Background: Data regarding Y-site compatibility of intravenous (IV) cloxacillin sodium with other drugs are scarce and incomplete. Objective: To establish the compatibility of IV cloxacillin with 89 injectable drugs during simulated Y-site administration. Methods: Cloxacillin sodium (10 mL, 100 mg/mL) was combined with 89 undiluted IV drugs (10 mL, each). Tests were duplicated and performed at room temperature. Visual evaluation and a light obscuration particle count test were performed on 1 of the 2 solutions immediately after mixing. The second mixture underwent visual evaluation after 15 minutes, 1 hour, and 4 hours, followed by a particle count test at 4 hours. Drugs were considered incompatible if the mixture precipitated or became turbid within the 4-hour period or exceeded the particle count limit allowed by Test 1.B of USP <788> initially or at 4 hours.Results: Of the 89 tested drugs, 64 were compatible for up to 4 hours. The remaining 25 drugs were incompatible. Of these incompatible drugs, 16 were identified visually, and 9 were identified by the light obscuration particle count test. Conclusions: Sixty-four IV drugs were found to be compatible with cloxacillin via simulated Y-site, whereas 25 drugs were found to be incompatible with the antibiotic. The light obscuration particle count test should be used to complement visual evaluation when samples do not precipitate immediately.

Objective: To test the compatibility of intravenous (IV) lactated Ringer’s injection (LR) with 94 injectable (IV) drugs during simulated Y-site administration. Methods: Ninety-four IV drugs were investigated for compatibility with LR (Baxter). Each sample was prepared in duplicate and performed at room temperature. Two observers performed visual evaluation independently immediately upon mixing and then 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after admixture. Another observer performed a particle counting test on 1 of the 2 duplicates of each admixture that did not immediately show incompatibility and then after 4 hours by a light obscuration particle count test. Results: Of the 94 tested drugs, 86 were found to be compatible with LR. A total of 8 drugs were found to be physically incompatible. Of these incompatible drugs, 7 were directly identified visually and 1 was confirmed by the light obscuration particle count test. Conclusion: Lactated Ringer’s injection was physically compatible for 4 hours with 86 tested drugs during simulated Y-site administration. Eight drugs, ciprofloxacin, cyclosporine, diazepam, ketamine, lorazepam, nitroglycerin, phenytoin, and propofol, were found to be incompatible and should not be administered with LR.

Background: 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

An extemporaneous formulation consisting of lansoprazole microgranules in Ora-Blend maintained acceptable quality attributes when stored for three days at 4.5-5.5 °C.

Samples of i.v. cyclosporine solutions of 0.2 and 2.5 mg/mL diluted in 0.9% sodium chloride injection or 5% dextrose injection and stored at 25 °C in polypropylene-polyolefin bags were physically and chemically stable for at least 14 days. When stored in polypropylene syringes, the samples were contaminated by an impurity within 1 day; however, the short-term (i.e., ≤10 minutes) use of the syringes for the preparation and transfer of i.v. cyclosporine solution is considered safe.