Objective
Drug quality in medical devices is not evaluated during the marketing authorization of radiopharmaceuticals. Therefore, the extemporaneous change of packaging made for preparation of patient unit doses in a syringe is the responsibility of radiopharmacists. The present study aimed to determine the impact of packaging and storage in a polypropylene syringe on the quality of hydrophilic drugs [99mTc]Tc-EDDA/HYNIC-TOC (Tektrotyd) and [68Ga]Ga-DOTA-TOC (Somakit-TOC).
Methods
Appearance, pH, radiochemical purity, sterility, and endotoxin tests were performed according the current European Pharmacopoeia. Subvisible and visible particles tests of the European Pharmacopoeia were adapted due to limited preparation volume (<25 ml). Sorption tests were performed according to the literature.
Results
After 2 h storage in a syringe, drug sorption of Tektrotyd and Somakit-TOC was of less than 2.5% and similar to other 99mTc-radiopharmaceuticals (range: from 1.1 ± 0.5% to 4.2 ± 0.6%). For Tektrotyd, this sorption phenomenon was positively influenced by the drug concentration and a short contact with the medical device (4.8 ± 0.2% up to 5 s vs. 2.3 ± 0.2%, n = 4; P < 0.001). For Somakit-TOC, the duration of contact with syringe had no impact (1.6 ± 0.2% up to 5 s vs. 1.7 ± 0.6%; P = 1.000). No drug radiolysis or alteration of microbiological aspects were observed. No impurity from a 3-piece-syringe was observed according to drug aspect, pH, and subvisible and visible particles, which remained within specification of the current European Pharmacopoeia.
Conclusion
This study found that drug sorption to packaging was compatible with clinical use and absence of drug alteration of Tektrotyd and Somakit-TOC after repackaging in a syringe in polypropylene and prolonged storage during 2 h.
the number of added links was 69, distributed in different categories:. Official websites of scientific institutions related to compounding pharmacy (eight). . Databases of compounding formulas and drugs (eight).. Books, journals and other documents (18).. Catalogues of paediatric formulae and other paediatric resources (10). . News, bulletins, blogs, Twitter list and forum related to pharmacy compounding (four). . Providers' websites (seven).. Consultation documents, medical calculators and other web resources ( 14).The webmix is currently used by 95 Symbaloo users. Conclusion Symbaloo is a dynamic tool that supplies access and organisation of the most useful web resources for the pharmacy-compounding area team, and can also act as a 'filter' for the excessive health information available on the Internet.By this method, the search and information query becomes more simple, reliable and potentially efficient in terms of time and clicks saving.
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