Recent Advances in Drug Delivery and Formulation - Online First

For centuries, injections have been the primary method for vaccination; however, these traditional approaches present challenges due to pain, fear, and difficulties in administration. Scientists from Stanford University have developed vaccine creams, representing a revolutionary approach to the field of vaccination. Genetically modified Staphylococcus epidermidis forms the basis of these cream products, which support skin-based, painless vaccination without invasive procedures, while playing an essential role in the immune response. Scientists using tetanus as a test subject have obtained positive data from animal studies demonstrating effective immune responses to vaccination, indicating potential future applications for treating diseases, such as influenza, COVID-19, and cancer. Vaccination creams outperform classic injections in several ways, as they eliminate needle-related concerns while reducing adverse reactions, streamlining mass vaccination programs, and making the delivery of immunizations simpler, especially for populations that lack regular access to healthcare. Several key barriers continue to hinder the development of vaccine creams, including regulatory hurdles, stability concerns, production scalability, and public acceptance. Research discusses how vaccine creams revolutionize immunization processes by improving treatment accessibility, affordability, and broader acceptance rates.

Biosimilars offer cost-effective alternatives for autoimmune disorder treatment. However, India’s stringent regulatory barriers, including mandatory local trials, unclear interchangeability guidelines, and strict pricing controls, hinder market access. This study conducts a comparative analysis of the FDA (US), EMA (EU), and CDSCO (India) regulatory frameworks, highlighting key differences in approval pathways, post-marketing surveillance, and import regulations. Unlike previous studies, this paper employs a structured SWOT analysis to assess the impact of India's regulatory landscape on biosimilar accessibility. The findings reveal that India's local clinical trial mandates and complex approval processes hinder biosimilar adoption despite prior FDA or EMA approvals. Additionally, the absence of interchangeability guidelines discourages physician confidence, while stringent pricing policies under the Drug Price Control Order (DPCO) reduce manufacturer incentives. To improve biosimilar market penetration, India must streamline regulatory approvals, harmonize clinical trial requirements with international standards, and establish clear interchangeability guidelines. These reforms are essential to enhance the affordability and accessibility of biosimilars in the management of autoimmune disorders.

The treatment of neurodegenerative illnesses remains a substantial problem due to the blood-brain barrier's restrictive nature, which restricts therapeutic agent penetration. Phospholipid Nanocomplexes (PNCs) have emerged as next-generation neurotherapeutics, utilizing natural BBB transport pathways to improve drug delivery. These nanocarriers, with lipid-based architectures, allow for receptor-mediated transcytosis, lipid raft-mediated transport, and adsorptive-mediated endocytosis, resulting in precise and sustained drug release inside the central nervous system. Recent preclinical and clinical studies have shown that PNC-based formulations of neurotrophic factors, antioxidants, and gene-silencing therapies significantly improve neuronal survival, cognitive function, and neuroprotection in conditions like Alzheimer's Disease (AD), Parkinson's Disease (PD), Glioblastoma (GBM), and multiple sclerosis. Despite the positive outcomes, issues such as scalability, long-term safety, and regulatory approval remain. This study critically assesses the present status of PNC-based neurotherapeutics, emphasizing their benefits over traditional therapies, analyzing the most recent clinical trial outcomes, and assessing difficulties and future prospects. To improve PNC effectiveness, the potential for artificial intelligence-driven medication design, multifunctionalized nanocarriers, and hybrid biomaterial methods is investigated. As biocompatible and patient-specific nanomedicine advances, PNCs represent a breakthrough approach to precision neuroscience, providing tailored, efficient, and safer therapies for neurodegenerative diseases.

The cosmetics business is a valuable and stable multibillion-dollar business that keeps growing yearly with new, specialized goods. Natural goods contain a wealth of medicinally active chemicals used to treat a wide range of skin problems, including infections, inflammation, and damage caused by UV light and pollution. Cosmeceuticals are a mix of cosmetic and medical chemicals. Based on their main ingredients, they can be used for both beauty and health purposes. Many people think that natural goods are a great way to obtain cosmeceuticals. It has strong anti-inflammatory, antibacterial, anti-cancer, and protective properties. The benefit for the skin has been said to be the most interesting. GA and its products have been used a lot as an adjuvant in many therapeutic formulations, as an alternative to hydro-cortisone in children with atopic dermatitis and other skin diseases, and as an ingredient in cosmetics because they are good for humans. GA is GRAS (generally recognized as safe) by the US Food and Drug Administration. Oxidative stress, which happens when too many free radicals build up, is the main cause of many skin diseases that get worse over time, like aging. Polyphenols, including gallic acid, represent a significant category of naturally occurring antioxidants. They have emerged as potent antioxidants suitable for incorporation into active makeup products. Recent advancements include patent filings related to novel applications and formulations of Gallic acid in cosmetic science that highlight innovative delivery systems, such as nano-formulations enhancing stability and efficacy, as well as its synergistic combinations with other active ingredients to address targeted skin concerns like pigmentation, aging, and sensitivity which meets the demands of modern consumers.

ADHD is a common condition that affects many kids in the United States, about 2 to 18 percent of children between 6 and 17 years old. ADHD manifests as hyperactivity, impulsivity, and inattention, impacting various aspects of life. Effective management involves a combination of psychostimulant medication, such as methylphenidate, and behavioral therapy. Modified-release formulations, including chewable tablets, transdermal patches, and osmotic-controlled release tablets, offer improved treatment adherence and overall quality of life. Understanding the pathophysiology involves neuroimaging studies that reveal alterations in brain regions rich in dopamine receptors. Methylphenidate, a common ADHD medication, works by inhibiting dopamine reuptake, thereby increasing extracellular dopamine levels. Different drug delivery systems, such as extended-release chewable tablets, transdermal patches, and OROS formulations, provide diverse options for individual needs. The advent of innovative formulations like methylphenidate hydrochloride extended-release oral suspension (Quillivant ER) and methylphenidate hydrochloride multilayer extended-release capsules (Aptensio XR) addresses challenges in pediatric medication administration. Recent additions like the orally disintegrating tablet (Cotempla X-ODT) offer convenience and flexibility. Understanding the pharmacokinetics, pharmacodynamics, and benefits of these formulations enhances the ability to tailor ADHD treatment to individual patient needs.

Modern technologies such as nanotechnology are being applied in almost every sector to deliver affordable, environmentally friendly products. The integration of nanotechnology in medicine has revolutionized drug delivery systems, with nanotechnology emerging as a promising frontier. This review explores the synthesis and characterization of nanotablet drug formulations designed to enhance their potential across various applications. By employing characterization techniques such as X-ray diffraction, electron microscopy, and physisorption analysis, researchers have developed innovative drug delivery systems like Sophora Alopecuroides nanotablets to treat deadly diseases such as cancer. Evaluation of pre- and post-compression results indicated that nanotablets exhibited good hardness and flow properties, making these formulations potential drug delivery systems for enhanced bioavailability and sustained release properties. Specifically, sublingual sufentanil nanotablets, such as Zalviso^®, have demonstrated efficacy in managing moderate to severe pain in healthcare settings when used in conjunction with a PCA device. However, recent regulatory updates indicate changes in the marketing authorization status of Zalviso^®. In conclusion, this novel approach for synthesizing nanotablets presents a promising avenue for diverse applications, and based on the results, it is worth considering for future work.