caa a22 4500 445311991 CHVBK 20180317142633.0 cr unu---uuuuu 170323e20110901xx s 000 0 eng 10.1007/s11095-011-0465-y doi (NATIONALLICENCE)springer-10.1007/s11095-011-0465-y Design of Dry Nanosuspension with Highly Spontaneous Dispersible Characteristics to Develop Solubilized Formulation for Poorly Water-Soluble Drugs [Elektronische Daten] [Toshiyuki Niwa, Satoru Miura, Kazumi Danjo] ABSTRACT: Purpose: The powderization of the aqueous nanosuspension of a poorly water-soluble drug, which was prepared by wet-milling technique developed by authors, was investigated to apply to the development of solid dosage forms. Methods: Drug particles were suspended and milled in the aqueous medium using the oscillating beads-milling apparatus. The recovered nanosuspension was spray-dried 1) with no additive or 2) with co-dissolving mannitol as a nanoparticle carrier. As a control, the solution of the drug and additives with the same formulation as nanosuspension was also spray-dried. Results: SEM observation and X-ray powder diffraction analysis revealed that the dried products from suspension formed a spherical particle with single-micron diameter, which was composed of thousands of nano-sized crystalline drug fragment. It was also found that the dried products from suspension could be spontaneously redispersed in water, transforming into nanosuspension with the original size distribution. Such dried powder with high dispersibility was named "dry nanosuspension.” The dry nanosuspension had immediate release behaviors in gastrointestinal buffered media, whereas the dried product from solution showed the poor dispersion and dissolution properties even if same content of additives were loaded. Conclusions: The present technique with combination of wet nano-milling and spray-drying processes would be a novel approach to develop the pharmaceutical products with poorly water-soluble and oral-absorbable drugs. Springer Science+Business Media, LLC, 2011 dry nanosuspension nationallicence nano-milling nationallicence redispersion nationallicence solubilization nationallicence spray drying nationallicence Niwa Toshiyuki Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut Miura Satoru Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut Danjo Kazumi Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut Pharmaceutical Research Springer US; http://www.springer-ny.com 28/9(2011-09-01), 2339-2349 0724-8741 28:9<2339 2011 28 11095 https://doi.org/10.1007/s11095-011-0465-y text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11095-011-0465-y text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Niwa Toshiyuki Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut NATIONALLICENCE 700 1- Miura Satoru Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut NATIONALLICENCE 700 1- Danjo Kazumi Department of Industrial Pharmacy, Faculty of Pharmacy, Meijo University, 150 Yagotoyama, Tempaku, 468-8503, Nagoya, Japan aut NATIONALLICENCE 773 0- Pharmaceutical Research Springer US; http://www.springer-ny.com 28/9(2011-09-01), 2339-2349 0724-8741 28:9<2339 2011 28 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer