Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial
Bibliographic record
Abstract
The objective of this study was to examine the role of dimension and design of stoppers on the vapor transfer rate during the lyophilization process. Glass vials (100 cc, 28-mm neck diameter) containing mannitol solutions (4% w/w) were fitted with specially designed Teflon discs with circular holes (area ranging 0.12 to 41.80 mm2) instead of stopper vents, which served as the vent for water vapor transfer. The rate of vapor transfer across the vent, the temperature of the frozen product, and the vapor pressure inside the vial were monitored during the early primary drying phase. It was observed that the rate of vapor transfer from the vial increased as the cross-sectional area of the vent was increased. However, this increase tapered off as the area of the vent approached approximately 6 mm2 in the case when the shelf temperature was at 0 °C and 10 mm2 in the case when the shelf temperature was at 25 °C. Despite the higher accumulated pressure inside the vial and the corresponding higher temperatures of the frozen product, the rate of water vapor transfer across the vents was lower at the smaller vents, suggesting that the vapor transfer flow regime was under the choked conditions. Mathematical modeling using the observed water vapor pressure values inside the vial indicated that the flow pattern transitioned from the choked to non-choked pattern at a point where the ratio of pressure in the vial to pressure in the chamber, Pvial/Pchamber, was 2.5. In another set of drying experiments using stoppers with various vent configurations (1-leg, 2-leg, and 3-leg) in glass vials (100 cc, 20-mm neck diameter) containing 4% w/w mannitol solutions, there was no statistical difference in the rate of drying among the three stoppers. The temperature of the frozen product/vial pressure profiles was also similar. This is due to the fact that the vent areas in all the cases were above ∼20 mm2 and coincided with the plateau region where mass transfer was not the rate-limiting factor across the vent areas. Partial blockage of the vent areas, even up to 50%, did not affect the rate of drying in any of the stoppers, whereas blockage of the vent areas of >75% did decrease the sublimation rate by 25%. LAY ABSTRACT: The objective of this study was to investigate if the dimension and the design of stoppers may affect the moisture vapor transfer rate during the lyophilization process. The rate of vapor transfer across the vent, the temperature of the frozen product, and the vapor pressure inside the vial were monitored during the early primary drying phase in vials that were fitted with specially designed Teflon discs with circular holes (area ranging from 0.12 to 41.80 mm2) instead of stoppers. It was observed that although the rate of vapor transfer from the vial increased with the cross-sectional area of the vent, the increase tapered off as the area of the vent approached approximately 6 mm2 in the case when the shelf temperature was at 0 °C and 10 mm2 in the case when the shelf temperature was at 25 °C. Despite the higher accumulated pressure inside the vial and the corresponding higher temperatures of the frozen product, the rate of water vapor transfer across the vents was lower at the smaller vents, suggesting that the vapor transfer flow regime was under the choked conditions. Studies with various stopper configurations (1-leg, 2-leg, and 3-leg) and vent areas also showed that as long as the vent areas are greater than the critical mass transfer restriction threshold then there should not be any difference in the overall drying behavior and that substitution of stoppers within the range should yield similar drying cycles.
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".