Preparation of synthetic bovine parathyroid hormone fragment 1–34 for parenteral use in human studies

W. M. Law, R. A. Nissenson, G. G. Klee, H. Heath

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

There is growing interest in use of synthetic parathyroid hormone peptides such as the ami noterminal 1–34 fragment (PTH 1–34) in human studies, since bovine parathyroid extract is no longer commercially available. We found no data concerning how to sterilize and dilute the synthetic bovine PTH 1–34 (bPTH 1–34) to minimize adsorptive losses and maximize conservation of bioactivity. Therefore, we examined adsorptive losses of electrolytically-labelled, biologically-active bPTH 1–34 onto sterile filtration devices (Millex GV, Millipore Corp.) in solutions of 0.1 M acetic acid containing varying human serum albumin (HSA) concentrations (0.1–5.0%, w/v) and varying hormone concentrations (1–50 μg bPTH 1–34/ml). We also assessed preservation of bPTH 1–34 bioactivity (canine renal cortical plasma membranes) in diluted, sterile-filtered solutions refrigerated for 4 days. Adsorptive losses were inversely related to bPTH 1–34 concentrations, being least with 50 μg bPTH 1–34/ml, at all concentrations of HSA. Losses during filtration were essentially indistinguishable at HSA concentrations of 0.1 – 1.0%, but were, surprisingly, increased by 2.5 and 5.0% HSA. There were no important differences in adsorptive losses among five different lots of Millex-GV filters. Full bioactivity was preserved over 4 days of refrigeration at a bPTH 1–34 concentration of 20 μg/ml. The data suggest that bPTH 1–34 should be sterile-filtered at a concentration of ≥ 20 μg/ml in 0.1M acetic acid containing 0.1 – 1.0% HSA. Such sterile solutions are stable at 4°C for at least 4 days.

Original languageEnglish (US)
Pages (from-to)1335-1337
Number of pages3
JournalJournal of Clinical Endocrinology and Metabolism
Volume56
Issue number6
DOIs
StatePublished - Jun 1983

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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