Recent Advances in Drug Delivery and Formulation - Online First
Description text for Online First listing goes here...
21 - 24 of 24 results
-
-
Global and Indian Regulatory Frameworks for Pharmaceutical Excipients, APIs, and Formulations: Challenges and Harmonization Strategies
Authors: P. Dhinesh Pandian and Rajaganapathy KaliyaperumalAvailable online: 16 June 2025More LessPharmaceutical excipients play a critical role in drug formulation, ensuring stability, bioavailability, manufacturability, and patient safety. While India has made progress in aligning with international excipient regulations, significant regulatory gaps persist, including inconsistent enforcement, lack of mandatory GMP compliance, and inadequate impurity testing standards. These challenges create quality inconsistencies and potential safety risks, particularly for high-risk excipients. Indian excipient manufacturers face difficulties meeting international regulatory expectations, such as FDA, EMA, and PMDA requirements, due to differences in documentation, quality control, and risk assessment standards. Case studies highlight successful compliance strategies, including supplier qualification, in-house impurity testing, and risk-based categorization. To strengthen excipient regulation, mandatory GMP certification, a risk-based excipient categorization system, and alignment with IPEC-PQG, WHO, and ICH Q7 guidelines are recommended. Additionally, CDSCO must enhance oversight through advanced impurity testing and improved traceability requirements. Ensuring regulatory harmonization with global standards will enhance India’s competitiveness in the excipient supply chain, facilitate international market access, and improve overall drug safety and efficacy. This review underscores the urgent need for structured regulatory reforms to streamline compliance, ensure excipient quality, and strengthen India’s position in the global pharmaceutical industry.
-
-
-
Recent Expansions and Future Outlook in the Delivery of Poorly Soluble Phytoconstituents through Solid Dispersion Technique
Authors: Bhavesh Sahu, Kalyani Sakure, Ajazuddin1 and Hemant BadwaikAvailable online: 23 May 2025More LessPhytoconstituents, derived from plants, possess significant therapeutic potential but often face challenges such as poor solubility and low bioavailability, limiting their efficacy. Solid dispersion (SD) is a promising approach to improve the solubility and bioavailability of these poorly water-soluble phytoconstituents. By dispersing the active drug in a hydrophilic carrier, solid dispersion enhances the surface area of the drug, improving its dissolution rate and enhancing absorption. This review provides an overview of the various generations of solid dispersions, highlighting the evolution from crystalline carriers in first-generation solid dispersions to the more advanced amorphous solid solutions in second and third-generation formulations, which offer enhanced solubility and bioavailability. The article also discusses various techniques for preparing solid dispersions, including solvent evaporation, melting, and spray-drying methods, and emphasizes the importance of selecting appropriate carriers, such as hydrophilic polymers, to optimize the dissolution rate of phytoconstituents. The study highlighted the recent case studies on several phytochemicals, like alkaloids, glycosides, Polyphenols, etc., demonstrating the effectiveness of solid dispersion in improving their solubility and therapeutic performance. Additionally, the review addresses the challenges related to the solubility of phytoconstituents and their impact on drug absorption, as well as the role of solid dispersion in overcoming these challenges. Overall, solid dispersion technology emerges as a versatile and effective tool for enhancing the oral bioavailability of phytoconstituents, paving the way for more efficient herbal therapies in modern medicine.
-
-
-
Drug Delivery Strategies for the Management of Attention-deficit/ Hyperactivity Disorder (ADHD): A Case of Differentiated Product Development of Methylphenidate
Authors: Shubham Kamble, Ganesh Deshmukh, Paras Jain, Abhishek Jha and Sanjeevani S. DeshkarAvailable online: 23 May 2025More LessADHD 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.
-
-
-
Identifying Optimized Parameters to Enhance the Productivity of Gas Generating Pellets Using a Dome Type Extruder
Authors: Ronak R. Patel and Dharmik M. MehtaAvailable online: 08 May 2025More LessIntroductionThe extrusion-spheronization process continues to be utilized in pharmaceutical manufacturing, as evidenced by several recent patents and articles. The primary challenge in pelletization via extrusion spheronization is optimizing the production process to achieve high yields of spherical pellets while keeping production costs low. Therefore, this study aimed to identify the ideal parameters for maximizing production rates using a dome extruder while maintaining the desired physical characteristics of the pellets.
MethodsThe pellet formulation comprised apixaban, microcrystalline cellulose, hypromellose, and sodium bicarbonate. The study employed the face-centered central design to assess the impact of various process variables. Key factors included extruder speed, spheronization speed, and spheronization time, which were determined based on the preliminary analyses. Characterization of pellets encompassed measurements of sphericity via aspect ratio, friability, bulk density, and percentage yield.
ResultsThe optimized parameters for extrusion speed spanned from 23 to 27 rpm, while spheronization speed extended from 700 to 900 rpm at 5 min to 7 min of spheronization time, yielding more than 90% of the desired fraction of spherical pellets with good physical properties.
DiscussionIt was discerned that extrusion and spheronization speed emerged as critical process parameters within a defined spheronization time for maximizing production rates while concurrently maintaining satisfactory pellet properties.
ConclusionThis study successfully optimized process parameters for pellet production using a dome-type extruder by employing a Quality by Design (QbD) approach. Key factors influencing pellet yield and quality, such as extrusion speed, spheronization speed, and time, were identified and systematically optimized.
-