Stability of Celecoxib Oral Suspension
Bibliographic record
Abstract
Background: Celecoxib is a selective cyclo-oxygenase 2 inhibitor that relieves pain without affecting platelet function, causing gastrointestinal toxic effects, or increasing the risk of bleeding.Objectives: To develop a suspension formulation for oral celecoxib and to determine its physical and chemical stability when packaged in amber polyvinyl chloride (PVC) bottles and stored with refrigeration (5°C) and at room temperature (23°C).Methods: The contents of celecoxib capsules were used to prepare a single suspension, with Ora-Blend used as the suspending and flavouring agent. The suspension (10 mg/mL) was then packaged in amber PVC bottles and stored at either 5°C or 23°C. Samples were collected on days 0, 7, 14, 21, 27, 56, and 93. Chemical stability was determined using a validated stability-indicating high-performance liquid chromatography method. At each sampling time, the suspensions were checked visually for changes in appearance (i.e., colour, layering, caking, and ease of resuspension), odour, and pH.Results: All of the suspensions were stable for at least 93 days, regardless of storage conditions. There were no apparent changes in physical appearance, nor were there any substantial changes in odour or pH.Conclusions: Suspensions of celecoxib (10 mg/mL in Ora-Blend) packaged in amber PVC bottles were stable for up to 93 days when stored at 5°C or 23°C. A 3-month expiry date has been established for this oral suspension on the basis of physical compatibility and chemical stability.RÉSUMÉ Contexte : Le célécoxib est un inhibiteur sélectif de la cyclo-oxygénase 2 qui soulage la douleur sans altérer la fonction plaquettaire ni causer d’effets gastro-intestinaux toxiques ou accroître le risque de saignement.Objectifs : Élaborer une suspension buvable de célécoxib et déterminer sa stabilité physique et chimique lorsqu’elle est conditionnée dans des flacons de polychlorure de vinyle (PVC) ambré et conservée au réfrigérateur (5 °C) et à la température ambiante (23 °C).Méthodes : Le contenu de capsules de célécoxib a été utilisé pour préparer une seule suspension avec l’agent de suspension et aromatisant, Ora-Blend. La suspension (10 mg/mL) a été conditionnée dans des flacons de PVC ambré puis conservée à 5 °C ou à 23 °C. Des échantillons ont été prélevés aux jours 0, 7, 14, 21, 27, 56 et 93. La stabilité chimique a été déterminée à l’aide d’une épreuve validée par chromatographie liquide haute performance. À chaque prélèvement d’échantillon, la suspension a été inspectée visuellement pour déceler tout changement d’apparence (c.-à-d., couleur, stratification, agglutination et facilité de remise en suspension), d’odeur et de pH.Résultats : Toutes les suspensions sont demeurées stables pendant au moins 93 jours, peu importe les conditions d’entreposage. On n’a observé aucun changement évident dans l’apparence des suspensions ni de changement substantiel dans l’odeur ou le pH des suspensions.Conclusions : Les suspensions de célécoxib (10 mg/mL dans de l’Ora-Blend) conditionnées dans des flacons de PVC ambré sont demeurées stables pendant une période allant jusqu’à 93 jours lorsqu’elles étaient entreposées à une température de 5 °C ou de 23 °C. On a établi une date de péremption de trois mois pour cette suspension buvable d’après la compatibilité physique et la stabilité chimique.
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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) | 0.003 | 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".