Addressing Segregation of a Low-Dosage Direct Blend - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Addressing Segregation of a Low-Dosage Direct Blend
The authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.


Pharmaceutical Technology
Volume 35, Issue 2, pp. 78-82

Results and conclusion


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 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 The CU data for the second demonstration batch showed minimal variation (RSD = 0.9%, n = 60 samples) and met the FDA draft guidance specifications.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.

Acknowledgment

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,
. 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.

References

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
10%
Provide treatment for patients globally.
6%
All of the above.
42%
No government involvement in patient treatment or drug development.
13%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here