Stability of Bortezomib Reconstituted with 0.9% Sodium Chloride at 4°C and Room Temperature (23°C)
Bibliographic record
Abstract
ABSTRACT Background : The bortezomib product monograph indicates that after reconstitution, the drug may be stored for up to 3 h in a syringe, and the total storage time for the reconstituted material must not exceed 8 h when exposed to normal indoor lighting. Given the product packaging and vial size, as well as the currently recommended dosage regimen (which, for a clinic treating between 1 and 10 patients daily, entails using about half a vial each day), there is potential for substantial wastage, about $13,000 for a 5-cycle course of bortezomib therapy for a single patient. The aim of this study was to evaluate the stability of bortezomib (3.5-mg vials) reconstituted with 3.5 mL of 0.9% sodium chloride (NS) to produce a 1 mg/mL solution. Methods: On study day 0, six 3.5-mg vials of bortezomib were reconstituted with 3.5 mL NS per vial, to prepare solutions of 1.0 mg/mL. Three of the vials were stored in the refrigerator, and 3 were stored at room temperature. Concentration was measured and physical inspection was completed for each vial on study days 0, 1, 4, 8, 11, 15, 18, 21, 28, 34, and 42. The intervals between study days were consistent with the recommended dosage regimen, as published in the product monograph. Bortezomib concentrations were determined by a validated, stability-indicating, liquid chromatographic method. Results : All solutions remained clear and colourless. During the study period, all solutions retained more than 98% of the initial concentration, and the amount remaining on day 42 was greater than 98% (with 95% confidence). During the study period, the absolute deviation from the known concentration for standards and quality control samples averaged less than 4%, and analytical reproducibility within a day (by coefficient of variation) was high, with error on replicate analysis averaging less than 2%. Conclusions : Bortezomib, supplied in 3.5-mg vials and reconstituted with 3.5 mL NS, is physically and chemically stable for up to 42 days at 4°C or at room temperature. RESUME Historique : La monographie du bortezomib mentionne qu'apres reconstitution, le medicament peut etre conserve jusqu'a trois heures dans une seringue, mais que la duree totale de conservation du medicament reconstitue ne doit pas depasser huit heures si le produit est expose a un eclairage interieur normal. Vu le conditionnement du produit, le format des fioles et la posologie recommandee actuellement (qui, dans une clinique qui traite de 1 a 10 patients par jour, signifie l'emploi d'environ une demi-fiole par jour), le potentiel de gaspillage est considerable, et peut etre evalue a environ 13 000 dollars pour cinq cycles de traitement par le bortezomib pour un seul patient. L'objectif de cette etude etait d'evaluer la stabilite du bortezomib (en fioles de 3,5 mg) reconstitue avec 3,5 mL de chlorure de sodium a 0,9 % (NS) pour obtenir une concentration de 1 mg/mL. Methodes : Au jour 0, on a reconstitue six fioles de 3,5 mg de bortezomib avec 3,5 mL de NS par fiole, pour obtenir des solutions a 1.0 mg/mL. Trois des fioles ont ete entreposees au refrigerateur et les trois autres, a la temperature ambiante. La concentration a ete mesuree et une inspection physique a ete effectuee pour chaque fiole aux jours 0, 1, 4, 8, 11, 15, 18, 21, 28, 34 et 42 de l'etude. Les intervalles entre les jours de l'etude correspondaient a l'intervalle posologique recommande conformement a la monographie du produit. Les concentrations de bortezomib ont ete determinees au moyen d'une epreuve de stabilite par chromatographie liquide validee. Resultats : Toutes les solutions sont demeurees limpides et incolores. Pendant la periode de l'etude, toutes les solutions ont conserve plus de 98 % de leur concentration initiale, et il en etait de meme au jour 42 (intervalle de confiance a 95 %). Pendant la periode de l'etude, l'ecart absolu par rapport a la concentration connue des echantillons de reference et de controle de la qualite etait en moyenne inferieur a 4 %, et la reproductibilite analytique au cours d'une journee (selon le coefficient de variation) etait elevee, avec une erreur moyenne entre les mesures inferieure a 2 %. Conclusions : Les solutions obtenues a partir de la reconstitution du contenu d'une fiole de 3,5 mg de bortezomib avec 3,5 mL de NS sont physiquement et chimiquement stables pendant une periode allant jusqu'a 42 jours a une temperature de 4 °C ou a la temperature ambiante.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".