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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) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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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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