Natural product-based excipients for topical green formulations

LAL Silvério, JC Coco, LM de Macedo… - Sustainable Chemistry …, 2023 - Elsevier
The industry has been paying more attention to the quality of excipients since they play a
fundamental role in the efficacy, safety, and acceptability of pharmaceutical products …

A combined differential scanning calorimetry and thermogravimetry approach for the effective assessment of drug substance-excipient compatibility

B Rojek, M Wesolowski - Journal of Thermal Analysis and Calorimetry, 2023 - Springer
Differential scanning calorimetry (DSC) is a tool particularly recommended for rapid
compatibility screening between active pharmaceutical ingredients (APIs) and excipients …

A Rational Hierarchy to Capture Raw Material Attribute Variability in the Pharmaceutical Drug Product Development and Manufacturing Lifecycle

SL Conway, KJ Rosenberg, S Sotthivirat… - Journal of …, 2024 - Elsevier
Assessing the robustness of a drug product formulation and manufacturing process to
variations in raw material (RM) properties is an essential aspect of pharmaceutical product …

Artificial intelligence (AI) in drug product designing, development, and manufacturing

S Chaudhary, P Muthudoss, T Madheswaran… - A handbook of artificial …, 2023 - Elsevier
By means of a science and risk-based systematic approach to pharmaceutical product
development through the DoE/QbD system, a control strategy will be defined for each of the …

[HTML][HTML] Indicator-based assessment of potential supply risks for pharmaceutical excipients: Method and application

K Nemoto, Y Hayashi, H Sugiyama - International Journal of Pharmaceutics, 2024 - Elsevier
This work presents an indicator-based assessment of potential supply risks for
pharmaceutical excipients. The assessment was conducted systematically through the steps …

Design and Process Considerations for Preparation of Modified Release Ivermectin and Praziquantel Tablets by Wet Granulation

RG Hollenbeck, R Fahmy, MN Martinez, A Ibrahim… - AAPS …, 2025 - Springer
Dosage forms containing Ivermectin (IVER) and Praziquantel (PRAZ) are important
combination drug products in animal health. Understanding the relationship between …

Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue

AS Hussain, K Morris, VJ Gurvich - AAPS PharmSciTech, 2021 - Springer
The AAPS PharmSciTech Theme Issue entitled “Team Science and Education for
Pharmaceuticals-the NIPTE Model” curates nineteen papers (1–19) listed in Table I and …

[PDF][PDF] Risk assessment of failures in generic drug development and approval procedure under competitive generic drug therapy and patent challenge exclusivities …

MV Reddy, GNK Ganesh, B Babu… - Acta Marisiensis-Seria …, 2022 - sciendo.com
Objective: The United States Food and Drug Administration implemented two exclusivity
programs Competitive generic therapy and Patent Challenge exclusivity to develop generic …