Review of real-time release testing of pharmaceutical tablets: state-of-the art, challenges and future perspective

Daniel Markl, Martin Warman, Melanie Dumarey, Eva-Lotta Bergman, Staffan Folestad, Zhenqi Shi, Leo Francis Manley, Daniel J. Goodwin, J. Axel Zeitler

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
180 Downloads (Pure)


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.

Original languageEnglish
Article number119353
Number of pages1
JournalInternational Journal of Pharmaceutics
Early online date20 Apr 2020
Publication statusPublished - 30 May 2020


  • models
  • process analytical technology
  • real-time release testing
  • soft sensors
  • tablet manufacturing


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