Evaluation of Super Refined™ Polysorbate 20 With Respect to Polysorbate Degradation, Particle Formation and Protein Stability.

Super Refined™ and Tween™ 20 HP polysorbate 20 (PS20) are two commercially available compendial grades of PS20 frequently used in biopharmaceutical formulations as protein stabilizing surfactants. PS20 degradation has been a major concern recently for potentially limiting drug product shelf life due to free fatty acid particle formation. This work is a side-by-side comparison of SR and HP PS20 in terms of PS20 degradation, particle formation and protein stability. The use of SR grade PS20 results in higher levels of oxidative PS20 degradation, protein oxidation, peroxides and protein aggregation, and therefore requires addition of methionine as an antioxidant to mitigate these issues. No clear root cause was identified as to why SR PS20 is more prone to oxidative degradation. This work also suggests that SR PS20 is less prone to particle formation than HP PS20 when there is preferential degradation of mono-esters of PS20, while more susceptible to particle formation when there is preferential degradation of higher order esters of PS20. Overall, this publication summarizes the potential risks and benefits of SR PS20 compared to HP PS20 to enable a formulator to make an informed decision when choosing between the two surfactant grades in their drug product formulations.

Prevalence of violence in childhood and adolescence and the impact on educational outcomes: evidence from the 2013 Peruvian national survey on social relations.

BACKGROUND: This study provides, for the first time, national population-based estimates describing violence during childhood and adolescence in Peru and the impact on educational outcomes. METHODS: A population-based school survey was conducted among children aged 9-11 (n=1587) and adolescents aged 12-17 (n=1489). The relationship between violence and educational outcomes were analysed using bivariate logistic regressions, controlling for potential confounding factors. RESULTS: The results show that psychological (78.1%) and physical violence (72.5%) at home were the most prevalent forms of violence experienced by adolescent girls. Adolescent boys reported experiencing similar levels of psychological violence from their peers (69.4%) and at home (68.1%). For the younger cohort, peer-to-peer psychological violence was reported more frequently among girls (70.6%) and boys (74.0%) than other forms of violence. Equal percentages of adolescent girls and boys reported experiencing sexual violence in their lifetime (44.3%). The relationship between violence experiences and educational outcomes varied by gender with strong associations between violence at home and failing a course or repeating a grade for girls and being expelled for boys. Sexual violence experienced by boys was associated with all negative educational outcomes. CONCLUSIONS: The relationship between violence in childhood and poorer educational outcomes is multi-faceted, potentially bi-directional, and manifests differently between genders. This research highlights the need for targeted research, policy and programming responses for prevention of violence.

Participation in Emergencies: Children's Perspective.

This article has as its objective the identification and analysis of child participation, from the point of view of the children, in the village of La Garita-Chincha, close to the epicenter of the 2007 earthquake. Ten children (six girls and four boys), aged between 8 and 12 years old, took part in the study. The results allow us to see the children as owners of capabilities to develop diagnostics about their rights, resources, and perceived needs. Furthermore, in their participation, they show their capacity to express opinions and take positions. Also, it was shown that children develop tasks to take care of the private sphere and make suggestions to solve their perceived needs. Finally, children also identified that there are limitations for the promotion of their participation.

Corneal endothelial safety after ultraviolet light treatment of the light-adjustable intraocular lens.

PURPOSE: To assess the safety to the corneal endothelium of ultraviolet (UV) light treatment to a light-adjustable intraocular lens (IOL). SETTING: Codet Vision Institute, Tijuana, Mexico. DESIGN: Cohort study. METHODS: The study evaluated consecutive patients scheduled for phacoemulsification cataract surgery with implantation of a light-adjustable IOL. Endothelial cell density (ECD), variation in the size of endothelial cells, and the percentage of hexagonal cells were determined centrally with a specular microscope preoperatively, 1 week postoperatively (before UV treatment), and 6 months postoperatively. Two adjustments and 2 lock-in procedures were performed with a light-delivery system between 2 weeks and 4 weeks postoperatively. RESULTS: The study enrolled 10 patients. Specular microscopy showed a mean ECD of 2344 cells/mm(2) preoperatively. The mean overall central ECD was 2047 cells/mm(2) 1 week postoperatively and 2130 cells/mm(2) at 6 months, representing an endothelial cell loss of 12.6% and 9.1%, respectively, from preoperative values. There was no statistically significant difference in the coefficient of variation or percentage of hexagonal cells at either postoperative evaluation. CONCLUSIONS: The endothelial cell loss at 6 months correlated well with previous reports of endothelial damage after phacoemulsification with IOL implantation. The light-adjustable IOL irradiation protocol for adjustment and lock-in procedures did not seem to add to the endothelial damage caused by the cataract surgery, indicating the protocol is safe to the corneal endothelium.

Early postoperative pain following Epi-LASIK and photorefractive keratectomy: a prospective, comparative, bilateral study.

PURPOSE: To compare postoperative pain associated with epi-LASIK versus photorefractive keratectomy (PRK). METHODS: This prospective observer-masked randomized study included 40 eyes of 20 patients with myopia and astigmatism who received epi-LASIK (Moria Epi-K) in one eye and PRK in the contralateral eye. Corneal ablation was done using the NIDEK EC-5000 excimer laser. Patients were seen at days 1, 3, and 6 to rate their pain via three measuring tools: 1) a global subjective rating, 2) a 10-cm visual analog scale, and 3) an 11-point numeric scale of pain. RESULTS: On postoperative day 1, 19 of 20 patients reported pain in both eyes. Using the global subjective rating scale, patients reported more pain for those eyes treated by PRK. Although clinically relevant, this difference was not statistically significant (P = .56). Based on the 11-point numeric scale of pain and visual analog scale, mean pain scores were similar for both groups. On day 3, using the global subjective rating scale, 11 of 12 patients who had pain reported more in the epi-LASIK treated eye (P = .0005). In addition, epi-LASIK eyes demonstrated higher mean pain scores based on the other two scales (visual analog scale, P = .045 and 11-point numeric scale of pain, P = .023). Only 6 patients reported minimal pain on day 6. It was more frequently reported and slightly more marked in epi-LASIK eyes, but did not reach statistical significance. CONCLUSIONS: Epi-LASIK and PRK have similar pain on postoperative day 1, but epi-LASIK demonstrated statistically more pain than PRK on days 3 and 6.