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Akademický článek

The role of SeDeM for characterizing the active substance and polyvinyilpyrrolidone eliminating metastable forms in an oral lyophilizate-A preformulation study.

Autor: Paloma Flórez Borges, Encarna García-Montoya, Pilar Pérez-Lozano, Enric Jo, Montserrat Miñarro, Albert Manich, Josep Maria Suñé-Negre

Publikováno v: PLoS ONE, Vol 13, Iss 4, p e0196049 (2018)

A preformulation study of an oral lyophilisate with cetirizine dihydrochloride (CTZ) as active ingredient, mannitol and PVP K30 as bulking agents is presented. CTZ shown a humidity content of 0.150% and a spontaneous hygroscopicity of 0.200% (both de

Externí odkaz: https://doaj.org/article/0a5aeabe891a4b7493245502b0d9ea4d

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Robust freeze-drying process re-design of a legacy product based on risk analysis and design of experiments

Autor: Gloria Clua-Palau, Enric Jo, Santiago Maspoch, Jordi Coello, Sasha Nikolic

In this study, a QbD freeze-drying process re-design applied to a lyophilized injectable drug product is presented. The main objective was to assess the freeze-drying process robustness using risk analysis and a proper experimental design. First, the

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a620c05ef3920581be2bd041a5642adb

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Finding a reliable limit of detection in the NIR determination of residual moisture in a freeze-dried drug product

Autor: Enric Jo, Gloria Clua-Palau, Santiago Maspoch, Jordi Coello, Sasha Nikolic

Publikováno v: Journal of Pharmaceutical and Biomedical Analysis. 183:113163

The validation of an analytical method in the pharmaceutical industry follows strictly regulated guidelines. The introduction of multivariable calibration methods requires a revision of these recommendations, since some of them are contradictory rega

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::575f63a95f04c34cc35c046faf52aab9
https://doi.org/10.1016/j.jpba.2020.113163

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The Role of SeDeM Characterizing the Active Substance and Polyvynilpyrrolidone Eliminating Metastable Forms in an Oral Lyophilizate - A Preformulation Study

Autor: Pilar Pérez-Lozano, Montserrat Miñarro, Encarna García-Montoya, Enric Jo, Albert M. Manich, Josep M. Suñé-Negre, Paloma Flórez Borges

Publikováno v: Dipòsit Digital de la UB
Universidad de Barcelona
PLoS ONE
Digital.CSIC. Repositorio Institucional del CSIC
instname
Recercat. Dipósit de la Recerca de Catalunya
PLoS ONE, Vol 13, Iss 4, p e0196049 (2018)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df8f759be8a30e2d58141dc983195130
http://hdl.handle.net/2445/129964

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