Journal of Drug Delivery and Therapeutics (JDDT)
Not a member yet
4948 research outputs found
Sort by
Parenteral Products in the Modern Era: Critical Analysis of Manufacturing Technologies, Regulatory Evolution, and Industry Challenges
No full textObjective: To provide a comprehensive review of parenteral product manufacturing with emphasis on aseptic processing, terminal sterilization, lyophilization technologies, and evolving regulatory requirements, while addressing current industry challenges and emerging trends.
Methods: Critical analysis of FDA/EMA/WHO regulatory guidance (2020-2025), peer-reviewed literature, industry case studies, and recent technological advances in sterile manufacturing.
Key Findings: The implementation of EU Annex 1 (2022) has introduced fundamental changes in contamination control strategies. Nitrosamine impurities have emerged as a critical quality concern across parenteral products. Advanced analytical technologies, including Process Analytical Technology (PAT) and real-time monitoring, are reshaping quality assurance approaches. Container-closure integrity testing has evolved from probabilistic to deterministic methods. The industry faces ongoing challenges in data integrity, environmental monitoring, and technology adoption while navigating complex regulatory expectations.
Conclusions: Success in modern parenteral manufacturing requires integration of Quality by Design principles, risk-based approaches, and advanced technologies while maintaining robust sterility assurance. The balance between innovation and regulatory compliance remains critical for ensuring patient safety and product quality.
Keywords: Parenteral products; aseptic processing; terminal sterilization; lyophilization; contamination control strategy; Quality by Design; regulatory complianc
A Brief Review on Pharmacological Efficacy of Chelidonic Acid
Get PDFChelidonic acid is a naturally occurring plant-based bioactive compound that has received significant attention due to its diverse biological and pharmacological properties. This current review broadly covers its antioxidant, anti-inflammatory, immunomodulatory, neuroprotective, cardioprotective, nephroprotective and regenerative properties. Chelidonic acid mitigates oxidative stress by modulating key signaling pathways and improving endogenous antioxidant defenses. It downregulates the inflammatory pathways by suppressing the production of TNF-α, IL-6 and IL-1β. It also protects chemotherapy-induced toxicities and stimulates hematopoiesis as well. These chelidonic acid effects could be considered for treating various disorders such as cancer, neurological disorders, cardiovascular disease, immunological and other related inflammatory diseases. Despite its favorable safety profile, more preclinical and clinical studies are needed to confirm its effectiveness and therapeutic potential. Due to its promising properties, chelidonic acid could be considered as a natural alternative for the treatment of several disorders.
Keywords: Chelidonic acid; Antioxidant; Inflammation; Cancer; Cardiovascular diseases
Pharmacovigilance in Cardiology: A Review of Adverse Drug Reactions in Practice
Get PDFCardiovascular diseases (CVDs) continue to be the major cause of death worldwide, affecting an estimated 640 million people as of 2021. Treatment success comes a new challenge, a growing population of people living longer with chronic heart issues, often taking multiple medications at once. This makes them more likely to experience adverse drug reactions (ADRs), especially as their health becomes more complex.
Pharmacovigilance plays a crucial role here. According to the World Health Organization, it’s the ongoing science and practice of spotting, understanding, and preventing harmful or unexpected effects from medications. Pharmacovigilance fills in the gaps through real-world monitoring.
This review explains side effects tied to commonly used heart drugs, based on research from the last five years. It aims to help clinicians better understand these risks and guide safer prescribing. Some key findings include: bleeding risks with antithrombotics, shifts in electrolyte levels with diuretics and drugs that target the renin-angiotensin system, and organ damage like lung scarring or liver injury with drugs such as amiodarone and statins.
Looking forward, improving drug safety will require stronger reporting systems, better training for healthcare professionals, more advanced tools for analyzing risks, and broader international cooperation.
Keywords: Pharmacovigilance, Adverse Drug Reactions (ADRs), Cardiovascular Drugs, Drug-Drug Interactions, Clinical Monitoring, Therapeutic Innovation
A Case Study on Management of Calcaneal Spur with Ḍimād (Paste) of Polyherbal Unani Medication
Get PDFObjective- To evaluate the effectiveness of Dimād therapy, a traditional Unani treatment method, in alleviating heel pain caused by calcaneal spur, and to explore its potential as a safe, affordable alternative to conventional therapies
Design - This is a single-case report detailing the clinical presentation, diagnosis, and treatment of a patient with a calcaneal spur using Dimād therapy within the Unani medical framework.
Intervention - The patient underwent Dimād therapy, which involves the local application of heat to the affected heel area, based on the principles of Unani medicine, which aim to restore humoral balance and eliminate morbid materials. Treatment was tailored according to the six essential factors of life in Unani medicine.
Main Outcome Measure- Reduction in heel pain, improvement in mobility, and overall patient satisfaction following completion of Dimād therapy.
Results- The patient experienced significant relief from heel pain and reported enhanced mobility following the course of Dimād therapy. No adverse effects were observed, and the therapy was well tolerated.
Conclusion- This case suggests that Dimād therapy may be an effective and non-invasive approach to managing calcaneal spurs. It supports the Unani view that addressing underlying humoral imbalance and lifestyle factors can contribute to sustainable pain relief. Further clinical studies are needed to validate these findings.
Keywords- Unani medicine, Waja-ul-Aqib, heel pain, traditional therapy, Ilaj bit tadbee
Hydrogels Platforms Addressing the Multiple Applications in Medicinal and Drug Delivery: A Critical Review
Get PDFHydrogels are three-dimensional polymeric networks renowned for their remarkable water-absorbing capacity, tunable physicochemical properties, and high biocompatibility. This review comprehensively explores the synthesis, classification, and physicochemical and biological characteristics of both natural and synthetic hydrogels. Advances in crosslinking mechanisms, including ionic, chemical, and physical methods, are critically analyzed alongside their functional properties such as pH-, temperature-, and photo-responsiveness. Special emphasis is given to the role of hydrogels in drug delivery systems, including buccal, oral, vaginal, transdermal, ocular, and injectable formulations. Additionally, their applications in wound healing, tissue engineering, biosensing, and 3D cell cultures are examined. Limitations and challenges in clinical translation, regulatory concerns, scale-up processes, and strategies to enhance drug loading and controlled release are discussed. The review underscores the transformative potential of hydrogels in personalized and regenerative medicine and calls for further translational research to address current constraints and expand clinical applicability.
Keywords: Hydrogel, crosslinked hydrogel, drug delivery, polymerizatio
Compressive Review on Plant Profile, Phytochemistry and Pharmacology of Crotalaria pallida Action
Get PDFMedicinal plants have significantly influenced the evolution of human civilization. Medicinal plants have long been used as a source of medicine in almost every society. Many modern medications are made from medicinal plants, which are considered to be abundant sources of traditional medicines. Medicinal herbs have been used for centuries to treat illnesses, preserve food, enhance flavor, and stop disease outbreaks. The biological traits of plant species used worldwide are typically caused by the secondary metabolites that the plants produce. Plant-derived compounds regulate microbial growth in a variety of settings. In this review, we presented a general overview of the therapeutic herbs. Healing with medicinal plants has been around since the dawn of humanity. The relationship between humans and their quest for natural remedies has roots in ancient history, which is well-documented through numerous sources: written records, enduring landmarks, and even ancient herbal medicines Crotalaria pallida, often referred to as the smooth crotalaria, is a type of flowering plant belonging to the Fabaceae family. Crotalaria pallida Aiton. is a species with extensive medicinal characteristics. Traditionally, the plant has been utilized to alleviate joint swelling, reduce fever, serve as a vermifuge, and treat skin ailments. Additionally, the plant and its components are claimed to exhibit anti-inflammatory, antimicrobial, antioxidant, antibacterial, and antifungal properties. Fresh leaves and dried leaf powder were employed for examining macroscopy, microscopy, preliminary phytochemical screening, and fluorescence analysis of the powdered drug.
Keywords: Crotalaria pallida action (Fabaceae), phytochemical constituent, pharmacological activity. medicinal use
Impact of conventional and advanced therapies in functional hair follicular regeneration in pesticide-induced hair loss: a Pharmacological perspective of review
Get PDFThis review highlights the impact of conventional, advanced, and gene therapy in hair follicular regeneration in pesticide-induced hair loss. Most states in India and abroad have agricultural land, where people of different age groups work and are exposed to various pesticides that affect their health and cause hair loss. Alopecia, thinning, and shedding arise from particular chemicals in pesticides that disrupt normal hair follicle function, leading to increasing concerns about hair loss due to pesticide exposure. Hormonal disruptions, oxidative damage, and inflammatory responses are a few of the mechanisms by which pesticides harm the scalp and hair roots. In this review, the authors have tried to explore the underlying mechanism of how the pesticides affect hair growth cycles and follicular health by analysing their toxicological impact, shedding light on the mechanisms that cause hair loss as well as the therapeutic effectiveness of various therapies including herbals like ginseng, green tea, hibiscus, and castor oil etc. those are able to counteract the negative impacts of pesticides with their molecular mechanism of action that will be helpful and will pave the way for further research in the field of hair growth and regeneration.
Keywords: pesticides, follicular damage, herbal bioactive, hair regeneration, advanced therapy, gene therap
Formulation and Evaluation of Nanogel Containing Silver Nanoparticle of Phytoconstituent of Lantana camara for Topical Delivery
Get PDFThe present study focuses on the formulation and evaluation of a nanogel incorporating silver nanoparticles (AgNPs) synthesized using the ethanolic extract of Lantana camara leaves for topical delivery. Initial pharmacognostical and phytochemical investigations confirmed the presence of bioactive compounds such as flavonoids, tannins, and terpenoids, indicating therapeutic potential. Silver nanoparticles were synthesized via a green route and characterized using UV-Vis spectroscopy, FTIR, SEM, and TEM, confirming their spherical morphology and antioxidant efficacy. The AgNPs were then incorporated into Carbopol-based nanogel formulations. Five batches (F1–F5) were developed and evaluated for physicochemical properties, drug content, in vitro release, and antibacterial activity. Among these, batch F3 exhibited optimal pH (6.1), viscosity (8600 cps), drug content (98.5%), and sustained drug release (87.6% over 8 hours), along with the highest antibacterial activity (21.5 mm zone of inhibition). The study concludes that the formulated nanogel, especially batch F3, holds significant potential for topical applications due to its antimicrobial, antioxidant, and controlled drug delivery properties.
Keywords: Lantana camara, Silver Nanoparticles, Nanogel, Topical Delivery, Antibacterial Activity, Antioxidant, Phytoconstituents, Green Synthesis, Drug Release.
Fast Dissolving Oral Strips: An Approach for the Delivery of Ondansetron
Get PDFFast dissolving oral strips provide a more convenient and patient-friendly alternative to conventional oral dosage forms for those patients having difficulty in swallowing tablets/capsules etc. strips uses a water-dispersing polymer to boost the drug\u27s bioavailability as it release straight into the bloodstream without the liver having to digest it first. Administering Ondansetron hydrochloride via fast dissolving strips has a number of benefits, including increased patient compliance and improved therapeutic efficacy due to the drug\u27s quick absorption from the highly vascularized oral mucosa, which prevents first-pass metabolism. The antiemetic medication Ondansetron, an antagonist for serotonin receptor type 5 (SERT5), is useful in managing nausea and vomiting brought on by chemotherapy for cancer. Only 60–70% of its limited oral bioavailability may be attributed to first-pass metabolism. Ondansetron has a half-life of three to five hours and is readily soluble in water, making this route of administration appropriate. The goal of this study is to formulate Ondansetron as fast dissolving oral strip intended for instant release in an effort to maximize its therapeutic impact.
Keywords: Ondansetron, fast dissolving, strip, antiemetic
Tadābīr-i-Navmawlūd (Child Health Care): A Holistic Framework in Unani System of Medicine for Child Well-Being
No full textInfancy, the critical phase from birth to early childhood, holds immense importance, with each day contributing significantly to a child\u27s development. Globally, approximately four million neonatal deaths occur annually, with 98% of these taking place in developing countries. In these regions, many newborns succumb to mortality at home, often under the care of mothers, family members, and traditional birth attendants. In Unani Medicine, this stage is associated with the temperament known as Mizāj Ḥārr Raṭb (hot and moist), highlighting a period of rapid growth and developmental milestones. Comprehensive neonatal and child care guidelines, referred to as Tadābīr-i-Navmawlūd, encompass various aspects, including newborn care, infant feeding, management of dentition, and therapeutic principles and treatments for children.Renowned Unani scholars such as Ibn Sīnā, Zakariyya Rāzī, Ali Ibn Abbas Majūsī, Ibn Rushd, and Ibn Hubal Baghdādī have extensively discussed these topics in classical Unani texts like Al-Qānūn fi’l Ṭibb, Kitāb al-Manṣūrī, Kāmil al-Ṣanāʻa, Kitāb al-Kulliyat, and Kitāb al-Mukhtārāt fi’l Ṭibb. Their writings outline regimens and medicinal practices aimed at promoting the health and well-being of newborns, infants, and children.
Keywords: Unani medicine, Tadābīr-i-Navmawlūd, child health care, infancy, Amrāḍ-i-Aṭfāl