Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

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dc.contributor.author Duque, Marcelo Dutra [UNIFESP]
dc.contributor.author Issa, Michele Georges
dc.contributor.author Silva, Daniela Amaral
dc.contributor.author Sakamoto Kakuda, Beatriz Ayumi [UNIFESP]
dc.contributor.author Carpentieri Rodrigues, Leticia Norma [UNIFESP]
dc.contributor.author Lobenberg, Raimar
dc.contributor.author Ferraz, Humberto Gomes
dc.date.accessioned 2020-09-01T13:21:25Z
dc.date.available 2020-09-01T13:21:25Z
dc.date.issued 2017
dc.identifier http://dx.doi.org/10.14227/DT240417P6
dc.identifier.citation Dissolution Technologies. Hockessin, v. 24, n. 4, p. 6-11, 2017.
dc.identifier.issn 1521-298X
dc.identifier.uri https://repositorio.unifesp.br/handle/11600/58251
dc.description.abstract Intrinsic dissolution testing allows characterizing drug substances through its dissolution rate when exposed to a specified surface area in a specific dissolution media, This can be used to determine if a drug substance is highly or poorly soluble. In this work. DDDPlus version 4.0 (Simulations Plus, Inc.) was used to simulate intrinsic dissolution experiments for pyrimethamine and metronidazole. These drugs have low and high solubility properties. Predicted intrinsic dissolution rates (IDR) were compared to observed in vitro IDR. Physicochemical parameters from literature and the experimental conditions of the intrinsic dissolution tests for each drug were used as input data into the software. The program was able to predict the IDR of pyrimethamine and metronidazole within a pH range of 1.0 to 7.2. Observed and predicted IDR values for both drugs showed high correlations (R-2 > 0.9424), The IDR values from simulations showed the pH-dependent solubility of pyrimethamine and metronidazole, allowing us to classify the solubility according to the Biopharmaceutics Classification System (BCS). Intrinsic dissolution test simulations using DDDPlus can be used to obtain a BCS solubility classification of a drug substance, helping to reduce the number of laboratory experiments. en
dc.description.sponsorship National Council of Scientific and Technological Development (CNPq/Brazil)
dc.format.extent 6-11
dc.language.iso eng
dc.publisher Dissolution Technologies, Inc
dc.relation.ispartof Dissolution Technologies
dc.rights Acesso aberto
dc.subject pyrimethamine en
dc.subject metronidazole en
dc.subject intrinsic dissolution rate en
dc.subject BCS en
dc.subject DDDPlus en
dc.subject dissolution en
dc.title Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification en
dc.type Artigo
dc.description.affiliation Univ Sao Paulo, Fac Pharmaceut Sci, Dept Pharm, Sao Paulo, Brazil
dc.description.affiliation Univ Fed Sao Paulo UNIFESP, Inst Environm Chem & Pharmaceut Sci, Dept Exact & Earth Sci, Sao Paulo, Brazil
dc.description.affiliation Univ Alberta, Ctr Pharm & Hlth Res, Fac Pharm & Pharmaceut Sci, Edmonton, AB, Canada
dc.description.affiliationUnifesp Univ Fed Sao Paulo UNIFESP, Inst Environm Chem & Pharmaceut Sci, Dept Exact & Earth Sci, Sao Paulo, Brazil
dc.description.sponsorshipID CNPq: 400455/2014-5
dc.identifier.file WOS000416133600001.pdf
dc.identifier.doi 10.14227/DT240417P6
dc.description.source Web of Science
dc.identifier.wos WOS:000416133600001
dc.coverage Hockessin
dc.citation.volume 24
dc.citation.issue 4



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