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Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets

The novelty in this study is the development of new orodispersible tablets containing nifedipine (NIF) as the active ingredient. Initially, the formation of inclusion complexes between nifedipine and two derivatives of beta-cyclodextrin, namely, hydroxypropyl-β-cyclodextrin (HP-β-CD) and methyl-β-cy...

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Autores principales: Ozon, Emma Adriana, Novac, Marian, Gheorghe, Daniela, Musuc, Adina Magdalena, Mitu, Mirela Adriana, Sarbu, Iulian, Anuta, Valentina, Rusu, Adriana, Petrescu, Simona, Atkinson, Irina, Lupuliasa, Dumitru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9415292/
https://www.ncbi.nlm.nih.gov/pubmed/36015141
http://dx.doi.org/10.3390/ph15080993
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author Ozon, Emma Adriana
Novac, Marian
Gheorghe, Daniela
Musuc, Adina Magdalena
Mitu, Mirela Adriana
Sarbu, Iulian
Anuta, Valentina
Rusu, Adriana
Petrescu, Simona
Atkinson, Irina
Lupuliasa, Dumitru
author_facet Ozon, Emma Adriana
Novac, Marian
Gheorghe, Daniela
Musuc, Adina Magdalena
Mitu, Mirela Adriana
Sarbu, Iulian
Anuta, Valentina
Rusu, Adriana
Petrescu, Simona
Atkinson, Irina
Lupuliasa, Dumitru
author_sort Ozon, Emma Adriana
collection PubMed
description The novelty in this study is the development of new orodispersible tablets containing nifedipine (NIF) as the active ingredient. Initially, the formation of inclusion complexes between nifedipine and two derivatives of beta-cyclodextrin, namely, hydroxypropyl-β-cyclodextrin (HP-β-CD) and methyl-β-cyclodextrin (Me-β-CD), was established. Inclusion complexes of nifedipine were prepared by different procedures: kneading, coprecipitation and lyophilization methods, using a 1:1 molar ratio among the drug and cyclodextrin compounds. A physical mixture was also developed for comparison, with the same molar ratio. The physicochemical and structural properties of these obtained complexes were subsequently analysed using Fourier-transform infrared spectroscopy, scanning electron microscopy, differential scanning calorimetry and X-ray diffraction techniques. The lyophilization method of preparation leads to obtaining the complete inclusion of nifedipine in the used cyclodextrin cavity, for both the derivative cyclodextrins. After that, preformulation studies and manufacturing of orodispersible tablets containing NIF-HP-β-CD and NIF-Me-β-CD, respectively, inclusion complexes were advanced. The obtained findings show that only F3 (which contains NIF-HP-β-CD) and F6 (which contains NIF-Me-β-CD) have a suitable flowability for the direct compression materials.
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spelling pubmed-94152922022-08-27 Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets Ozon, Emma Adriana Novac, Marian Gheorghe, Daniela Musuc, Adina Magdalena Mitu, Mirela Adriana Sarbu, Iulian Anuta, Valentina Rusu, Adriana Petrescu, Simona Atkinson, Irina Lupuliasa, Dumitru Pharmaceuticals (Basel) Article The novelty in this study is the development of new orodispersible tablets containing nifedipine (NIF) as the active ingredient. Initially, the formation of inclusion complexes between nifedipine and two derivatives of beta-cyclodextrin, namely, hydroxypropyl-β-cyclodextrin (HP-β-CD) and methyl-β-cyclodextrin (Me-β-CD), was established. Inclusion complexes of nifedipine were prepared by different procedures: kneading, coprecipitation and lyophilization methods, using a 1:1 molar ratio among the drug and cyclodextrin compounds. A physical mixture was also developed for comparison, with the same molar ratio. The physicochemical and structural properties of these obtained complexes were subsequently analysed using Fourier-transform infrared spectroscopy, scanning electron microscopy, differential scanning calorimetry and X-ray diffraction techniques. The lyophilization method of preparation leads to obtaining the complete inclusion of nifedipine in the used cyclodextrin cavity, for both the derivative cyclodextrins. After that, preformulation studies and manufacturing of orodispersible tablets containing NIF-HP-β-CD and NIF-Me-β-CD, respectively, inclusion complexes were advanced. The obtained findings show that only F3 (which contains NIF-HP-β-CD) and F6 (which contains NIF-Me-β-CD) have a suitable flowability for the direct compression materials. MDPI 2022-08-12 /pmc/articles/PMC9415292/ /pubmed/36015141 http://dx.doi.org/10.3390/ph15080993 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ozon, Emma Adriana
Novac, Marian
Gheorghe, Daniela
Musuc, Adina Magdalena
Mitu, Mirela Adriana
Sarbu, Iulian
Anuta, Valentina
Rusu, Adriana
Petrescu, Simona
Atkinson, Irina
Lupuliasa, Dumitru
Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title_full Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title_fullStr Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title_full_unstemmed Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title_short Formation and Physico-Chemical Evaluation of Nifedipine-hydroxypropyl-β-cyclodextrin and Nifedipine-methyl-β-cyclodextrin: The Development of Orodispersible Tablets
title_sort formation and physico-chemical evaluation of nifedipine-hydroxypropyl-β-cyclodextrin and nifedipine-methyl-β-cyclodextrin: the development of orodispersible tablets
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9415292/
https://www.ncbi.nlm.nih.gov/pubmed/36015141
http://dx.doi.org/10.3390/ph15080993
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