Effect of Freezing on Stability of a Fortified 5 mg/mL Ticarcillin Ophthalmic Solution
Bibliographic record
Abstract
ABSTRACT Background and Objective: Degradation of ticarcillin limits its shelf life under certain storage conditions. This study was undertaken to determine the stability of 5 mg/mL ticarcillin ophthalmic solution in 0.9% sodium chloride in frozen and unfrozen preparations. Methods: Ticarcillin ophthalmic solutions were prepared in 0.9% sodium chloride. One set of samples was frozen (–20°C) for 9 weeks, thawed at room temperature, and stored for 15 days at either 4°C or room temperature (25°C), with or without protection from light. Another set of samples was stored, without freezing, for 15 days at either 4°C or room temperature (25°C), with or without protection from light. Physical and chemical analysis of the samples included visual inspection, determination of pH and osmolarity, reverse-phase liquid chromatographic analysis of the ticarcillin concentration (with ultraviolet light detection at 240 nm), and analysis of microbial growth. The stored solutions were opened twice a day to reproduce conditions of use after dispensing. Results: Ticarcillin ophthalmic solutions (5 mg/mL) were physically stable during the study period, and there was no evidence of microbial growth. The samples that had not been previously frozen retained more than 90% of their initial ticarcillin concentration (with 95% confidence) for 7 days at 4°C and for 3 days at room temperature with or without protection from light. Samples that had been frozen for 9 weeks also retained more than 90% of their initial concentration (with 95% confidence) after thawing, for 6 days at 4°C and for 3 days at room temperature with or without protection from light. Conclusions: Ticarcillin ophthalmic solutions can be made up in advance and stored frozen, without affecting the expiry date. The thawed solutions should be used within 3 days if stored at room temperature or 6 days if stored at 4°C. Freezing allows chemical and microbiological testing to be completed before use, if necessary. RESUME Historique et objectif : La degradation de la ticarcilline limite la duree de conservation de celle-ci dans certaines conditions d’entreposage. Cette etude a ete menee pour determiner la stabilite de preparations gelees et non gelees de solutions ophtalmiques de ticarcilline disodique a 5 mg/mL dans du chlorure de sodium a 0,9 %. Methodes : Les solutions de ticarcilline disodique ont ete preparees dans du chlorure de sodium a 0,9 %. Une serie d’echantillons ont ete congeles (–20 °C) pendant 9 semaines, decongeles a la temperature ambiante, puis entreposes pendant 15 jours a 4 °C ou a la temperature ambiante (25 °C), a l’abri ou non de la lumiere. Une autre serie d’echantillons ont ete entreposes, sans etre congeles, pendant 15 jours a 4 °C ou a la temperature ambiante (25 °C), a l’abri ou non de la lumiere. L’analyse physique et chimique des echantillons a compris une inspection visuelle, une determination du pH et de l’osmolarite, une analyse de la concentration en ticarcilline disodique au moyen d’une epreuve par chromatographie liquide en phase inverse (avec detection ultraviolette a 240 nm) ainsi qu’une analyse de croissance microbienne. Les solutions ainsi entreposees ont ete ouvertes deux fois par jour afin de reproduire les conditions d’utilisation apres leur distribution. Resultats : Les solutions ophtalmiques de ticarcilline (5 mg/mL) sont demeurees physiquement stables durant la periode de l’etude, et on n’a observe aucun signe de contamination microbienne. Les echantillons qui n’avaient pas ete congeles ont conserve plus de 90 % de leur concentration initiale de ticarcilline (intervalle de confiance a 95 %) pendant 7 jours a 4 °C et pendant 3 jours a la temperature ambiante, a l’abri ou non de la lumiere. Les echantillons qui avaient ete congeles pendant 9 semaines ont conserve egalement plus de 90 % de leur concentration initiale (intervalle de confiance a 95 %) une fois decongeles, pendant 6 jours a 4 °C et pendant 3 jours a la temperature ambiante, a l’abri ou non de la lumiere. Conclusions : Les solutions ophtalmiques de ticarcilline peuvent etre preparees a l’avance et congelees, sans que cela n’affecte leur duree de conservation. Une fois decongelees, les solutions doivent etre utilisees dans les 3 jours si elles sont conservees a la temperature ambiante ou pendant 6 jours si elles sont conservees a 4 °C. La congelation permet de completer les epreuves chimiques et microbiologiques avant l’utilisation, au besoin.
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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".