(M1230-11-73) Impact of Clean Label Lubricant Inclusion Level and Mixing Time on Tablet Properties

Purpose: The global market continues to expand for nutritional products, and with consumers having more access to information the demand for label friendly ingredients has increasing importance. Most of the current nutritional formulations in the market still use pharmaceutical ingredients such as fillers and lubricants. The present study focuses on the development of clean label lubricant blends to develop tablet formulations from natural sources. This study evaluates the lubrication properties of two novel clean label lubricant blends referred as NCL190032 and NCL190033. The lubricant properties were evaluated by: Evaluation of different levels of clean label lubricants in placebo tablets; Impact of lubricant mixing time on placebo and dietary supplement containing tablets

Methods: Tablets were prepared as per the composition given in Table 1. Placebo blends were prepared by adding the label friendly filler blend and respective lubricant in a V-blender and blended for 2 minutes. Dietary supplement-containing tablets were prepared using ashwagandha as a model ingredient. The blends were prepared by adding ashwagandha and label friendly filler blend in a v-blender and blending for 3 minutes, followed by adding the respective lubricant and then blended for a further 2 minutes as lubricant mixing. The resulting blend was used for tablet compression using Piccola tablet press at 50 rpm turret speed. Tablets were prepared at 450 mg tablet weight, 10 mm biconvex shape, compressed at 20, and 25 KN compression force. One hundred tablets were collected for tablet characterization. Impact of Different Concentration of Lubricant and Lubricant Mixing Time; Different concentrations of each lubricant in the placebo tablet formulation were evaluated to determine the optimum level for each lubricant. Tablets were prepared as per formulation compositions given in Table 1 and evaluated for appearance, tensile strength, and ejection forces. Based on the results for the optimal lubrication level, the impact of lubricant mixing time was determined. The lubricant mixing time was evaluated at 2, 5, and 10 minutes for both placebo and active tablets, respectively. The formulation composition for placebo and active tablets are shown in Table 1. Tablets were evaluated for their appearance, tensile strength, and ejection forces.

Results: The results for the impact of the lubricant concentration for NCL190032 are given in Figure 1. Based on the results the tablets have tensile strength above 1.5 MPa and a friability value < 0.1% which shows excellent mechanical strength. With an increase in concentration of the lubricant blend from 1.0% to 5.0%, there was no significant impact on the tensile strength. The ejection force was < 400 N for all the batches showing excellent lubricant properties. The formulation with NCL190032 at 2.5% showed better reduction in ejection force with acceptable tablet tensile strength. Therefore, a lubricant level of 2.5% was selected for further studies. Similar results were observed for the tablets prepared with NCL190033 (results not shown here). A level of 1.5% for NCL190033 was selected for further studies, based on acceptable tensile strength and better ejection force. Tablets prepared with NCL190032 and NCL190033 were evaluated for the impact of lubricant mixing time. The results for NCL190032 are given in Figure 2. Based on the results of tensile strength, with increase in lubricant mixing time, the tensile strength showed upward trend with increase in tensile strength for placebo tablets. For the active tablets, the tensile strength is similar for the different lubricant mixing times studied. The ejection force was also found to be similar for different mixing time. This indicates the different lubricant mixing time did not affect the tablet performance. Similar results were observed for NCL190033 (results not shown here).

Conclusion: The clean label lubricant was prepared and evaluated for its performance on tablet properties. Both NCL190032 and NCL190033 demonstrated excellent tabletability with acceptable tensile strength and ejection force when tablets prepared with label friendly filler blend. The desired level of lubricant was determined and evaluated for the study of lubricant mixing time. Both the lubricants showed similar tablet properties with different lubricant mixing times, concluding that the lubricant performance is independent of mixing time. The current study demonstrates an innovative new range of label friendly lubricants that will meet the technical and manufacturing needs of nutraceutical and supplement formulations.

Table 1: Formulation Composition for Tablet Formulation Containing Clean Label Lubricants

Figure 1: Impact of Concentration of NCL190032 on a) Tablet Tensile Strength and b) Ejection Force

Figure 2: Impact of Lubricant Mixing Time for NCL190032 on a) Placebo Tablet Tensile Strength, b) Placebo Tablet Ejection Force, c) Active Tablet Tensile Strength, and d) Active Tablet Ejection Force