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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

10406 - Analytical chemistry

Project

—

Continuities

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

Publication year

2023

Confidentiality

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

Name of the periodical

International Journal of Pharmaceutics: X

ISSN

2590-1567

e-ISSN

2590-1567

Volume of the periodical

6

Issue of the periodical within the volume

December

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

10

Pages from-to

100188

UT code for WoS article

001058398400001

EID of the result in the Scopus database

2-s2.0-85162115796