Review of real-time release testing of pharmaceutical tablets : state-of-the art, challenges and future perspective
Markl, Daniel and Warman, Martin and Dumarey, Melanie and Bergman, Eva-Lotta and Folestad, Staffan and Shi, Zhenqi and Manley, Leo Francis and Goodwin, Daniel J. and Zeitler, J. Axel (2020) Review of real-time release testing of pharmaceutical tablets : state-of-the art, challenges and future perspective. International Journal of Pharmaceutics, 582. 119353. ISSN 1873-3476 (https://doi.org/10.1016/j.ijpharm.2020.119353)
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Abstract
In the last decade significant advances have been made in process analytical technologies and digital manufacturing of pharmaceutical oral solid dosage forms leading to enhanced product knowledge and process understanding. These developments provide an excellent platform for realising real-time release testing (RTRT) to eliminate all, or certain, off-line end product tests assuring that the drug product is of intended quality. This review article presents the state of the art, an RTRT development workflow as well as challenges and opportunities of RTRT in batch and continuous manufacturing of pharmaceutical tablets. Critical quality attributes, regulatory aspects and the scientific basis of enabling technologies and models for RTRT are discussed and a systematic development workflow for the robust design of an RTRT environment is presented. This includes the discussion of key considerations for the identification of the critical quality attributes and points of testing as well as the development of the sampling strategy, a hard and/or soft sensor approach and operational procedures. The final sections present two RTRT use cases in an industrial setting as well as critically discuss challenges and provide a future perspective of RTRT.
ORCID iDs
Markl, Daniel ORCID: https://orcid.org/0000-0003-0411-733X, Warman, Martin, Dumarey, Melanie, Bergman, Eva-Lotta, Folestad, Staffan, Shi, Zhenqi, Manley, Leo Francis, Goodwin, Daniel J. and Zeitler, J. Axel;-
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Item type: Article ID code: 72604 Dates: DateEvent30 May 2020Published20 April 2020Published Online18 April 2020AcceptedSubjects: Medicine > Pharmacy and materia medica Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
Faculty of Science > Pure and Applied ChemistryDepositing user: Pure Administrator Date deposited: 08 Jun 2020 13:20 Last modified: 04 Dec 2024 12:38 Related URLs: URI: https://strathprints.strath.ac.uk/id/eprint/72604