Chemical Stability of Plerixafor after Opening of Single-Use Vial
Bibliographic record
Abstract
ABSTRACT Background: The addition of the immunostimulant plerixafor to the current standard-of-care regimens of granulocyte colony-stimulating growth factor with or without chemotherapy has improved clinical results in terms of successful stem cell mobilization and the outcomes of stem cell transplant in various settings. With this medical innovation has come an added financial cost for institutions where stem cell transplants are routinely performed, and there may be a further financial burden when the contents of partial vials of the drug are wasted, given that plerixafor vials (Mozobil, Sanofi-Aventis Canada Inc) are currently deemed suitable only for single use. Objective: To determine whether the portion of plerixafor remaining in an opened vial of the Mozobil product after administration of a single dose is chemically stable, by comparison with the original product. Methods: Stability testing of partial drug contents of an opened vial, stored at room temperature or under refrigeration (4°C), was conducted using liquid chromatography–tandem mass spectrometry analysis. The mean concentration of plerixafor (μmol/L), standard deviation, coefficient of variation, and bias were determined on days 2, 3, 11, 17, 24, and 31. Method validation included determination of precision, sensitivity, recovery, dilution linearity, and carryover. Results: Throughout the 4-week testing period, measured plerixafor concentration in aliquots stored at room temperature and under refrigeration, tested in series over time, appeared similar. The mean residual drug concentration after initial opening was slightly, but not significantly, higher for the sample designated for storage at room temperature than the one designated for refrigerated storage (40.4 versus 39.9 μmol/L; p = 0.37). Conclusions: Residual plerixafor after initial opening of a vial of the Mozobil product remained chemically stable for at least 2 weeks both at room temperature and under refrigeration. The results of this study provide in vitro evidence to support multiple uses, instead of single use, of vials of this drug in an aseptic, controlled environment. RÉSUMÉ Contexte : L’ajout de l’immunostimulant plérixafor aux traitements reconnus comme la norme de soins actuelle quant au facteur de stimulation des colonies de granulocytes, accompagné ou non de chimiothérapie, a amélioré les résultats cliniques de mobilisation des cellules souches et les résultats de greffe de cellules souches dans différents contextes. Cela dit, avec cette innovation médicale vient un poids financier supplémentaire pour les établissements où l’on exécute couramment des greffes de cellules souches. En outre, comme les fioles de plérixafor (Mozobil, Sanofi-Aventis Canada Inc.) sont présentement jugées adéquates pour un usage unique seulement, l’excédent de médicament gaspillé peut représenter une dépense additionnelle. Objectif : Déterminer si ce qui reste de Mozobil dans une fiole ouverte après l’administration d’une dose unique est chimiquement stable comparativement au produit de départ. Méthodes : Une étude de stabilité du contenu partiel d’une fiole de médicament ouverte, entreposé à température ambiante ou conservé au réfrigérateur (4°C), a été réalisée par chromatographie en phase liquide couplée à la spectrométrie de masse en tandem. La concentration moyenne de plérixafor (μmol/L), l’écart-type, le coefficient de variation et le biais ont été établis aux jours 2, 3, 11, 17, 24 et 31. La méthode de validation comprenait la détermination de : la précision, la sensibilité, la récupération, la limite de linéarité et la contamination inter-échantillons. Résultats : Tout au long des quatre semaines d’analyse, les concentrations mesurées des aliquotes de plérixafor, entreposées à température ambiante ou conservées au réfrigérateur et analysées en séries chronologiques, semblaient similaires. Les concentrations moyennes de médicament restant après l’ouverture initiale étaient légèrement plus élevées lorsqu’entreposées à température ambiante (40,4 μmol/L) que lorsque réfrigérées (39,9 μmol/L) (p = 0,37), mais pas de façon significative. Conclusions : Le plérixafor résiduel, après l’ouverture initiale des fioles de Mozobil, demeurait chimiquement stable pendant au moins deux semaines, qu’il soit entreposé à température ambiante ou conservé au réfrigérateur. Les résultats de la présente étude offrent des données in vitro qui soutiennent une utilisation multiple, plutôt qu’un usage unique, des fioles de ce médicament en milieu aseptique contrôlé.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".