Stability of Nitrofurantoin in Extemporaneously Compounded Suspensions
Bibliographic record
Abstract
ABSTRACT Background: To evaluate the stability of nitrofurantoin suspensions in a vehicle consisting of equal parts of Ora-Sweet and Ora-Plus vehicles after storage at 4°C and 25°C for up to 91 days. Methods: Suspensions of nitrofurantoin 10 mg/mL in a 1:1 mixture of Ora-Sweet and Ora-Plus were prepared in 50-mL amber plastic prescription bottles. Three bottles of the suspension were stored at 4°C (refrigerated), and 3 were stored at 25°C (room temperature). Physical characteristics, including pH, odour, and taste, were evaluated, and visual testing of colour, viscosity, precipitation, and ease of resuspension was performed weekly up to 91 days. Samples were removed from each bottle weekly and stored at –85°C until analysis by a validated high-pressure liquid chromatography method. A suspension was considered stable if it maintained 90% or more of its initial concentration. Results: No notable changes in pH or colour were observed in the suspensions after storage at 4°C or 25°C for 91 days. Very slight changes in odour and taste were observed between days 14 and 21, but these characteristics then remained constant until the end of the study. Viscosity was constant. Precipitates were easily resuspended, and there was no caking or clumping of material. Suspensions of nitrofurantoin maintained at least 90% of initial concentration at both temperatures throughout the 91-day period. Conclusions: Nitrofurantoin suspensions of 10 mg/mL in a 1:1 mixture of Ora-Sweet and Ora-Plus were stable for a period of up to 91 days, with or without refrigeration. The expiry date for these products can thus be set at 91 days. RESUME Objectifs : Evaluer la stabilite de preparations de nitrofurantoine en suspension dans un excipient compose de parties egales d’Ora-Sweet® (edulcorant) et d’Ora-Plus® (agent de suspension) entreposees a 4°C et a 25°C pendant une periode allant jusqu’a 91 jours. Methodes : Des suspensions de nitrofurantoine de 10 mg/mL dans un melange 1:1 d’Ora-Sweet et d’Ora-Plus ont ete preparees dans des flacons pour medicaments d’ordonnance en plastique ambre de 50 mL. Trois flacons de preparations ont ete entreposes a 4°C (refrigeres), et trois autres a 25°C (temperature ambiante). Les proprietes physiques, notamment : pH, odeur, gout, couleur, viscosite, presence de precipite et facilite de remise en suspension, ont ete evaluees toutes les semaines sur une periode allant jusqu’a 91 jours. Des aliquotes ont ete retirees de chaque flacon toutes les semaines, puis conservees a –85°C jusqu’a ce qu'elles soient soumises a une analyse validee par chromatographie liquide a haute pression. Une preparation en suspension etait jugee stable lorsqu'elle avait conserve 90 % ou plus de sa concentration initiale. Resultats : Aucun changement notable du pH ou de la couleur des preparations n’a ete observe apres entreposage a 4 °C ou a 25 °C pendant une periode de 91 jours. Une tres legere modification de l’odeur et du gout est survenue entre les jours 14 et 21, mais ces proprietes sont ensuite demeurees stables jusqu’a la fin de l’etude. La viscosite n’a pas ete modifiee. Les precipites ont ete facilement remis en suspension et aucune agglutination ou agglomeration de materiel n’a ete notee. Les preparations de nitrofurantoine en suspension ont conserve au moins 90 % de leur concentration initiale aux deux temperatures pendant toute la periode de 91 jours. Conclusions : Les preparations de nitrofurantoine en suspension de 10 mg/mL dans un melange 1:1 d’Ora-Sweet et d’Ora-Plus ont ete jugees stables pendant une periode allant jusqu’a 91 jours, avec ou sans refrigeration. La duree de conservation de ces preparations peut donc etre etablie a 91 jours.
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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) | 0.001 | 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 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".