Basic Considerations for Container Closure Selection of Parenteral Drug ProductsLakshmi Prasanna Kolluru*
Medefil Inc, Glendale Heights, IL 60139, USA.
- *Corresponding Author:
- Lakshmi Prasanna Kolluru
Sr. Formulation Scientist, Medefil Inc
250/405 Windy Point Drive, Glendale Heights, IL 60139, USA
Email: [email protected]
Received Date: May 02, 2017; Accepted Date: May 10, 2017; Published Date: May 16, 2017
Citation: Kolluru LP (2017) Basic Considerations for Container Closure Selection of Parenteral Drug Products. Pharm Anal Acta 8:e189. doi: 10.4172/2153-2435.1000e189
Copyright: © 2017 Kolluru LP. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
By definition, container closure system encompasses all components of the packaging system that hold and protect the drug product. It includes primary packaging system (components with which the drug product comes in direct contact) and secondary packaging system (components that offer additional protection to the system but do not come in direct contact with the drug product). This article focuses on primary packaging components as they have a significant effect on the critical quality attributes of the drug product throughout the product shelf-life. Selection of an appropriate container closure system for a parenteral drug product is of utmost importance as Food and Drug Administration (FDA) classified that the probability of interaction of the drug product with the packaging component is high and the risks associated from such interactions are highest for injections administered via parenteral route . Impeachment of container closure integrity leads to compromised sterility of the drug product system, which in turn is one of the major reasons for FDA drug product recalls in 2016 .