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Research and Reviews: A Journal of Pharmaceutical Science Review Article

A Literature Review on Extrusion/Spheronisation-A Pelletization Technology

  1. Nandlal B. Savaliya Department of Pharmacy, Dr. Subhash University, Junagadh
  2. Chetan H.Borkhataria B.K. Mody Government Pharmacy College, Rajkot
  3. Chintankumar J. Tank School of Pharmacy, Dr. Subhash University, Junagadh
  4. Harshal A. Sadhariya Formulation and Development, Troikaa Pharmaceuticals Ltd

Abstract

Extrusion-spheronization is a leading pelletization technology, widely favored for its economic and commercial viability. It is a cost-effective method suitable for large-scale production, making it the most efficient approach for oral drug delivery. This process provides multiple benefits, such as improved flow characteristics, lower friability, a narrow particle size range, easier coating, consistent packing, reduced likelihood of dose dumping, and more predictable gastric emptying. Pellets usually measure between 0.5 and 1.5 mm in size. The formation of these pellets involves several stages, including nucleation, coalescence, layering, and abrasion transfer. Additionally, processes like attrition, breakage, and fragmentation contribute to the size reduction of pellets. Pelletization techniques include agitation (balling), compaction (compression, extrusion-spheronization), layering (powder or solution/suspension), and globulation (spray drying and spray congealing). Among these, extrusion-spheronization is the most prominent due to its versatility and process efficiency. Extrusion-spheronization involves distinct steps: it comprises dry mixing, wet massing, extrusion, spheronization, and drying. Various formulation factors (moisture content, granulating fluid, excipients, drugs), process parameters (spheronization time, speed, temperature), and equipment variables (mixer, extruder, extrusion screen) influence pellet quality. Pellet characterization is crucial and includes particle size distribution (PSD), surface area, sphericity, friability, and dissolution. This technology not only ensures efficient drug delivery but also facilitates the production of robust, high-quality pellets for pharmaceutical applications. Extrusion/spheronization is the most promising pelletization technology because it is both economic and commercial. Due to its affordability for large-scale production, extrusion spheronization is currently the most efficient method for oral drug delivery. Numerous benefits are available, including improved flow characteristics, a less friable dosage form, a narrow particle size distribution, ease of coating, and uniform packing. Pellets usually range in size from 0.5 to 1.5 mm. The mechanism of pellet formation involves nucleation, coalescence, layering, and abrasion transfer. Mechanisms and techniques for pelletization include agitation (balling), compaction (compression, extrusion spheronization) layering (powder, solution/suspension), and globulation (spray drying, spray congealling) described in the next section of this literature. It outlines the procedures involved in extrusion spheronization (dry mixing, wet massing, extrusion, spheronization, and drying). It also discusses the variables, such as formulation, process (moisture content, granulating fluid, excipients, drugs) equipment parameters (spheronization time, spheronization speed, spheronization temperature), and equipment parameters. (Mixer, extruder, extrusion screen that affects pellet formation. The description of pellet characterization, including PSD, surface area, sphericity, friability, and dissolution is given at last.

Keywords

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