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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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materials
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%

methods tableting
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
slide4

Sample collecting strategy

96251-2, 96251-3 and 96251-12

Rest of the granulations

methods
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%

materials1
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
methods tableting1
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
methods1
Methods

July 15th, 2010 96251-2-7 Temp: 22°C R.H.(%): 69%

  • Disintegration
    • Medium: distilled water
    • Temp: 37oC
    • Apparatus: USP<701>