Abstract
An accumulation model for predicting the equilibrium solution concentration of leachables migrating from polymeric containers has been applied to the leaching of several solutes from a blend of a styrene-butadiene-styrene block co-polymer and polypropylene. The model considers three accumulation-limiting mechanisms: total available pool, solute solubility and solute partitioning. Equations relating a solute’s solvent-water partition coefficients (P0/w and Ph/w) and its polymer partitioning properties have been developed. With these equations, one can predict leachable accumulation from the container weight, solution volume and the solute’s partition coefficients. The maximal accumulation of the leachable in solution will be the lowest value predicted via the three accumulation-limiting mechanisms.
- Received August 10, 1992.
- Accepted January 5, 1993.
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.