Analysis and Simulation of Capsule Dissolution Problem Encountered During Prodkt Scale-Up |
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Authors: | I. Ullah G. J. Wiley S. N. Agharkar |
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Affiliation: | a Pharmaceutics Research and Development Department Pharmaceutical Research Institute, Bristol-Myers Squibb Company, Syracuse, NY |
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Abstract: | An in vitro capsule dissolution rate problem was encountered during scale-up of cofadroxil monohydrate, a water-soluble drug product. Initial formulation development had been carried out on a Zanasi LZ-64 with a blend containing 1.0% magnesium stearate lubricant. Scale-up capsules manufactured using a Hoflinger-Karg model GFK-1500 (H&K) showed a significantly slower dissolution rate when compared to those produced on a Zanasi LZ-64. Analysis of the problem indicated that during encepsulation on the H&K capsule machine, powder was being sheared resulting in slower in vitro capsule dissolution rate.
Shear simulation studies were conducted to select the level of magnesium stearate for encapsulation on the H&K which would maintain a satisfactory in capsule dissolution rate. A 0.3% level of magnesium stearate was selected on the basis of the simulation studies. At this lubricant level, capsules have been routinely produced on the H&K with satisfactory dissolution and encapsulation characteristics. |
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