Recent Advances in Drug Delivery and Formulation - Online First
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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.
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Advancements and Challenges in Gastroretentive Drug Delivery Systems: A Comprehensive Review of Research Innovation, Technologies, and Clinical Applications
Authors: Ayush Dubey, Mohammad Ovais, Amol Chhatrapati Bisen and A. RajendiranAvailable online: 28 April 2025More LessGastroretentive drug delivery systems (GRDDS) have emerged as a focal point of research and development, attracting substantial attention due to their potential to revolutionize oral drug administration. Their ability to enhance the bioavailability and therapeutic effectiveness of orally administered medications, particularly those with narrow absorption windows or susceptible to gastrointestinal degradation, has spurred considerable interest. By extending gastric residence time, GRDDS offers a pathway to optimize drug absorption while minimizing dosing frequency, thereby improving patient compliance and therapeutic outcomes. This comprehensive review delves into the diverse array of gastroretentive drug delivery approaches, providing in-depth insights into their classification, mechanisms of retention, recent innovations with patented technologies, and existing marketed formulations of the domain. Furthermore, it meticulously examines the challenges inherent in GRDDS implementation and elucidates effective strategies to surmount them. From novel formulation techniques to ingenious drug-carrier systems, this review explores the multifaceted landscape of GRDDS development, shedding light on promising avenues for future research and development. By advancing current knowledge and anticipating future trends, this review serves as a valuable resource for researchers, clinicians, and pharmaceutical professionals navigating the dynamic terrain of gastroretentive drug delivery.
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