IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

Purpose When establishing IVIVC, a special problem arises by interpretation of averagedin vivoprofiles insight of considerable individual variations in term of time and number of mechanical stress events in GI-tract. The objective of the study was to investigate and forecast the effect of mechanical stress onin vivobehavior in human of hydrophilic matrix tablets. Methods Dissolution profiles for the marketed products were obtained at different conditions (stirring speed, single- or repeatable mechanical stress applied) and convoluted into C-t profiles. Vice versa, publishedin vivoC-t profiles of the products were deconvoluted into absorption profiles and compared with dissolution profiles by similarity factor. Results Investigated hydrophilic matrix tablets varied in term of their resistance against hydrodynamic stress or single stress during the dissolution. Different scenarios, including repeatable mechanical stress, were investigated on mostly prone Seroquel (R) XR 50 mg. None of the particular scenarios fits to the publishedin vivoC-t profile of Seroquel (R) XR 50 mg representing, however, the average of individual profiles related to scenarios differing by number, frequency and time of contraction stress. When different scenarios were combined in different proportions, the profiles became closer to the originalin vivoprofile including a burst between 4 and 5 h, probably, due to stress-events in GI-tract. Conclusion For establishing IVIVC of oral dosage forms susceptible mechanical stress, a comparison of the deconvoluted individualin vivoprofiles within vitroprofiles of different dissolution scenarios can be recommended

Metal nanoparticle‐hydrogel nanocomposites for biomedical applications – An atmospheric pressure plasma synthesis approach

The development of multifunctional nanocomposite materials is of great interest for various biomedical applications. A popular approach to produce tailored nanocomposites is to incorporate functional nanoparticles into hydrogels. Here, a benign atmospheric pressure microplasma synthesis approach has been deployed for the synthesis of metal and alloy NPs in‐situ in a poly (vinyl alcohol) hydrogel. The formation of gold, silver, and gold‐silver alloy NPs was confirmed via spectroscopic and microscopic characterization techniques. The properties of the hydrogel were not compromised during formation of the composites. Practical applications of the NP/PVA nanocomposites has been demonstrated by anti‐bacterial testing. This establishes AMP processing as a viable one‐step technique for the fabrication of NP/hydrogel composites, with potential multifunctionality for a range of biomedical applications

Giant planet formation in radially structured protoplanetary discs

This article has been accepted for publication in MNRAS ©: 2016: The authors. Published by Oxford University Press on behalf of the Royal Astronomical Society. All rights reserved.We acknowledge the comments received from an anonymous referee, which helped to improve the quality of this paper. GALC acknowledges the support of an STFC PhD studentship. This research utilised Queen Mary’s MidPlus computational facilities, supported by QMUL Research-IT and funded by EPSRC grant EP/K000128/

The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region

A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required