ScienceDirect ® is a registered trademark of Elsevier B.V.Extrusion–spheronization a promising pelletization technique: In-depth review© 2016 Shenyang Pharmaceutical University. - Duration: 16:01. Production and hosting by Elsevier B.V.ScienceDirect ® is a registered trademark of Elsevier B.V. How extrusion-spheronization can help to control delivery and enhance performance of complex therapies Humera Sarwar 23 views. This review article deals with various aspects of the extrusion–spheronization technique.
Modified release formulations are effective for drug substances that have a narrow therapeutic index or need to support better dose compliance. Explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust way to manufacture today’s most complex therapies. The main objective of the extrusion spheronization is to produce pellets/spheroids of uniform size with high drug loading capacity. Then the parameters that can influence the pellet quality which involves formulation, equipment and process parameters are discussed.
Finally, methods available for characterization of the pellets are explained.Peer review under responsibility of Shenyang Pharmaceutical University.We use cookies to help provide and enhance our service and tailor content and ads. Multi-unit particle systems for example are proving to demonstrate higher levels of desired reproducible pharmacokinetic and pharmacodynamic (PK and PD) behaviours (including insoluble APIs) resulting in improved therapeutic effect in patients.As patient preferences manifest themselves across the life-sciences industry, tailoring medications to better suit a particular patient population’s special needs has become a priority. capsule filling ), and this can be achieved by extrusion spheronization technique. The first part includes different steps in the production process of pellets such as granulation, extrusion, spheronization, and drying.
This includes tailoring compounds and developing fixed-dose combinations (FDCs) to create new best-in-class, patient preferred products.To accomplish therapeutic effect, and deliver API payloads with precision, pharmaceutical formulators are leveraging a number of drug delivery tactics, including fixed-dose combinations (FDCs) and combined, modified-release, single-capsule forms.Spheronized drug particles offer a variety of versatile attributes that drug developers can leverage to control the dosing and support the therapeutic performance of their encapsulated medications. cessing steps of extrusion–spheronization, MCC grades with different particle sizes in the dry state were broken up into smaller units with more or less similar size (45). We also discuss the key considerations for drug developers who are looking to select a contract manufacturer as a partner to deliver this technique.In the right hands, with the right capabilities, extrusion spheronization is a well-understood process ready to manufacture today’s and tomorrow’s complex and potent capsule-delivered solid dose therapeutics.Because of its broad drug-engineering utility, extrusion-spheronization can also support emerging 505(B)(2) development pathways. In this blog, we explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust, proven way to manufacture today’s most complex therapies. By continuing you agree to the Copyright © 2020 Elsevier B.V. or its licensors or contributors. For those seeking more strategic outsourcing relationships, it is now more important than ever to match drug strategy as closely as possible to the expertise and technical capabilities of your manufacturing partners.Want to learn more about how to unlock extrusion-spheronization’s commercial potential for your new compound or life-cycle management strategy? Lecture 28 - Extrusion and Spheronization technique - Part 1 - Duration: 24:14.
First Flight on Another Planet! In the second part, the parameters which can influence the quality of pellets including formulation (moisture content, granulating liquid, excipients, and drugs), equipment (mixer, extruder, friction plate, and extrusion screen) and process (extrusion speed, extrusion temperature, spheronizer load, spheronization time, spheronization speed, and drying method) are discussed. It is also possible to prepare a sustained release pellets without coating of the pellets by extrusion spheronization process. This can help them to achieve patient preferred goals like reducing side effects or reducing the frequency of dosing.Extrusion-spheronization allows for a broad range of controls to manage API release.
In the final part, methods available for characterization (particle size distribution, surface area, shape and sphericity, porosity, density, hardness and friability, flow properties, disintegration, and dissolution) of the pellets are explained.First, different steps such as granulation, extrusion, spheronization and drying of the extrusion–spheronization process are mentioned. 24:14. The technique which is setting horizon in pelletization is “Extrusion Spheronization” because of its simple and easy steps involved in pellet production in a faster way. Extrusion/spheronization technique can be used for the preparation of pellets of various materials; natural extract, bacterial culture, drugs, etc., and one can also prepare different types of pellets (immediate release, modified release). But where the movement is being realized most profoundly is in drug engineering, with much of pharma pursuing fundamental improvements to the therapeutic formulation, functionality, and form of solid dose drugs.Extrusion-spheronization is a mature methodology but the process and the equipment integral to it have benefited with time. The technology itself has seen steady improvement (along with a host of incumbent tertiary systems) and consequently some contract manufacturers have been better prepared to manufacture complex encapsulated solid dose drugs with this technique than others.Pharma is relying more and more on its contract manufacturing partners to make complex drugs with increasingly complex processes.
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