Results 11 to 20 of about 741 (144)

A Quality by Design Framework for Capsule-Based Dry Powder Inhalers

Pharmaceutics, 2021
Capsule-based dry powder inhalers (cDPIs) are widely utilized in the delivery of pharmaceutical powders to the lungs. In these systems, the fundamental nature of the interactions between the drug/formulation powder, the capsules, the inhaler device, and ...
Li Ding, Ashlee D. Brunaugh, Sven Stegemann, Scott V. Jermain, Matthew J. Herpin, Justin Kalafat, Hugh D. C. Smyth   +6 more
doaj   +2 more sources

Application of Quality-by-Design Approach to Justify the Composition and Technology of Two-component Suppositories

Разработка и регистрация лекарственных средств, 2022
Introduction. One of the modern remedies used to treat vaginal infections are suppositories "Depantol", which have an antiseptic, regenerating effect due to the combination of chlorhexidine and dexpanthenol.
I. E. Smekhova, L. V. Shigarova, P. I. Andreeva, E. V. Flisyuk, A. S. Dzyuba   +4 more
doaj   +2 more sources

Edaravone for the Treatment of Motor Neurone Disease: A Critical Review of Approved and Alternative Formulations against a Proposed Quality Target Product Profile

Pharmaceutics
Edaravone is one of two main drugs for treating motor neurone disease (MND). This review proposes a specific quality target product profile (QTPP) for edaravone following an appraisal of the issues accounting for the poor clinical uptake of the approved ...
Riuna O’Neill, Okhee Yoo, Philip Burcham, Lee Yong Lim   +3 more
doaj   +2 more sources

Itraconazole Amorphous Solid Dispersion Tablets: Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools [PDF]

Pharmaceutics, 2022
BCS Class II drugs, such as itraconazole (ITZ), exhibit poor solubility (1–4 ng/mL) and so require solubility enhancement. Therefore, ITZ and Kollidon® VA64 (KOL) amorphous solid dispersions (ASDs) were produced using hot-melt extrusion (HME) to improve ...
Hetvi Triboandas, Kendal Pitt, Mariana Bezerra, Delphine Ach-Hubert, Walkiria Schlindwein   +4 more
doaj   +2 more sources

Beyond QTPP: Introducing the Quality Target Administration (QTAP) Profile for Enteral Feeding Tube Medications

There remains a clear gap between product development and real-world drug administration, particularly for medicines intended for delivery via enteral feeding tubes (EFTs). While drug formulation and manufacturing quality is often systematically addressed via the Quality by Design (QbD) framework, where the Quality Target Product Profile (QTPP ...
Smita Salunke, Chi Kin Anthony Chan, Sifan Hu   +2 more
openaire   +2 more sources

Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach [PDF]

Acta Pharmaceutica, 2017
The main objective of the present study was to apply QbD methodology in the development of once-a-day sustained release quetiapine tablets. The quality target product profile (QTPP) was defined after the pharmaceutical properties and kinetic release of ...
Gavan Alexandru, Porfire Alina, Marina Cristina, Tomuta Ioan   +3 more
doaj   +3 more sources

Macro- and Micro-Heterogeneity of Natural and Recombinant IgG Antibodies

Antibodies, 2019
Recombinant monoclonal antibodies (mAbs) intended for therapeutic usage are required to be thoroughly characterized, which has promoted an extensive effort towards the understanding of the structures and heterogeneity of this major class of molecules ...
Alain Beck, Hongcheng Liu
doaj   +2 more sources

INVESTIGATION OF QUALITY TARGET PROCESS PARAMETERS (QTPP) AND CRITICAL MATERIAL ATTRIBUTES (CMA) OF NANOCELLULOSE AS A POTENTIAL EXCIPIENT [PDF]

International Journal of Applied Pharmaceutics, 2019
Objective: The current work highlights the use of the Quality by Design (QbD) for optimization of Nanocellulose (NC) production from corn husk by two techniques, namely, Acid hydrolysis (AH) and High pressure homogenization (HPH). Methods: Characterization of NC involved Fourier transform infrared spectroscopy (FTIR), thermo gravimetric analysis (TGA),
ROSHNI VORA, Yamini Shah
core   +4 more sources

Quality-by-Design Compounding of Semisolids Using an Electronic Mortar and Pestle Device for Compounding Pharmacies: Uniformity, Stability, and Cleaning [PDF]

Pharmaceutics
Background/Objectives: Manual preparation of semisolid formulations (creams, ointments, gels) is prone to variability in mixing energy and time, which may compromise uniform API distribution.
Hudson Polonini, Carolina Schettino Kegele, Savvas Koulouridas, Marcone Augusto Leal de Oliveira   +3 more
doaj   +2 more sources

Quality by Design-Driven Formulation Development of Cannabidiol Orally Disintegrating Tablets. [PDF]

Scientifica (Cairo)
The development of cannabidiol (CBD) orally disintegrating tablets (ODTs) is effective in treating anxiety in a patient‐friendly manner. The application of Quality by Design (QbD) enhances the efficiency and robustness of the pharmaceutical development of CBD ODTs.
Monton C, Kulvanich P, Sucontphunt A, Suksaeree J, Charoenchai L, Songsak T.   +5 more
europepmc   +2 more sources