Suspensions for intravenous (IV) injection: a review of development, preclinical and clinical aspects.
There has been growing interest in nanoparticles as an approach to formulate poorly soluble drugs. Besides enhanced dissolution rates, and thereby, improved bioavailability, nanoparticles can also provide targeting capabilities when injected intravenously. The latter property has led to increased research and development activities for intravenous suspensions. The first intravenously administered nanoparticulate product, Abraxane (a reformulation of paclitaxel), was approved by the FDA in 2006. Additional clinical trials have been conducted or are ongoing for multiple other indications such as oncology, infective diseases, and restenosis. This article reviews various challenges associated with developing intravenous nanosuspension dosage forms. In addition, various formulation considerations specific to intravenous nanosuspensions as well as reported findings from various clinical studies have been discussed.
Wong
Joseph
J
Baxter Pharmaceuticals and Technologies, Global Research and Development, Baxter Healthcare Corporation, 25212 West Illinois Route 120, Round Lake, IL 60073-0490, USA. joe_wong@baxter.com
Brugger
Andrew
A
Khare
Atul
A
Chaubal
Mahesh
M
Papadopoulos
Pavlos
P
Rabinow
Barrett
B
Kipp
James
J
Ning
John
J
D000818:Animals; D001682:Biological Availability; D002986:Clinical Trials as Topic; D016503:Drug Delivery Systems; D004353:Drug Evaluation, Preclinical; D006801:Humans; D007275:Injections, Intravenous; D053758:Nanoparticles; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry; D012995:Solubility; D013535:Suspensions
D004364:Pharmaceutical Preparations; D013535:Suspensions