This study used Raman and near-infrared (NIR) spectroscopy to monitor small real-time changes in powder blends and tablets in low-dose pharmaceutical formulations. The research aims to enhance process analytical technology (PAT) in pharmaceutical manufacturing, ensuring high-quality and uniform products with applications to produce drugs with narrow therapeutic indices (NTI). The study utilizes Raman and NIR spatially resolved spectroscopy (SRS) techniques to monitor a moderate cohesive material's active pharmaceutical ingredient (API) concentrations during manufacturing. The sampling locations were a bin blender for the batch blending procedure where the powder heterogeneity plays a significant role in product homogeneity, a feed frame of a tablet press where powder blend dynamics is critical to final product quality, and the outlet port of the tablet press where tablets immediately after ejection can be monitored in real-time. The study used semifine acetaminophen (APAP) as the API. Results indicated that Raman and NIR SRS could detect small API concentration changes as low as 0.50 %w/w, demonstrating their sensitivity and utility in real-time monitoring. The findings support the feasibility of these techniques in ensuring tight process control and highlight the performance of reducing waste and optimizing manufacturing processes in line with quality by design principles. The results highlight the importance of residence time distribution (RTD) in understanding the flow of the materials and powder behavior within the tablet press feed frame. RTD analyses showed that both Raman and NIR SRS techniques could effectively track concentration changes and ensure uniformity in the powder blends and tablets with signal-to-noise ratios higher than 3, demonstrating the sensitivity of the methods to small API changes. The %RSD during a steady state of 250 s (corresponding to 1.04 kg of material at 15 kg/h) for the step changes presented values of 6.74 % at 0.50 %w/w, 5.39 % at 1.00 %w/w, and 2.99 % at 1.50 %w/w for Raman predictions in powder blends within the feed frame and 15.46 % at 0.50 %w/w, 9.64 % at 1.00 %w/w, and 5.68 % at 1.50 %w/w for NIR SRS predictions of tablets ejected at the outlet port of the tablet press. In conclusion, this research demonstrates the potential of advanced spectroscopic techniques and data analysis in pharmaceutical manufacturing. By enabling precise real-time monitoring and control, these techniques contribute to higher-quality drug products, particularly NTI drugs, aligning with modern regulatory expectations and advancing pharmaceutical production technology.
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http://dx.doi.org/10.1016/j.ijpharm.2025.125165 | DOI Listing |
Int J Pharm
January 2025
Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ, 08854, USA; Center for Structured Organic Particulate Systems (C-SOPS), Cranbury, NJ, 08512, USA.
This study used Raman and near-infrared (NIR) spectroscopy to monitor small real-time changes in powder blends and tablets in low-dose pharmaceutical formulations. The research aims to enhance process analytical technology (PAT) in pharmaceutical manufacturing, ensuring high-quality and uniform products with applications to produce drugs with narrow therapeutic indices (NTI). The study utilizes Raman and NIR spatially resolved spectroscopy (SRS) techniques to monitor a moderate cohesive material's active pharmaceutical ingredient (API) concentrations during manufacturing.
View Article and Find Full Text PDFAnal Chem
December 2024
State Key Laboratory of Continental Dynamics, Department of Geology, Northwest University, Xi'an 710069, China.
Matrix effects can significantly bias Hf isotopic ratios in situ Hf isotope analyses using laser ablation (LA-) multicollector inductively coupled plasma mass spectrometry (MC-ICP-MS), necessitating the use of matrix-matched reference materials for accurate microanalysis. This work introduces a novel fast hot-pressing (FHP) sintering method to produce such reference materials efficiently for in situ analysis. By optimizing sintering temperatures, FHP technology enables the rapid preparation of in situ analysis reference materials with dense structures and homogeneous Hf isotopic compositions.
View Article and Find Full Text PDFInt J Pharm
December 2024
School of Chemical Engineering, The University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
High shear wet granulation (HSWG) is widely used in tablet manufacturing mainly because of its advantages in improving flowability, powder handling, process run time, size distribution, and preventing segregation. In-line process analytical technology measurements are essential in capturing detailed particle dynamics and presenting real-time data to uncover the complexity of the HSWG process and ultimately for process control. This study is to find relationships between Lenterra in-line measurements and granule properties and tablet properties.
View Article and Find Full Text PDFmedRxiv
December 2024
School of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi.
Purpose: Intimate partner violence (IPV) victimization is a pressing issue among men who have sex with men (MSM) and has profound health implications. This study aims to estimate the prevalence of IPV and identify factors associated with its occurrence among MSM in Hanoi, Vietnam.
Methods: A cross-sectional study was conducted from March to May 2023 at an MSM-friendly sexual health clinic in Hanoi.
JMIR Med Inform
November 2024
Department of Pediatrics, Seoul National University Bundang Hospital, 166 Gumi-ro, Bundang-gu, Seongnam, 03080, Republic of Korea, 82 317877297.
Background: Accurate history taking is essential for diagnosis, treatment, and patient care, yet miscommunications and time constraints often lead to incomplete information. Consequently, there has been a pressing need to establish a system whereby the questionnaire is duly completed before the medical appointment, entered into the electronic health record (EHR), and stored in a structured format within a database.
Objective: This study aimed to develop and evaluate a streamlined electronic questionnaire system, BEST-Survey (Bundang Hospital Electronic System for Total Care-Survey), integrated with the EHR, to enhance history taking and data management for patients with pediatric headaches.
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