METHODS: CMC/PLA/ZnO/CUR nanocomposite films were prepared by the dispersion of CMC and ZnO NPs in solubilized PLA/curcumin medium, followed by solvent casting step. Curcumin is poorly water-soluble and used as the model drug in this study. The films with different contents of CMC, PLA and ZnO NPs were characterized using FTIR, impedance spectroscopy, tensile testing and FESEM imaging. The in vitro drug release of the films was carried out in deionized water under DC electric field of 4.5 V.
RESULTS: The ionic conductivity of the films increased with increasing the CMC concentration of the film. The addition of a small amount of ZnO NPs (2%) successfully restored the tensile properties of the film. In response to the application of the electric field, the composite films released drug with a near-linear profile. There was no noticeable amount of passive diffusion of the drug from the film with the absence of the electric field.
CONCLUSION: The outcome of this study enabled the design of an electric-responsive nanocomposite platform for the delivery of poorly water-soluble/non-ionic drugs. Graphical abstract.
METHODS: The OpERA tool was used to collect specific milestone data that identify time periods, review stages, and data points for new active substances and biosimilars approved by NPRA in 2017.
RESULTS: In 2017, 25 new active substances and 1 biosimilar were approved by NPRA in a median of 515 days, representing both agency and applicant time. The median time between dossier receipt and the initiation of NPRA scientific assessment was 135 days, but there was a wide variation in queuing time. The median total assessment time was 279 days (agency and applicant timing). NPRA took a median of 166 days; applicants took a median of 131 days to respond to deficiency questions, with up to 6 cycles of review required for approval and 65% of applications requiring 4-5 cycles to provide satisfactory responses.
CONCLUSIONS: As a result of these data, NPRA proposes three improvements: target start for scientific assessment 100 days after file acceptance, a maximum of 5 review cycles, and applicant response time limited to 6 months. These results will serve as a baseline for further assessment.
METHODS: A parallel-group unblinded randomized controlled trial involving 300 patients was conducted in two hospital orthopedics clinics in Malaysia. Patients were randomly assigned to receive cognitive behavioral-based group therapy (n = 150) or no further intervention (n = 150). The primary outcome was the change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 months. The data collected were analyzed by covariate-adjusted mixed design repeated measures analysis of variance. All analyses were performed under the terms of intention-to-treat.
RESULTS: At 6 months, mean change from baseline in the KOOS knee pain score was 0.6 points (95% CI -1.73 to 2.94) in the control group and 8.9 points (95% CI 6.62 to 11.23) (denoting less knee pain intensity) in the intervention group (significant treatment effect p < 0.0001). Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
CONCLUSION: The intervention module delivered by healthcare professionals had a sustained effect on knee OA pain and functionality over 6 months, thereby leading to an overall improvement in psychological well-being, thus benefitting most of the Malaysian knee OA patients.