Silicone Microdroplets in Protein Formulations—Detection and Enumeration - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Silicone Microdroplets in Protein Formulations—Detection and Enumeration
The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.


Pharmaceutical Technology
Volume 33, Issue 4, pp. 74-79

References

1. E.J. Smith et al., "Siliconization of Parenteral Drug Packaging Components," J. Parent. Sci. Technol. 42 (Supplement 4S), S1–S13 (1988).

2. S. Branley, "Chemistry and Properties of Medical Grade Silicones," J. Macromol. Sci. Chem A. 4 (3), 529–544 (1970).

3. E.A. Chantelau, "Silicone Oil Contamination of Insulin," Diabet. Med. 6 (3), 278 (1989). ]

4. R.K. Bernstein, "Clouding and Deactivation of Clear (Regular) Human Insulin: Association with Silicone Oil from Disposable Syringes," Diabetes Care 10 (6), 786–787 (1987).

5. R.N. Baldwin, "Contamination of Insulin by Silicone Oil: A Potential Hazard of Plastic Insulin Syringes," Diabet. Med. 5 (8), 789–790 (1988).

6. G.L. Shearer, "Contaminant Identification in Pharmaceutical Products," The Microscope 51 (1), 3–10 (2003).

7. L. S. Jones et al., "Silicone Oil Induced Aggregation of Proteins," J. Pharm. Sci. 94 (4), 918–927 (2005).

8. USP 29–NF 24 (suppl 2) General Chapter <788>, "Particulate Matter in Injections." US Pharmacopeial Convention, Rockville, MD, 2006.

9. "Particulate Contamination: Visible Particles" in European Pharmacopoeia, (European Pharmacopoeia Commission, Council of Europe, European Department for the Quality of Medicines, 2005) 5th ed. Vol. 5.0 (incl. suppl 5.1). General Chapter 2.9.20.

10. "Foreign Insoluble Particulate Matter Test for Injections" in Japanese Pharmacopoeia (Society of Japanese Pharmacopoeia, 2006) 14th edn. General Chapter 20.

11. D.K. Sharma et al., "Flow Microscopy for Particulate Analysis in Parenteral and Pharmaceutical Fluids," European J. Parent. Pharma. Sci. 12 (4), 97–101 (2007).


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.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here