Screening of lubricants towards their applicability for external lubrication.

Autor: de Backere C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg, 460, 9000 Ghent, Belgium., Surmont M; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg, 460, 9000 Ghent, Belgium., De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg, 460, 9000 Ghent, Belgium., Vervaet C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg, 460, 9000 Ghent, Belgium., Vanhoorne V; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg, 460, 9000 Ghent, Belgium. Electronic address: valerie.vanhoorne@ugent.be.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2023 Feb 05; Vol. 632, pp. 122553. Date of Electronic Publication: 2022 Dec 28.
DOI: 10.1016/j.ijpharm.2022.122553
Abstrakt: Internal lubrication is associated with decreasing tensile strength and prolonged disintegration. These effects can be minimized using external lubrication. In current study, six lubricants (magnesium stearate, sodium stearyl fumarate, stearic acid, glyceryl dibehenate, poloxamer 188 and sucrose monopalmitate) were processed with an external lubrication system implemented in a compaction simulator. The effect of process parameters related to the tableting process (main compaction pressure and tableting speed) and external lubrication system (spraying time, atomizing pressure and dust extraction system) on the responses was studied for a placebo formulation (80% mannitol - 20% microcrystalline cellulose). Internally lubricated blends (0.75 - 4%) were processed as reference. All lubricants proved successful in reducing ejection forces through external lubrication while yielding substantially lower lubricant concentrations compared to internal lubrication. No negative effect of external lubrication on tensile strength and disintegration time was observed, irrespective of lubricant type. Similar tensile strengths and disintegration times were measured for the different lubricants. This was in contrast to internal lubrication where a decrease in tensile strength and prolonged disintegration was generally observed. Additionally, the lubricant types affected tensile strength and disintegration differently. This study demonstrates the versatility of external lubrication as an alternative lubrication method for production of pharmaceutical tablets.
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 © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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