Physicochemical Stability and Biological Activity of<i>Withania somnifera</i>Extract under Real-Time and Accelerated Storage Conditions

Patil, Dada; Gautam, Manish; Jadhav, Umesh; Mishra, Sanjay; Karupothula, Suresh; Gairola, Sunil; Jadhav, Suresh; Patwardhan, Bhushan

doi:10.1055/s-0029-1186220

Cited by 26 publications

(16 citation statements)

References 24 publications

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“…An ideal stability studies protocol for such a drug/product should involve quantitative analysis of marker(s), whose levels can be extrapolated to its intended benefits. For instance, withanolides in Withania somnifera are related to immunomodulatory activity (Patil et al, ); rebaudiside and stevioside are related to sweetness of Stevia rebaudiana (Tanaka, ); curcumin is responsible for antiinflammatory activity of Curcuma longa (Akram et al, ); and hyperforin is chiefly responsible for antidepressant activity of H . perforatum (Barnes et al, ).…”

Section: Challenges In Stability Testing Of Herbal Drugs/productsmentioning

confidence: 99%

“…For instance, immunomodulatory activity of W . somnifera is found to vary proportionally to the concentration of withanolide (Patil et al, ); decrease in free radical scavenging activity of Bacopa monnieri corresponds well with decrease in concentration of Bacopaside I (Srivastava et al, ); free radical scavenging activity of Orthosiphon stamineus extract is proportional to the content of polyphenols (Akowuah and Zhari, ); and antiangiogenic activity of Matricaria chamomilla extract is directly related to flavonoids and apigenin‐7‐ O ‐glucoside content (Srivastava and Gupta, ). Nevertheless, contrary to these correlating reports, some studies have defied a correlation between stability of a selected marker and a particular biological activity tested during the stability studies.…”

Section: Challenges In Stability Testing Of Herbal Drugs/productsmentioning

confidence: 99%

“…officinalis (Hiegl and Franz, ), Crataegus oxyacantha (Bilia et al, ), Hieracium pilosella (Bilia et al, ), Mentha piperita (Sachan et al, ), Piper longum (Srivastava et al, ), Piper sarmentosum (Hussain et al, ), Sesbania grandiflora (Dwivedi and Gupta, ), Solanum nigrum (Hiegl and Franz, ), Verbena officinalis (Goppel and Franz, ) and W . somnifera (Patil et al, ).…”

Section: Conformity and Contravention With Recommended Stability Condmentioning

confidence: 99%

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Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives

et al. 2016

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Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd.

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Section: Challenges In Stability Testing Of Herbal Drugs/productsmentioning

confidence: 99%

Section: Challenges In Stability Testing Of Herbal Drugs/productsmentioning

confidence: 99%

Section: Conformity and Contravention With Recommended Stability Condmentioning

confidence: 99%

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Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives

et al. 2016

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“…Therefore, these were used for the standardization as reported earlier (Malik et al, 2007;Patil et al, 2010). Chromatography was performed using a HPLC system consisting of Waters 515 pumps, Waters 2998 photodiode array detector, and Empower 2 software (Waters, Milford, MA).…”

Section: Standardization Of the Extractmentioning

confidence: 99%

Withania somniferashows a protective effect in monocrotaline-induced pulmonary hypertension

Kaur¹,

Singh²,

Samuel³

et al. 2014

Pharmaceutical Biology

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Context: Withania somnifera (Linn.) Dunal (Solanaceae), a clinically used herbal drug in Ayurveda, shows potent antioxidant, anti-inflammatory, pro-apoptotic, and cardioprotective effects. However, the efficacy of W. somnifera in pulmonary hypertension (PH), a cardiopulmonary disorder, remains unexplored. Objective: The present study investigates the effect of W. somnifera root powder on monocrotaline (MCT)-induced PH in rats. Materials and methods: In preventive studies, W. somnifera root powder (50 and 100 mg/kg/d, p.o.) was administered from day 1 following single administration of MCT (60 mg/kg, s.c.) in Sprague-Dawley (SD) rats. After 35 d, right ventricular pressure (RVP) was measured in anesthetized rats. Various physical markers of right ventricular hypertrophy (RVH) were measured in isolated hearts. Markers of endothelial function, inflammation, and oxidative stress were estimated in lung homogenate. Vasoreactivity of pulmonary arteries was also studied. In therapeutic treatment, W. somnifera (50 and 100 mg/kg/d, p.o.) was administered from day 21 to 35 post-MCT administration. Results: Preventive treatment with 50 and 100 mg/kg W. somnifera significantly reduced the RVP (32.18 ± 1.273 mm Hg and 29.98 ± 1.119 mm Hg, respectively, versus 42.96 ± 1.789 mm Hg of MCT) and all markers of RVH in MCT-challenged rats. There was an improvement in inflammation, oxidative stress and endothelial dysfunction, and attenuation of proliferative marker and apoptotic resistance in lungs. Therapeutic treatment with W. somnifera (100 mg/kg) also reduced RVP and RVH. Discussion: This study demonstrated that W. somnifera significantly protected against MCTinduced PH due to its antioxidant, anti-inflammatory, pro-apoptotic, and cardioprotective properties.

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“…18 WSE was chemically characterized on the basis of contents of withanolides such as withaferin A and withanolide A using our previously reported HPLC-DAD (HPLC with diode array detection) method. 19 Protoberberine alkaloids such as berberine, palmatine, and jatrorrhizine were used as marker compounds for chemical characterization of TCE using our earlier HPLC-DAD coupled with mass spectrometer method. 20 …”

Section: Phytochemical Analysis Of Are Wse and Tcementioning

confidence: 99%

Effect of Botanical Immunomodulators on Human CYP3A4 Inhibition

et al. 2013

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Purpose. Many botanical immunomodulators are used as adjuvants along with cancer chemotherapy. However, information on the impact of concurrent administration of such botanicals on pharmacokinetics of chemotherapy agents is inadequate. This study investigates inhibitory activities of 3 popular botanical adjuvants: Asparagus racemosus (root aqueous extract; ARE), Withania somnifera (root aqueous extract; WSE), and Tinospora cordifolia (stem aqueous extract, TCE) on human CYP3A4 isoenzyme, responsible for metabolism of several chemotherapy agents. Experimental design. Testosterone 6-β hydroxylation was monitored using high-performance liquid chromatography as an indicator of CYP3A4 catalytic activities. Ketoconazole (positive control) and extracts were studied at their in vivo-relevant concentrations. Results. TCE showed mild inhibition while no significant inhibitory activities were observed in WSE and ARE. TCE was further fractionated to obtain polar and nonpolar fractions. The nonpolar fraction showed significant CYP3A4 inhibition with IC 50 13.06 ± 1.38 µg/mL. Major constituents of nonpolar fraction were identified using HPLC-DAD-MS profiling as berberine, jatrorrhizine, and palmatine, which showed IC 50 values as 6.25 ± 0.30, 15.18 ± 1.59, and 15.53 ± 1.89 µg/mL, respectively. Conclusion. Our findings suggest that constituents of TCE extract especially protoberberine alkaloids have the potential to interact with cancer chemotherapy agents that are metabolized by CYP3A4 in vivo.

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Physicochemical Stability and Biological Activity ofWithania somniferaExtract under Real-Time and Accelerated Storage Conditions

Abstract: Withania somnifera l " Solanaceae l " Ayurveda l " ashwagandha l " stability l " withaferin A l " withanolide A

Cited by 26 publications

References 24 publications

Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives

Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives

Withania somniferashows a protective effect in monocrotaline-induced pulmonary hypertension

Effect of Botanical Immunomodulators on Human CYP3A4 Inhibition

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