Advanced implantable drug delivery systems via continuous manufacturing process
journal contribution
posted on 2023-06-09, 03:44authored byMohammed Maniruzzaman, Ali Nokhodchi
Polymeric implantable drug delivery systems have been shown to exhibit remarkable potential for systemic delivery of various therapeutic agents. Generally, drug-loaded implants do not require a vehicle for delivery and can be used to attain prolonged delivery of active pharmaceutical ingredients (APIs) with enhanced drug bioavailability into the systemic circulation. Furthermore, implants can provide drug release ranging from months to years which improves patient compliance, especially for the poorly bioavailable and rapidly metabolized compounds. Recently continuous manufacturing technology e.g. hot-melt extrusion (HME) has been seen successfully employed to prepare drug-loaded polymeric implants. Such single unit HME based operations, employing heat and mechanical shear, have displayed a significant potential to retain the stability of thermo-labile therapeutics (e.g. proteins) in implants. HME has emerged as an important technique due to its varied applications that combine economic viability with that of its solvent-free and ease of scale-up processing. HME has now explicitly been established from a quality by design (QbD) viewpoint per the guidelines issued by the FDA. The foregoing subject areas are primarily discussed in this review article.
History
Publication status
Published
File Version
Accepted version
Journal
Critical Reviews in Therapeutic Drug Carrier Systems