efficacy of xanthohumol in a Western-type diet (WTD) induced model of obesity, diabetes and non-alcoholic fatty liver disease (NAFLD). After 3 weeks feeding with WTD, XN was additionally applied per oral gavage as micellar solubilizate (s-XN) or native extract (n-XN) at a daily dose of 2.5 mg/kg body weight for a further 8 weeks. Control mice received vehicle only in addition to the WTD. WTD-induced body weight-gain and glucose intolerance were significantly inhibited by s-XN application. Furthermore, WTD-induced hepatic steatosis, pro-inflammatory gene expression (MCP-1 and CXCL1) and immune cell infiltration as well as activation of hepatic stellate cells (HSC) and expression of collagen alpha I were significantly reduced in the livers of s-XN-treated mice compared to WTD controls. In contrast, application of n-XN had no or only slight effects on the WTD-induced pathological effects. In line with this, plasma XN concentration ranged between 100–330 nmol/L in the s-XN group while XN was not detectable in the serum samples of n-XN-treated mice. In conclusion, micellar solubilization enhanced the bioavailability and beneficial effects of xanthohumol on different components of the metabolic syndrome including all pathological steps of NAFLD. Notably, this was achieved in a dose more than 10-fold lower than effective beneficial doses of native xanthohumol reported in previous in vivo studies.
Abdo Mahli; Tatjana Seitz; Kim Freese; Jan Frank; Ralf Weiskirchen; Mona Abdel-Tawab; Dariush Behnam; Claus Hellerbrand. Therapeutic Application of Micellar Solubilized Xanthohumol in a Western-Type Diet-Induced Mouse Model of Obesity, Diabetes and Non-Alcoholic Fatty Liver Disease. Cells 2019, 8, 359 .
AMA StyleAbdo Mahli, Tatjana Seitz, Kim Freese, Jan Frank, Ralf Weiskirchen, Mona Abdel-Tawab, Dariush Behnam, Claus Hellerbrand. Therapeutic Application of Micellar Solubilized Xanthohumol in a Western-Type Diet-Induced Mouse Model of Obesity, Diabetes and Non-Alcoholic Fatty Liver Disease. Cells. 2019; 8 (4):359.
Chicago/Turabian StyleAbdo Mahli; Tatjana Seitz; Kim Freese; Jan Frank; Ralf Weiskirchen; Mona Abdel-Tawab; Dariush Behnam; Claus Hellerbrand. 2019. "Therapeutic Application of Micellar Solubilized Xanthohumol in a Western-Type Diet-Induced Mouse Model of Obesity, Diabetes and Non-Alcoholic Fatty Liver Disease." Cells 8, no. 4: 359.
Boswellic acids (BAs) the pharmacologically active ingredients of the gum resin extract of Boswellia serrata are known for their anti-inflammatory effects. However they suffer from poor bioavailability because of their hydrophobicity and poor water solubility. The present study aimed at investigating the effect of AQUANOVA micellation technology on the bioavailability of Boswellia extract in rats compared to its native form. Study design. Female albino wistar rats (n = 6) weighing around 250 g were orally administered solubilized (Sol-BE) and native (Nat-BE) Boswellia extract at an equimolar dosage of 128 mg/kg. Plasma samples collected at defined time points (0, 0.5, 1, 2, 3, 4, 6 and 8 h) were analyzed for the content of the six major boswellic acids (KBA, AKBA, αBA, βBA, AαBA and AβBA) using a sensitive LC-MS/MS method. The oral administration of Sol-BE led to a remarkable increase in the AUC and Cmax of all BAs in plasma compared to Nat-BE. Whereas no KBA could be detected after the administration of Nat-BE, KBA could be detected at a maximal plasma concentration of 439.21 ng/mL and an AUClast of 1185.37 ng/mL*h following the administration of Sol-BE. The highest increase was observed in the case of AKBA where a 56-fold increase in the AUClast and a 25-fold increase in the Cmax was determined compared to Nat-BE. Micellar solubilisation represents a promising approach for enhancing the bioavailability of poorly soluble substances achieving even better absorption rates than other absorption enhancing strategies.
Jürgen Meins; Dariush Behnam; Mona Abdel-Tawab. Enhanced absorption of boswellic acids by a micellar solubilized delivery form of Boswellia extract. NFS Journal 2018, 11, 12 -16.
AMA StyleJürgen Meins, Dariush Behnam, Mona Abdel-Tawab. Enhanced absorption of boswellic acids by a micellar solubilized delivery form of Boswellia extract. NFS Journal. 2018; 11 ():12-16.
Chicago/Turabian StyleJürgen Meins; Dariush Behnam; Mona Abdel-Tawab. 2018. "Enhanced absorption of boswellic acids by a micellar solubilized delivery form of Boswellia extract." NFS Journal 11, no. : 12-16.
Objective: Native extracts of curcumin and boswellia are known to exert anti-inflammatory properties, but have poor bioavailability when given orally. Using advanced micellation technology, it has been possible to produce stable solubilisates of these extracts with markedly enhanced bioavailability. In the present study, we compared the chronic anti-inflammatory activities of native and micellar curcumin in the rat adjuvant arthritis model, using diclofenac as a reference drug. Methods & procedures: Adjuvant arthritis was induced by injecting Freund's complete adjuvant into the right hind paw of rats and monitoring paw volume over 3 weeks. The drugs were given daily for 3 weeks, starting from the day of adjuvant inoculation. The serum was collected at end of the experiment for the assay of inflammatory and oxidative stress parameters. Statistical comparisons between different groups were carried out by one-way analysis of variance followed by Tukey-Kramer multiple comparison test. Results: Solubilized curcumin showed a better anti-inflammatory activity than its native form. The reduction in paw volume was reflected in corresponding changes in relevant mediators of inflammation like tumor necrosis factor-α, interleukin-6 and C-reactive protein, myloperoxidase and lipid peroxidation markers. The combination of curcumin and boswellia solubilisates synergistically produced an even more potent therapeutic effect. Conclusion: The findings confirm that micellar solubilisation of curcumin and boswellia not only increases their bioavailability, but also enhances their biological activity. Micellar curcumin, in particular in combination with micellar boswellia, may thus represent a promising concomitant tool for anti-inflammatory treatment and a potential anti-inflammatory alternative to synthetic drugs.
Mohamed T. Khayyal; Rania M. El-Hazek; Walaa Elsabbagh; Jan Frank; Dariush Behnam; Dr. Mona Abdel-Tawab. Micellar solubilisation enhances the antiinflammatory activities of curcumin and boswellic acids in rats with adjuvant-induced arthritis. Nutrition 2018, 54, 189 -196.
AMA StyleMohamed T. Khayyal, Rania M. El-Hazek, Walaa Elsabbagh, Jan Frank, Dariush Behnam, Dr. Mona Abdel-Tawab. Micellar solubilisation enhances the antiinflammatory activities of curcumin and boswellic acids in rats with adjuvant-induced arthritis. Nutrition. 2018; 54 ():189-196.
Chicago/Turabian StyleMohamed T. Khayyal; Rania M. El-Hazek; Walaa Elsabbagh; Jan Frank; Dariush Behnam; Dr. Mona Abdel-Tawab. 2018. "Micellar solubilisation enhances the antiinflammatory activities of curcumin and boswellic acids in rats with adjuvant-induced arthritis." Nutrition 54, no. : 189-196.
Introduction: Despite recent advances in critical care, sepsis remains a crucial cause of morbidity and mortality in intensive care units. Therefore, the identification of new therapeutic strategies is of great importance. Since ancient times, frankincense is used in traditional medicine for the treatment of chronic inflammatory disorders such as rheumatoid arthritis. Thus, the present study intends to evaluate if Casperome® (Casp), an orally bioavailable soy lecithin-based formulation of standardized frankincense extract, is able to ameliorate systemic effects and organ damages induced by severe systemic inflammation using a murine model of sepsis, i.e., intraperitoneal administration of lipopolysaccharides (LPS). Methods: Male 60-day-old mice were assigned to six treatment groups: (1) control, (2) LPS, (3) soy lecithin (blank lecithin without frankincense extract), (4) Casp, (5) soy lecithin plus LPS, or (6) Casp plus LPS. Soy lecithin and Casp were given 3 h prior to LPS treatment; 24 h after LPS administration, animals were sacrificed and health status and serum cytokine levels were evaluated. Additionally, parameters representing liver damage or liver function and indicating oxidative stress in different organs were determined. Furthermore, markers for apoptosis and immune cell redistribution were assessed by immunohistochemistry in liver and spleen. Results: LPS treatment caused a decrease in body temperature, blood glucose levels, liver glycogen content, and biotransformation capacity along with an increase in serum cytokine levels and oxidative stress in various organs. Additionally, apoptotic processes were increased in spleen besides a pronounced immune cell infiltration in both liver and spleen. Pretreatment with Casp significantly improved health status, blood glucose values, and body temperature of the animals, while serum levels of pro-inflammatory cytokines and oxidative stress in all organs tested were significantly diminished. Finally, apoptotic processes in spleen, liver glycogen loss, and immune cell infiltration in liver and spleen were distinctly reduced. Casp also appears to induce various cytochromeP450 isoforms, thus causing re-establishment of liver biotransformation capacity in LPS-treated mice. Conclusion: Casp displayed anti-inflammatory, anti-oxidative, and hepatoprotective effects. Thus, orally bioavailable frankincense extracts may serve as a new supportive treatment option in acute systemic inflammation and accompanied liver dysfunction.
Konstantin Loeser; Semjon Seemann; Stefanie König; Isabell Lenhardt; Mona Abdel-Tawab; Andreas Koeberle; Oliver Werz; Amelie Lupp. Protective Effect of Casperome®, an Orally Bioavailable Frankincense Extract, on Lipopolysaccharide- Induced Systemic Inflammation in Mice. Frontiers in Pharmacology 2018, 9, 1 .
AMA StyleKonstantin Loeser, Semjon Seemann, Stefanie König, Isabell Lenhardt, Mona Abdel-Tawab, Andreas Koeberle, Oliver Werz, Amelie Lupp. Protective Effect of Casperome®, an Orally Bioavailable Frankincense Extract, on Lipopolysaccharide- Induced Systemic Inflammation in Mice. Frontiers in Pharmacology. 2018; 9 ():1.
Chicago/Turabian StyleKonstantin Loeser; Semjon Seemann; Stefanie König; Isabell Lenhardt; Mona Abdel-Tawab; Andreas Koeberle; Oliver Werz; Amelie Lupp. 2018. "Protective Effect of Casperome®, an Orally Bioavailable Frankincense Extract, on Lipopolysaccharide- Induced Systemic Inflammation in Mice." Frontiers in Pharmacology 9, no. : 1.
Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission.
Mona Abdel-Tawab. Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework. Planta Medica 2017, 84, 372 -393.
AMA StyleMona Abdel-Tawab. Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework. Planta Medica. 2017; 84 (06/07):372-393.
Chicago/Turabian StyleMona Abdel-Tawab. 2017. "Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework." Planta Medica 84, no. 06/07: 372-393.
Near infrared (NIR) spectroscopy is increasingly gaining significance in the pharmaceutical industry for quality and in-process control. However, the potential of this method for quantitative quality control in pharmacies has long been neglected and little data is available on its application in analysis of creams and ointments. This study evaluated the applicability of NIR spectrometer with limited wavelength range (1000-1900nm) for quantitative quality control of six different dermatological semi-solid pharmaceutical preparations. Each contained a frequently used active ingredient in a common concentration either in a water-free lipid base or in an aqueous cream matrix. Based on direct NIR transflectance measurements through standardized glass beakers and partial least squares (PLS) multivariate calibration, quantitative models were generated comparing several data pre-processing methods Whereas difficulties were observed for mixtures containing 2% (w/w) metronidazole or 4% (w/w) erythromycin, content determination was possible with sufficient accuracy for salicylic acid (5 % (w/w)) and urea (10% (w/w)) in hydrophilic as well as in lipophilic formulations meeting the limit of a maximum deviation of±5% (relative) from the reference values. Exemplarily, one of the methods was successfully validated according to the EMA Guideline, determining several figures of merit such as specificity, linearity, accuracy, precision and robustness.
Lisa B. Schlegel; Manfred Schubert-Zsilavecz; Dr. Mona Abdel-Tawab. Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy. Journal of Pharmaceutical and Biomedical Analysis 2017, 142, 178 -189.
AMA StyleLisa B. Schlegel, Manfred Schubert-Zsilavecz, Dr. Mona Abdel-Tawab. Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy. Journal of Pharmaceutical and Biomedical Analysis. 2017; 142 ():178-189.
Chicago/Turabian StyleLisa B. Schlegel; Manfred Schubert-Zsilavecz; Dr. Mona Abdel-Tawab. 2017. "Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy." Journal of Pharmaceutical and Biomedical Analysis 142, no. : 178-189.
Curcumin, the active constituent of Curcuma longa L. (family Zingiberaceae), has gained increasing interest because of its anti-cancer, anti-inflammatory, anti-diabetic, and anti-rheumatic properties associated with good tolerability and safety up to very high doses of 12 g. Nanoscaled micellar formulations on the base of Tween 80 represent a promising strategy to overcome its low oral bioavailability. We therefore aimed to investigate the uptake and transepithelial transport of native curcumin (CUR) vs. a nanoscaled micellar formulation (Sol-CUR) in a Caco-2 cell model. Sol-CUR afforded a higher flux than CUR (39.23 vs. 4.98 μg min−1 cm−2, respectively). This resulted in a higher Papp value of 2.11 × 10−6 cm/s for Sol-CUR compared to a Papp value of 0.56 × 10−6 cm/s for CUR. Accordingly a nearly 9.5 fold higher amount of curcumin was detected on the basolateral side at the end of the transport experiments after 180 min with Sol-CUR compared to CUR. The determined 3.8-fold improvement in the permeability of curcumin is in agreement with an up to 185-fold increase in the AUC of curcumin observed in humans following the oral administration of the nanoscaled micellar formulation compared to native curcumin. The present study demonstrates that the enhanced oral bioavailability of micellar curcumin formulations is likely a result of enhanced absorption into and increased transport through small intestinal epithelial cells.
Jan Frank; Christina Schiborr; Alexa Kocher; Jürgen Meins; Dariush Behnam; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. Transepithelial Transport of Curcumin in Caco-2 Cells Is significantly Enhanced by Micellar Solubilisation. Plant Foods for Human Nutrition 2016, 72, 48 -53.
AMA StyleJan Frank, Christina Schiborr, Alexa Kocher, Jürgen Meins, Dariush Behnam, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab. Transepithelial Transport of Curcumin in Caco-2 Cells Is significantly Enhanced by Micellar Solubilisation. Plant Foods for Human Nutrition. 2016; 72 (1):48-53.
Chicago/Turabian StyleJan Frank; Christina Schiborr; Alexa Kocher; Jürgen Meins; Dariush Behnam; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. 2016. "Transepithelial Transport of Curcumin in Caco-2 Cells Is significantly Enhanced by Micellar Solubilisation." Plant Foods for Human Nutrition 72, no. 1: 48-53.
: 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. : In order to verify these encouraging results in human, the absorption of a standardized Boswellia serrata extract and its lecithin formulation (CSP) was comparatively investigated in healthy volunteers. : 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 at a dosage of 2×250 mg capsules. : The plasma concentrations of the six major BAs (KBA, AKBA, βBA, αBA, AβBA, AαBA) were determined using LC/MS. : 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 Cmax in the range required for the interaction with their molecular targets. : 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.
Antonella Riva; Paolo Morazzoni; Christian Artaria; Pietro Allegrini; Jürgen Meins; Daniele Savio; Giovanni Appendino; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation. Phytomedicine 2016, 23, 1375 -1382.
AMA StyleAntonella Riva, Paolo Morazzoni, Christian Artaria, Pietro Allegrini, Jürgen Meins, Daniele Savio, Giovanni Appendino, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab. A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation. Phytomedicine. 2016; 23 (12):1375-1382.
Chicago/Turabian StyleAntonella Riva; Paolo Morazzoni; Christian Artaria; Pietro Allegrini; Jürgen Meins; Daniele Savio; Giovanni Appendino; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. 2016. "A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation." Phytomedicine 23, no. 12: 1375-1382.
In consideration of the increasing popularity of frankincense and the widely published quality problems associated with botanical dietary supplements, a survey was conducted for the first time on the quality of frankincense containing botanical dietary supplements. Six US products representing 78 % of the units sold and 70 % of the market value, and 11 European products representing 30 % of the units sold and 40 % of the market value were tested for their boswellic acid composition profile, label compliance, and claimed health benefits. Special focus was also set on the statements made with regard to the frankincense applied. Only five products out of seventeen disclosed all relevant information for the Boswellia extract, mentioning the species, the part of plant used, and the boswellic acid content. Whereas all products but one claimed to use Boswellia serrata, three products did not mention the resin as the part applied and 10 products did not declare the boswellic acid content. Apart from the different boswellic acid composition determined with a sensitive LC/MS method, 41 % of the products did not comply with the label declaration. Hence, one product from Italy did not contain any of the six characteristic boswellic acids (KBA, AKBA, αBA, βBA, AαBA, AβBA) at all and another US product contained only traces, suggesting the absence of frankincense or the use of Boswellia frereana instead of B. serrata. In another product, the ratios of the individual boswellic acids were different from B. serrata gum resin, indicating the use of another species such as Boswellia sacra or Boswellia carterii. Furthermore, two products revealed different boswellic acid contents from those declared on the label. Further, two products did not declare the use of manipulated Boswellia gum resin extract being enriched in acetyl-11-keto-boswellic acid content reaching up to 66 %. In addition, consumers could be misled by outdated literature or references to in vitro studies performed at dosages that can never be achieved in humans following oral administration. In summary, this survey reveals that in spite of increased regulations on botanical dietary supplements, the problem of mislabeling still exists and needs to be addressed by the manufacturers, so that consumers get greater confidence in the botanical dietary supplements they use.
Jürgen Meins; Christian Artaria; Antonella Riva; Paolo Morazzoni; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. Survey on the Quality of the Top-Selling European and American Botanical Dietary Supplements Containing Boswellic Acids. Planta Medica 2016, 82, 573 -579.
AMA StyleJürgen Meins, Christian Artaria, Antonella Riva, Paolo Morazzoni, Manfred Schubert-Zsilavecz, Mona Abdel-Tawab. Survey on the Quality of the Top-Selling European and American Botanical Dietary Supplements Containing Boswellic Acids. Planta Medica. 2016; 82 (06):573-579.
Chicago/Turabian StyleJürgen Meins; Christian Artaria; Antonella Riva; Paolo Morazzoni; Manfred Schubert-Zsilavecz; Mona Abdel-Tawab. 2016. "Survey on the Quality of the Top-Selling European and American Botanical Dietary Supplements Containing Boswellic Acids." Planta Medica 82, no. 06: 573-579.
The anti-inflammatory properties of Boswellia serrata extracts (BSEs) have been demonstrated in vitro and in animal studies [1 – 2]. Clinical trials covering a wide spectrum of disorders like asthma, osteo- and reumathoid arthritis, Crohn's disease and collagenous colitis have shown encouraging but not compelling results, which are mostly explained by the low quality and variability of BSEs [3]. In addition, pharmacokinetic studies have evidenced low and erratic systemic absorption of the putative active principles, the boswellic acids (BAs) [2]. In this context, we are reporting here a survey of BAs contents (detected with LC-MS/MS method) and the label claims of 17 top selling products from USA and EU. This survey confirms the great variability in the compositions and label misleading. Furthermore, we will discuss an original way to ameliorate and improve the clinical potential of BAs through the natural delivery system of lecithin phospholipids. This formulation has been shown to significantly improve the absorption of BAs and tissue distribution in rats [4]. In the wake of this promising result, we have carried out a comparative pharmacokinetic study in 12 healthy volunteers on weight-equivalent (500 mg) dosages of the lecithin phospholipids formulated BSE and the non-formulated BSE extract. References: [1] Abdel-Tawab M, Werz O, Schubert-Zsilavecz M. Boswellia serrata: an overall assessment of in vitro, preclinical, pharmacokinetic and clinical data. Clin Pharmacokinet. 2011; 50: 349 – 69. [2] Du Z., Llu Z, Ning Z, Llu Y, Song Z, Wang C, Lu A. Prospects of boswellic acids as potential pharmaceutics. Planta Med 2015; 81: 259 – 271 [3] Ernst E. Frankincense: systematic review. BMJ 2008; 337: 2813 – 2816. [4] Husch J, Bohnet J, Fricker G, Skarke C, Artaria C., Appendino G, Schubert-Zsilavecz M, Abdel-Tawab M. Enhanced absorption of boswellic acids by a lecithin delivery form (Phytosome®) of Boswellia extract. Fitoterapia 2013; 84: 89 – 98.
A Riva; P Morazzoni; G Appendino; M Abdel-Tawab. Quality, bioavailability and clinical application of a new lecithin delivery system of Boswellia serrata extract. Planta Medica 2015, 81, SL2A_03 .
AMA StyleA Riva, P Morazzoni, G Appendino, M Abdel-Tawab. Quality, bioavailability and clinical application of a new lecithin delivery system of Boswellia serrata extract. Planta Medica. 2015; 81 (16):SL2A_03.
Chicago/Turabian StyleA Riva; P Morazzoni; G Appendino; M Abdel-Tawab. 2015. "Quality, bioavailability and clinical application of a new lecithin delivery system of Boswellia serrata extract." Planta Medica 81, no. 16: SL2A_03.
Objective: The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy. Methods: Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Statistical analysis was performed using Student’s t test. Results: Both pens delivered all doses within ISO limits. The difference between the average measured dose and the target dose was significantly smaller for SoloSTAR than FlexTouch at 40 U ( P = .009) and 80 U ( P = .008), but not at 1 U ( P = .417). Conclusion: Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.
Mona Abdel-Tawab; Mario Schmitz; Stefan Kamlot; Manfred Schubert-Zsilavecz. Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1. Journal of Diabetes Science and Technology 2015, 10, 157 -161.
AMA StyleMona Abdel-Tawab, Mario Schmitz, Stefan Kamlot, Manfred Schubert-Zsilavecz. Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1. Journal of Diabetes Science and Technology. 2015; 10 (1):157-161.
Chicago/Turabian StyleMona Abdel-Tawab; Mario Schmitz; Stefan Kamlot; Manfred Schubert-Zsilavecz. 2015. "Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1." Journal of Diabetes Science and Technology 10, no. 1: 157-161.
This study demonstrates clearly that also medicinal teas licensed as medicinal products may partly contain high amounts of PAs exceeding current recommendations. For that reason manufacturers are advised to carry out more rigorous quality control tests devoted to the detection of PAs. This is very important to minimize PAs in medicinal teas accounting for possible additional exposure of the consumer to PAs from other food sources (e.g. honey).
M. Schulz; J. Meins; S. Diemert; P. Zagermann-Muncke; Rainer Goebel; D. Schrenk; M. Schubert-Zsilavecz; M. Abdel-Tawab. Detection of pyrrolizidine alkaloids in German licensed herbal medicinal teas. Phytomedicine 2015, 22, 648 -656.
AMA StyleM. Schulz, J. Meins, S. Diemert, P. Zagermann-Muncke, Rainer Goebel, D. Schrenk, M. Schubert-Zsilavecz, M. Abdel-Tawab. Detection of pyrrolizidine alkaloids in German licensed herbal medicinal teas. Phytomedicine. 2015; 22 (6):648-656.
Chicago/Turabian StyleM. Schulz; J. Meins; S. Diemert; P. Zagermann-Muncke; Rainer Goebel; D. Schrenk; M. Schubert-Zsilavecz; M. Abdel-Tawab. 2015. "Detection of pyrrolizidine alkaloids in German licensed herbal medicinal teas." Phytomedicine 22, no. 6: 648-656.
J. Bohnet; V. Korger; M. Schubert-Zsilavecz; M. Abdel-Tawab. P96 Dosing accuracy of different insulin glargine pens available in India. Diabetes Research and Clinical Practice 2014, 103, S61 .
AMA StyleJ. Bohnet, V. Korger, M. Schubert-Zsilavecz, M. Abdel-Tawab. P96 Dosing accuracy of different insulin glargine pens available in India. Diabetes Research and Clinical Practice. 2014; 103 ():S61.
Chicago/Turabian StyleJ. Bohnet; V. Korger; M. Schubert-Zsilavecz; M. Abdel-Tawab. 2014. "P96 Dosing accuracy of different insulin glargine pens available in India." Diabetes Research and Clinical Practice 103, no. : S61.
The introduction of the FlexTouch® (FT; Novo Nordisk; insulin aspart), a prefilled insulin pen with a spring-loaded mechanism, has created more insulin pen options. The present study compared the dosing accuracy of the FT with that of the manually operated SoloSTAR® (SS; Sanofi; insulin glulisine). The volumetric flow rate of insulin delivery with the FT was also evaluated. Thirty unused pens from one batch of each pen type were used to test dosing accuracy at minimum (1 U), mid (40 U), and maximum dose (80 U). Statistical analysis was performed using Student's t-test. Insulin flow was determined with 20 FT pens ejecting 80 U three times per pen using a mass flow meter. Both insulin pens revealed excellent dosing accuracy, delivering all doses within the limits set by ISO 11608-1:2000. The average relative deviation of the actual dose from the target dose was +6.86% and +3.87% at the minimum, -0.72% and -1.01% at the mid, and -0.68% and -1.06% at the maximum dose for the SS and FT, respectively. The difference at maximum dose was statistically significant (p = .006) in favor of the SS. The FT showed a mean maximum flow rate of 15.61 U/s, with 80.52% of the total dose delivered at an injection speed exceeding 10 U/s. This study demonstrated excellent dosing accuracy for the SS and FT at all tested dosage levels. The average maximum injection speed of the FT was considerably higher than the usual range of 6-10 U/s assumed for a smooth and painless injection. Further investigations should confirm the clinical relevance.
Janine Bohnet; Mario Schmitz; Stefan Kamlot; Mona Abdel-Tawab. Dosing accuracy and insulin flow rate characteristics of a new disposable insulin pen, FlexTouch, compared with SoloSTAR. Journal of Diabetes Science and Technology 2013, 7, 1021 -6.
AMA StyleJanine Bohnet, Mario Schmitz, Stefan Kamlot, Mona Abdel-Tawab. Dosing accuracy and insulin flow rate characteristics of a new disposable insulin pen, FlexTouch, compared with SoloSTAR. Journal of Diabetes Science and Technology. 2013; 7 (4):1021-6.
Chicago/Turabian StyleJanine Bohnet; Mario Schmitz; Stefan Kamlot; Mona Abdel-Tawab. 2013. "Dosing accuracy and insulin flow rate characteristics of a new disposable insulin pen, FlexTouch, compared with SoloSTAR." Journal of Diabetes Science and Technology 7, no. 4: 1021-6.
Intramuscular (L-)epinephrine is used as self-medication for serious hypersensitivity reactions. Inhalative administration has the theoretical advantage of a more rapid absorption and better controllability. The current trial was conducted to explore pharmacokinetics and pharmacodynamics of two nebulized inhalative epinephrine doses (4 mg and 8 mg in aqueous solution) using a mobile pocket inhaler relative to intramuscular administration (0.3 mg) and placebo. This randomized, open-label, change-over pilot study involved eight young healthy men and women. Noncompartmental pharmacokinetic and pharmacodynamic parameters were calculated from epinephrine plasma concentrations and hemodynamic parameters. Mean exposure to epinephrine decreased from the 8 mg dose to the 4 mg inhalative dose, and further with the 0.3 mg intramuscular dose, with active treatments showing significantly higher concentrations than placebo (geometric mean area under the curve AUC0-t(last) values: 282, 236, 204 and 81.6 hr*ng/L). Maximal concentrations were reached within approximately 15 min for all active treatments. Epinephrine effects for inhalative administrations on heart rates were significantly higher than those for the intramuscular or placebo administration, while no excessive effects occurred. Pronounced overall variability prohibited a definite assessment of relative bioavailability between treatments. However, results indicated that epinephrine concentrations obtained following the 8 mg inhalative dose were not inferior to those after 0.3 mg i.m. A relevant fraction of moist inhalation epinephrine doses is absorbed and mediates systemic effects. This suggests that administration of epinephrine via a suitable pocket inhaler device may be beneficial in ambulatory emergency treatment of systemic hypersensitivity reactions. EudraCT number: 2010-021493-11
C. Breuer; B. Wachall; K. Gerbeth; M. Abdel-Tawab; U. Fuhr. Pharmacokinetics and pharmacodynamics of moist inhalation epinephrine using a mobile inhaler. European Journal of Clinical Pharmacology 2013, 69, 1303 -1310.
AMA StyleC. Breuer, B. Wachall, K. Gerbeth, M. Abdel-Tawab, U. Fuhr. Pharmacokinetics and pharmacodynamics of moist inhalation epinephrine using a mobile inhaler. European Journal of Clinical Pharmacology. 2013; 69 (6):1303-1310.
Chicago/Turabian StyleC. Breuer; B. Wachall; K. Gerbeth; M. Abdel-Tawab; U. Fuhr. 2013. "Pharmacokinetics and pharmacodynamics of moist inhalation epinephrine using a mobile inhaler." European Journal of Clinical Pharmacology 69, no. 6: 1303-1310.
Boswellia serrata gum resin extracts (BSE) revealed potent anti-inflammatory actions in preclinical and clinical studies. In 2002 BSE was assigned an orphan drug status by the European Medicines Agency (EMA) for the treatment of peritumoral edema. In the past pharmacological effects of BSE were mainly attributed to 11-keto-β-boswellic acid (KBA) and 3-acetyl-11-keto-β-boswellic acid (AKBA). Therefore pharmacokinetic and pharmacodynamic studies focused mainly on these two boswellic acids (BAs). However, other BAs, like β-boswellic acid (βBA), might also contribute to the anti-inflammatory actions of BSE. Here, we determined the metabolic stability, permeability and brain availability of six major BAs, that is, KBA, AKBA, βBA, 3-acetyl-β-boswellic acid (AβBA), α-boswellic acid (αBA), and 3-acetyl-α-boswellic acid (AαBA). For permeability studies, the Caco-2 model was adapted to physiological conditions by the addition of bovine serum albumin (BSA) to the basolateral side and the use of modified fasted state simulated intestinal fluid (FaSSIF) on the apical side. Under these conditions the four BAs lacking the 11-keto moiety revealed moderate permeability. Furthermore the permeability of AKBA and KBA was improved compared to earlier studies. In contrast to Aα- and AβBA, βBA and αBA were intensively metabolized after incubation with human and rat liver microsomes. Finally, the availability of all six major BAs could be confirmed in rat brain 8h after oral administration of 240mg/kg BSE to rats showing mean concentrations of 11.6ng/g for KBA, 37.5ng/g for AKBA, 485.1ng/g for αBA, 1066.6ng/g for βBA, 43.0ng/g for AαBA and 163.7ng/g for AβBA.
Kathleen Gerbeth; Jan Hüsch; Gert Fricker; Oliver Werz; Manfred Schubert-Zsilavecz; Dr. Mona Abdel-Tawab. In vitro metabolism, permeation, and brain availability of six major boswellic acids from Boswellia serrata gum resins. Fitoterapia 2013, 84, 99 -106.
AMA StyleKathleen Gerbeth, Jan Hüsch, Gert Fricker, Oliver Werz, Manfred Schubert-Zsilavecz, Dr. Mona Abdel-Tawab. In vitro metabolism, permeation, and brain availability of six major boswellic acids from Boswellia serrata gum resins. Fitoterapia. 2013; 84 ():99-106.
Chicago/Turabian StyleKathleen Gerbeth; Jan Hüsch; Gert Fricker; Oliver Werz; Manfred Schubert-Zsilavecz; Dr. Mona Abdel-Tawab. 2013. "In vitro metabolism, permeation, and brain availability of six major boswellic acids from Boswellia serrata gum resins." Fitoterapia 84, no. : 99-106.