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

Sabbatini, Beatrice; Perinelli, Diego Romano; Palmieri, G; Cespi, Marco; Bonacucina, Giulia

doi:10.1016/j.ijpharm.2023.123265

Cited by 3 publications

(1 citation statement)

References 36 publications

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“…Stearic acid can cause the tablets to become sticky and difficult to handle during the manufacturing process. Talcum has a concern over health hazards due to the presence of asbestos fibers in some natural talc deposits, while the role of SLS as a tablet lubricant has recently been questioned, with the experimental data not supporting its use in tablet formulations [ 9 ]. Other commercially available pharmaceutical lubricants include sodium stearyl fumarate, glyceryl dibehenate, L-leucine, and hydrogenated plant seed oils.…”

Section: Introductionmentioning

confidence: 99%

Utilization and Evaluation of Rice Bran and Rice Bran Wax as a Tablet Lubricant

Kittipongpatana,

Trisopon,

Wattanaarsakit

et al. 2024

Pharmaceutics

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The rice bran and rice bran wax of the KJ CMU107 rice strain were investigated as potential tablet lubricants in a directly compressed tablet formulation. Stabilized full-fatted rice bran (sFFRB), stabilized defatted rice bran (sDFRB), and rice bran wax (RBW) extracted and purified from crude rice bran oil (cRBO) were tested. Two commercial lubricants, including magnesium stearate (MGS) and hydrogenated cottonseed oil (HVO), were employed as the standards in the formulated mixtures, which contained spray-dried rice starch (SDRS) as a diluent. The tableting was carried out for each formulation, and the obtained tablets were physically and mechanically evaluated. Among the parameters investigated were the general appearance, ejection force, weight variation, hardness, friability, and disintegration time. The powder flow was also determined for each formulation. The results showed that the tablet ejection forces for all the lubricated formulations (58–259 N) were significantly lower than that of the non-lubricated control formulation (349 N). The use of sFFRB as a lubricant at 0.5–2.0% w/w could lower the ejection force up to 78%, but the hardness reduced so drastically that the formulations failed the friability test due to the chipping of the tablets’ edges. Moreover, sDFRB performed significantly better as the use at 0.5–1.0% w/w in the formulation helped to lower the ejection forces by up to 80% while maintaining the changes in the tablet hardness within 10%. RBW functioned effectively as a tablet lubricant at a concentration of 0.5% w/w, yielding tablets with good strength comparable to standard HVO lubricant while helping to reduce the ejection force by 82%. In formulations with good lubrication, i.e., friability < 1%, the powder flow was improved, and the tablet disintegration times were within the same range as the control and HVO formulations. In conclusion, sDFRB displayed a lubricant property at concentrations between 0.5 and 1.0% w/w, with slightly negative effects on the tablet hardness. RBW from KJ CMU107 rice was an effective tablet lubricant at 0.5% w/w, with no effect on tablet hardness. Both materials can be further developed for use as commercial lubricants in direct compression.

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Section: Introductionmentioning

confidence: 99%

Utilization and Evaluation of Rice Bran and Rice Bran Wax as a Tablet Lubricant

Kittipongpatana,

Trisopon,

Wattanaarsakit

et al. 2024

Pharmaceutics

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Exploring the impact of high shear mixing process parameters on the physical characteristics of excipient powder blend by design of experiments

Kovács,

Tőkés,

Kelemen

et al. 2024

Acta Marisiensis - Seria Medica

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Objective Dry-route manufacturing technology development poses challenges to pharmaceutical technology research specialists, relying on active substance characteristics, excipient selection, and parameter optimization. Amongst various technological possibilities high shear mixing generally ensures dosage uniformity and tablet dissolution through influential shear forces, potentially enhancing dry powder blend processability. This study explores the processability of a placebo formulation within the quality by design framework to address some of the aforementioned challenges. Methods A 24 full-factorial experimental design was used to assess the manufacturability of a placebo formulation via high shear mixing. The effect of impeller and chopper speed, high shear mixing time, and homogenization/lubrication times on powder blend rheology and compression properties was investigated. Results The findings of the present study showed that product critical quality attributes like resistance to crushing or disintegration time are mainly dependent on the mixing efficiency translated by the impeller speed and high shear mixing time. Software augmented process development enabled the attainment of the design space, ensuring the fulfilment of desired product performance criteria. Furthermore, the study has also shown that the careful selection of excipients is crucial in the case of dry-route manufacturing technologies, as sodium lauryl sulphate can noticeably influence the processability of powder blends due to its lubricant properties. Conclusions Considering the advantages and challenges raised by high-shear mixing, software aided data analysis can further augment the formulation, scale-up and lifecycle management of products developed using this technological process.

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A Method for the Colorimetric Quantification of Sodium Lauryl Sulphate in Tablets: A Proof of Concept

Paulausks,

Mazurs,

Mohylyuk

2024

Pharmaceutics

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The deformulation stage of original drug products, which includes the quantification of critical excipients, is crucial for the successful development of generic drug products of solid dosage form. Sodium lauryl sulphate (SLS) belongs to the group of critical excipients due to its influence on the bioavailability of drugs, such as metformin. The purpose of this work is to carry out a feasibility study in order to develop a simple, economical, and robust analytical method for the quantification of SLS in metformin-containing tablets after their dissolution in water. Firstly, SLS is extracted with chloroform in acidic conditions, followed by the addition of methylene blue (MB) in order to form a SLS-MB ion pair, which is then measured photometrically at a wavelength of 651 nm. Additionally, interference from matrix components (excipients and APIs) was assessed, and it was found that metformin also forms a blue complex; therefore, this specific extraction method was developed. Other matrix components did not interfere with SLS determination. This method shows a well-estimated precision of 3.3% and accuracy of 5%, a calibration linearity of R2 = 0.99990, and a working range of 0.38 µg/mL to 10 µg/mL of SLS in water. The midpoint of the calibration graph corresponds to the concentration of SLS obtained by dissolving a single tablet in 1 L of water. This method seems appropriate for total SLS determination in tablets and can be applicable for deformulation.

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

Cited by 3 publications

References 36 publications

Utilization and Evaluation of Rice Bran and Rice Bran Wax as a Tablet Lubricant

Utilization and Evaluation of Rice Bran and Rice Bran Wax as a Tablet Lubricant

Exploring the impact of high shear mixing process parameters on the physical characteristics of excipient powder blend by design of experiments

A Method for the Colorimetric Quantification of Sodium Lauryl Sulphate in Tablets: A Proof of Concept

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