Journal of Drug Delivery and Therapeutics (JDDT)
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Toxicity Evaluation of a VLP-Based Vaccine Аgainst Human Rotavirus Infection Following a Single Administration in Rats: Serum Biochemistry and Histopathological Examination of Organs and Injection Site
Get PDFVirus-like particle (VLP) - based vaccines exhibit outstanding clinical, epidemiological, and immunological efficacy and specificity. The novel technology used for producing their active component without incorporating live viruses enables both injectable and non-injectable (e.g., intranasal) administration, emphasizing the need for a comprehensive safety assessment. This study is part of a preclinical toxicological evaluation program aimed at assessing the safety profile of the “Gam-VLP-rota” vaccine candidate targeting human rotavirus infection.
The goal of this extended toxicology study was to confirm the safety of a single intramuscular administration of the vaccine in Sprague-Dawley rats. The study focused on identifying possible adverse effects both acutely (within 24 hours post-administration) and after a 14-day recovery period, aiming to detect delayed toxicological signs. Toxicological endpoints included evaluation of target organs, coagulation parameters, hematology, clinical biochemistry, necropsy findings, and histopathological analysis.
This article presents a segment of the results, including changes in serum biochemical parameters after a single immunization and histological examination of internal organs and the injection site in rats.
Keywords: VLP; vaccines; preclinical studies; vaccine safety; toxicological chemistry
Psoralea corylifolia L. (Babchi): A Comprehensive Review of Its Phytochemistry, Pharmacology and Ethnomedicinal Applications in the AYUSH (Unani) System of Medicine
Get PDFPsoralea corylifolia L., commonly known as Babchi, is a well-known medicinal plant that has been utilized for centuries in traditional medical systems such as Ayurveda, Siddha, and particularly the Unani system of medicine, where it is referred to as Babchi. Belonging to the Fabaceae family, P. corylifolia is native to tropical and subtropical regions, including China, South Africa, and extensively across the Indian subcontinent—namely Maharashtra, West Bengal, Uttar Pradesh, Rajasthan, Karnataka, Bihar, and the Deccan plateau.
In the Unani system, different parts of the plant are used therapeutically: roots for dental caries; leaves for diarrhoea; fruits for conditions such as anaemia, asthma, bronchitis, dysuria, inflammation, and vomiting; and seeds for skin conditions like scabies, ulcers, vitiligo, leucoderma, eczema, leprosy, and psoriasis. Phytochemical investigations have revealed more than seventy bioactive compounds, including flavonoids, coumarins, Quinone’s, phenols, benzofurans, benzopyrans, sesquiterpenoids, triterpenes, and steroids. Various pharmacological activities have been reported, such as anti-inflammatory, hepatoprotective, hemostatic, antioxidant, antimicrobial, antibacterial, antifungal, anti-obesity, antiviral, anti-mutagenic, anti-filarial, estrogenic, anticancer, anti-asthmatic, anti-diabetic, anti-aging, and immunomodulatory properties. Additionally, potential therapeutic effects have been observed in Alzheimer’s disease and alopecia areata.
Several traditional and proprietary Unani formulations such as Roghan Babchi, Sufoof-e-Babchi, Zimad-e-Bars, Habb-e-Bars, and Habb-e-Hindi are commercially available for therapeutic use. This review aims to consolidate classical Ethnomedicinal knowledge and recent pharmacological research on P. corylifolia to facilitate its broader integration into evidence-based phytomedicine.
Keywords. Psoralea corylifolia, Babchi, Dermatological disorders, Unani medicine
Bisphenol F induced alteration in testicular p53 and localization: Implications for cauda epididymal sperm characteristics and morphology
Get PDFBisphenol F (BPF), a structural analogue of Bisphenol A (BPA), is widely used in the production of plastics and epoxy resins. Emerging evidence suggests that BPF may disrupt endocrine function and impair fertility. This study investigates the effects of BPF on sperm characteristics, morphology, and germ cell viability, with a focus on its potential mechanisms of action in male reproductive toxicity. Wistar rats were randomly assigned to five groups (n=5/group): control (Group I), BPF-treated groups (100 (Group II), 500 (Group III), and 1000 (Group IVa) µg/kg/day for 45 days), and a recovery group (IVb) (1000 µg/kg/day for 45 days followed by a 45-day recovery). Post-treatment, sperm parameters were assessed, and immunohistochemical analysis of p53 expression in testicular tissue was performed. BPF exposure led to significant, dose-dependent declines in sperm count, motility, and viability, accompanied by increased morphological abnormalities, particularly in the sperm head region. Irregularities in the acrosomal system, plasma membrane, and perforatorium suggested oxidative stress during epididymal transit. A 5–8% reduction in sperm viability and a 2–15% increase in abnormalities were observed across dose groups. Elevated p53 expression in testicular tissues indicated germ cell apoptosis and impaired spermiogenesis. Recovery period showed significant resumption, indicative of temporary damage to testicular function. In conclusion, BPF exerts direct, dose-dependent toxicity on male reproductive function by promoting oxidative stress and upregulating p53-mediated germ cell elimination, ultimately contributing to teratozoospermia and reduced fertility potential.
Keywords: Bisphenol F, Spermatogenesis, P53, Sperm morpholog
In-Vitro Antibacterial Evaluation of Hawan Ash: A Traditional Material with Emerging Therapeutic Potential
Get PDFAsh derived from ritualistic fire offerings has been traditionally considered to possess medicinal properties, yet its antibacterial potential remains scientifically unexplored. The lack of systematic evaluation necessitates an in-depth investigation of its efficacy. This study comprehensively examines the antibacterial activity of Hawan ash, assessing the influence of ash type, solvent selection, and dosage on bacterial inhibition to provide insights into its potential as a natural antimicrobial agent. Hawan ash extracts were prepared using different ash types (HA-1, HA-2 and HA-3) and solvents and tested at various concentrations against multiple bacterial species. Antibacterial activity was evaluated using the agar well diffusion method by measuring the zone of inhibition (ZOI). Results revealed significant variability in antibacterial activity depending on ash type, solvent, and dosage. Although standard antibiotic (Neomycin 30µg/disc) as a positive agent exhibited the highest ZOI (23.21 ± 0.06 mm), confirming the effectiveness of conventional antibiotics. Methanol ash extracts showed stronger activity than aqueous extracts (p < 0.05) with the highest inhibition against S. typhi (18.33 ± 0.29 mm at 0.6g/mL, HA-2). Aqueous extracts exhibited moderate activity with P. vulgaris being the most susceptible (10.00 ± 0.51 mm at 0.6g/mL, HA-1). These findings highlight the antibacterial potential of Hawan ash, influenced by extraction parameters. The observed variability underscores the need for advanced phytochemical profiling to identify bioactive constituents and optimize formulations for therapeutic applications.
Keywords: Hawan ash, Antibacterial activity, Well diffusion method, ZOI, Therapeutic potentia
Cytotoxic Activity of a Niclosamide–Caffeic Acid Multicomponent Cocrystal in T47D Breast Cancer Cells
Get PDFObjective: This study aimed to evaluate the cytotoxic activity of a niclosamide–caffeic acid multicomponent cocrystal against T47D breast cancer cells.
Methods: The multicomponent cocrystal was prepared using the solvent-drop grinding method. Cytotoxic activity was assessed using the Microculture Tetrazolium Test (MTT) assay.
Results: The results demonstrated that both niclosamide alone and the niclosamide–caffeic acid multicomponent cocrystal exhibited cytotoxic effects against T47D cells, with IC50 values of 2.92 μg/mL and 2.50 μg/mL, respectively. Microplate spectrophotometric analysis confirmed a concentration-dependent decrease in cell viability for both treatments. Notably, the niclosamide–caffeic acid multicomponent cocrystal displayed a more pronounced cytotoxic effect than niclosamide alone.
Conclusions: These findings suggest that the formation of niclosamide–caffeic acid multicomponent crystals may enhance anticancer potential and warrant further investigation as a promising therapeutic approach for breast cancer treatment.
Keywords: breast cancer, niclosamide, caffeic acid, multicomponent crystal, cytotoxicity, T47D cells, MTT assay
Recent Advances in Pickering Emulsions: Stabilizers, Applications and Future Directions
Get PDFPickering emulsions are a type of dispersion in which solid particles stabilize the interface between oil and water, often offering greater stability than traditional emulsions that rely on surfactants. This review thoroughly examines the main factors that affect the performance and stability of Pickering emulsions, such as the particles\u27 wettability, dimensions, morphology, and how densely they cover the interface. A crucial factor, particle wettability, is typically measured by the contact angle formed at the interface of the three phases. Crucial for effective emulsion stabilization, with particles exhibiting intermediate wettability (θ ≈ 90°) offering optimal stability. Particle size plays a complex role, with smaller particles enhancing stability by forming dense interfacial layers and resisting sedimentation. Non-spherical particles, such as rods, ellipsoids, and Janus particles, exhibit unique stabilization mechanisms due to their high aspect ratios and deformability at the interface. Surface coverage and electrostatic interactions also significantly impact emulsion stability. The review discusses the pickering emulsions offer several benefits compared to traditional surfactant-based emulsions. These advantages include enhanced stability due to the irreversible adsorption of solid particles at the interface, reduced reliance on synthetic surfactants, and improved biocompatibility and environmental friendliness, reduced toxicity and suitability for various applications. The preparation methods and characterization techniques for Pickering emulsions are summarized, along with their diverse applications in pharmaceuticals, biomedicine, cosmetics, and functional foods. Recent advances and future directions are explored, emphasizing the potential of engineered colloidal particles, multiparticle stabilization, and microencapsulation techniques for enhancing stability and functionality. This comprehensive review provides valuable insights into the fundamental principles and practical applications of Pickering emulsions, guiding future research and development in this promising field.
Keywords: Pickering emulsion, applications, future scop
Real-World Effectiveness and Safety of Virulina in Adults with Respiratory and Post-Viral Inflammatory Conditions: A Multicenter Retrospective Cohort Study
No full textBackground: Respiratory illnesses are a major contributor to global morbidity. Conventional treatments, though effective, are constrained by adverse effects and incomplete recovery. Virulina, a standardized polyherbal formulation with antiviral and immunomodulatory activity, was evaluated for its real-world effectiveness and safety. Methods: This multicenter, retrospective, post-marketing cohort study analyzed the treatment records of 300 adults (aged 18–65 years) treated with Virulina across five Ayurvedic outpatient clinics in India. Patients received 1 g TID for 14–28 days. The primary outcome was safety, assessed by adverse event incidence. Secondary outcomes included symptom resolution, inflammatory and hematological biomarker changes, and physician-rated vitality scores. Results: Of 300 patients (56% male, mean age 45 years), 70% presented with symptoms, and 54.4% had comorbidities. Virulina therapy yielded marked symptom resolution, with reductions ranging from 75.9% in bronchitis, 78.3% in bronchial asthma, 82.6% in post-viral musculoskeletal symptoms, 84.1% in lung inflammation, to 89.7% in viral respiratory infections (all p < 0.001. Laboratory outcomes showed significant normalization: CRP declined by up to 96.8%, D-dimer by 55%, and leukocyte and eosinophil counts by 48–65% (p < 0.001 for all). Physician-assessed vitality and immune modulation scores improved by 89 - 96%, correlating with clinical recovery. Notably, no adverse events or therapy discontinuations were reported, underscoring an excellent safety profile. Conclusion: Virulina demonstrated substantial symptom improvement, biomarker normalization, and excellent tolerability across a heterogeneous outpatient population with respiratory illnesses. These findings highlight its potential as a safe, accessible adjunct to standard care, meriting validation in prospective randomized controlled trials.
Keywords: lower and upper respiratory tract infections, post-viral inflammation, Virulin
Green Synthesis and Bioactive Potential of Silver Nanoparticles: Antimicrobial and Anticancer Evaluation
No full textThe current work describes the green synthesis and characterization of silver nanoparticles (AgNPs) and their assessment with antimicrobial, bioassay, and anticancer properties. UV-vis spectroscopy was used to verify the formation of nanoparticles by a distinct plasmon resonance point at 440 nm, which corresponds to the average plasmon resonance of silver nanoparticles (400-460 nm). FTIR analysis identified the presence of functional groups of hydroxyl, carbonyl and ether/ alcohol, which is the evidence of the use of phytochemicals in stabilizing the nanoparticles. SEM-imaging revealed spherical-to-quasi-spherical sized AgNPs with diameter between 52 and 84 nm, with low agglomeration and uniform distribution reflecting stability and biomedical application. Antibacterial tests revealed strong anti-microbial effects against Staphylococcus aureus, Bacillus subtilis, Escherichia coli and Klebsiella pneumoniae with an anti-microbial zone of 14-26 mm, which were more potent against antibiotics. Antifungal testing showed activity against Aspergillus flavus, but only slight inhibition of Aspergillus terreus and Aspergillus niger. The presence of dose-dependent cytotoxicity was shown in studies on bioassay against K. pneumoniae, where cell death was up to 73.61 per cent at the highest concentrations. Evaluation of anticancer activity with MCF-7 breast cancer cell line demonstrated that there was minimum concentration-dependent cell viability reduction, and the greatest reduction (21.8% viability) was at 2 µL concentration. In general, the prepared silver nanoparticles have positive multifunctional bioactivities, suggesting their potential in therapeutic and biomedical applications.
Keywords: Silver nanoparticles, Green synthesis, Antibacterial activity, Bioassay, MCF-7 cell lin
Etiopathogenesis of Chronic Bronchitis: A Symptom-Based Correlation with Sūʿāl and Its Management in Unani Medicine
No full textChronic bronchitis is a major phenotype of chronic obstructive pulmonary disease (COPD), characterized by a persistent productive cough and excessive mucus secretion resulting from chronic airway inflammation. In Unani medicine, the term Waram-i- shoab Muzmin has been used in later writings as a literal translation, though the clinical description more closely resembles Sūʿāl, particularly Sūʿāl Aṣlī mentioned in classical sources. The present review explores the etiopathogenesis, symptomatology, and management of chronic bronchitis in both modern and Unani frameworks. Modern medicine attributes its development mainly to cigarette smoking, air pollution, and oxidative stress, which trigger airway remodelling, mucus hypersecretion, and epithelial injury. Unani physicians described similar mechanisms in terms of Sū’-i-Mizāj, Waram, Yubūsat, and accumulation of Mawād-i-Fāsida, often precipitated by cold, dust, and irritants, especially in individuals of Balghamī Mizāj . Preventive strategies, lifestyle regulation, and holistic management form the core of Unani practice, including Ilāj bi’l-Tadbīr (regimenal therapy), Ilāj bi’l-Ghizā (dietotherapy), and Ilāj bi’l-Dawā (pharmacotherapy). Various single drugs such as Asl-us-Soos (Glycyrrhiza glabra), Arusa (Adhatoda vasica), Behidana (Cydonia oblonga), and compound formulations like Laʿūq-e-Sapistān and Joshānda-e-Munḍij are employed, along with preventive measures such as avoiding phlegm-producing foods and exposure to cold air. Importantly, recent clinical evidence has validated the efficacy of licorice-based formulations in chronic cough, further supporting the relevance of Unani interventions. These insights demonstrate that Unani intervention can be effectively applied in clinical practice as a complementary option, offering safer and more sustainable strategies for managing chronic bronchitis.
Keywords: Chronic bronchitis, COPD, Sūʿāl, Unani medicine, Etiopathogenesi
Standardization and Development of Standard Operating Procedures (SOPs) of a Polyherbal Unani Formulation Qurṣ-i Bawāsīr
No full textQurṣ-i Bawāsīr (QB) is a highly potent compound Unani formulation as it has synergistic effect in the treatment of Bawāsīr (Piles). Its ingredients act as anti- inflammatory, analgesics, purgative and emollient. The present study aims at identification and authentication of the crude ingredients of QB, development of SOPs and HPTLC fingerprinting by modern analytical techniques to comprehend its quality. QB in its three different batches was evaluated for organoleptic parameters, microscopic studies, physicochemical parameters, phytochemical screening, TLC and HPTLC profile, aflatoxin, microbial load and heavy metal analysis. QB was successfully standardized with all the parameters such as total ash, acid insoluble ash, water and alcohol soluble matter and loss of weight on drying. Further, TLC and HPTLC fingerprinting profile was developed and detected under various detection systems, viz. UV 366nm, UV 254nm, exposure to iodine vapours and anisaldehyde sulphuric acid. The present study ensured authenticity of the Unani formulation and furnished referential facts for its identification and purity thereby substantiating a validated scientific data.
Keywords: Qurṣ-i Bawāsīr, Unani formulation, Standardization, HPTL