RT Journal Article T1 Testing drug release from medicated contact lenses: the missing link to predict in vivo performance A1 Mota, Ana F. Pereira da A1 Phan, Chau-Minh A1 Concheiro Nine, Ángel Joaquín A1 Jones, Lyndon A1 Álvarez Lorenzo, Carmen K1 Drug-eluting contact lens K1 In vitro release tests K1 In vivo release K1 Release rate specifications K1 Therapeutic response K1 In vitro-in vivo correlations AB Contact lenses (CLs) offer a wide variety of advantages as ocular drug-releasing platforms, but the feasibility of medicated CL development is constrained by numerous scientific, technological, and regulatory challenges. One main difficulty is the setting of release rate specifications for each drug, since at present there are no standardized in vitro release models that can appropriately predict the performance of drug-eluting CLs once placed onto the eye. CL-adapted release tests may provide knowledge on how the drug release pattern should perform in vivo to trigger and maintain the therapeutic effects for both anterior and posterior ocular tissues. Moreover, in vitro release tests are valuable tools for quality assessment during production and to investigate the effect of a change in composition or process variables. This review aims to shed light on biorelevant ways of evaluating in vitro drug release from CLs and the feasibility of establishing in vitro-in vivo correlations (IVIVC) to predict in vivo performance. First, general guidelines and Pharmacopeia release tests for topical ophthalmic formulations as well as in vitro release tests implemented for drug-CLs in the last two decades are analyzed. Then, development of an appropriate method to investigate IVIVC is attempted from the few papers simultaneously reporting in vitro release profiles and either in vivo release or therapeutic response. Finally, key points to be considered for in vitro testing drug release from a medicated CL are suggested to pave the way to the clinical arena PB Elsevier YR 2022 FD 2022 LK http://hdl.handle.net/10347/27634 UL http://hdl.handle.net/10347/27634 LA eng NO Journal of Controlled Release 343 (2022) 672-702 NO This project is funded by the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie Actions grant agreement N° 813440 (ORBITAL–Ocular Research by Integrated Training And Learning). The work was also partially supported by MCIN [PID2020-113881RB-I00/AEI/10.13039/501100011033] Spain, Xunta de Galicia [ED431C 2020/17], and FEDER DS Minerva RD 22 abr 2026