Bibliographic record
Abstract
ABSTRACT Background: 4-Aminopyridine (4-AP) is a known potassium channel blocker that has been used to treat multiple sclerosis and spinal cord injury. 4-AP capsules must be prepared extemporaneously. Objective: To determine the chemical stability of 4-AP capsules containing 10 mg of active ingredient. Methods: Ten-milligram capsules were prepared from 4-AP obtained from 2 suppliers, with either lactose or microcrystalline cellulose as diluent. The hard gelatin capsules were stored in amber snap-top prescription vials at room temperature (20°C to 25°C) with protection from light. Two capsules were collected from each group on days 0, 14, 28, 62, 96, 125, 180, and 365 and stored in a rubber-stoppered glass test tube containing desiccant material at –70°C. On the day of analysis, solutions were prepared from the contents of the capsules, which had been accurately weighed and appropriately diluted; the solutions were assayed, in duplicate, by means of a stability-indicating high-pressure liquid chromatography assay. Results: Ten-milligram capsules of 4-AP, prepared from material obtained from each supplier and diluted with either lactose or microcrystalline cellulose, retained at least 94% of the initial content for 365 days when stored in plastic prescription vials at room temperature with protection from light. Conclusions: Extemporaneously prepared 10-mg capsules of 4-AP were considered stable for 365 days when stored in plastic prescription vials at room temperature with protection from light. RESUME Historique : La 4-aminopyridine (4-AP) est un inhibiteur des canaux potassiques connu, qui a ete utilise dans le traitement de la sclerose en plaques et des lesions medullaires. Les capsules de 4-AP doivent etre preparees extemporanement. Objectif : On a mene une etude pour determiner la stabilite chimique des capsules de 4-AP renfermant 10 mg de principe actif. Methodes : On a prepare des capsules de 10 mg avec de la 4-AP provenant de deux fournisseurs, et du lactose ou de la cellulose microcristalline comme excipient. Les capsules de gelatine dure ont ete conservees a la temperature de la piece (entre 20 et 25 oC) et protegees de la lumiere dans des flacons d’ordonnance de couleur ambre a bouchon pression. On a recueilli deux capsules de chaque groupe aux jours 0, 14, 28, 62, 96, 125, 180 et 365, qu’on a entreposees a -70 oC dans des eprouvettes de verre munies d’un bouchon de caoutchouc et contenant un dessicatif. Le jour de l’analyse, on a prepare des solutions a partir du contenu des capsules, qu’on a pese avec precision et dilue de facon appropriee; on les a ensuite soumises a un double dosage au moyen d’une epreuve de stabilite par chromatographie liquide a haute pression. Resultats : Les capsules de 10 mg de 4-AP, preparees a partir du produit de chaque fournisseur dilue avec du lactose ou de la cellulose microcristalline, ont conserve au moins 94 % de leur contenu initial pendant 365 jours, lorsqu’elles etaient conservees dans des flacons d’ordonnance de plastique a la temperature de la piece et a l’abri de la lumiere. Conclusions : Les capsules de 10 mg de 4-AP preparees extemporanement et conservees dans des flacons d’ordonnance de plastique a la temperature de la piece et a l’abri de la lumiere ont ete jugees stables pendant une periode de 365 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) | 0.002 | 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".