Results and conclusion
The process and equipment modifications implemented for the second demonstration batch were successful in reducing the CU
variation and alleviating the upward CU trend that was observed at the end of compression in the first demonstration batch,
as shown in Figure 4. The CU data for the second demonstration batch showed minimal variation (RSD = 0.9%, n = 60 samples) and met the FDA draft guidance specifications. The successful validation of the commercial process further
demonstrated the robustness of these modifications.
Figure 4: Stratified tablet content-uniformity data for (a) demonstration batch #1 with segregation and (b) demonstration
batch #2 after process and equipment modifications. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
The authors thank their colleagues Prasad Challapalli, senior scientist at Patheon; Jacques Mowrer, associate director of
analytical chemistry, and Alicia Ng, analytical chemist, at Transcept; and Mary Thomas, former manufacturing-process engineer
at Patheon for their collaboration on this project.
Nipun Davar is a vice-president of pharmaceutical sciences at Transcept Pharmaceuticals. Thomas Baxter is a senior consultant at Jenike & Johanson. Pauly Kavalakatt is a senior scientist of formulation development, and Sangita Ghosh* is an associate director of product development, both at Transcept Pharmaceuticals, 1003 W. Cutting Blvd., Pt. Richmond,
CA, 94804, tel. 510.215.3500, email@example.com
. Herbert Schock is a technical manager of commercial operations at Patheon Pharmaceuticals
*To whom all correspondence should be addressed.
Submitted: Aug. 19, 2010. Accepted: Nov. 8, 2010.
1. FDA, Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment (Rockville, MD, Oct. 2003).
2. FDA, Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment, Revised Attachments (Rockville, MD, Nov. 2003).
3. J.K. Prescott and T.P. Garcia, Pharm. Technol.
25 (3), 68–79 (2001).
4. J.K. Prescott, and R.J. Hossfeld, Pharm. Technol.
18 (6), 99–114 (1994).
5. J.K. Prescott et al., Pharm. Technol.
30 (12), 54–64 (2006).
6. J.K. Prescott and R.A. Barnum, Pharm. Technol.
24 (10), 60–84 (2000).