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Gabapentin Tableting Studies

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This report outlines the methods and results from a series of tableting studies on Gabapentin granulations performed at Abbott on May 27-28 and June 23-48, 2010. Utilizing various tablet presses and conditions, these studies assessed tablet compression force, disintegration time, and overall granulation performance. Measurements were made against parameters like temperature, relative humidity, and pressure variations, ensuring a detailed understanding of formulation effectiveness. Key findings highlight the breaking forces and disintegration times under specified conditions, contributing to the optimization of tablet manufacturing processes.

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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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