Journal of Drug Delivery and Therapeutics (JDDT)
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Comparative Pharmaceutical Evaluation and Bioavailability Assessment of Levothyroxine Sodium in Different Dosage Forms
No full textLevothyroxine sodium is recognized as a narrow-therapeutic-index drug, making its clinical performance highly sensitive to formulation variables that can influence systemic bioavailability. This study focused on the development, physicochemical evaluation, and comparative bioavailability assessment of levothyroxine sodium formulated into three distinct dosage forms: tablets, HPMC based capsules, and soft gelatin capsules. Each formulation was manufactured using optimized processing strategies to ensure stability and dose accuracy. Physical evaluation and comprehensive in vitro testing, including assay, content uniformity, dissolution profiling, and analysis of related substances, were conducted in accordance with compendial standards. All three dosage forms exhibited satisfactory predefined quality criteria, indicating acceptable pharmaceutical performance. In vivo characterization was carried out in healthy volunteers using a randomized, open-label, two-treatment, two-period crossover design to compare the test products with the reference capsule. Blood samples were collected over an extended sampling period, and levothyroxine plasma concentrations were quantified using a validated analytical method. Pharmacokinetic parameters, including Cmax, AUC0–t, and AUC0–∞, were derived through non-compartmental analysis and evaluated for bioequivalence using standard statistical approaches. The in vivo results demonstrated that the soft gelatin capsules exhibited bioavailability parameters closely aligned with those of the reference product, with 90% confidence intervals for both rate and extent of absorption falling within accepted regulatory bioequivalence limits. Conversely, the directly compressed tablets and HPMC-based capsule formulations displayed higher inter-subject variability and did not consistently meet equivalence criteria across all pharmacokinetic endpoints. Among the dosage forms investigated, soft gelatin capsule provided the most reliable pharmaceutical quality and bioavailability performance relative to the reference product. These findings highlight the critical role of formulation design in achieving consistent levothyroxine exposure and support the liquid-filled soft gelatin system as a promising alternative for clinical application.
Keywords: Levothyroxine sodium; Different dosage forms; Soft-gelatin capsules; Bioavailability; Bioequivalence.
Development of UV Spectrophotometric Method and Estimation of Simvastatin in Tablet Formulation
No full textA simple, precise, accurate, and cost-effective UV–visible spectrophotometric method for simvastatin was developed and validated in accordance with ICH Q2 (R1) guidelines. The maximum absorbance wavelength (λmax) of simvastatin was determined to be 238 nm. The range of the calibration curve was between 1-20 µg/mL, and absorbance values were recorded at 238 nm to generate a calibration curve, yielding a correlation coefficient of 0.999. The calculated limit of detection (LOD) and limit of quantitation (LOQ) were 0.11406 µg/mL and 0.34565 µg/mL, respectively. The method demonstrated acceptable accuracy, precision, robustness, and ruggedness when evaluated with quality control standards. This validated method is suitable for the estimation of simvastatin in bulk drug and plant extract samples. The method demonstrated acceptable accuracy, precision, robustness, and ruggedness when evaluated with quality control standards. It was successfully applied for the estimation of simvastatin in bulk drug and commercial tablet formulations.
Keywords: UV-method, Simvastatin, Zocor, Tablet Estimation, Validation
Unani Perspective on Polymenorrhea (Kathrat-I-Ḥayd): Understanding Etiology and Pathogenesis
No full textMenstrual disorders have long been a subject of significant concern for gynaecologists and physicians, both in ancient and modern times, due to their profound impact on women’s health. Among these, Polymenorrhea represents one of the most prevalent complaints among menstruating women, affecting approximately 5–15% of the adult female population. It adversely influences physical, emotional, and social well-being, thereby diminishing the overall quality of life. Polymenorrhea refers to abnormally frequent or shortened menstrual cycles, which may occur as a physiological variation or as a manifestation of underlying pathological conditions. Under normal circumstances, menstruation follows a cyclical pattern lasting up to seven days; however, deviations in frequency or duration may indicate menstrual dysfunction. In the Unani system of medicine, this condition is referred to as Kathrat-i-Ḥayḍ, denoting excessive menstrual bleeding. When the bleeding persists beyond the normal menstrual period or occurs irregularly on non-menstrual days, it is termed Istiḥaza. The Unani scholars have elaborated extensively on its causes, underlying mechanisms, and management strategies. This paper aims to elucidate the etiological factors and pathogenesis of Kathrat-i-Ḥayḍ as described in classical Unani literature, thereby contributing to a deeper understanding of its conceptual and clinical significance.
Keywords: Polymenorrhea, Kathrat-i-Ḥayd, Unani medicin
Plant-Based Antidepressants: An Overview of Bioactive Compounds and Screening Strategies
No full textDepression is a complicated mental illness that affects mood, cognition, and neuroendocrine function. Despite the widespread use of synthetic antidepressants, their limited efficacy, delayed onset of action, and adverse effects underscore the need for safer and more effective substitutes. Therefore, it appears vital to find effective treatments with sufficient efficacy, fewer side effects, and a cheaper cost. Phytoconstituents, such as alkaloids, flavonoids, saponins, terpenoids, and phenolic acids, exhibit antidepressant potential by altering monoaminergic neurotransmission, reestablishing the hypothalamic-pituitary-adrenal (HPA) axis, enhancing brain-derived neurotrophic factor (BDNF) expression, and reducing oxidative stress and inflammation. All of these pathways were found to be involved in the pathophysiology of depression. All things considered, though, plant-based substances provide a promising foundation for the methodical and scientific creation of next-generation antidepressant therapies.
Keywords: Depression; Antidepressants, medicinal plants, herbal medicine, bioactive compound
Evaluation of Regulatory Requirements Relating to Quality Control of Skin-Lightening Cosmetic Products in Côte D\u27ivoire
No full textIn many countries around the world, in Africa and specially in Côte d\u27Ivoire, many women and sometimes men use cosmetic products containing skin-lightening active ingredients. These substances are toxic and cause several public health problems. Their presence in cosmetics is restricted, or even prohibited. Furthermore, regulatory changes set maximum concentrations for certain substances, requiring quantification in various cosmetic products. Our work aims to assess current technical specifications regulations compliance with skin-lightening cosmetic products quality control in Côte d\u27Ivoire. To carry out this study, we identified the characteristic elements of these specifications as described at national level. Next, we collected and analyzed the national, West African, and international regulations applicable to cosmetic products in Côte d\u27Ivoire. It appears that specifications established, by organization named "Côte d\u27Ivoire - Standardization", for skin-lightening cosmetic products were compliant with Ivorian Presidential Decree No. 2015-288 of April 29, 2015. The same specifications were also found in Council Decision No. 07/2010/CM/UEMOA on West African Economic and Monetary Union (UEMOA) cosmetic products registration. This Decision includes references to European Union (EU) regulations relevant annexes regarding prohibited or restricted substances lists, with which common specifications have been identified. While the national specifications comply with international standards, they must be supplemented and fully implemented for a strict analysis of skin-lightening cosmetics in Côte d\u27Ivoire.
Keywords: Regulation, cosmetics, skin-lightening preparations, specifications, Côte d’Ivoire
Molecular Docking and Pharmacological In-silico evaluation of Nitrogen and oxygen Heterocyclic Compounds as promising anticancer agents with an aim of drug repurposing
No full textA
Cancer is one of the leading causes of death among deadly diseases that occur in humans. Due to its ability to spread and the uncontrolled cell growth, it affects various organs and tissues. The present study evaluates the interactions between two receptors, 6JOR (FLT3 in complex with Gilteritinib) and HER-2 (Human epidermal growth factor receptor 2), and five existing drugs, with different biological actions and Safety Profiles. The aim is to repurpose established drugs. Molecular dynamics (MD) simulation of the ligand with the target 6JOR showed the most likely binding for Albendazole, with an IDDT value of 0.6598. The Binding affinity prediction maximum for Aripiprazole (-7.24425). Gilteritinib gave IDDT value -6.228. GROMACS was used for dynamic binding and docking using the new wrap mime platform. Pharmacokinetic evaluation based on the rule of five and Prediction of Pharmacology by PASS online. This research highlights the significance of drug repurposing and eliminates the need for drugs with an established safety profile. The study of existing drugs with established safety profiles and in silico pharmacological activity prediction using PASS online leveraged insights into biological activity. Further clinical testing should be conducted to assess anticancer activity in Humans.
Keywords: Docking, Dynamics, Cancer, Heterocyclic, Nitrogen, Oxyge
Validated UV-Visible Spectrophotometric Method for Quantitative Analysis of Glycyrrhizin
No full textAim: The study aimed to develop and validate a simple, accurate, precise and cost-effective UV-Visible spectrophotometric method for the estimation of Glycyrrhizin in bulk as well as in formulation.
Methods: A UV-Visible spectrophotometric method for Glycyrrhizin was developed using HPLC grade water. The solution was scanned across the UV-Visible range of 200-800 nm to identify its wavelength of maximum absorbance. The linearity of the method was established using six calibration standards over a concentration range of 5–75 μg/mL. Three different quality control standard solutions of the Glycyrrhizin were used for establishing the accuracy and precision of the proposed method. Proposed method was validated using ICH Q2 (R1) guidelines on the basis of accuracy, precision, robustness, limit of Detection (LOD), and limit of Quantitation (LOQ).
Results: Glycyrrhizin when dissolved in methanol and diluted by using HPLC grade water showed maximum absorbance at wavelength of 254 nm. The developed UV–Visible spectrophotometric method demonstrated excellent linearity across the concentration range of 5–75 μg/mL, with a Correlation coefficient (r²) of 0.999. The intra-day accuracy of the proposed UV–Visible Spectrophotometric method in terms of % Difference was in the range of +0.5487 to +1.8644 whereas the inter-day accuracy was in the range of +0.6250 to + 1.9096. The intra-day precision of the proposed UV–Visible spectrophotometric method in terms of % RSD was found to be in Between 0.2681 to 1.3558 whereas the inter-day precision values were in between 0.2581 to 1.3052. The variation (% RSD) during the robustness study of the proposed UV–Visible spectrophotometric method was found be below 2%. The limit of detection (LOD) and limit of quantitation (LOQ) of the proposed UV–Visible spectrophotometric method was found to be 1.7285 μg/mL and 5.2380 μg/mL respectively, ensuring adequate sensitivity for routine analysis. Proposed method was successfully used for the estimation of Glycyrrhizin in the formulation.
Conclusion: The proposed UV-Visible spectrophotometric method for estimation of Glycyrrhizin is simple, sensitive, accurate, and cost effective. It is suitable for routine analysis of Glycyrrhizin in commercial formulation.
Keywords: Glycyrrhizin, UV-Visible method, ICH Q2 (R1
Pharmacology of Vitamin C in the Treatment of Cancer: A Comprehensive Review
No full textVitamin C (ascorbate) has re-emerged as a promising adjunct in oncology due to a clearer understanding of its distinct pharmacology when administered intravenously versus orally. Oral dosing is constrained by saturable intestinal absorption and tight renal regulation, limiting plasma concentrations to low micromolar levels. In contrast, intravenous (IV) administration achieves pharmacologic millimolar plasma concentrations, enabling mechanisms not accessible through dietary or supplemental intake. At these higher levels, ascorbate functions as a pro-drug to generate hydrogen peroxide (H₂O₂) in the extracellular space, selectively inducing oxidative stress and cytotoxicity in cancer cells, which often possess impaired antioxidant defences. Additional proposed mechanisms include modulation of redox signalling, enhancement of sensitivity to chemotherapy and radiotherapy, and regulation of epigenetic enzymes such as TET and HIF hydroxylases. Preclinical studies consistently demonstrate dose-dependent tumour cell killing and synergy with conventional therapies, while early-phase clinical trials report good tolerability, improved quality of life, and signals of therapeutic benefit in malignancies such as pancreatic, ovarian, and glioblastoma. However, definitive efficacy data remain limited due to small sample sizes and heterogeneous protocols. Safety concerns include haemolytic risk in G6PD deficiency and oxalate nephropathy in predisposed patients, underscoring the need for appropriate screening. Overall, current evidence supports the biological plausibility and safety of pharmacologic ascorbate as an adjunct to standard cancer therapy, but well-powered randomized trials and validated biomarkers are required before widespread clinical implementation.
Keywords: Vitamin C, Ascorbate, Intravenous Vitamin C, Cancer Therapy, Oxidative stress, Hydrogen Peroxide, Pharmacokinetics, Chemo-radiation Sensitization, Adjunctive oncolog
Curcumin-Loaded Nanoemulsions: Advances in Formulation Strategies and Anti-Inflammatory Therapeutic Applications
No full textCurcumin, the principal bioactive compound of Curcuma longa, has drawn significant attention for its potent anti-inflammatory properties. However, its clinical translation remains limited due to poor solubility in aqueous environments, rapid degradation, and extremely low oral bioavailability. In recent years, nanoemulsion-based delivery systems have emerged as a promising strategy to overcome these barriers. By encapsulating curcumin within nanoscale oil-in-water emulsions, researchers have achieved enhanced solubility, improved physicochemical stability, and more efficient absorption across biological membranes. Preclinical studies demonstrate that curcumin-loaded nanoemulsions exhibit superior anti-inflammatory activity compared to free curcumin, as evidenced by greater suppression of pro-inflammatory cytokines, reduced oxidative stress, and more effective modulation of key signalling pathways in both in vitro and in vivo models. These advances highlight nanoemulsions not only as carriers that protect curcumin from degradation but also as facilitators of targeted and sustained therapeutic action. Future directions should prioritise large-scale clinical evaluations, standardised formulation protocols, and clear regulatory frameworks to ensure safety, reproducibility, and patient accessibility. Overall, curcumin-loaded nanoemulsions represent a compelling avenue for harnessing the therapeutic potential of curcumin, particularly for managing inflammation-driven disorders.
Keywords: Curcumin, Nanoemulsion, Drug delivery, Anti-inflammatory therapy, Bioavailability, Clinical translatio
Beyond the Beverage: The Versatility and Health Benefits of Coconut Water
No full textYoung coconuts contain a clear liquid called coconut water, which has attracted a lot of interest due to its inherent qualities and potential health benefits. Coconut water, which has long been used as a hydration beverage, is now valued for its diverse nutritional composition, which includes vital sugars, proteins, amino acids, vitamins, minerals, and other substances that promote growth. This review provides an overview of recent studies on the physicochemical traits, medicinal qualities, and practical uses of coconut water. Research has emphasized its cardioprotective, anti-inflammatory, and antioxidant properties as well as its possible application in the treatment of kidney disease, diabetes, and hypertension. The review also looks at how coconut water has been used historically and traditionally in medicine across cultures as a natural cure for a range of illnesses. In addition to its nutritional and therapeutic value, coconut water is being investigated for use in pharmaceutical and cosmetic formulations, as well as for food preservation and biotechnological applications. The results highlight that coconut water is a multipurpose biofluid with potential uses in the health and wellness sectors, making it more than just a cool beverage. Its therapeutic potential could be further established and its commercial use expanded with further research into its bioactive compounds and mechanisms of action. To sum up, coconut water is a naturally occurring, sustainable, and biologically active resource with a variety of advantages that warrant further research and incorporation into contemporary medical procedures.
Keywords: Coconut water, Hydration, Therapeutic potential, Biofluid, Cardioprotective, Anti-inflammatory, Anti-oxidant