Sodium lauryl sulfate as lubricant in tablets formulations: is it worth?

Lubricants are excipients used in tablet formulations to reduce friction and adhesion forces within the die or on the punches surface during the manufacturing process. Despite these excipients are always required for the tablets production, their amount must be carefully evaluated since lubricants can negatively impact on mechanical strength, disintegration and dissolution behavior of solid dosage forms. Alternative compounds have been suggested to overcome the issues of conventional lubricants and sodium lauryl sulfate (SDS) is one of the most promising one. Despite SDS has been object of several investigations, a definitive conclusion on its effectiveness cannot still be drawn. Particularly, its efficacy on tablets disaggregation and API dissolution is still unclear. Here, the effect of SDS on all the relevant features of tablets and tableting process has been evaluated on immediate release hydrophobic tablets formulations in comparison with conventional lubricants. The results of this investigation are quite outspoken: SDS has a low lubricant power while it determines only a limited improvement on tablets hardness. It greatly improves the tablets wettability but only on model formulations, the presence of superdisintegrants resets its effectiveness and any possible effect on tablets disaggregation. None of the tested formulations showed improvement on the API dissolution rate.

2.1. Materials

Acetaminophen was a gift from from Janssen Pharma. Sodium Stearyl Fumarate (Pruv®, JRS Pharma), croscarmellose sodium (Vivasol® JRS Pharma), sodium Starch Glycolate (Vivastar®, JRS Pharma) and anhydrous calcium hydrogen phosphate (Emcompress Anhydrous, JRS Pharma), was donated by JRS Pharma, while Cross-linked PVP (Kollidon® CL, BASF Pharma) was donated by BASF pharma. Sodium Lauryl Sulfate (purity ≥ 98.5%) was purchased from Sigma-Aldrich, (St. Louis, MO, USA), magnesium stearate benzoic acid and hydrochlorothiazide were purchased from ACEF (Fiorenzuola d’Arda, IT)

Throughout the manuscript the materials are reported with the following abbreviations: acetaminophen (AAP), hydrochlorothiazide (HCT), benzoic acid (BA), magnesium stearate (MgSt), Sodium Stearyl Fumarate (SSF), Sodium Lauryl Sulfate (SDS), croscarmellose sodium (CCS), sodium Starch Glycolate (SSG), Cross-linked PVP (XPVP) and anhydrous calcium hydrogen phosphate (DCP).

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Beatrice Sabbatini, Diego Romano Perinelli, Giovanni Filippo Palmieri, Marco Cespi, Giulia Bonacucina, Sodium lauryl sulfate as lubricant in tablets formulations: is it worth?, International Journal of Pharmaceutics, 2023, 123265, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2023.123265.

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