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Release property study on the novel divalproex sodium enteric-coated capsules

In the present study, a novel divalproex sodium (DS) enteric-coated capsule was prepared, and high performance liquid chromatography (HPLC) assay method for DS was developed. Their uniformity, release curve and release characteristics in different solvents were examined. The release studies were per...

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Detalles Bibliográficos
Autores principales: Yang, Shuoye, Wang, Xin, Jia, Jiangsong, Li, Pengyuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881217/
https://www.ncbi.nlm.nih.gov/pubmed/27275109
http://dx.doi.org/10.1016/j.jsps.2016.04.006
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author Yang, Shuoye
Wang, Xin
Jia, Jiangsong
Li, Pengyuan
author_facet Yang, Shuoye
Wang, Xin
Jia, Jiangsong
Li, Pengyuan
author_sort Yang, Shuoye
collection PubMed
description In the present study, a novel divalproex sodium (DS) enteric-coated capsule was prepared, and high performance liquid chromatography (HPLC) assay method for DS was developed. Their uniformity, release curve and release characteristics in different solvents were examined. The release studies were performed using marketed sample as a reference and data were analyzed in terms of cumulative release amounts as a function of time. It was demonstrated by the results that assay developed was specific, rapid and reliable, which can be used to determine DS in vitro accurately, and our developed samples were similar to reference preparation in in vitro release characteristics. The release characteristics of different batches of samples were quite similar to each other, and the total release percents of DS from enteric-coated capsule were within 0–10% in HCl, and reached close to 100% in phosphate buffer. Similarity factors (f(2)) of three batches between two preparations were all higher than 50. The developed enteric-coated capsule may be a promising alternative dosage form for treatment of related diseases.
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spelling pubmed-48812172016-06-06 Release property study on the novel divalproex sodium enteric-coated capsules Yang, Shuoye Wang, Xin Jia, Jiangsong Li, Pengyuan Saudi Pharm J Original Article In the present study, a novel divalproex sodium (DS) enteric-coated capsule was prepared, and high performance liquid chromatography (HPLC) assay method for DS was developed. Their uniformity, release curve and release characteristics in different solvents were examined. The release studies were performed using marketed sample as a reference and data were analyzed in terms of cumulative release amounts as a function of time. It was demonstrated by the results that assay developed was specific, rapid and reliable, which can be used to determine DS in vitro accurately, and our developed samples were similar to reference preparation in in vitro release characteristics. The release characteristics of different batches of samples were quite similar to each other, and the total release percents of DS from enteric-coated capsule were within 0–10% in HCl, and reached close to 100% in phosphate buffer. Similarity factors (f(2)) of three batches between two preparations were all higher than 50. The developed enteric-coated capsule may be a promising alternative dosage form for treatment of related diseases. Elsevier 2016-05 2016-04-26 /pmc/articles/PMC4881217/ /pubmed/27275109 http://dx.doi.org/10.1016/j.jsps.2016.04.006 Text en © 2016 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Article
Yang, Shuoye
Wang, Xin
Jia, Jiangsong
Li, Pengyuan
Release property study on the novel divalproex sodium enteric-coated capsules
title Release property study on the novel divalproex sodium enteric-coated capsules
title_full Release property study on the novel divalproex sodium enteric-coated capsules
title_fullStr Release property study on the novel divalproex sodium enteric-coated capsules
title_full_unstemmed Release property study on the novel divalproex sodium enteric-coated capsules
title_short Release property study on the novel divalproex sodium enteric-coated capsules
title_sort release property study on the novel divalproex sodium enteric-coated capsules
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881217/
https://www.ncbi.nlm.nih.gov/pubmed/27275109
http://dx.doi.org/10.1016/j.jsps.2016.04.006
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