Process analytical technology tools for monitoring pharmaceutical unit operations: a control strategy for continuous process verification

EJ Kim, JH Kim, MS Kim, SH Jeong, DH Choi - Pharmaceutics, 2021 - mdpi.com
Various frameworks and methods, such as quality by design (QbD), real time release test
(RTRT), and continuous process verification (CPV), have been introduced to improve drug …

Recent progress in continuous manufacturing of oral solid dosage forms

V Vanhoorne, C Vervaet - International Journal of Pharmaceutics, 2020 - Elsevier
Continuous drug product manufacturing is slowly being implemented in the pharmaceutical
industry. Although the benefits related to the quality and cost of continuous manufacturing …

Recent progress in continuous crystallization of pharmaceutical products: precise preparation and control

Y Ma, S Wu, EGJ Macaringue, T Zhang… - … Process Research & …, 2020 - ACS Publications
Crystallization, as a solid–liquid separation process, is employed to purify and isolate a
great diversity of crystalline pharmaceutical products. In recent years, continuous …

Determination of aflatoxin B1 (AFB1) in maize based on a portable Raman spectroscopy system and multivariate analysis

J Deng, H Jiang, Q Chen - Spectrochimica Acta Part A: Molecular and …, 2022 - Elsevier
Abstract Aflatoxin B 1 (AFB 1) is the most widely distributed, most toxic, and most harmful,
and it is widely present in moldy grains. This study proposes a new method for quantitative …

Challenges, opportunities and recent advances in near infrared spectroscopy applications for monitoring blend uniformity in the continuous manufacturing of solid oral …

NL Velez, JK Drennen, CA Anderson - International Journal of …, 2022 - Elsevier
Near infrared (NIR) spectroscopy has been widely recognized as a powerful PAT tool for
monitoring blend uniformity in continuous manufacturing (CM) processes. However, the …

Trends-process analytical technology in solid oral dosage manufacturing

L Zhong, L Gao, L Li, H Zang - European Journal of Pharmaceutics and …, 2020 - Elsevier
Quality is the lifeline for all pharmaceuticals. Process analytical technology (PAT),
introduced by FDA in 2004, providing significant opportunities for improving pharmaceutical …

Characterization of near-infrared and Raman spectroscopy for in-line monitoring of a low-drug load formulation in a continuous manufacturing process

ZD Harms, Z Shi, RA Kulkarni, DP Myers - Analytical chemistry, 2019 - ACS Publications
Reflectance spectroscopy is an excellent candidate for process analytical technology (PAT)
applications in continuous manufacturing of pharmaceutical tablets. Spectroscopic methods …

Sampling optimization for blend monitoring of a low dose formulation in a tablet press feed frame using spatially resolved near-infrared spectroscopy

AD Román-Ospino, Y Baranwal, J Li, J Vargas… - International Journal of …, 2021 - Elsevier
In-line measurements of low dose blends in the feed frame of a tablet press were performed
for API concentration levels as low as 0.10% w/w. The proposed methodology utilizes the …

Feed frame: The last processing step before the tablet compaction in pharmaceutical manufacturing

NO Sierra-Vega, RJ Romañach, R Méndez - International journal of …, 2019 - Elsevier
The feed frame is a force-feeding device used in the die filling process. The die filling
process is crucial within pharmaceutical manufacturing to guarantee the critical quality …

Development of near infrared spectroscopic calibration models for in-line determination of low drug concentration, bulk density, and relative specific void volume …

C Ortega-Zúñiga, C Pinzón-De la Rosa… - … of pharmaceutical and …, 2019 - Elsevier
This study describes the development of a near infrared (NIR) calibration model for real time
determination of drug concentration, powder density, and porosity or relative specific void …