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- W1972972919 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." @default.
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- W1972972919 date "1992-01-01" @default.
- W1972972919 modified "2023-09-25" @default.
- W1972972919 title "Analysis and Simulation of Capsule Dissolution Problem Encountered During Prodkt Scale-Up" @default.
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- W1972972919 doi "https://doi.org/10.3109/03639049209069305" @default.
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