title: Nanocarriers for intravenous injection--the long hard road to the market.
abstract: Nanodispersed drug delivery systems for the intravenous injection have successfully overcome the hurdle of drug approval in the European Union and the United States. Although there is a need for highly advanced nanocarrier devices they have not been the result of a rational formulation design but were developed as stand-alone products in a long chain of case-by-case studies. This review focuses on aspects in development, composition, and manufacture of these innovative dosage forms that are relevant for the translation into new drug products.
authors.affiliation: Institute of Pharmaceutical Technology, Goethe University, Max-von-Laue-Str. 9, D-60438 Frankfurt am Main, Germany. Electronic address: info@nanomedicines.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Wacker
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical; D004337:Drug Carriers / Q000737:chemistry / Q000633:toxicity; D006801:Humans; D007275:Injections, Intravenous; D049329:Nanostructures / Q000737:chemistry / Q000633:toxicity
chemical_list: D004337:Drug Carriers
keywords: API; CARPA; Commercialization; DLS; Drug delivery; EMA; EPR; EU; European Medicines Agency; European Union; FDA; Food and Drug Administration; GMP; Good Manufacturing Practice; HPH; HSA; Industry; LD; LUV; MLV; Market; NDA; Nanoparticles; PACA; PEG; PLA; PLGA; PRINT; PTT; Particle Replication In Non-wetting Templates; RES; SPARC; SUV; Secreted Protein Acid and Rich in Cysteine; TIF; US; USIOP; Ultrasmall Superparamagnetic Particles of Iron Oxide; United States; active pharmaceutical ingredient; complement activation-related pseudoallergy; dynamic light scattering; enhanced permeation and retention; glycoprotein 60; gp60; high pressure homogenisation; human serum albumin; large unilamellar vesicles; laser diffraction; multi lamellar vesicles; new drug application; phase transition temperature; poly ethylene glycol; poly-alkyl-cyano acrylates; poly-lactic acid; poly-lactic-co-glycolic acid; reticulo-endothelial system; small unilamellar vesicles; tumour interstitial fluid