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Review
. 2022 Feb 15;8(2):e08956.
doi: 10.1016/j.heliyon.2022.e08956. eCollection 2022 Feb.

Quality aspects in the development of pelletized dosage forms

Surendra Agrawal  1 , Joneth Fernandes  1 , Fuzail Shaikh  1 , Vishwa Patel  1
Affiliations
Review

Quality aspects in the development of pelletized dosage forms

Surendra Agrawal et al. Heliyon. .

Abstract

The aim of this work was to identify and collate the major common challenges that arise during pellet development. These challenges focus on aspects right from raw material properties until the final drying process of the pelletization. The challenges associated with the particle size of drug and excipients, physicochemical properties, drug excipient interaction and the effect of type/grade and amount of raw material on the pellet properties are covered in this review. Technological and process related challenges within the commonly used pelletization techniques such as extrusion-spheronization, hot-melt extrusion and layering techniques are also emphasized. The paper likewise gives an insight to the possible ways of addressing the quality of pellets during development.

Keywords: Crosspovidone; Extrusion spheronization; Hot melt extrusion; Microcrystalline cellulose; Pellet development challenges; Solution/suspension/powder layering.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Image 1
Graphical abstract
Figure 1
Figure 1
Important aspects during Pelletized drug delivery development.
See this image and copyright information in PMC

References

    1. Al-Hashimi N., Begg N., Alany R.G., Hassanin H., Elshaer A. Oral modified release multiple-unit particulate systems: compressed pellets, microparticles and nanoparticles. Pharmaceutics. 2018;10(4) - PMC - PubMed
    1. Dukić-Ott A., Thommes M., Remon J.P., Kleinebudde P., Vervaet C. Production of pellets via extrusion-spheronisation without the incorporation of microcrystalline cellulose: a critical review. Eur. J. Pharm. Biopharm. 2009;71(1):38–46. - PubMed
    1. Censi R., Gigliobianco M.R., Casadidio C., Di Martino P. Hot melt extrusion: highlighting physicochemical factors to Be investigated while designing and optimizing a hot melt extrusion process. Pharmaceutics. 2018;10(3) - PMC - PubMed
    1. Zaman M., Saeed-Ul-Hassan S., Sarfraz R.M., Batool N., Qureshi M.J., Akram M.A., et al. Pellets and pelletization: emerging trends in the pharma industry. Acta Pol. Pharm. 2016;73(6):1415–1425. - PubMed
    1. Shukla D., Chakraborty S., Singh S., Mishra B. Lipid-based oral multiparticulate formulations - advantages, technological advances and industrial applications. Expet Opin. Drug Deliv. 2011;8(2):207–224. - PubMed

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