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Novel delivery systems for coagulation proteins

S I Miekka1, T Jameson, M Singh

  • 1Jerome H. Holland Laboratory, American Red Cross, Rockville, MD 20855, USA. miekka@usa.redcross.org

Haemophilia : the Official Journal of the World Federation of Hemophilia
|January 5, 1999
PubMed
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Stable liquid formulations of human coagulation factors were developed for long-term hemophilia prophylaxis. These formulations, including human coagulation factor IX (hCFIX) and human coagulation factor VIII (hCFVIII), show promising stability and bioavailability for alternative delivery methods.

Area of Science:

  • Biochemistry
  • Pharmacology
  • Materials Science

Background:

  • Long-term hemophilia prophylaxis necessitates stable clotting factor formulations for alternative delivery.
  • Current delivery methods for clotting factors pose challenges for sustained therapeutic levels.

Purpose of the Study:

  • To develop stable liquid formulations of human coagulation factors for long-term hemophilia prophylaxis.
  • To evaluate the stability and bioavailability of novel formulations for subcutaneous delivery.

Main Methods:

  • Development of aqueous-formulated human coagulation factor IX (hCFIX) and freeze-dried human coagulation factor VIII (hCFVIII).
  • Assessment of in vitro half-life at different temperatures.
  • Evaluation of subcutaneous (s.c.) and intravenous (i.v.) bioavailability in animal models.

Related Experiment Videos

  • Utilizing hydrogels of hCFIX with N,O-carboxymethyl chitosan (NOCC) for sustained release.

    • Main Results:

    • Aqueous hCFIX demonstrated an in vitro half-life of 6 weeks at 37°C and 18 months at 4°C.
    • Subcutaneous injection of hCFIX showed up to 16% bioavailability compared to i.v. dose.
    • S.c. implanted pumps delivering hCFIX achieved >2% of normal human plasma levels.
    • hCFIX in NOCC hydrogels provided prolonged plasma levels after s.c. injection.
    • Freeze-dried hCFVIII in non-aqueous solvents exhibited an in vitro half-life of up to 80 days at 37°C.

    Conclusions:

    • Stable liquid formulations of hCFIX and hCFVIII are achievable for hemophilia prophylaxis.
    • Alternative delivery modes, such as s.c. injection and hydrogel formulations, offer potential for improved pharmacokinetic profiles.
    • These advancements pave the way for more convenient and effective long-term hemophilia management.