The formation of lactose plugs for hard shell capsule fills

Pharmaceutical Development and Technology
A Tattawasart, N A Armstrong

Abstract

The purpose of this investigation was to study the effects of lubricant concentration, dosator pressure, and dosator piston height on the properties of lactose plugs. An apparatus designed to simulate Macofar 13/2 capsule filling equipment was used, and the relationship between the variables and the responses was established using a Box-Behnken three-factor, three-level experimental design followed by multiple regression. Plug porosity, both under compression and after ejection, was found to be dependent on dosator pressure. Plug weight and length were dependent on dosator piston height, and uniformity of plug weight was independent of all the factors studied. Plug ejection pressure was dependent on dosator pressure and dosator piston height, even when ejection pressure was corrected for changes in plug length. Lubricant concentration had no significant effect on any plug property, and it must be concluded that 0.5% magnesium stearate provides adequate lubrication for lactose plugs. No interaction between variables was noted, and values of the variables raised to the power 2 had no significant effect, permitting a simplified experimental design to be adopted for future work.

References

Jan 1, 1979·The Journal of Pharmacy and Pharmacology·A G StewartJ M Newton
May 1, 1975·The Journal of Pharmacy and Pharmacology·G C Cole, G May
Apr 1, 1977·Journal of Pharmaceutical Sciences·L E Small, L L Augsburger
Feb 1, 1995·Pharmaceutical Research·J R BrittenN A Armstrong
Mar 1, 1996·The Journal of Pharmacy and Pharmacology·J R BrittenN A Armstrong

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Citations

Sep 13, 2014·Drug Development and Industrial Pharmacy·Vikas MoolchandaniStephen W Hoag
Jul 15, 2015·Drug Development and Industrial Pharmacy·Vikas MoolchandaniStephen W Hoag
Apr 1, 2003·Pharmaceutical Development and Technology·Mintong Guo, Larry L Augsburger

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