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Preparation of solid dispersion of dronedarone hydrochloride with Soluplus(®) by hot melt extrusion technique for enhanced drug release.
Chem Pharm Bull (Tokyo). 2015; 63(4):295-9.CP

Abstract

In order to enhance the dissolution rate of dronedarone hydrochloride (DRN), a novel Soluplus(®) (polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer)-based solid dispersion (SD) was formulated using a hot melt extrusion technique. The physical characteristics determined using scanning electron microscopy and X-ray powder diffraction, revealed that the active compound was molecularly dispersed in the amphiphilic polymer in a stable amorphous form. The dissolution rate of DRN from the tablet dosage form of SD extrudate consisted of the drug and Soluplus(®) in a weight ratio of 1 : 1, and was obviously more rapid and higher than that of the intact drug and marketed product (Multaq(®), Sanofi, U.S.A.) at pH 1.2, 4.0 and 6.8. This suggests that Soluplus(®)-based SD formula can be a promising approach for enhancing the dissolution and oral absorption of DRN with a simple preparation process.

Authors+Show Affiliations

Dong-A Pharmaceutical Co., Ltd.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25832024

Citation

Han, Sang Duk, et al. "Preparation of Solid Dispersion of Dronedarone Hydrochloride With Soluplus(®) By Hot Melt Extrusion Technique for Enhanced Drug Release." Chemical & Pharmaceutical Bulletin, vol. 63, no. 4, 2015, pp. 295-9.
Han SD, Jung SW, Jang SW, et al. Preparation of solid dispersion of dronedarone hydrochloride with Soluplus(®) by hot melt extrusion technique for enhanced drug release. Chem Pharm Bull (Tokyo). 2015;63(4):295-9.
Han, S. D., Jung, S. W., Jang, S. W., Jung, H. J., Son, M., Kim, B. M., & Kang, M. J. (2015). Preparation of solid dispersion of dronedarone hydrochloride with Soluplus(®) by hot melt extrusion technique for enhanced drug release. Chemical & Pharmaceutical Bulletin, 63(4), 295-9. https://doi.org/10.1248/cpb.c14-00725
Han SD, et al. Preparation of Solid Dispersion of Dronedarone Hydrochloride With Soluplus(®) By Hot Melt Extrusion Technique for Enhanced Drug Release. Chem Pharm Bull (Tokyo). 2015;63(4):295-9. PubMed PMID: 25832024.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preparation of solid dispersion of dronedarone hydrochloride with Soluplus(®) by hot melt extrusion technique for enhanced drug release. AU - Han,Sang Duk, AU - Jung,Sang Won, AU - Jang,Sun Woo, AU - Jung,Hyuck Jun, AU - Son,Miwon, AU - Kim,Byoung Moon, AU - Kang,Myung Joo, PY - 2015/4/3/entrez PY - 2015/4/4/pubmed PY - 2015/12/17/medline SP - 295 EP - 9 JF - Chemical & pharmaceutical bulletin JO - Chem Pharm Bull (Tokyo) VL - 63 IS - 4 N2 - In order to enhance the dissolution rate of dronedarone hydrochloride (DRN), a novel Soluplus(®) (polyethyleneglycol-polyvinyl caprolactam-polyvinyl acetate grafted copolymer)-based solid dispersion (SD) was formulated using a hot melt extrusion technique. The physical characteristics determined using scanning electron microscopy and X-ray powder diffraction, revealed that the active compound was molecularly dispersed in the amphiphilic polymer in a stable amorphous form. The dissolution rate of DRN from the tablet dosage form of SD extrudate consisted of the drug and Soluplus(®) in a weight ratio of 1 : 1, and was obviously more rapid and higher than that of the intact drug and marketed product (Multaq(®), Sanofi, U.S.A.) at pH 1.2, 4.0 and 6.8. This suggests that Soluplus(®)-based SD formula can be a promising approach for enhancing the dissolution and oral absorption of DRN with a simple preparation process. SN - 1347-5223 UR - https://www.unboundmedicine.com/medline/citation/25832024/Preparation_of_solid_dispersion_of_dronedarone_hydrochloride_with_Soluplus_®__by_hot_melt_extrusion_technique_for_enhanced_drug_release_ L2 - https://doi.org/10.1248/cpb.c14-00725 DB - PRIME DP - Unbound Medicine ER -