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Fulltext Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Sani NM, McAuslane N, Kasbon SH, Ahmad R, Yusof FAM, Patel P

Ther Innov Regul Sci, 2020 Sep;54(5):1225-1226.
PMID: 32865806 DOI: 10.1007/s43441-020-00150-2

The authors have revised Figure 1. The revised figure is presented below.
Fulltext Processing and Characterisation of Banana Leaf Fibre Reinforced Thermoplastic Cassava Starch Composites

Jumaidin R, Diah NA, Ilyas RA, Alamjuri RH, Yusof FAM

Polymers (Basel), 2021 Apr 28;13(9).
PMID: 33924842 DOI: 10.3390/polym13091420

Increasing environmental concerns have led to greater attention to the development of biodegradable materials. The aim of this paper is to investigate the effect of banana leaf fibre (BLF) on the thermal and mechanical properties of thermoplastic cassava starch (TPCS). The biocomposites were prepared by incorporating 10 to 50 wt.% BLF into the TPCS matrix. The samples were characterised for their thermal and mechanical properties. The results showed that there were significant increments in the tensile and flexural properties of the materials, with the highest strength and modulus values obtained at 40 wt.% BLF content. Thermogravimetric analysis showed that the addition of BLF had increased the thermal stability of the material, indicated by higher-onset decomposition temperature and ash content. Morphological studies through scanning electron microscopy (SEM) exhibited a homogenous distribution of fibres and matrix with good adhesion, which is crucial in improving the mechanical properties of biocomposites. This was also attributed to the strong interaction of intermolecular hydrogen bonds between TPCS and fibre, proven by the FT-IR test that observed the presence of O-H bonding in the biocomposite.
Effect of palm wax on the mechanical, thermal, and moisture absorption properties of thermoplastic cassava starch composites

Hafila KZ, Jumaidin R, Ilyas RA, Selamat MZ, Yusof FAM

Int J Biol Macromol, 2022 Jan 01;194:851-860.
PMID: 34838853 DOI: 10.1016/j.ijbiomac.2021.11.139

Thermoplastic starch is a potentially sustainable and biodegradable material. However, it possesses some limitations in terms of mechanical performance and high moisture sensitivity. In this current work, the characteristics of thermoplastic cassava starch (TPCS) containing palm wax at various loading were evaluated. TPCS was prepared via hot pressing by varying the ratios of palm wax (2.5, 5, 10, and 15 wt%). Next, characterization via scanning electron microscopy (SEM), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FT-IR), mechanical, water solubility, thickness swelling and moisture absorption tests, were conducted on the samples. The findings showed that incorporating starch-based thermoplastics with palm wax has remarkably improved mechanical characteristics of the thermoplastic blends. Besides, the morphology of the samples demonstrated irregular and rougher cleavage fracture after palm wax addition. FT-IR indicated the existence of intermolecular interaction between TPCS and palm wax with the intermolecular hydrogen bonds that existed between them. The thermal stability of TPCS has improved with rising palm wax content. The incorporation of 15 wt% palm wax resulted in the lowest moisture absorption value among the samples. Overall, the developed TPCS/palm wax with improved mechanical and moisture resistance characteristics has the potential to be used as biodegradable materials.
Fulltext An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Sani NM, McAuslane N, Kasbon SH, Ahmad R, Yusof FAM, Patel P

Ther Innov Regul Sci, 2020 Sep;54(5):1215-1224.
PMID: 32865804 DOI: 10.1007/s43441-020-00140-4

INTRODUCTION: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements.
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.
Fulltext Homalomena pineodora essential oil nanoparticle inhibits diabetic wound pathogens

Rozman NAS, Tong WY, Leong CR, Anuar MR, Karim S, Ong SK, et al.

Sci Rep, 2020 02 24;10(1):3307.
PMID: 32094395 DOI: 10.1038/s41598-020-60364-0

Essential oil of Homalomena pineodora inhibits diabetic pathogens; however, the activity was not sustainable when applied as wound dressing. This study aims to synthesise the essential oil nanoparticle using chitosan. The nanoparticles were synthesised with ion gelation method, confirmed by spectroscopic analysis. The spherical nanoparticles display a size of 70 nm, with strong surface charge of +24.10 mV. The nanoparticles showed an initial burst release followed by a slow release pattern for 72 h, following the first order of kinetic. The release behaviour was ideal for wound dressing. The antimicrobial activity was broad spectrum. The formation of nanoparticle enhanced the antimicrobial efficacy of the essential oil. The nanoparticle also showed a concentration-dependent killing behaviour on time-kill assay. In the 3D collagen wound models, the nanoparticles reduced the microbial growth by 60-80%. In conclusion, H. pineodora nanoparticles showed pharmaceutical potential in inhibiting microbial growth on diabetic ulcers.