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Stability of bortezomib reconstituted under clinical use conditions in original vials and polypropylene syringes at 4°C and room temperature
  1. Daniela Carati1,
  2. Carla Masini2,
  3. Martina Minguzzi2,
  4. Benedetta Petocchi3,
  5. Cristiana Romanazzi4,
  6. Cristina Rondoni5,
  7. Elisa Sangiorgi1,
  8. Stella Sferra4,
  9. Sara Simonetta6,
  10. Alessandra Stancari7,
  11. Federica Locchi7,
  12. Alessandra Zanardi8
  1. 1Servizio Politica del Farmaco-Assessorato alla Sanità della Regione Emilia Romagna, Bologna, Italy
  2. 2Farmacia Oncologica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola (FC), Italy
  3. 3Farmacia Oncologica, Azienda Ospedaliera Policlinico di Modena, Modena, Italy
  4. 4Farmacia Oncologica, Azienda Ospedaliero-Universitaria S.Anna di Ferrara, Ferrara, Italy
  5. 5Farmacia Oncologica, Azienda Unità Sanitaria Locale di Ravenna, Ravenna, Italy
  6. 6Farmacia Oncologica, Azienda Ospedaliera Santa Maria Nuova, Reggio Emilia, Italy
  7. 7Farmacia Oncologica, Azienda Ospedaliero-universitaria S Orsola Malpighi, Bologna, Italy
  8. 8Farmacia Oncologica, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
  1. Correspondence to Dr A Stancari, Azienda Ospedaliero-universitaria di Bologna Farmacia Clinica, via Massarenti 9, Bologna 40138, Italy; alessandra.stancari{at}aosp.bo.it

Abstract

Purpose Bortezomib (Velcade) is an antineoplastic drug widely used in the treatment of multiple myeloma. According to the manufacturer, once reconstituted, bortezomib is only stable for 8 h at 25 °C. The aim of this study was to evaluate the stability of reconstituted bortezomib stored in original vials and syringes at 4 °C and 28 °C, for up to 10 days.

Methods Samples were prepared by dissolving 3·5 mg of bortezomib powder in 3·5 ml of physiological saline (final concentration 1 mg/ml) under routine clinical conditions. Samples were stored in vials or syringes at 4 °C and 28 °C with photoprotection, and drug stability was analysed by high performance liquid chromatography.

Results Bortezomib was stable in both original vials and syringes for up to 10 days at 4 °C with photoprotection. Furthermore, it was stable for up to 8 days at 28 °C in original vials with photoprotection.

Conclusions Our results showed an extended stability of bortezomib prepared under routine clinical conditions and stored at 4 °C, which could make an important contribution towards reducing drug waste and, consequently, improving cost efficiency.

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