SOLUMER™ TECHNOLOGY: A VIABLE ORAL DOSAGE FORM OPTION FOR BCS CLASS II MOLECULES

In this article, Mark Mitchnick, MD, Chief Executive Officer, and Robert Lee, PhD, VicePresident, Pharmaceutical Development, both of Particle Sciences, and Amir Zalcenstein, PhD, Chief Executive Officer, SoluBest, introduce Particle Sciences’ formulaic DOSE™ system for dosage form development and drug delivery technology selection, and discuss one such technology, Solubest’s Solumer™, a scalable solid dispersion approach based on spray drying that is suitable for BCS Class II APIs and NCEs.

[1]  Lawrence X. Yu,et al.  The BCS, BDDCS, and Regulatory Guidances , 2011, Pharmaceutical Research.

[2]  K. Kohli,et al.  Self-emulsifying drug delivery systems: an approach to enhance oral bioavailability. , 2010, Drug discovery today.

[3]  I. Miroshnyk,et al.  Pharmaceutical co-crystals–an opportunity for drug product enhancement , 2009, Expert opinion on drug delivery.

[4]  Yogesh Kadam,et al.  Micelles from PEO-PPO-PEO block copolymers as nanocontainers for solubilization of a poorly water soluble drug hydrochlorothiazide. , 2011, Colloids and surfaces. B, Biointerfaces.

[5]  J. Kanwar,et al.  The use of cyclodextrins nanoparticles for oral delivery. , 2011, Current medicinal chemistry.

[6]  G. Van den Mooter,et al.  Review: physical chemistry of solid dispersions , 2009 .

[7]  M. A. Mirza,et al.  Oral lipid based drug delivery system (LBDDS): formulation, characterization and application: a review. , 2011, Current drug delivery.

[8]  Lawrence X. Yu,et al.  A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan. , 2006, Molecular pharmaceutics.

[9]  Vinod P. Shah,et al.  Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions , 2002, Pharmaceutical Research.

[10]  Jouni Hirvonen,et al.  Pharmaceutical nanocrystals by nanomilling: critical process parameters, particle fracturing and stabilization methods , 2010, The Journal of pharmacy and pharmacology.

[11]  Yasuhiro Tsume,et al.  The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation. , 2010, Molecular pharmaceutics.

[12]  D. Hauss Oral lipid-based formulations. , 2007, Advanced drug delivery reviews.