Evaluation of performance testing and computer simulations for Quality by Design approaches of oral dosage forms

• Author / Creator

  Almukainzi, May

• Performance testing and computer simulations have promising applications in Quality by Design approaches. The objectives of these studies were to investigate the performance of the disintegration test using different setups in addition to comparing the performance of the disintegration test with the rupture test using soft gelatin dietary supplements capsules. Classifying common herbs according to the Biopharmaceutical Classification System approach was also investigated using ADMET predictor TM. The final objective was evaluation the predictive power of computer simulations of in vitro dissolution in different media. The studies concluded that the disintegration test is robust only if firm specifications were applied. However, this test has no advantage over the rupture test. In silico methods can be used to classify herbs according to the BCS. Computer simulations of dissolution in vitro can be also a potential tool to estimate the dissolution behavior. These tools facilitate prediction of quality desired in a product.

• Subjects / Keywords

  • Quality by Design (QbD)
  • Disintegration test
  • Rupture test
  • BCS Classification

• Graduation date

  Spring 2011

• Type of Item

  Thesis

• Degree

  Master of Sciences

• DOI

  https://doi.org/10.7939/R3JM69

• License

  This thesis is made available by the University of Alberta Libraries with permission of the copyright owner solely for non-commercial purposes. This thesis, or any portion thereof, may not otherwise be copied or reproduced without the written consent of the copyright owner, except to the extent permitted by Canadian copyright law.