{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:00:32Z","timestamp":1787166032281,"version":"build-2736575974"},"reference-count":21,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T00:00:00Z","timestamp":1708646400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Egis Pharmaceuticals Plc.","award":["TKP2021-EGA-32"],"award-info":[{"award-number":["TKP2021-EGA-32"]}]},{"name":"Egis Pharmaceuticals Plc.","award":["TKP2021-EGA"],"award-info":[{"award-number":["TKP2021-EGA"]}]},{"name":"Ministry of Innovation and Technology of Hungary","award":["TKP2021-EGA-32"],"award-info":[{"award-number":["TKP2021-EGA-32"]}]},{"name":"Ministry of Innovation and Technology of Hungary","award":["TKP2021-EGA"],"award-info":[{"award-number":["TKP2021-EGA"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>This study focuses on how to define an Analytical Target Profile (ATP) which is intended for use in practice and on facilitating the selection of in vitro release test (IVRT) technology for diclofenac sodium topical hydrogel and cream. The implementation involves incorporating the new draft guidelines of the International Council for Harmonisation (ICH Q14) and USP (United States Pharmacopeia) Chapter 1220. Four IVRT apparatuses were compared (USP Apparatus II with immersion cell, USP Apparatus IV with semisolid adapter, static vertical diffusion cell, and a new, in-house-developed flow-through diffusion cell) with the help of the ATP. Performance characteristics such as accuracy, precision, cumulative amount released at the end of the IVRT experiment, and robustness were investigated. We found that the best apparatus for developing IVRT quality control (QC) tests in both cases was USP II with an immersion cell. All four different IVRT apparatuses were compared with each other and with the data found in the literature.<\/jats:p>","DOI":"10.3390\/pharmaceutics16030313","type":"journal-article","created":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T10:47:30Z","timestamp":1708685250000},"page":"313","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["An Analytical Target Profile for the Development of an In Vitro Release Test Method and Apparatus Selection in the Case of Semisolid Topical Formulations"],"prefix":"10.3390","volume":"16","author":[{"given":"R\u00e9ka","family":"Szoleczky","sequence":"first","affiliation":[{"name":"Egis Pharmaceuticals Plc., Laboratory of Finished Product Analytical Development 3, B\u00f6k\u00e9nyf\u00f6ldi Str. 116-120, 1165 Budapest, Hungary"},{"name":"Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, E\u00f6tv\u00f6s Str. 6, 6720 Szeged, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5593-1329","authenticated-orcid":false,"given":"Anita","family":"Kov\u00e1cs","sequence":"additional","affiliation":[{"name":"Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, E\u00f6tv\u00f6s Str. 6, 6720 Szeged, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3842-8876","authenticated-orcid":false,"given":"Szilvia","family":"Berk\u00f3","sequence":"additional","affiliation":[{"name":"Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, E\u00f6tv\u00f6s Str. 6, 6720 Szeged, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5187-5702","authenticated-orcid":false,"given":"M\u00e1ria","family":"Budai-Sz\u0171cs","sequence":"additional","affiliation":[{"name":"Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, E\u00f6tv\u00f6s Str. 6, 6720 Szeged, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,2,23]]},"reference":[{"key":"ref_1","unstructured":"(2023). ICH Guideline Q14 on Analytical Procedure Development. Step 5."},{"key":"ref_2","unstructured":"(2023). ICH Guideline Q2(R2) on Validation of Analytical Procedures. Step 5."},{"key":"ref_3","unstructured":"USP (2022). Chapter <1220>  Analytical Procedure Life Cycle, United States Pharmacopeia."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Ermer, J., Aguiar, D., Boden, A., Ding, B., Obeng, D., Rose, M., and Vokrot, J. (2020). Lifecycle management in pharmaceutical analysis: How to establish an efficient and relevant continued performance monitoring program. J. Pharm. Biomed. Anal., 181.","DOI":"10.1016\/j.jpba.2019.113051"},{"key":"ref_5","unstructured":"USP (2023). 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Immersion Cell (with Small Volume Vessel) User Guide. 65-190-027 Rev. C. Available online: https:\/\/www.teledynelabs.com\/en-us\/resources\/Documents\/Manuals-Instructions\/Dissolution-Immersion-Cell-User-Guide.pdf."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Szoleczky, R., Budai-Sz\u0171cs, M., Cs\u00e1nyi, E., Berk\u00f3, S., Tonka-Nagy, P., Cs\u00f3ka, I., and Kov\u00e1cs, A. (2022). Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel. Pharmaceutics, 14.","DOI":"10.3390\/pharmaceutics14040707"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Ermer, J., and Nethercote, P. (2015). Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, Wiley-VCH Verlag GmbH & Co. KGaA. [2nd ed.].","DOI":"10.1002\/9783527672202"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1007\/s00769-012-0899-x","article-title":"Using target measurement uncertainty to determine fitness for purpose","volume":"17","author":"Weitzel","year":"2012","journal-title":"Accredit. Qual. Assur."},{"key":"ref_13","unstructured":"(2022). The In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs Draft Guidance."},{"key":"ref_14","unstructured":"(2018). Draft Guideline on Quality and Equivalence of Topical Products EMA\/CHMP\/QWP\/708282\/2018."},{"key":"ref_15","unstructured":"(1995). ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"118695","DOI":"10.1016\/j.ijpharm.2019.118695","article-title":"AQbD as a Platform for IVRT Method Development\u2014A Regulatory Oriented Approach","volume":"572","author":"Miranda","year":"2019","journal-title":"Int. J. Pharm."},{"key":"ref_17","first-page":"19","article-title":"A Comparative Study of the Release of Active Ingredients from Semisolid Cosmeceuticals Measured with Franz, Enhancer or Flow-Through Cell Diffusion Apparatus","volume":"12","author":"Liebenberg","year":"2004","journal-title":"J. Food Drug Anal."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/j.ijpharm.2017.06.018","article-title":"Critical quality attributes, in vitro release and correlated in vitro skin permeation\u2014In vivo tape stripping collective data for demonstrating therapeutic (non)equivalence of topical semisolids: A case study of \u201cready-to-use\u201d vehicles","volume":"528","author":"Lunter","year":"2017","journal-title":"Int. J. 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