Withania somnifera is a traditional Indian herb described under the ‘Rasayana’ class in Ayurveda, which gained immense popularity as a dietary supplement in the USA, Europe, Asia, and the Indian domestic market. Despite enormous research on the pharmacological effect of withanosides and withanolides, bioanalytical method development and pharmacokinetics remained challenging and unexplored for these constituents due to isomeric and isobaric characteristics. In current research work, molecular descriptors, pharmacokinetic, and toxicity prediction (ADMET) of these constituents were performed using Molinspiration and admetSAR tools. A rapid, selective, and reproducible bioanalytical method was developed and validated for seven withanosides and withanolides as per USFDA/EMA guidelines, further applied to determine pharmacokinetic parameters of Withania somnifera root extract (WSE) constituents in male Sprague Dawley rats at a dose of 500 mg/kg. Additionally, an ex vivo permeability study was carried out to explore the absorption pattern of withanosides and withanolides from the intestinal lumen. In silico, ADMET revealed oral bioavailability of withanosides and withanolides following Lipinski’s rules of five with significant absorption from the gastrointestinal tract and the ability to cross the blood-brain barrier. Upon oral administration of WSE, Cmax was found to be 13.833 ± 3.727, 124.415 ± 64.932, 57.536 ± 7.523, and 7.283 ± 3.341 ng/mL for withanoside IV, withaferin A, 12-Deoxy-withastramonolide, and withanolide A, respectively, with Tmax of 0.750 ± 0.000, 0.250 ± 0.000, 0.291 ± 0.102, and 0.333 ± 0.129 h. Moreover, at a given dose, withanoside V, withanolide B, and withanone were detected in plasma; however, the concentration of these constituents was found below LLOQ. Thus, these four major withanoside and withanolides were quantified in plasma supported by ex vivo permeation data exhibiting a time-dependent absorption of withanosides and withanolides across the intestinal barrier. These composite findings provide insights to design a clinical trial of WSE as a potent nutraceutical.
The aim of this study was to formulate and evaluate niosomes of venlafaxine HCl. It is a selective serotonin reuptake inhibitor type of drug used in the treatment of depression. It is practically soluble in water belongs to BCS class I with a bioavailability approximately 45%. Niosomes of venlafaxine HCl were prepared by using the cholesterol and span 80(1:1) by Ether Injection Method which is further used for targeted drug delivery. Nine batches were prepared by the Ether Injection Method and evaluated for In vitro drug release and drug release kinetics. Niosomes are acceptable and superior carriers and also have ability to encapsulate hydrophilic and lipophilic drugs and protect them from degradation. Niosomes were characterized for entrapment efficiency, vesicle size, percentage yield, FTIR, DSC, and physical stability. Formulation F 9 niosomes batch was found to be optimized and followed zero-order release kinetic. Niosomes dispersion were found to be stable and preparation of niosomes using factorial design was found to be well suited and sound approach to be stable niosomal formulations.
The Dalbergia sissoo leaves traditionally have medicinal values and are well known for current research on osteoporosis and bone health. The present research aims to develop and validate a simple, sensitive, and comprehensive analytical method to standardize Dalbergia sissoo leaves. An ultra‐high performance liquid chromatography method was developed for seven isoflavone glycosides, and isoflavone's identification, including bioactive caviunin and biochanin‐A based glycosides with genistein, pratensein, biochanin‐A, and biochanin‐A‐7‐O‐glucoside for simultaneous quantification in Dalbergia sissoo leaves. Also, a novel high‐performance thin‐layer chromatography‐based method has been developed for isoflavone glycosides as a visual quality control tool for Dalbergia sissoo. Further, seven isoflavonoids were also characterized using mass spectrometry in sample matrices. A qualitative high‐performance thin‐layer chromatography‐based method was found helpful in identifying four major isoflavone glycosides in leaves. The performance of the method and the validation data showed the ultra‐high performance liquid chromatography method was precise (relative standard deviation < 5.0%), accurate (recoveries 80%–110%), robust (relative standard deviation < 5.0%), and linear (r2 > 0.99) for quantification. This well‐separated novel and rapid determination of Dalbergia sissoo compounds in leaves will be helpful in the standardization of the quality assessment tool for Dalbergia sissoo.
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