Weight and weight uniformity of hard gelatin capsules filled with microcrystalline cellulose and silicified microcrystalline cellulose.
The objective of this study was to investigate the weight and weight uniformity of hard gelatin capsules filled with microcrystalline cellulose (MCC) and silicified microcrystalline cellulose (SMCC) powdered formulations. A tamping-type encapsulation apparatus was used to fill the capsules. The four formulations that were tested included MCC alone, MCC blended with fumed silica, SMCC, and high-density SMCC (SMCC-HD). The mean capsule weight and the average variation in mean capsule weight of each formulation were determined. Both SMCC products exhibited better flow than the MCC alone, with SMCC-HD being the freest flowing of the powders investigated. Capsules filled with the SMCC products had higher fill weights than those containing the MCC powders. The SMCC-containing capsules exhibited the lowest variation in weight, although these findings were not significantly different from either of the MCC-containing capsules. Significantly higher weight variations were found in capsules filled with SMCC-HD. A relationship between Carr's compressibility index and capsule weight variation was found, with more compressible materials producing more uniformly filled capsules. No relationship could be established between powder flow and capsule weight uniformity. These findings suggest that powder flow may not be a critical parameter in ensuring capsule weight uniformity when the encapsulation equipment utilizes a tamping-type filling system.
Felton
Linda A
LA
University of New Mexico, College of Pharmacy, Albuquerque 87131, USA. lfelton@unm.edu
Garcia
Daniel I
DI
Farmer
Ryan
R
D002214:Capsules; D002482:Cellulose / Q000138:chemical synthesis* / Q000737:chemistry*; D005079:Excipients / Q000138:chemical synthesis* / Q000737:chemistry*; D011208:Powders; D011786:Quality Control; D012822:Silicon Dioxide / Q000138:chemical synthesis* / Q000737:chemistry*; D014894:Weights and Measures
D002214:Capsules; D005079:Excipients; D011208:Powders; D012822:Silicon Dioxide; D002482:Cellulose; C109691:microcrystalline cellulose