Scoping review protocol for a System of Classification of Ophthalmic Topical Drugs: Integration of biopharmaceutical, pharmacokinetic, physicochemical, formulation, and physiological criteria
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| Format: | Recurso digital |
| Langue: | espagnol |
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2025
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| _version_ | 1866901183306661888 |
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| author | Gonzalez-Jimenez, Natalia C Baena, Yolima Carracedo, Gonzalo Valencia, Angie Alzate, Maykol Galindo, Wilson Argote, Daniela |
| author_facet | Gonzalez-Jimenez, Natalia C Baena, Yolima Carracedo, Gonzalo Valencia, Angie Alzate, Maykol Galindo, Wilson Argote, Daniela |
| contents | <p><strong>Abstract</strong><br>Topical ocular drugs face specific challenges for biopharmaceutical evaluation due to the anatomical and physiological barriers of the anterior segment. Despite increasing research, the available information is dispersed and lacks an integrated synthesis that organizes pharmacokinetic, physicochemical, formulation, and physiological criteria. This scoping review aims to map the scientific and regulatory literature related to these parameters in order to generate a solid evidence base for research applications.</p> <p><strong>Methods</strong><br>The review will follow the PRISMA-ScR guideline and the Arksey and O’Malley methodological framework. Structured and reproducible search strategies will be conducted in PubMed/MEDLINE, Scopus, and Web of Science. Complementary sources will include editorial platforms (ScienceDirect, SpringerLink, Taylor & Francis) and regulatory documents from international agencies (FDA, EMA, ICH, OECD, USP). Eligible evidence will include in vitro, ex vivo, in vivo studies, PBPK/PBBM models, and in silico simulations. Three independent reviewers will perform blinded screening of titles, abstracts, and full texts in Rayyan, with documented justifications for exclusions. Data extraction will be organized in comparative tables according to four axes: regulatory and pharmacokinetic determinants, physicochemical properties, formulation parameters, and physiological determinants.</p> <p><strong>Ethics and dissemination</strong><br>This protocol does not require ethical approval, as it does not involve human or animal subjects. Findings will be disseminated through a scientific publication, the consolidation of a structured database, academic presentations, and deposition of the protocol and its outputs in Zenodo to ensure open access and traceability.</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_17148455 |
| institution | Zenodo |
| language | spa |
| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Scoping review protocol for a System of Classification of Ophthalmic Topical Drugs: Integration of biopharmaceutical, pharmacokinetic, physicochemical, formulation, and physiological criteria Gonzalez-Jimenez, Natalia C Baena, Yolima Carracedo, Gonzalo Valencia, Angie Alzate, Maykol Galindo, Wilson Argote, Daniela Scoping review Ophthalmic topical drugs Biopharmaceutics Ocular pharmacokinetics Physicochemical properties Pharmacology Ophthalmology Drug Delivery Systems <p><strong>Abstract</strong><br>Topical ocular drugs face specific challenges for biopharmaceutical evaluation due to the anatomical and physiological barriers of the anterior segment. Despite increasing research, the available information is dispersed and lacks an integrated synthesis that organizes pharmacokinetic, physicochemical, formulation, and physiological criteria. This scoping review aims to map the scientific and regulatory literature related to these parameters in order to generate a solid evidence base for research applications.</p> <p><strong>Methods</strong><br>The review will follow the PRISMA-ScR guideline and the Arksey and O’Malley methodological framework. Structured and reproducible search strategies will be conducted in PubMed/MEDLINE, Scopus, and Web of Science. Complementary sources will include editorial platforms (ScienceDirect, SpringerLink, Taylor & Francis) and regulatory documents from international agencies (FDA, EMA, ICH, OECD, USP). Eligible evidence will include in vitro, ex vivo, in vivo studies, PBPK/PBBM models, and in silico simulations. Three independent reviewers will perform blinded screening of titles, abstracts, and full texts in Rayyan, with documented justifications for exclusions. Data extraction will be organized in comparative tables according to four axes: regulatory and pharmacokinetic determinants, physicochemical properties, formulation parameters, and physiological determinants.</p> <p><strong>Ethics and dissemination</strong><br>This protocol does not require ethical approval, as it does not involve human or animal subjects. Findings will be disseminated through a scientific publication, the consolidation of a structured database, academic presentations, and deposition of the protocol and its outputs in Zenodo to ensure open access and traceability.</p> |
| title | Scoping review protocol for a System of Classification of Ophthalmic Topical Drugs: Integration of biopharmaceutical, pharmacokinetic, physicochemical, formulation, and physiological criteria |
| topic | Scoping review Ophthalmic topical drugs Biopharmaceutics Ocular pharmacokinetics Physicochemical properties Pharmacology Ophthalmology Drug Delivery Systems |
| url | https://doi.org/10.5281/zenodo.17148455 |