Assessment of Dissolution Profile of Marketed Aceclofenac Formulations

Statistical comparison of dissolution profiles under a variety of conditions relating to formulation characteristics, lot-to-lot, and brand-to-brand variation attracts interest of pharmaceutical scientist. The objective of this work is to apply several profile comparison approaches to the dissolution data of five-marketed aceclofenac tablet formulations. Model-independent approaches including ANOVA-based procedures, ratio test procedure, and pair wise procedure. The ratio test includes percentage, area under the curve, mean dissolution time, while the pair wise procedure includes difference factor (f1), similarity factor (f2), and Rescigno index. In the model-dependent approach, zero order, first order, Hixson-Crowell, Higuchi, and Weibull models were applied to the utilization of fit factors. All the approaches were applicable and useful. ANOVA with multiple comparison tests was found to be sensitive and discriminating for comparing the profiles. Weibull parameters were more sensitive to the difference between two release kinetic data in terms of curve shape and level

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere

The large grey area between ‘bona fide’ and ‘rogue’ stem cell interventions — ethical acceptability and the need to include local variability

This article aims to put into perspective the binary opposition between ‘scientific’ clinical research trials and ‘rogue’ experimental stem cell therapies, and to show why the ethics criteria used by the dominant science community are not suitable for distinguishing between adequate and inadequate treatments. By focusing on the grey area between clinical stem cell trials and stem cell experimentation, the experimental space where patients, medical professionals and life scientists negotiate for diverging reasons and aims, I show why idealised notions of ethics are not feasible for many stem cell scientists in low- and middle-income countries. Drawing on fieldwork in China from 2012 to 2013, the article asks why ‘the unethical’ according to some is acceptable to Chinese life scientists. The case study of stem cell service provider Beike Biotech illustrates how stem cell interventions take place in a large grey area, where narrow notions of ethics are blurred with and supplanted by broader notions of ethics, co-determined by estimations of socio-economic, political and cultural understandings of risk, opportunity and benefit. I borrow the term ‘bionetworking’, understood as the entrepreneurial aspects of scientific networks that engage in creating biomedical products, to analyse various forms of medical experimentation. I speak of the ‘externalisation’ and ‘internalisation’ of local factors to elucidate how features of patient populations and their environments are subsumed in clinical research applications. Compared to polarised views of stem cell therapy, this approach increases the transparency of clinical interventions and broadens our understanding of why ‘stem cell tourism’ to some is ‘stem cell therapy’ to others

Defining patient value in haemophilia care

Clinical epidemiolog

Thresholds of Toxicological Concern for Cosmetics-Related Substances: New Database, Thresholds, and Enrichment of Chemical Space

A new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-Adverse-Effect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 μg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 μg/kg-bw/day are broadly similar to those of the original Munro dataset

Comparing national home-keeping and the regulation of translational stem cell applications: an international perspective

A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the notion of ‘national home-keeping’, referring to the way governments articulate international standards and regulation with conflicting demands on local players at home. Identifying particular dimensions of regulatory tools – authority, permissions, space and acceleration – as crucial to national home-keeping in Asia, Europe and the USA, we show how local regulation works to enable development of the field, notwithstanding international (i.e. principally ‘western’) regulation. Triangulating regulation with empirical data and archival research between 2012 and 2015 has helped us to shed light on how countries and organisations adapt and resist internationally dominant regulation through the manipulation of regulatory tools (contingent upon country size, the state's ability to accumulate resources, healthcare demands, established traditions of scientific governance, and economic and scientific ambitions)