Fei Cai
Endo International PLC, USA
Title: Advanced technologies in oral delivery: Extrusion spheronization, multiple unit pellet system, sublingual microtablets
Biography
Biography: Fei Cai
Abstract
Taking one or two pills a day with a glass of water is the easiest and the most acceptable way of administration of a drug to a patient. Various controlled release, solubilization and intraoral delivery technologies have been developed to tailor the drug release profile to meet specific theuraputic needs. A brief overview of various oral and intraoral drug delivery technologies. Controlled release includes taste masking, delayed release, extended relase, multiphasic release, and pulsatile release. Solubilization includes surfactants, particle size reduction, lipid-based systems, and amorphous solid dispersions. Intraoral delivery includes buccal, sublingual, periodontal, lingual, and gingival. Examples of extrusion spheronization, Mutiple Unit Pellet System (MUPS), and sublingual microtablet are presented. Extrusion spheronization has been utilized to produce high drug load spherical substrate for further controlled release coating. Water content, salt level, and wet granules feed rate were found critical of the extrudability and sphere roundness and uniformity for Drug A. MUPS tablets (beads in tablet) offer the benefits of splitable dose and high production rate compared to beads in capsule. However, compaction of pellets is challenging, and beads tend to crack or fuse together and change dissolution profile. Approches of filler particle engineering, and a mixture design of a 3-filler system have been applied to Drug B and C. Sufentanil sublingual microtablet offers the advantage of reducing the amount of swallowed drug. The Zalviso Patient Controlled Analgesia (PCA) system using sufentanil microtablets has been desmontrated superior to current standard of care (IV PCA) in Phase 3 clincical trials.