title: NanoCrySP technology for generation of drug nanocrystals: translational aspects and business potential.
abstract: Drug nanocrystals have rapidly evolved into a mature drug delivery strategy in the last decade, with almost 16 products currently on the market. Several "top-down" technologies are available in the market for generation of nanocrystals. Despite several advantages, very few bottom-up technologies have been explored for commercial purpose. This short communication highlights a novel, bottom-up, spray drying based technology-NanoCrySP-to generate drug nanocrystals. Nanocrystals are generated in the presence of non-polymeric excipients that act as crystallization inducer for the drug. Excipients encourage crystallization of drug by plasticization, primary heterogeneous nucleation, and imparting physical barrier to crystal growth. Nanocrystals have shown significant improvement in dissolution and thereby oral bioavailability. NanoCrySP technology is protected through patents in India, the USA, and the European Union. NanoCrySP can be utilized for (i) pharmaceutical development of new chemical entities, (ii) differentiated products of existing molecules, and (iii) generic drug products. The aggregation of drug nanocrystals generated using NanoCrySP poses significant challenges in the nanocrystal-based product development. Addition of stabilizers either during spray drying or during dissolution has shown beneficial effects.
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, Sector-67, Mohali, Punjab, 160 062, India.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Shete
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, Sector-67, Mohali, Punjab, 160 062, India. akbansal@niper.ac.in.
authors.forename: Arvind Kumar
authors.initials: AK
authors.lastname: Bansal
mesh_terms: D003132:Commerce; D003460:Crystallization; D004337:Drug Carriers / Q000737:chemistry* / Q000191:economics*; D016503:Drug Delivery Systems / Q000191:economics / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006801:Humans; D053758:Nanoparticles / Q000737:chemistry / Q000191:economics*; D013678:Technology, Pharmaceutical / Q000191:economics* / Q000379:methods*
chemical_list: D004337:Drug Carriers; D005079:Excipients
keywords: Bottom-up technology; Formulation development; NanoCrySP; Nanocrystals; Solid dispersion