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 1

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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here