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Critical Reviews™ in Therapeutic Drug Carrier Systems
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ISSN Druckformat: 0743-4863
ISSN Online: 2162-660X

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Critical Reviews™ in Therapeutic Drug Carrier Systems

DOI: 10.1615/CritRevTherDrugCarrierSyst.v26.i3.20
pages 275-331

Extrusion-Spheronization: Process Variables and Characterization

Vivek Ranjan Sinha
University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh, India, 160014
M. K. Agrawal
Division of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh-160 014, India
A. Agarwal
Division of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh-160 014, India
Gurpreet Singh
Division of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
D. Ghai
Division of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh-160 014, India

ABSTRAKT

Multiparticulate systems have undergone great development in the past decade fueled by the better understanding of their multiple roles as a suitable delivery system. With the passage of time, significant advances have been made in the process of pelletization due to the incorporation of specialized techniques for their development. Extrusion-spheronization seems to be the most promising process for the optimum delivery of many potent drugs having high systemic toxicity. It also offers immense pharmaceutical applicability due to the benefits of high loading capacity of active ingredient(s), narrow size distribution, and cost-effectiveness. On application of a specific coat, these systems can also aid in site-specific delivery, thereby enhancing the bioavailability of many drugs. The current review focuses on the process of extrusion-spheronization and the operational (extruder types, screen pressure, screw speed, temperature, moisture content, spheronization load, speed and time) and formulation (excipients and drugs) variables, which may affect the quality of the final pellets. Various methods for the evaluation of the quality of the pellets with regard to the size distribution, shape, friability, granule strength, density, porosity, flow properties, and surface texture are discussed.


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