Regulatory and risk assessment perspective for core-multishell nanocarriers: A novel excipient on its way towards marketing authorization

Abstract Core-multishell (CMS) nanocarriers (DendroSol) are innovative biocompatible excipients, which can be used to improve the dermal penetration of medicinal drug substances. The basis of CMS nanocarriers is a hyperbranched polyglycerol core surrounded by an amphiphilic shell. By varying chain lengths and charge density, the excipients can be adapted to different drug substances. As excipients within drugs, CMS nanocarriers are required to fulfill regulatory requirements, including 2015/C 95/02—an EU guideline on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. The risk assessment also considers the quality management system, as well as the source and intended use of the excipients. Specifically, CMS nanocarriers are well suited as excipients following a careful risk assessment.