An efficient and aseptic preparation of "sodium fluoride ( 18F) Injection" in a GMP compliant facility

Chih Hao K. Kao, Wen Lin Hsu, Pan Fu Kao, Wen Chun Lan, Heng Li Xie, Ming Chi Lin, Hao Yu Chao

Research output: Contribution to journalJournal Article peer-review

8 Scopus citations

Abstract

Introduction "Sodium fluoride (18F) injection" is an isotonic NaCl solution containing [18F]NaF to be used as bone imaging agent. Although its NDA was approved by the US FDA in 1972, it has not been commercially available since 1975 due to mostly the popularity of 99mTc- MDP. Recently, advances in PET/CT technology and the often interrupted 99mTc supply have led to the renewed interest in the use of [18F]NaF to detect bone metastases in cancer patients. This report introduces an efficient, lowcost and aseptic preparation of "Sodium fluoride (18F) injection" for PET scan. Method 18F-Fluoride in target water from cyclotron was adsorbed onto four different forms of anion-exchange resins then desorbed by isotonic NaCl solution into the product vial. One of the resins that yielded the product at the suitable pH was used for the aseptic preparation. The components for this setup, including stopcocks, extension tubes, etc., were all single-use, individually packed and sterile. The process was done in a lead-line isolator maintained in grade A (PIC/S) aseptic condition. The quality of the obtained "Sodium fluoride (18F) injection" was analyzed according to its monograph in the European Pharmacopoeia (EP). Results The resin in the chloride form yielded the product of pH 6.7 and was chosen for the subsequent preparation. The radiochemical yield was quantitative. The product met all criteria specified in EP, including biological, physical and chemical specifications. Conclusions This method is an efficient, space-saving and extremely low-cost operation that easily performed in an aseptic environment meeting GMP standard. The quality of the "Sodium fluoride (18F) injection" so yielded meets EP specifications. This setup provides hospital with facility meeting GMP standard a cost effective and efficient method for "Sodium fluoride (18F) injection" production without the need for the expensive automatic module and extra QC instrument.

Original languageEnglish
Pages (from-to)149-155
Number of pages7
JournalAnnals of Nuclear Medicine
Volume24
Issue number3
DOIs
StatePublished - 04 2010
Externally publishedYes

Keywords

  • Bone scan
  • European pharmacopoeia
  • PET drug GMP
  • Sodium fluoride (F) injection
  • [F]NaF

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