Effect of particle size on the dispersion behavior of magnesium stearate blended with microcrystalline cellulose.

Autor: Puckhaber D; Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany., Finke JH; Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany. Electronic address: j.finke@tu-braunschweig.de., David S; Novartis Pharma AG, Basel 4002, Switzerland., Gururajan B; Novartis Pharma AG, Basel 4002, Switzerland., Rane S; Novartis Pharma AG, Basel 4002, Switzerland., Kwade A; Institute for Particle Technology, Technische Universität Braunschweig, Volkmaroder Straße 5, 38104 Braunschweig, Germany; Center of Pharmaceutical Engineering (PVZ), Technische Universität Braunschweig, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2024 Feb 15; Vol. 651, pp. 123792. Date of Electronic Publication: 2024 Jan 07.
DOI: 10.1016/j.ijpharm.2024.123792
Abstrakt: The majority of tablets manufactured contain lubricants to reduce friction during ejection. However, especially for plastically deforming materials, e.g., microcrystalline cellulose (MCC), the internal addition of lubricants is known to reduce tablet tensile strength. This reduction is caused by the surface coverage by lubricant particles, the extent of which depends on both process and formulation parameters. Previously published models to predict the lubrication effect on mechanical strength do not account for changes in the excipient particle size. In this study, the impact of both lubricant concentration and mixing time on the tensile strength of tablets consisting of three different grades of MCC and four grades of magnesium stearate (MgSt) was evaluated. By taking into account the particle size of the applied excipients, a unifying relationship between the theoretically estimated surface coverage and compactibility reduction was identified. Evaluating the dispersion kinetics of MgSt as a function of time reveals a substantial impact of the initial surface coverage on the dispersion rate, while the minimal tensile strength was found to be comparable for the majority of formulations. In summary, the presented work extends the knowledge of lubricant dispersion and facilitates the reduction of necessary experiments during the development of new tablet formulations.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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