End-point determination of heterogeneous formulations using inline torque measurements for a high-shear wet granulation process

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F23%3A10472934" target="_blank" >RIV/00216208:11310/23:10472934 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=G~SSkBcDk1" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=G~SSkBcDk1</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ijpx.2023.100188" target="_blank" >10.1016/j.ijpx.2023.100188</a>

Jazyk výsledku

angličtina

Název v původním jazyce

End-point determination of heterogeneous formulations using inline torque measurements for a high-shear wet granulation process

Popis výsledku v původním jazyce

In this study, the torque profiles of heterogeneous granulation formulations with varying powder properties in terms of particle size, solubility, deformability, and wettability, were studied, and the feasibility of identifying the end-point of the granulation process for each formulation based on the torque profiles was evaluated. Dynamic median particle size (d50) and porosity were correlated to the torque measurements to understand the relationship between torque and granule properties, and to validate distinction between different granulation stages based on the torque profiles made in previous studies. Generally, the torque curves obtained from the different granulation runs in this experimental design could be categorized into two different types of torque profiles. The primary factor influencing the likelihood of producing each profile was the binder type used in the formulation. A lower viscosity, higher solubility binder resulted in a type 1 profile. Other contributing factors that affected the torque profiles include API type and impeller speed. Material properties such as the deformability and solubility of the blend formulation and the binder were identified as important factors affecting both granule growth and the type of torque profiles observed. By correlating dynamic granule properties with torque values, it was possible to determine the granulation end-point based on a pre-determined target median particle size (d50) range which corresponded to specific markers identified in the torque profiles. In type 1 torque profiles, the end-point markers corresponded to the plateau phase, whereas in type 2 torque profiles the markers were indicated by the inflection point where the slope gradient changes. Additionally, we proposed an alternative method of identification by using the first derivative of the torque values, which facilitates an easier identification of the system approaching the end-point. Overall, this study identified the effects of different variations in formulation parameters on torque profiles and granule properties and implemented an improved method of identification of granulation end-point that is not dependent on the different types of torque profiles observed.

Název v anglickém jazyce

End-point determination of heterogeneous formulations using inline torque measurements for a high-shear wet granulation process

Popis výsledku anglicky

In this study, the torque profiles of heterogeneous granulation formulations with varying powder properties in terms of particle size, solubility, deformability, and wettability, were studied, and the feasibility of identifying the end-point of the granulation process for each formulation based on the torque profiles was evaluated. Dynamic median particle size (d50) and porosity were correlated to the torque measurements to understand the relationship between torque and granule properties, and to validate distinction between different granulation stages based on the torque profiles made in previous studies. Generally, the torque curves obtained from the different granulation runs in this experimental design could be categorized into two different types of torque profiles. The primary factor influencing the likelihood of producing each profile was the binder type used in the formulation. A lower viscosity, higher solubility binder resulted in a type 1 profile. Other contributing factors that affected the torque profiles include API type and impeller speed. Material properties such as the deformability and solubility of the blend formulation and the binder were identified as important factors affecting both granule growth and the type of torque profiles observed. By correlating dynamic granule properties with torque values, it was possible to determine the granulation end-point based on a pre-determined target median particle size (d50) range which corresponded to specific markers identified in the torque profiles. In type 1 torque profiles, the end-point markers corresponded to the plateau phase, whereas in type 2 torque profiles the markers were indicated by the inflection point where the slope gradient changes. Additionally, we proposed an alternative method of identification by using the first derivative of the torque values, which facilitates an easier identification of the system approaching the end-point. Overall, this study identified the effects of different variations in formulation parameters on torque profiles and granule properties and implemented an improved method of identification of granulation end-point that is not dependent on the different types of torque profiles observed.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

International Journal of Pharmaceutics: X

ISSN

2590-1567

e-ISSN

2590-1567

Svazek periodika

6

Číslo periodika v rámci svazku

December

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

10

Strana od-do

100188

Kód UT WoS článku

001058398400001

EID výsledku v databázi Scopus

2-s2.0-85162115796