title: Pharmaceutical development and regulatory considerations for nanoparticles and nanoparticulate drug delivery systems.
abstract: Pharmaceutical nanomaterials (NMs) encompass a wide variety of materials including drug nanoparticles (NPs), which can be amorphous or crystalline; or nanoparticulate drug delivery systems, such as micelles, microemulsions, liposomes, drug-polymer conjugates, and antibody-drug conjugates. These NMs are either transient or persistent-depending on whether the integrity of their structure and size is maintained until reaching the site of drug action. Examples of several approved drug products are included as pharmaceutical nanoparticulate systems along with a commentary on the current development issues and paradigms for various categories of NPs. This commentary discusses the preparation of nanoparticulate systems for commercial development, and the biopharmaceutical and pharmacokinetic advantages of these systems. A criterion of criticality is defined that incorporates the structure, in addition to size requirement of pharmaceutical NPs to identify systems that may require special development and regulatory considerations.
authors.affiliation: Bristol-Myers Squibb, Company, New Brunswick, New Jersey, 08901.
authors.forename: Ajit S
authors.initials: AS
authors.lastname: Narang
authors.forename: Rong-Kun
authors.initials: RK
authors.lastname: Chang
authors.forename: Munir A
authors.initials: MA
authors.lastname: Hussain
mesh_terms: D017277:Drug Approval; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D016503:Drug Delivery Systems / Q000379:methods*; D004655:Emulsions / Q000737:chemistry; D006801:Humans; D008823:Micelles; D053758:Nanoparticles / Q000737:chemistry*; D036103:Nanotechnology / Q000379:methods; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry; D011108:Polymers / Q000737:chemistry*
chemical_list: D004337:Drug Carriers; D004655:Emulsions; D008823:Micelles; D004364:Pharmaceutical Preparations; D011108:Polymers
keywords: liposomes; micelle; microemulsion; nano milling; nanoparticles; nanotechnology; polymeric drug carrier; polymeric drug delivery systems; polymeric drugs