Best practices for integration of dissolution data into physiologically based biopharmaceutics models (PBBM): a biopharmaceutics modeling scientist perspective

S Kollipara, AK Bhattiprolu, R Boddu, T Ahmed… - AAPS …, 2023 - Springer
Dissolution is considered as a critical input into physiologically based biopharmaceutics
models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by …

Assessment of food effects during clinical development

Z Vinarov, J Butler, F Kesisoglou, M Koziolek… - International Journal of …, 2023 - Elsevier
Food-drug interactions frequently hamper oral drug development due to various
physicochemical, physiological and formulation-dependent mechanisms. This has …

Effect of Buffer pH and Concentration on the Dissolution Rates of Sodium Indomethacin–Copovidone and Indomethacin–Copovidone Amorphous Solid Dispersions

CW Chiang, S Tang, C Mao, Y Chen - Molecular Pharmaceutics, 2023 - ACS Publications
The incorporation of counterions into amorphous solid dispersions (ASDs) has been proven
to be effective for improving the dissolution rates of ionizable drugs in ASDs. In this work, the …

肠道菌群孵育技术及其在中药分析中的应用研究进展

崔晓静, 张辉, 刘月涛, 秦雪梅 - 分析测试学报, 2023 - fxcsxb.com
近年来, 肠道菌群作为隐形器官成为研究机体代谢和疾病治疗的新热点, 在中药分析中也受到
广泛关注. 中药口服后部分原型成分经肠道菌群转化为药效更强的物质, 肠道菌群被认为是解释 …

[HTML][HTML] When interactions between bile salts and cyclodextrin cause a negative food effect: dynamic dissolution/permeation studies with itraconazole (Sporanox®) …

A Cuoco, JB Eriksen, B Luppi, M Brandl… - Journal of …, 2023 - Elsevier
The marketed oral solution of itraconazole (Sporanox®) contains 40%(259.2 mM) of 2-
hydroxypropyl-β-cyclodextrin (HP-β-CD). The obvious role of HP-β-CD is to solubilize …

Development of an extemporaneous preparation formulation using a simple and non-solubilizing matrix for first in human clinical study

CW Chiang, S Tang, JM Boonstra… - International Journal of …, 2024 - Elsevier
Extemporaneous preparation (EP) formulation is an attractive strategy to accelerate the
formulation development of new chemical entities for first entry into human study. In this …

Generality of Enhancing the Dissolution Rates of Free Acid Amorphous Solid Dispersions by the Incorporation of Sodium Hydroxide

HJ Zhang, CW Chiang… - Molecular …, 2024 - ACS Publications
The incorporation of a counterion into an amorphous solid dispersion (ASD) has been
proven to be an attractive strategy to improve the drug dissolution rate. In this work, the …

Exploring biorelevant conditions and release profiles of ritonavir from HPMCAS-based amorphous solid dispersions

P Bapat, R Schwabe, S Paul, YC Tseng… - Journal of …, 2024 - Elsevier
Abstract Development of a release test for amorphous solid dispersions (ASDs) that is in
vivo predictive is essential to identify optimally performing formulations early in …

Digitalizing the TIM-1 Model using Computational Approaches–Part One: TIM-1 Data Explorer

I Sarcevica, B Hens, I Tomaszewska… - Molecular …, 2023 - ACS Publications
The TIM-1 gastrointestinal model is one of the most advanced in vitro systems currently
available for biorelevant dissolution testing. This technology, the initial version of which was …

Integrating Dynamic in vitro Systems and Mechanistic Absorption Modeling: Case Study of Pralsetinib

MJ Dolton, C Bowman, F Ma, S Cheeti… - Journal of …, 2024 - Elsevier
Dynamic in vitro absorption systems and mechanistic absorption modeling via PBPK have
both shown promise in predicting human oral absorption, although these efforts have been …