Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate - Pharmaceutical Technology

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Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate
The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.

Pharmaceutical Technology

Figure 6
Predicted blend homogeneity and assay. The profile of the baseline run with neat MCC is depicted in Figure 4. Results show an average effusivity for the placebo material of 171 Ws0.5 /m2 K (n = 20), with RSD = 0.7%. Figures 5 (Batch 7) and 6 (Batch 11) show the effusivity profiles for ternary blends of MCC, DCP (75:25), and 2.5% w/w APAP lubricated with 1.0% w/w MgSt-M and MgSt-D, respectively. Figures 7 (Batch 12) and 8 (Batch 14) show the effusivity profiles for ternary blends of MCC, LAC (75:25), and 1.25% w/w APAP lubricated with 1.0% w/w MgSt-M and MgSt-D, respectively. Table IV shows the results of the physical and chemical testing for the blends. Blend results indicate that the prelubrication end-points as predicted by effusivity sensors gave good correlation to the blend assay from HPLC analysis. Blend uniformity results for Batch 12, after 4 min of lubrication with MgSt-M, however, show a mean blend uniformity assay of 109.0%, with a failing RSD of 23.5%. Conversely, Batch 14 lubricated with MgSt-D shows an acceptable mean blend uniformity assay of 94.8% with an RSD of 1.6%.

Figure 7
The influence of lubrication and MgSt type on blend integrity. The influence of MgSt type and concentration on effusivity was analyzed using one-way analysis of variance (ANOVA). Analysis of the change (delta) in average effusivity between prelubrication and postlubrication blends containing MgSt-M and MgSt-D, using Tukey's paired comparison at 95% confidence limit, shows statistical significance of p <0.05 (see Table V). The pairwise comparison is indicative of the differing influence attributable to the distinct hydrate forms of the lubricant. In addition, a plot of main effects using the data means from the responses shows that the delta on average effusivity was greater for MgSt-M than for MgSt-D (see Figure 9).

Figure 8
Results from the blending studies, as profiled by the in-line effusivity sensors, also show that when ternary systems containing MCC–DCP and MCC–LAC as diluents were lubricated with MgSt-M and MgSt-D, the delta effusivity values were higher for the blends containing MgSt-M. (Compare Batch 7 and Batch 12 versus Batch 11 and Batch 14 in Table V). These results indicate the ternary systems containing MgSt-D show less degree of densification for both MCC–LAC and MCC–DCP diluent systems before and after lubrication.


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