International Journal of Pharmaceutical and

Clinical Research

e-ISSN: 0975 1556

p-ISSN 2820-2643

Peer Review Journal

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1. DEPTH Study: A Retrospective Study on the Demographic Characteristics, Clinical Profile, Triggering Factors, Quality of Life and Treatment Patterns of Depression in Indian Patients
Nitin Kapure, Siddharth Nikam, Mayur Mayabhate, Akhilesh Sharma
Abstract
Introduction: Depression is a significant global health concern, causing personal distress, functional impairment, and increased healthcare burden. Understanding its specific characteristics in the Indian population is vital for effective management. This study aimed to assess the demographic and clinical profile, triggering factors, quality of life, and treatment patterns among Indian patients with depression. Methods: This retrospective, multi-centric cross-sectional study collected data from healthcare facilities across India on patients diagnosed with depression per ICD-10 criteria. Information on demographics, triggers, symptoms, quality of life impact, and treatment was analyzed using IBM SPSS Statistics. Results: The study included 7,888 patients, with a mean age of 48.0 years. The prevalence of depression was slightly higher in males (56.5%). Key triggering factors included stressful events, chronic illness or pain, and social isolation. Commonly reported symptoms were fatigue or low energy, persistent sadness or low mood, and disturbed sleep. Depression significantly affects patients’ quality of life, particularly sleep quality, financial/social functioning, and daily chores. Cognitive behavioral therapy (CBT) and pharmacotherapy were the most common treatments. Among antidepressants, escitalopram was most frequently prescribed (47.7%), followed by vortioxetine (2.6%), while bupropion and the bupropion-dextromethorphan combination were each prescribed in 0.05% of cases. Conclusions: The study highlights the considerable clinical and psychosocial burden of depression among Indian patients, particularly middle-aged individuals. Key triggers such as stress and chronic illness demand early recognition and tailored interventions. Although CBT and pharmacotherapy remain the mainstays of treatment, the underutilization of multimodal strategies indicates a gap in optimal care. These findings underscore the need for integrated, culturally sensitive, and patient-centered approaches to improve depression management and outcomes in India.

2. A Chronotherapeutic Floating Pulsatile Delivery System for Valsartan and Hydrochlorothiazide: Formulation, Optimization and In-vitro Evaluation
Ashish Kumar Gupta, Mayank Bansal, Ashutosh Sharma, Vaibhav Khatri
Abstract
Background: Hypertension is a chronic cardiovascular disorder characterized by persistently elevated arterial blood pressure and remains one of the leading causes of global morbidity and mortality. A key physiological feature of hypertension is its circadian rhythm, particularly the early morning surge in blood pressure, which is associated with an increased risk of adverse cardiovascular events such as myocardial infarction and stroke. Objective: The present study aimed to design, develop, and evaluate a gastroretentive floating pulsatile drug delivery system (FPDDS) of Valsartan and Hydrochlorothiazide to achieve time-specific drug release aligned with circadian rhythm for improved antihypertensive therapy. Methods: Core tablets containing Valsartan and Hydrochlorothiazide were prepared by direct compression using suitable diluents and superdisintegrants. These core tablets were subsequently compression-coated with hydrophilic polymers (Polyox WSR-205 and Polyox WSR N12K) along with effervescent agents (sodium bicarbonate and citric acid) to impart floating behavior and pulsatile drug release. Preformulation studies, including physicochemical characterization and drug-excipient compatibility (FTIR and DSC), were performed. The prepared formulations were evaluated for hardness, friability, weight variation, drug content uniformity, floating lag time, and total floating duration. In-vitro dissolution studies were conducted using USP apparatus, and drug release kinetics were analyzed using various mathematical models. Stability studies were carried out as per ICH guidelines. Results: The formulated floating pulsatile drug delivery system of Valsartan (80 mg) and Hydrochlorothiazide (12.5 mg) demonstrated satisfactory preformulation, physicochemical, and in-vitro performance. Powder blends exhibited good flow properties with angle of repose (25–35°), Carr’s index (10–20%), and Hausner’s ratio (<1.25), indicating suitability for direct compression. The developed UV spectrophotometric method showed excellent linearity with R² = 0.996 for Valsartan (2–12 µg/mL) and R² = 0.999 for Hydrochlorothiazide (5–25 µg/mL), confirming accuracy for drug estimation. The prepared tablets exhibited acceptable physicochemical properties including uniform weight (~250 mg), adequate hardness, and friability below 1%, indicating good mechanical strength. The optimized formulation showed a floating lag time of <1 minute and total floating duration exceeding 12 hours, confirming effective gastroretentive behavior. In-vitro dissolution studies revealed a distinct pulsatile release pattern with a lag time of 4–6 hours, followed by a rapid drug release of approximately 90–100% within 1–2 hours post-lag. Drug release kinetics followed Higuchi and Korsmeyer–Peppas models, indicating a combination of diffusion and polymer erosion mechanisms. Conclusion: The developed floating pulsatile drug delivery system successfully achieved chronotherapeutic drug release of Valsartan and Hydrochlorothiazide. This approach holds significant potential for improving the therapeutic management of hypertension by synchronizing drug release with the biological rhythm of the disease.

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