Measurement of the surface energy of lubricated pharmaceutical powders by inverse gas chromatography.
The objective of the study was to determine whether lubrication of pharmaceutical powders with magnesium stearate (MgSt) results in a change in the surface energy of the powder, and to assess whether surface energy changes, if any, are correlated to lubricant concentration and blend time. The surface energies of microcrystalline cellulose (MCC), lactose, and blends of each material with MgSt, prepared at a range of concentrations and blending times were measured using inverse gas chromatography. The physical distribution of MgSt in the blend was mapped by energy dispersive spectrometry. Overall, there was a reduction in the dispersive surface energy of MCC-MgSt blends with increase in MgSt concentration, that was attributed to increasing coverage of the high-energy sites on microcrystalline cellulose by magnesium stearate. MgSt concentration had a larger effect on dispersive energy than the blending time of the powder with lubricant. X-ray maps of blend samples indicated a heterogeneous distribution of the lubricant in the blend and on the excipient particles. Measurement of the specific component of surface energy indicated that MgSt interacts with excipient powders through non-specific forces rather than acid-base interactions. No distinction among lactose-MgSt blends could be made on the basis of dispersive energy because of similar surface energies of the native materials.
Swaminathan
Vidya
V
Pfizer Global R&D, Groton Laboratories, Groton, CT 06340, USA. vidya.swaminathan@pfizer.com
Cobb
Jaclyn
J
Saracovan
Ilie
I
D002482:Cellulose / Q000737:chemistry*; D002849:Chromatography, Gas; D005079:Excipients / Q000737:chemistry*; D007785:Lactose / Q000737:chemistry*; D008153:Lubrication; D011208:Powders / Q000737:chemistry*; D013229:Stearic Acids / Q000737:chemistry*; D013499:Surface Properties
D005079:Excipients; D011208:Powders; D013229:Stearic Acids; C031183:stearic acid; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose