Using Tiny-TIM Dissolution and In Silico Simulation to Accelerate Oral Product Development of a BCS Class II Compound

[1] Fleisher D(1999)Drug, meal and formulation interactions influencing drug absorption after oral administration Clin Implications Clin Pharmacokinet 36 233-254

[2] Li C(2014)Comparison of in vitro tests at various levels of complexity for the prediction of in vivo performance of lipid-based formulations: case studies with fenofibrate Eur J Pharm Biopharm 86 427-437

[3] Zhou Y(2019)In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review J Pharm Pharmacol 71 536-556

[4] Pao LH(2019)In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration Eur J Pharm Biopharm 136 70-83

[5] Karim A(2020)A review of current methods for food effect prediction during drug development Curr Pharmacol Rep 6 267-279

[6] Griffin BT(2014)Evolution of dissolution media over the last twenty years Dissolution Technol 21 6-10

[7] Kuentz M(2020)Selection of in vivo predictive dissolution media using drug substance and physiological properties AAPS J 22 1-13

[8] Vertzoni M(2020)On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: case example sodium salt of A6197 Eur J Pharm Biopharm 149 154-162

[9] Kostewicz ES(2016)Evaluation of two dynamic in vitro models simulating fasted and fed state conditions in the upper gastrointestinal tract (TIM-1 and tiny-TIM) for investigating the bioaccessibility of pharmaceutical compounds from oral dosage forms Int J Pharm 498 178-186

[10] Fei Y(2017)Gastrointestinal and systemic disposition of diclofenac under fasted and fed state conditions supporting the evaluation of in vitro predictive tools Mol Pharm 14 4220-4232

[1] Fleisher D(1999)Drug, meal and formulation interactions influencing drug absorption after oral administration Clin Implications Clin Pharmacokinet 36 233-254

[2] Li C(2014)Comparison of in vitro tests at various levels of complexity for the prediction of in vivo performance of lipid-based formulations: case studies with fenofibrate Eur J Pharm Biopharm 86 427-437

[3] Zhou Y(2019)In vitro methods to assess drug precipitation in the fasted small intestine – a PEARRL review J Pharm Pharmacol 71 536-556

[4] Pao LH(2019)In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration Eur J Pharm Biopharm 136 70-83

[5] Karim A(2020)A review of current methods for food effect prediction during drug development Curr Pharmacol Rep 6 267-279

[6] Griffin BT(2014)Evolution of dissolution media over the last twenty years Dissolution Technol 21 6-10

[7] Kuentz M(2020)Selection of in vivo predictive dissolution media using drug substance and physiological properties AAPS J 22 1-13

[8] Vertzoni M(2020)On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: case example sodium salt of A6197 Eur J Pharm Biopharm 149 154-162

[9] Kostewicz ES(2016)Evaluation of two dynamic in vitro models simulating fasted and fed state conditions in the upper gastrointestinal tract (TIM-1 and tiny-TIM) for investigating the bioaccessibility of pharmaceutical compounds from oral dosage forms Int J Pharm 498 178-186

[10] Fei Y(2017)Gastrointestinal and systemic disposition of diclofenac under fasted and fed state conditions supporting the evaluation of in vitro predictive tools Mol Pharm 14 4220-4232