RT Journal Article
SR Electronic
T1 A Wide pH Range Stopper for Improved Particulate Quality in Parenteral Solutions
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 128
OP 138
VO 38
IS 4
A1 Knapp, J. Z.
A1 Dull, H. F.
A1 Bjorndal, P. M.
A1 Brakl, S. F.
A1 Yuen, P. C.
YR 1984
UL http://journal.pda.org/content/38/4/128.abstract
AB The combination of chemical inertness and compliance required of a stopper for parenteral products has, to date, been inadequately met by any single material. Attempts to achieve these requirements by coating elastomeric stoppers have proven unsatisfactory. Lamination of chemically impervious PTFE to elastomeric base material has been shown to yield functionally desirable stoppers with limited cost effectiveness. An alternative technique in which polypropylene or polyethylene is bonded to a variety of elastomers has been proposed for a wide pH range parenteral stopper. Stability studies in which the functionality of the new stoppers is compared to the widely used bare butyl stopper and to PTFE faced stoppers are presented.