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Journal of Microencapsulation
Micro and Nano Carriers
Volume 30, 2013 - Issue 3
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Research Article

Effect of antioxidants on the stability of ONO-1301, a novel long-acting prostacyclin agonist, loaded in PLGA microspheres

Takahiro UchidaDepartment of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Hyogo, JapanCorrespondence[email protected]
,
Mai HazekawaDepartment of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Hyogo, Japan
,
Tomomi MorisakiDepartment of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Hyogo, Japan
,
Miyako YoshidaDepartment of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Hyogo, Japan
&
Yoshiki SakaiOno Pharmaceutical Co., Ltd, Research Headquarters, Osaka, Japan
Pages 245-256 | Received 12 Mar 2012, Accepted 06 Aug 2012, Published online: 25 Oct 2012
 
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Abstract

The purpose of this study was to investigate the physicochemical stability of ONO-1301 in poly(lactide-co-glycolide) microspheres (PLGA MS) under storage for 28 days in the absence or presence of butylated hydroxytoluene (BHT) or α-tocopherol as antioxidant. First, we observed the hydrolysed product: (i) in acidic solution and oxidized product and (ii) in PLGA MS under storage in HPLC study, each structure was determined by liquid chromatography–nuclear magnetic resonance/mass spectrometry. Second, ONO-1301-loaded PLGA MS containing 10% BHT was shown to be superior to ONO-1301-loaded PLGA MS without BHT, in the standpoint of the stability under storage or in vitro drug-release test, and AUC0–28 following subcutaneous injection in rats. Finally, ONO-1301-loaded PLGA MS with 10% BHT were demonstrated to be significantly more effective than ONO-1301-loaded PLGA MS without BHT in a murine sponge model of angiogenesis. In conclusion, BHT is an effective antioxidant on the stability of ONO-1301 in PLGA MS under storage.

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