Results 31 to 40 of about 3,493,135 (324)

Downstream processing from hot-melt extrusion towards tablets : a quality by design approach [PDF]

, 2017
Since the concept of continuous processing is gaining momentum in pharmaceutical manufacturing, a thorough understanding on how process and formulation parameters can impact the critical quality attributes (CQA) of the end product is more than ever ...
Bostijn, Nils, De Beer, Thomas, Grymonpré, Wouter, Nuhn, Lutz, Remon, Jean Paul, Rombouts, Pieter, Van Herck, Simon, Vanhoorne, Valérie, Verstraete, Glenn, Vervaet, Chris   +9 more
core   +2 more sources

A Hot-Melt Extrusion Risk Assessment Classification System for Amorphous Solid Dispersion Formulation Development

Pharmaceutics, 2022
Several literature publications have described the potential application of active pharmaceutical ingredient (API)–polymer phase diagrams to identify appropriate temperature ranges for processing amorphous solid dispersion (ASD) formulations via the hot ...
Samuel O. Kyeremateng, Kristin Voges, Stefanie Dohrn, Ekaterina Sobich, Ute Lander, Stefan Weber, David Gessner, Rachel C. Evans, Matthias Degenhardt   +8 more
doaj   +1 more source

Pharmaceutical product development: A quality by design approach

International Journal of Pharmaceutical Investigation, 2016
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration
J. Ali, K. Pramod, MAbu Tahir, NaseemA Charoo, ShahidH Ansari   +4 more
semanticscholar   +1 more source

Tablets Development Based on Clover Meadow Grass Phytosubstance Using Design of the Experiment Method and QdD Tools

Разработка и регистрация лекарственных средств, 2020
Introduction. Quality, along with efficacy and safety, are the key characteristics of a drug. Therefore, it is important in frame of pharmaceutical development to lay the foundation for obtaining a quality product and achieving the desired product ...
A. N. Golubev, Th. I. Nguen, V. V. Sorokin, I. E. Kauhova   +3 more
doaj   +1 more source

Development of an HPLC-MS/MS Method for Chiral Separation and Quantitation of (R)- and (S)-Salbutamol and Their Sulfoconjugated Metabolites in Urine to Investigate Stereoselective Sulfonation

Molecules, 2023
The aim of this study was to develop and optimize a chiral HPLC-MS/MS method for quantitative analysis of (R)-/(S)-salbutamol and (R)-/(S)-salbutamol-4′-O-sulfate in human urine to allow for bioanalytical quantitation of the targeted analytes and ...
Lukas Corbinian Harps, Annika Lisa Jendretzki, Clemens Alexander Wolf, Ulrich Girreser, Gerhard Wolber, Maria Kristina Parr   +5 more
doaj   +1 more source

A quality by design (QbD) twin—screw extrusion wet granulation approach for processing water insoluble drugs [PDF]

, 2017
In this study, a Quality by Design (QbD) approach was used to identify the effect of formulation parameters in a twin screw wet extrusion granulation process for the manufacturing of ibuprofen (IBU) granules with increased dissolution rates. A fractional
Dey, Tumpa, Douroumis, Dennis, Maniruzzaman, Mohammed, Nair, Arun, Ross, Steven A, Snowden, Martin J   +5 more
core   +2 more sources

Reconciling Quality by Design and Transdermal Product Development

Pharmaceutics, 2020
Since my first exposure to the acronym ‘QbD’ more than ten years ago, I have been trying to understand exactly what QbD is and how I might incorporate its teachings into my twenty-odd years of experience developing transdermal systems. I feel
Kenneth Miller
doaj   +1 more source

Rational Development of a Carrier-Free Dry Powder Inhalation Formulation for Respiratory Viral Infections via Quality by Design: A Drug-Drug Cocrystal of Favipiravir and Theophylline

Pharmaceutics, 2022
Formulating pharmaceutical cocrystals as inhalable dosage forms represents a unique niche in effective management of respiratory infections. Favipiravir, a broad-spectrum antiviral drug with potential pharmacological activity against SARS-CoV-2, exhibits
Si Nga Wong, Jingwen Weng, Ignatius Ip, Ruipeng Chen, Richard Lakerveld, Richard Telford, Nicholas Blagden, Ian J. Scowen, Shing Fung Chow   +8 more
doaj   +1 more source

Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development

Pharmaceuticals, 2022
A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented.
Kostas Gkountanas, Anđelija Malenović, Yannis Dotsikas   +2 more
doaj   +1 more source

The potential of computed crystal energy landscapes to aid solid-form development [PDF]

, 2016
Solid-form screening to identify all solid forms of an active pharmaceutical ingredient (API) has become increasingly important in ensuring the quality by design of pharmaceutical products and their manufacturing processes.
Price, SL, Reutzel-Edens, SM
core   +1 more source