Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary.
Eur J Pharm Sci
; 188: 106505, 2023 Sep 01.
Article
in En
| MEDLINE
| ID: mdl-37343604
ABSTRACT
Due to the strong tendency towards poorly soluble drugs in modern development pipelines, enabling drug formulations such as amorphous solid dispersions, cyclodextrins, co-crystals and lipid-based formulations are frequently applied to solubilize or generate supersaturation in gastrointestinal fluids, thus enhancing oral drug absorption. Although many innovative in vitro and in silico tools have been introduced in recent years to aid development of enabling formulations, significant knowledge gaps still exist with respect to how best to implement them. As a result, the development strategy for enabling formulations varies considerably within the industry and many elements of empiricism remain. The InPharma network aims to advance a mechanistic, animal-free approach to the assessment of drug developability. This commentary focuses current status and next steps that will be taken in InPharma to identify and fully utilize 'best practice' in vitro and in silico tools for use in physiologically based biopharmaceutic models.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Body Fluids
/
Cyclodextrins
Type of study:
Guideline
Language:
En
Journal:
Eur J Pharm Sci
Journal subject:
FARMACIA
/
FARMACOLOGIA
/
QUIMICA
Year:
2023
Document type:
Article
Affiliation country:
Greece