| Literature DB >> 24036012 |
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.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
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Year: 2013 PMID： 24036012 DOI： 10.1016/j.ijpharm.2013.08.079
Source DB: PubMed Journal: Int J Pharm ISSN： 0378-5173 Impact factor: 5.875