Formulation and process optimization to eliminate picking from market image tablets.
A tablet formulation when compressed using market image tooling may cause picking of powder. A D-optimal statistical experiment was designed to optimize the direct compression formulation and the process to alleviate picking of powder. The effects of levels of magnesium stearate, colloidal silicon dioxide (CSD), and lubrication time on picking were investigated using original compression tooling. These optimization results provided a small robust manufacturing region, hence a change in the cut angles of embossed letters and numbers from 70 degrees to 90 degrees in the modified compression tooling was evaluated. A statistical analysis of the data identified a robust manufacturing region that included formulations containing magnesium stearate 1-1.25% w/w, CSD 0.1-0.3% w/w, with a lubrication time of 5-10 min when compressed using modified compression tooling. The results indicate a significant reduction in picking by increasing the cut angles of embossed letters and numbers in the modified compression tooling. By evaluating interactions between various variables, we demonstrate a concentration dependent effect of CSD on the lubrication efficiency of magnesium stearate and compactability of microcrystalline cellulose containing formulation. In addition, the lubrication efficiency of magnesium stearate is maintained by blending CSD with powder blend prior to lubrication with magnesium stearate.
Pharmaceutical Sciences, GlaxoWellcome Inc., Research Triangle Park, Durham, NC 27709, USA.
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Sabir
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Evans
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Jain
D004339:Drug Compounding; D005079:Excipients; D006244:Hardness; D008153:Lubrication; D011312:Pressure; D012822:Silicon Dioxide; D013229:Stearic Acids; D013608:Tablets, Enteric-Coated / Q000737:chemistry*
D005079:Excipients; D013229:Stearic Acids; D013608:Tablets, Enteric-Coated; C031183:stearic acid; D012822:Silicon Dioxide