RABBIT PYROGEN TEST STUDY OF INFUSIBLE PLATELET MEMBRANE AS A PLATELET SUBSTITUTE FOR BLOOD TRANSFUSION

  • Setareh Gholizadeh Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
  • Saleh Nasiri Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
  • Siavash Ahmadi Noorbakhsh Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.
  • Esmat Mirabzadeh Ardakani Pasteur Institute, Tehran, Iran
  • Saeid Rivandi Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.

Abstract

Blood transfusion centers are under considerable pressure to produce platelet concentrates with a shelf life limited to 3-5 days. Many approaches have been investigated experimentally to produce new hemostatically active platelet products that are capable of long term storage. In this article infusible platelet membrane (IPM) as a platelet substitute was investigated with regard to rabbit pyrogen test as a requirement for parenteral drugs according to the EU Pharmacopoeia monograph to demonstrate its safety. Lyophilized IPM was prepared from fresh and outdated platelet concentrates. Platelet concentrates were pooled, disrupted by freeze-thaw procedure and pasteurized for 20 hours to inactivate possible viral or bacterial contaminants. Sterility test, size particle test and rabbit pyrogen test were then performed. Administration of IPM at various dosage forms were carried out on a group of three rabbits with a total of five groups. The summed response of body temperature of each group was calculated. At dosage forms of 1.0, 2.0, 4.0, 6.0 and 9.0 mg per kg of body weight, the summed responses of each group were 0.1, 0.2 , 0.5, 0.7 and 1.0 degree centigrade, respectively. As might be expected, there was shown a strong direct correlation between dose and response with r=0.996. Preparations being examined passed the test according to the EU Pharmacopoeia monograph. It was concluded that IPM as a platelet substitute is sterile and safe without endotoxins and non-endotoxin pyrogens that may be originated from bacteria, intracellular and extracellular proinflamatory cytokines and other biologic response modifiers in conventional platelet concentrates.

Keywords: Infusible platelet membrane, rabbit pyrogen test, platelet substitute

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Author Biographies

Setareh Gholizadeh, Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
Saleh Nasiri, Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran

Assistant Professor (Ph.D.) IBTO-Research Center, Tehran, Iran.

Siavash Ahmadi Noorbakhsh, Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.

Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.

Esmat Mirabzadeh Ardakani, Pasteur Institute, Tehran, Iran

Pasteur Institute, Tehran, Iran

Saeid Rivandi, Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.

Iranian Blood Research and Fractionation Company, Quality Control Department, Tehran, Iran.

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How to Cite
Gholizadeh, S., Nasiri, S., Noorbakhsh, S., Ardakani, E., & Rivandi, S. (2014). RABBIT PYROGEN TEST STUDY OF INFUSIBLE PLATELET MEMBRANE AS A PLATELET SUBSTITUTE FOR BLOOD TRANSFUSION. Journal of Drug Delivery and Therapeutics, 4(6), 53-57. https://doi.org/10.22270/jddt.v4i6.993