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Gabapentin Tableting Studies

Gabapentin Tableting Studies. 96251-2 96251-3 96251-4 96251-5 96251-6 96251-7 96251-8 96251-9 96251-10 96251-11 96251-12 96251-13 96251-14 96251-15. Materials. Granulations: manufactured at Abbott May 27 th & 28 th , 2010 Temp.:23 & 21 ℃ R.H.:54 & 56%. Methods: Tableting.

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Gabapentin Tableting Studies

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  1. Gabapentin Tableting Studies

  2. 96251-2 96251-3 96251-4 96251-5 96251-6 96251-7 96251-8 96251-9 96251-10 96251-11 96251-12 96251-13 96251-14 96251-15 Materials Granulations: manufactured at Abbott May 27th & 28th, 2010 Temp.:23 & 21℃ R.H.:54 & 56%

  3. Methods: Tableting • Press • 10-station, instrumented tablet press • Piccola rotary tablet press (Model B, Knoll pharmaceutical Co., Argetina) • Instrumentation • Tablet compression • Tooling • one set punch die set • concave oval (L 17.45 mm, W 10.35mm) shape • Speed • 25 RPM • Peak compression force • Granulation 2,3 &12 ca 20, 15, 10 and 5 KN • Other granulations ca 20 KN

  4. Sample collecting strategy 96251-2, 96251-3 and 96251-12 Rest of the granulations

  5. Weight and weight variation of the 14 granulations at different pressures-- within 2%

  6. Pmax vs Breaking force

  7. The comparison of breaking forces of 14 granulations under similar compression force(~20kN)

  8. Methods • Disintegration • Medium: distilled water • Temp: 37oC • Apparatus: USP<701> June 17th, 2010 96251-2-7 R.T.: 21°C R.H.(%): 61% June 18th, 2010 96251-8-15 R.T.: 22°C R.H.(%): 54%

  9. Disintegration Time

  10. Materials Granulations: manufactured at Abbott June 23th & 48th, 2010 Temp.:21 ℃ R.H.:59% • 96251-21 • 96251-22 • 96251-23 • 96251-24 • 96251-25 • 96251-27

  11. Methods: Tableting • Press • 35-station, no instrumentation • Manesty BB4 rotary tablet press (OYSTAR USA, NJ, USA) • Instrumentation • Tablet compression • Tooling • Seven set punch die set • Concave oval (L 17.45 mm, W 10.35mm) shape • Speed • 25 RPM • Peak compression force • Granulation 22, four levels, targeted breaking force: 15, 10, 7 & 3kP • Other granulations targeted breaking force 10kP

  12. Sample collecting strategy for 96251-22

  13. Sample collecting strategy for the rest of granulations

  14. Weight and weight variation of the 6 granulations at different pressures-- within 2%

  15. Methods July 15th, 2010 96251-2-7 Temp: 22°C R.H.(%): 69% • Disintegration • Medium: distilled water • Temp: 37oC • Apparatus: USP<701>

  16. Disintegration Time

  17. Disintegration data for Rutgerts simulation tablets, they will present that data

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