Journal of Drug Vigilance and Alternative Therapies

Serum Leptin in Cerebrovascular Stroke: A Case–Control Study with Implications for Pharmacotherapy and Risk Stratification

Syeda Asiya Fazilath, N. Jaya — Fri, 30 Jun 2023 00:00:00 +0000

Leptin, an adipocyte-derived hormone with pro-inflammatory and atherogenic properties, has been implicated in vascular pathology, though its association with cerebrovascular stroke remains controversial. This hospital-based case–control study evaluated circulating serum leptin levels in 100 subjects, including 50 patients with cerebrovascular stroke (ischemic and hemorrhagic) and 50 age-and sex-matched healthy controls. Serum leptin levels were measured using ELISA, while fasting blood glucose and lipid profile parameters were assessed by standard enzymatic methods. Statistical analysis was performed using SPSS version 16, with p < 0.05 considered significant. Serum leptin levels were significantly higher in stroke patients compared to controls (p < 0.001), with mean values of 10.39 ± 4.25 ng/mL in ischemic stroke, 9.32 ± 3.45 ng/mL in hemorrhagic stroke, and 5.54 ± 0.85 ng/mL in controls. Leptin showed positive correlations with LDL cholesterol, body mass index, and blood pressure, and LDL and total cholesterol were significantly elevated in stroke patients (p < 0.05). These findings suggest that elevated leptin levels may serve as a biomarker of metabolic and vascular risk in cerebrovascular disease and may have clinical relevance in therapeutic risk stratification and drug safety monitoring. Integrative approaches, including nutraceuticals and lifestyle interventions targeting leptin modulation, may complement conventional therapy. Further prospective studies are required to clarify its predictive and clinical utility.

Formulation and In-vitro Evaluation of Orodispersible Sumatriptan Tablets: Implications for Rapid Therapeutic Delivery and Drug Safety

Ruheena Sultana — Fri, 30 Jun 2023 00:00:00 +0000

The demand for Orodispersible Tablets (ODTs) has increased notably in recent years, particularly for pediatric and geriatric populations with swallowing difficulties. Sumatriptan, a selective serotonin 5 HT1B/1D receptor agonist, is widely used in the treatment of acute migraine; however, its oral bioavailability is limited (~15%) due to extensive first-pass metabolism. The present study aimed to formulate and evaluate orodispersible tablets of sumatriptan using the wet granulation method to enhance dissolution and improve therapeutic performance. The prepared formulations were evaluated for pre- and post-compression parameters, all of which were within pharmacopeial limits. Among the formulations, batch F5 demonstrated optimal performance, achieving 98% drug release within 15 minutes. FTIR and DSC analyses confirmed the absence of significant drug–excipient interactions, indicating formulation stability. The enhanced dissolution profile suggests the potential for faster onset of action, which is critical in acute migraine management. Such rapid-release formulations may improve therapeutic outcomes, enhance patient compliance, and potentially reduce the need for repeated dosing, thereby minimizing dose-related adverse effects and supporting safer, patient-centered therapy.

Therapeutic Potential of Vitexin and Isovitexin in Central Nervous System Disorders: A Preclinical Systematic Review

Syed Yousuf Hussain, Rahathunnisa Begum, Afzalunnisa Begum, Hajera Begum — Fri, 30 Jun 2023 00:00:00 +0000

Central nervous system (CNS) disorders are complex conditions involving oxidative stress, neuroinflammation, and neurotransmitter imbalance, necessitating the development of multi-target therapeutic strategies. Plant-derived flavonoids such as vitexin (apigenin-8-C-glucoside) and isovitexin have gained increasing attention due to their potential neuroprotective properties. This preclinical systematic review evaluates the therapeutic potential of these compounds in CNS disorders. A comprehensive literature search was conducted across PubMed, Scopus, ScienceDirect, SpringerLink, and Google Scholar for studies published between January 2000 and April 2023, including in-vitro and in-vivo experimental investigations assessing neuroprotective, anticonvulsant, antidepressant, anxiolytic, and anti-neurodegenerative effects. A total of 20 studies met the inclusion criteria, predominantly involving in-vivo animal models. The findings indicate that vitexin and isovitexin exert significant neuroprotective effects through antioxidant activity, modulation of neuroinflammatory pathways, regulation of neurotransmitter systems, and inhibition of neuronal apoptosis. Beneficial outcomes were consistently observed in experimental models of epilepsy, depression, anxiety, ischemic brain injury, and Alzheimer’s disease. However, the available evidence is limited to preclinical studies with variable methodological quality and absence of clinical data. In conclusion, vitexin and isovitexin demonstrate promising multi-target neuroprotective potential, but further clinical validation and safety evaluation are required to support their therapeutic application in humans.