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Formulation and delivery of improved amorphous fenofibrate solid dispersions prepared by thin film freezing.
Eur J Pharm Biopharm. 2012 Nov; 82(3):534-44.EJ

Abstract

The objective of this study was to prepare amorphous fenofibrate (FB) solid dispersions using thin film freezing (TFF) and to incorporate the solid dispersions into pharmaceutically acceptable dosage forms. FB solid dispersions prepared with optimized drug/polymer ratios were characterized by modulated differential scanning calorimetry (MDSC), powder X-ray diffraction (XRD), scanning electron microscopy (SEM), Brunauer-Emmett-Teller (BET) specific surface area measurements, Fourier-transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR), and supersaturation dissolution testing. Furthermore, a dry granulation technique was used to encapsulate the TFF compositions for in vitro dissolution and in vivo animal pharmacokinetic studies. The results showed that the TFF process produced amorphous, porous, microstructured, and stable solid dispersions with high surface areas. Development of solid oral dosage forms revealed that the performance of the FB containing solid dispersions was not affected by the formulation process, which was confirmed by DSC and XRD. Moreover, an in vivo pharmacokinetic study in rats revealed a significant increase in FB absorption compared to bulk FB. We confirmed that amorphous solid dispersions with large surface areas produced by the TFF process displayed superior dissolution rates and corresponding enhanced bioavailability of the poorly water-soluble drug, FB.

Authors+Show Affiliations

School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, PR China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22974985

Citation

Zhang, Meimei, et al. "Formulation and Delivery of Improved Amorphous Fenofibrate Solid Dispersions Prepared By Thin Film Freezing." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 82, no. 3, 2012, pp. 534-44.
Zhang M, Li H, Lang B, et al. Formulation and delivery of improved amorphous fenofibrate solid dispersions prepared by thin film freezing. Eur J Pharm Biopharm. 2012;82(3):534-44.
Zhang, M., Li, H., Lang, B., O'Donnell, K., Zhang, H., Wang, Z., Dong, Y., Wu, C., & Williams, R. O. (2012). Formulation and delivery of improved amorphous fenofibrate solid dispersions prepared by thin film freezing. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 82(3), 534-44. https://doi.org/10.1016/j.ejpb.2012.06.016
Zhang M, et al. Formulation and Delivery of Improved Amorphous Fenofibrate Solid Dispersions Prepared By Thin Film Freezing. Eur J Pharm Biopharm. 2012;82(3):534-44. PubMed PMID: 22974985.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation and delivery of improved amorphous fenofibrate solid dispersions prepared by thin film freezing. AU - Zhang,Meimei, AU - Li,Houli, AU - Lang,Bo, AU - O'Donnell,Kevin, AU - Zhang,Haohao, AU - Wang,Zhouhua, AU - Dong,Yixuan, AU - Wu,Chuanbin, AU - Williams,Robert O,3rd Y1 - 2012/09/05/ PY - 2012/02/12/received PY - 2012/05/25/revised PY - 2012/06/29/accepted PY - 2012/9/15/entrez PY - 2012/9/15/pubmed PY - 2013/5/11/medline SP - 534 EP - 44 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 82 IS - 3 N2 - The objective of this study was to prepare amorphous fenofibrate (FB) solid dispersions using thin film freezing (TFF) and to incorporate the solid dispersions into pharmaceutically acceptable dosage forms. FB solid dispersions prepared with optimized drug/polymer ratios were characterized by modulated differential scanning calorimetry (MDSC), powder X-ray diffraction (XRD), scanning electron microscopy (SEM), Brunauer-Emmett-Teller (BET) specific surface area measurements, Fourier-transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR), and supersaturation dissolution testing. Furthermore, a dry granulation technique was used to encapsulate the TFF compositions for in vitro dissolution and in vivo animal pharmacokinetic studies. The results showed that the TFF process produced amorphous, porous, microstructured, and stable solid dispersions with high surface areas. Development of solid oral dosage forms revealed that the performance of the FB containing solid dispersions was not affected by the formulation process, which was confirmed by DSC and XRD. Moreover, an in vivo pharmacokinetic study in rats revealed a significant increase in FB absorption compared to bulk FB. We confirmed that amorphous solid dispersions with large surface areas produced by the TFF process displayed superior dissolution rates and corresponding enhanced bioavailability of the poorly water-soluble drug, FB. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/22974985/Formulation_and_delivery_of_improved_amorphous_fenofibrate_solid_dispersions_prepared_by_thin_film_freezing_ DB - PRIME DP - Unbound Medicine ER -