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Pharmaceuticals 2013, 6(1), 25-31; doi:10.3390/ph6010025

Article

Stability of Recombinant Tissue Plasminogen Activator at −30 °C over One Year

Abdulmalik Alkatheri ^1,2

¹ College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh 11426, Saudi Arabia ² National Guard Health Affairs, King Abdulaziz Medical City, Riyadh, 11426, Saudi Arabia

Received: 12 November 2012; in revised form: 24 December 2012 / Accepted: 26 December 2012 / Published: 2 January 2013

Download PDF Full-Text [202 KB, uploaded 2 January 2013 16:03 CET]

Abstract: Recombinant tissue plasminogen activator (rt-PA) is used to restore patency and avoid inadvertent removal of peripheral and central venous catheters. rt-PA was reconstituted (1 mg/mL) then cryopreserved at −30 °C for 1, 2, 3, 6, 8, and 12 months and, then its stability was determined. After cryopreservation for one and two months, rt-PA kept more than 95% of its activity compared to standard samples, while cryopreservation for three months caused 8% loss of activity. However, after cryopreservation for six months or more, rt-PA retained only 87.5% or less activity compared to standard samples. Therefore, it is recommended that reconstituted rt-PA be cryopreserved at −30 °C for a maximum period of three months.

Keywords: cryopreservation; fibrinolysis; stability; tissue plasminogen activator

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