Stability of Methadone Hydrochloride for Injection in Saline Solution
Bibliographic record
Abstract
ABSTRACTBackground: Until October 2014, methadone hydrochloride forinjection (10 mg/mL) was available in Canada through Health Canada’s Special Access Programme. Diluted to 5 mg/mL in saline, it was used in pediatrics for acute and cancer-related pain. More recently, the department of pharmacy of the Centre hospitalier universitaire Sainte-Justine in Montréal, Quebec, proposed compounding a solution of methadone hydrochloride for injection (5 mg/mL) from bulk powder and saline solution for pediatric administration.Objective: To assess the stability of the proposed compounded preparation.Methods: Solutions of methadone hydrochloride in saline were prepared from bulk powder and stored in clear glass vials for up to 180 days at room temperature (25 °C) or with refrigeration (5 °C), with testing on days 0, 7, 14, 30, 60, 90, and 180. The appearance of the solutions and presence of particulate matter were assessed. A stability-indicating highperformance liquid chromatography (HPLC) method was developed to assay the concentration of methadone over time.Results: No notable changes in appearance of the methadone solution were observed, particle counts did not exceed limits specified by the United States Pharmacopeia, and no microbial growth was observed. The HPLC analysis showed that the concentration of methadone remained above 90% on all study days.Conclusions:Methadone hydrochloride for injection prepared from bulk powder in saline solution at a concentration of 5 mg/mL remained chemically stable for at least 180 days when stored in clear glass vials at 5 °C and at 25 °C.RÉSUMÉContexte : Jusqu’en octobre 2014, le chlorhydrate de méthadone pourinjection (10 mg/mL) était disponible au Canada à l’aide du Programme d’accès spécial de Santé Canada. Dilué à 5 mg/mL dans une solutionsaline, il était utilisé en pédiatrie contre les douleurs aigües et celles liées au cancer. Plus récemment, le département de pharmacie du Centre hospitalier universitaire Sainte-Justine de Montréal au Québec a proposé de préparer une solution de chlorhydrate de méthadone pour injection (5 mg/mL) à partir d’une poudre en vrac et d’une solution saline en vue de l’administrer en pédiatrie.Objectif : Évaluer la stabilité de la préparation proposée.Méthodes : Les préparations de chlorhydrate de méthadone diluées dans une solution saline se font à partir d’une poudre en vrac, elles sont stockées dans des fioles en verre transparent pendant180 jours à la température ambiante (25 °C) ou réfrigérées (5 °C) et sont soumises à des tests les jours 0, 7, 14, 30, 60, 90 et 180. L’apparence des solutions et la présence de substances particulaires ont fait l’objet d’une évaluation. Une méthode de chromatographie liquide à haute performance (CLHP) indiquant la stabilité a été développée pour tester la concentration de methadone dans le temps.Résultats : Aucun changement notable de l’apparence de la solution de méthadone n’a été observé, le nombre de particules ne dépassait pas les limites précisées par l’United States Pharmacopeia et aucune croissance microbienne n’a été observée. L’analyse CLHP a indiqué que la concentration de méthadone était demeurée au-delà de 90% durant toute la durée de l’étude.Conclusions : Le chlorhydrate de méthadone pour injection préparé à partir de poudre en vrac dans une solution saline à une concentration de5 mg/mL est resté chimiquement stable pendant au moins 180 jours lorsqu’il était stocké dans des fioles en verre transparent à 5 °C et à 25 °C
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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 | 0.001 | 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) | 0.002 | 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".