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

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

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 / Revised: 24 December 2012 / Accepted: 26 December 2012 / Published: 2 January 2013
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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 cryopreservation; fibrinolysis; stability; tissue plasminogen activator
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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Alkatheri, A. Stability of Recombinant Tissue Plasminogen Activator at −30 °C over One Year. Pharmaceuticals 2013, 6, 25-31.

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