IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress

Valentyn Mohylyuk, Seyedreza Goldoozian, Gavin Andrews, Andriy Dashevskiy*

*Corresponding author for this work

Research output: Contribution to journalArticle

122 Downloads (Pure)

Abstract

Purpose: When establishing IVIVC, a special problem arises by interpretation of averaged in vivo profiles insight of considerable individual variations in term of time and number of mechanical stress events in GI-tract. The objective of the study was to investigate and forecast the effect of mechanical stress on in vivo behavior in human of hydrophilic matrix tablets.
Methods: Dissolution profiles for the marketed products were obtained at different conditions (stirring speed, single- or repeatable mechanical stress applied) and convoluted into C-t profiles. Vice versa, published in vivo C-t profiles of the products were deconvoluted into absorption profiles and compared with dissolution profiles by similarity factor.
Results: Investigated hydrophilic matrix tablets varied in term of their resistance against hydrodynamic stress or single stress during the dissolution. Different scenarios, including repeatable mechanical stress, were investigated on mostly prone Seroquel® XR 50 mg. None of the particular scenarios fits to the published in vivo C-t profile of Seroquel® XR 50 mg representing, however, the average of individual profiles related to scenarios differing by number, frequency and time of contraction stress. When different scenarios were combined in different proportions, the profiles became closer to the original in vivo profile including a burst between 4 and 5 h, probably, due to stress-events in GI-tract.
Conclusion: For establishing IVIVC of oral dosage forms susceptible mechanical stress, a comparison of the deconvoluted individual in vivo profiles with in vitro profiles of different dissolution scenarios can be recommended.
Original languageEnglish
Article number227
Number of pages10
JournalPharmaceutical Research
Volume37
Issue number11
DOIs
Publication statusPublished - 22 Oct 2020

Bibliographical note

Mohylyuk, V., et al., IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress. Pharm Res, 2020. 37(11): p. 227 DOI: 10.1007/s11095-020-02940-7.

Keywords

  • extended-release
  • gastrointestinal contraction
  • hydrophilic matrix tablet
  • IVIVC
  • pharmacokinetic profile

Fingerprint Dive into the research topics of 'IVIVC for Extended Release Hydrophilic Matrix Tablets in Consideration of Biorelevant Mechanical Stress'. Together they form a unique fingerprint.

Cite this