title: Issues and concerns in nanotech product development and its commercialization.
abstract: The revolutionary and ubiquitous nature of nanotechnology has fetched it a considerable attention in the past few decades. Even though its enablement and application to various sectors including pharmaceutical drug development is increasing with the enormous government aided funding for nanotechnology-based products, however the parallel commercialization of these systems has not picked up a similar impetus. The technology however does address the unmet needs of pharmaceutical industry, including the reformulation of drugs to improve their solubility, bioavailability or toxicity profiles as observed from the wide array of high-quality research publications appearing in various scientific journals and magazines. Based on our decade-long experience in the field of nanotech-based drug delivery systems and extensive literature survey, we perceive that the major hiccups to the marketing of these nanotechnology products can be categorized as 1) inadequate regulatory framework; 2) lack of support and acceptance by the public, practicing physician, and industry; 3) developmental considerations like scalability, reproducibility, characterization, quality control, and suitable translation; 4) toxicological issues and safety profiles; 5) lack of available multidisciplinary platforms; and, 6) poor intellectual property protection. The present review dwells on these issues elaborating the trends followed by the industry, regulatory role of the USFDA and their implication, and the challenges set forth for a successful translation of these products from the lab and different clinical phases to the market.
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India. Electronic address: indupalkaur@yahoo.com.
authors.forename: Indu Pal
authors.initials: IP
authors.lastname: Kaur
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India.
authors.forename: Vandita
authors.initials: V
authors.lastname: Kakkar
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India.
authors.forename: Parneet Kaur
authors.initials: PK
authors.lastname: Deol
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India.
authors.forename: Monika
authors.initials: M
authors.lastname: Yadav
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India.
authors.forename: Mandeep
authors.initials: M
authors.lastname: Singh
authors.affiliation: Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, UGC Centre for Advanced Studies, Panjab University, Chandigarh 160014, India.
authors.forename: Ikksheta
authors.initials: I
authors.lastname: Sharma
mesh_terms: D016503:Drug Delivery Systems; D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000639:trends*; D005380:Financing, Government; D005381:Financing, Organized; D018973:Intellectual Property; D036103:Nanotechnology / Q000191:economics* / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000639:trends*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D012449:Safety; D018581:Technology Transfer
chemical_list: D004364:Pharmaceutical Preparations
keywords: Challenges; Marketed products; Nanoscale drug delivery systems; Pharmaceutical industry; USFDA