Premix technologies for drug delivery: manufacturing, applications, and opportunities in regulatory filing.
Drug Discov Today
; 29(6): 104011, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38705511
ABSTRACT
Active pharmaceutical ingredients (APIs) and excipients can be carefully combined in premix-based materials before being added to dosage forms, providing a flexible platform for the improvement of drug bioavailability, stability, and patient compliance. This is a promising and transformative approach in novel and generic product development, offering both the potential to overcome challenges in the delivery of complex APIs and viable solutions for bypassing patent hurdles in generic product filing. We discuss the different types of premixes; manufacturing technologies such as spray drying, hot melt extrusion, wet granulation, co-crystal, co-milling, co-precipitation; regulatory filing opportunities; and major bottlenecks in the use of premix materials in different aspects of pharmaceutical product development.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug Delivery Systems
Limits:
Humans
Language:
En
Journal:
Drug Discov Today
Journal subject:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2024
Document type:
Article
Affiliation country:
India
Country of publication:
United kingdom