International Journal of Health and Clinical Research

Comprehensive review on quality by design in fast dissolving tablets

Aditya Nishad — 2026-03-03

Fast-disintegrating tablets (FDT), also known as orally disintegrating tablets (ODT), are innovative oral dosage forms designed to quickly disintegrate in the mouth without the need for water, providing an effective solution for patients with swallowing difficulties, including pediatricians, geriatricians, and patients with dysphagia. It is preferred over traditional tablets due to its rapid disintegration, improved taste, and increased patient compliance. However, due to their fragile structure, high porosity, and sensitivity to humidity, FDTs require precise design strategies to ensure optimal performance, safety, and stability. Quality by Design (QbD), as described in the ICH guidelines, provides a systematic and scientific approach to developing reliable FDT formulations. QbD includes defining a quality target product profile (QTPP), defining critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs), and creating a design space to ensure consistent product quality. Through risk assessment and design of experiments (DoE), manufacturers can optimize formulation parameters such as superdisintegrants, binders, porosity, and compressive strength to achieve the desired balance between rapid disintegration and mechanical strength. Control strategies that include raw material evaluation, in-process monitoring, humidity control, and final product testing further improve product reliability. Case studies show that the QbD approach significantly improves the solubility, stability, and bioavailability of FDT. Overall, QbD enables efficient and cost-effective development of high-quality FDTs, ensuring compliance with regulatory requirements and improving patient outcomes.

A cross-sectional study to evaluate the correlation of covid-19 infection with avascular necrosis of hip joint

Kundan Kushwah — 2026-03-03

Background: Avascular necrosis (AVN) of the hip is a progressive and disabling condition resulting from compromised blood supply to the femoral head. During the COVID-19 pandemic, increasing reports of post-COVID musculoskeletal complications have raised concern regarding a possible association between SARS-CoV-2 infection and AVN, particularly in the setting of corticosteroid use and COVID-19–related vascular injury. However, available evidence remains limited, especially from the Indian population. The present study aimed to evaluate the correlation between prior COVID-19 infection and avascular necrosis of the hip joint and to analyze demographic characteristics, disease severity, steroid exposure, and time to onset in a tertiary care setting.Methods: This cross-sectional observational study was conducted in the Department of Orthopaedics at a tertiary care center over one year. Sixty patients diagnosed with idiopathic AVN of the hip were included. Clinical history focusing on COVID-19 infection, steroid therapy, and symptom onset was recorded. Radiological assessment using X-ray and MRI was performed, and AVN was graded using the Ficat and Arlet classification. Data were analyzed using descriptive statistics.Results: The mean age of patients was 38.78 ± 10.58 years, with a male predominance of 75%. Grade 2 AVN was the most common stage (40%), followed by Grade 3 (30%) and Grade 4 (26.7%). Bilateral hip involvement was observed in 61.7% of cases. Twenty patients (33.3%) had a history of COVID-19 infection, among whom Grade 2 and Grade 3 AVN predominated. Only 35% of COVID-19–positive patients had documented steroid exposure. The mean interval between COVID-19 infection and AVN onset was 6.53 months.Conclusion: The study suggests a possible association between COVID-19 infection and AVN of the hip, with evidence supporting a multifactorial pathogenesis beyond steroid exposure alone. Long-term surveillance and early evaluation of hip symptoms in post-COVID patients are essential.

Orodispersible Delivery Systems for Verapamil Hydrochloride

Jyoti — 2026-03-03

Verapamil Hydrochloride, a Class IV calcium channel antagonist, is a primary intervention for hypertension and arrhythmias. However, its clinical efficacy is restricted by a significant first-pass effect, yielding only 10%-20% systemic bioavailability. To overcome these pharmacokinetic barriers and address patient non-compliance due to dysphagia, Orodispersible Tablets (ODTs) have been developed as a high-performance alternative. This review explores the engineering of ODTs designed to liquefy instantly in the oral cavity. Success depends on the strategic use of superdisintegrants like Crospovidone and sublimation agents (e.g., camphor) to create a highly porous internal architecture. These methods facilitate rapid wicking and capillary action, often ensuring disintegration in under 30 seconds. Beyond convenience, the ODT platform offers a potential "shunt" for drug molecules to be absorbed via the pregastric mucosa, partially bypassing hepatic degradation.
Current research highlights the move toward natural polymers and factorial design optimization to balance mechanical durability with rapid dissolution. By masking the drug’s inherent bitterness through ion-exchange resins or complexation, ODTs provide a seamless, water-free delivery system. This technology represents a vital advancement in cardiovascular pharmacotherapy, ensuring rapid onset and enhanced patient-centric care.