Insights into Thermal Interactions in Frozen Pharmaceutical Vials: Effects on Ice Nucleation Times and Inhibition.
Pharm Res
; 41(6): 1285-1297, 2024 Jun.
Article
em En
| MEDLINE
| ID: mdl-38769275
ABSTRACT
PURPOSE:
This study investigates the thermal interactions between adjacent vials during freezing and assesses their impact on nucleation times.METHODS:
Various loading configurations were analyzed to understand their impact on nucleation times. Configurations involving direct contact between vials and freeze-dryer shelves were studied, along with setups using empty vials between filled ones. Additionally, non-conventional loading configurations and glycol-filled vials were tested. The analysis includes 2R and 20R vials, which are commonly utilized in the freezing and lyophilization of drug products, along with two different fill depths, 1 and 1.4 cm.RESULTS:
The investigation revealed that configurations with direct contact between vials and freeze-dryer shelves led to substantial thermal interactions, resulting in delayed nucleation in adjacent vials and affecting the temperature at which nucleation takes place in a complex way. In another setup, empty vials were placed between filled vials, significantly reducing thermal interactions. Further tests with non-conventional configurations and glycol-filled vials confirmed the presence of thermal interactions with a minimal inhibitory effect.CONCLUSIONS:
These findings carry significant implications for the pharmaceutical industry, highlighting the role of thermal interactions among vials during freezing and their impact on the temperature at which ice nucleation occurs.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Liofilização
/
Congelamento
/
Gelo
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article