An integrative review to progress the responsible development of nano-drugs

Abstract

There has been extensive research on improving and innovating current treatments for irritable-bowel-syndrome using nanotechnology. However, there are growing challenges to progress these drugs to clinical trials and commercialisation. This study sought to develop a framework to manage key features, overlooked in current studies, to improve the development of drugs. An integrative literature review was used to extract themes by using a summative content analysis to interrogate information. Validity was established when saturation of information was achieved. Reliability focussed on the repeatability of key information. Absorption, distribution, metabolism, excretion and toxicity, quality by design attributes, metrology, and standardisation of practice emerged as important themes. These themes together among others, were used to develop the framework to manage the drug development process: Knowledge-based society, Foresight planning, Multidisciplinary approach, Unified definition, Adapt to existing standards and guidelines, Precautionary principle, Case-by-case approach, Quality-by-design, Scale-up and Training. The framework provided reflections that no study has considered. The framework will ensure that drug development will be approached strategically to avoid duplication of research-designs, including risk mitigation, quality at the source and supplier-chain management to progress drug development to clinical trials and beyond.</jats:p>