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Solid Form Characterization of Gabapentin: Analysis by the NIPTE Stability Group

This report provides an in-depth analysis of gabapentin solid forms by the National Institute for Pharmaceutical Technology and Education (NIPTE) Stability Group. It includes the examination of multiple forms of gabapentin, focusing on the monohydrate and desolvate states, and interconversions during analysis. Key findings include the identification of Form III in milled samples and the detection of gabapentin lactam as a primary degradation product. SSNMR characterizations reveal the effects of recrystallization on the stability of various gabapentin forms, highlighting important implications for pharmaceutical sciences.

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Solid Form Characterization of Gabapentin: Analysis by the NIPTE Stability Group

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  1. National Institute for Pharmaceutical Technology and Education (NIPTE) Stability Group - Solid Form Characterization Eric Munson

  2. Outline • Samples of Gabapentin Analyzed • Gabapentin - multiple forms • Gabapentin monohydrate/desolvate • Interconversion of forms upon analysis • Identification - Form III in milled samples • Gabapentin Lactam (primary degradation product)

  3. Gabapentin as Received - SSNMR

  4. Gabapentin as Received - SSNMR O 8 9 2 1 7 3 OH NH2 6 5 4 1H T1 = 134 s Tentative NMR Assignments 3 7 (6,8) 2 (5,9) Not shown: Carbon 1 at 179.5 ppm 4

  5. SSNMR of Gabapentin Forms

  6. SSNMR of Gabapentin Forms - Effects of Recrystallization

  7. Lot D Intensity (arbitrary units) Lot C Lot B Lot A Two-Theta (deg) SSNMR of Gabapentin Forms - Effects of Recrystallization

  8. Lot D Intensity (arbitrary units) Lot C Lot B Lot A Two-Theta (deg) SSNMR of Gabapentin Forms - Effects of Recrystallization

  9. SSNMR of Gabapentin Forms - Effects of Recrystallization Lot A, 20x Lot B, 20x Lot C, 10x Lot D, 20x

  10. SSNMR of Gabapentin Forms

  11. SSNMR of Gabapentin Forms - Monohydrate

  12. SSNMR of Gabapentin Forms - Milled Samples

  13. SSNMR of Gabapentin Forms - Milled Samples

  14. SSNMR of Gabapentin Forms - Milled Samples

  15. Effect of Grinding on Forms • Particles of bulk lactose monohydrate before processing • Lactose monohydrate cryoground for 60 minutes Crystalline Amorphous Crystalline

  16. Lactose 1H T1 Relaxation Data - SSNMR Lubach, J. W.; Xu, D.; Segmuller, B. E., Munson, E. J. In Press J. Pharm. Sci. 2006.

  17. Lactose 1H T1 Relaxation Data - SSNMR Lubach, J. W.; Xu, D.; Segmuller, B. E., Munson, E. J. In Press J. Pharm. Sci. 2006.

  18. Gabapentin Relaxation Times Stability - High, Medium, Low

  19. Degradation of Gabapentin Forms - Milled Samples

  20. Gabapentin Relaxation Times

  21. Degradation of Gabapentin Forms - Milled Samples

  22. Summary

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