[HTML][HTML] Question-based review for pharmaceutical development: An enhanced quality approach

A Simões, F Veiga, C Vitorino - European Journal of Pharmaceutics and …, 2024 - Elsevier
Over the last years, the pharmaceutical industry has faced real challenges regarding quality
assurance. In this context, the establishment of more holistic approaches to the …

Innovations in thermal processing: hot-melt extrusion and KinetiSol® dispersing

DK Tan, DA Davis Jr, DA Miller, RO Williams III… - Aaps Pharmscitech, 2020 - Springer
Thermal processing has gained much interest in the pharmaceutical industry, particularly for
the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical …

Analytical quality by design (AQbD) approach to the development of analytical procedures for medicinal plants

G Park, MK Kim, SH Go, M Choi, YP Jang - Plants, 2022 - mdpi.com
Scientific regulatory systems with suitable analytical methods for monitoring quality, safety,
and efficacy are essential in medicinal plant drug discovery. There have been only few …

Machine learning for process monitoring and control of hot-melt extrusion: current state of the art and future directions

N Munir, M Nugent, D Whitaker, M McAfee - Pharmaceutics, 2021 - mdpi.com
In the last few decades, hot-melt extrusion (HME) has emerged as a rapidly growing
technology in the pharmaceutical industry, due to its various advantages over other …

Optimized reversed phase liquid chromatography methodology for the determination of vonoprazan fumarate impurities: Towards Six Sigma quality standards and …

BM Kanaan, AM Algohary, AM Ibrahim - Microchemical Journal, 2024 - Elsevier
Vonoprazan fumarate (VPZ), a potent potassium-competitive acid blocker, holds great
promise as a therapeutic option for addressing acid-related disorders. This study introduces …

Advancements of hot-melt extrusion technology to address unmet patient needs and pharmaceutical quality aspects

C Park, VS Renuka, BJ Lee, I de la Peña… - Journal of Pharmaceutical …, 2024 - Springer
Background Hot-melt extrusion (HME) significantly affects pharmaceutical manufacturing by
enhancing drug solubility and bioavailability. Advancements in HME technology to produce …

Quality by design in pharmaceuticals: a review of its impact on regulatory compliance and product quality

RS Nunavath, MT Singh, A Jain, M Chakma… - Drug …, 2023 - thieme-connect.com
The pharmaceutical industry has embraced the quality-by-design (QbD) approach as a
promising development, formulation and manufacturing strategy. QbD provides a systematic …

Analytical Quality by Design (AQbD) approach to the development of in vitro release test for topical hydrogel

R Szoleczky, M Budai-Szűcs, E Csányi, S Berkó… - Pharmaceutics, 2022 - mdpi.com
The aim of our study was to adapt the analytical quality by design (AQbD) approach to
design an effective in vitro release test method using USP apparatus IV with a semi-solid …

In-line monitoring of solid dispersion preparation in small scale extrusion based on UV–vis spectroscopy

J Winck, M Daalmann, A Berghaus… - Pharmaceutical …, 2022 - Taylor & Francis
The poor solubility of a large number of active pharmaceutical ingredients (APIs) is a major
challenge in pharmaceutical research. Therefore, the extrusion of amorphous solid …

Formulation and development of Serratiopeptidase enteric coated tablets and analytical method validation by UV Spectroscopy

VK Panthi, SK Jha, R Chaubey… - International Journal of …, 2021 - Wiley Online Library
Serratiopeptidase (SRP) is a proteolytic enzyme that emerged as one of the most potent anti‐
inflammatory and analgesic drugs. The purpose of the present study was to formulate and …