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Related Experiment Videos

Liquid growth hormone: preservatives and buffers.

Anne-Marie Kappelgaard1, Anders Bojesen, Karsten Skydsgaard

  • 1Scientific Marketing GHT, Novo Nordisk A/S, Bagsvaerd, Denmark. amk@novonordisk.com

Hormone Research
|November 13, 2004
PubMed
Summary

Optimizing growth hormone (GH) formulations with specific preservatives and buffers can reduce injection pain. This improvement in patient comfort is key to enhancing long-term compliance with GH therapy.

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Area of Science:

  • Endocrinology
  • Pharmaceutical Science

Background:

  • Growth hormone (GH) therapy is crucial for conditions like GH deficiency and growth retardation.
  • Long-term daily subcutaneous injections are required, making patient compliance critical.
  • Injection pain is a significant barrier to patient compliance.

Purpose of the Study:

  • To investigate the impact of preservatives and buffers in liquid GH formulations on injection pain.
  • To identify formulation components that contribute to or alleviate injection discomfort.
  • To inform the development of more patient-friendly GH formulations.

Main Methods:

  • Comparative analysis of injection pain associated with different preservatives (phenol, m-cresol, benzyl alcohol) and buffers (histidine, citrate, phosphate).
  • Review of toxicological data for subcutaneous administration of preservatives.

Related Experiment Videos

  • Clinical evaluation of patient-reported pain levels with various GH formulations.

    • Main Results:

    • Phenol and benzyl alcohol preservatives showed similar pain profiles, while m-cresol was associated with more pain.
    • Histidine buffer resulted in less reported pain compared to citrate buffer.
    • Higher injection volumes and protein concentrations correlated with increased pain.

    Conclusions:

    • Formulation optimization, particularly regarding preservatives and buffers, can significantly reduce injection pain.
    • Reduced injection pain is likely to improve patient compliance in long-term GH treatment.
    • Histidine-buffered, phenol-preserved GH formulations may offer a more comfortable treatment option.