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Improvement in the water solubility of drugs with a solid dispersion system by spray drying and hot-melt extrusion with using the amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and d-mannitol.
Eur J Pharm Sci. 2018 Jan 01; 111:205-214.EJ

Abstract

The aim of this study was to prepare and characterize solid dispersion particles with a novel amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, as a water-soluble carrier. Solid dispersion particles were prepared by hot-melt extrusion and spray drying. Indomethacin (IMC) was used as a model comprising drugs with low solubility in water and d-mannitol (MAN) was used as an excipient. The physicochemical properties of prepared particles were characterized by scanning electron microscopy, thermal analysis, powder X-ray diffraction (PXRD) analysis, FTIR spectra analysis, and drug release studies. Stability studies were also conducted under stress conditions at 40°C, 75% relative humidity. We found that dissolution behavior of the original drug crystal could be improved by solid dispersion with the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The PXRD pattern and thermal analysis indicated that the solid dispersion prepared with the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and IMC was in an amorphous state. FTIR spectra analysis indicated that the interaction manner between the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and IMC may differ with the preparation method and formulation of solid dispersions. Stability studies proved that the amorphous state of IMC in solid dispersion particles was preserved under stress conditions for more than two weeks.

Authors+Show Affiliations

Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Mechanical Engineering, Faculty of Engineering, Aichi Institute of Technology, 1247 Yachigusa, Yakusa Cho, Toyota City, Aichi 470-0392, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan.Department of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, Aichi 464-8650, Japan. Electronic address: hitromitu@dpc.agu.ac.jp.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28893625

Citation

Ogawa, Noriko, et al. "Improvement in the Water Solubility of Drugs With a Solid Dispersion System By Spray Drying and Hot-melt Extrusion With Using the Amphiphilic Polyvinyl Caprolactam-polyvinyl Acetate-polyethylene Glycol Graft Copolymer and D-mannitol." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 111, 2018, pp. 205-214.
Ogawa N, Hiramatsu T, Suzuki R, et al. Improvement in the water solubility of drugs with a solid dispersion system by spray drying and hot-melt extrusion with using the amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and d-mannitol. Eur J Pharm Sci. 2018;111:205-214.
Ogawa, N., Hiramatsu, T., Suzuki, R., Okamoto, R., Shibagaki, K., Fujita, K., Takahashi, C., Kawashima, Y., & Yamamoto, H. (2018). Improvement in the water solubility of drugs with a solid dispersion system by spray drying and hot-melt extrusion with using the amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and d-mannitol. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 111, 205-214. https://doi.org/10.1016/j.ejps.2017.09.014
Ogawa N, et al. Improvement in the Water Solubility of Drugs With a Solid Dispersion System By Spray Drying and Hot-melt Extrusion With Using the Amphiphilic Polyvinyl Caprolactam-polyvinyl Acetate-polyethylene Glycol Graft Copolymer and D-mannitol. Eur J Pharm Sci. 2018 Jan 1;111:205-214. PubMed PMID: 28893625.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improvement in the water solubility of drugs with a solid dispersion system by spray drying and hot-melt extrusion with using the amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and d-mannitol. AU - Ogawa,Noriko, AU - Hiramatsu,Tomoki, AU - Suzuki,Ryohei, AU - Okamoto,Ryohei, AU - Shibagaki,Kohei, AU - Fujita,Kosuke, AU - Takahashi,Chisato, AU - Kawashima,Yoshiaki, AU - Yamamoto,Hiromitsu, Y1 - 2017/09/08/ PY - 2017/06/13/received PY - 2017/08/18/revised PY - 2017/09/07/accepted PY - 2017/9/13/pubmed PY - 2018/7/11/medline PY - 2017/9/13/entrez KW - Amorphous KW - Hot-melt extrusion technique KW - Powder technology KW - Solid dispersion KW - Spray drying SP - 205 EP - 214 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 111 N2 - The aim of this study was to prepare and characterize solid dispersion particles with a novel amphiphilic polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, as a water-soluble carrier. Solid dispersion particles were prepared by hot-melt extrusion and spray drying. Indomethacin (IMC) was used as a model comprising drugs with low solubility in water and d-mannitol (MAN) was used as an excipient. The physicochemical properties of prepared particles were characterized by scanning electron microscopy, thermal analysis, powder X-ray diffraction (PXRD) analysis, FTIR spectra analysis, and drug release studies. Stability studies were also conducted under stress conditions at 40°C, 75% relative humidity. We found that dissolution behavior of the original drug crystal could be improved by solid dispersion with the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The PXRD pattern and thermal analysis indicated that the solid dispersion prepared with the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and IMC was in an amorphous state. FTIR spectra analysis indicated that the interaction manner between the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer and IMC may differ with the preparation method and formulation of solid dispersions. Stability studies proved that the amorphous state of IMC in solid dispersion particles was preserved under stress conditions for more than two weeks. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/28893625/Improvement_in_the_water_solubility_of_drugs_with_a_solid_dispersion_system_by_spray_drying_and_hot_melt_extrusion_with_using_the_amphiphilic_polyvinyl_caprolactam_polyvinyl_acetate_polyethylene_glycol_graft_copolymer_and_d_mannitol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0928-0987(17)30506-7 DB - PRIME DP - Unbound Medicine ER -