Results 251 to 260 of about 10,215,756 (277)

Impact of material attributes & process parameters on critical quality attributes of the amorphous solid dispersion products obtained using hot melt extrusion [PDF]

open access: yes, 2019
The feasibility of hot melt extrusion (HME) was explored for development of amorphous solid dispersion systems. Controlled release formulations were developed using a cellulose based derivative, AffinisolTMHPMC 100cP and 4M grades. BCS class II drugs ibuprofen and posaconazole were selected due to their difference in glass transition temperature and ...
Sabnis, Aniket D.
core   +5 more sources

Critical Self-Evaluation: An Attribute of Systemic Behavior: Authors of Natural Science Learning Materials as Evaluators

Systemic Practice and Action Research, 2013
Social responsibility (SR) requires critical self-evaluating personalities. Here is a case of self-measurement. Some basic content-, methodology- and implementation-related characteristics of evaluation in education are presented. Particularly emphasized are attributes of good evaluation and good evaluators.
Branka Čagran, Milena Ivanuš Grmek
openaire   +1 more source

Minimising variation in aspalathin content of aqueous green rooibos extract: optimising extraction and identifying critical material attributes

Journal of the Science of Food and Agriculture, 2017
AbstractBACKGROUNDHigh levels of aspalathin, an antidiabetic dihydrochalcone, in green rooibos underpins interest in the production of a standardised extract. Elements of a quality‐by‐design approach were applied to optimise extraction conditions, aiming at the delivery of a dry matter yield (DMY) ≥ 160 g kg−1 and an extract with an aspalathin content (
Neil Miller   +2 more
openaire   +2 more sources

New approach to optimizing risk management of the sticking problem using scale-independent critical material attributes and the quantitative process parameter

International Journal of Pharmaceutics, 2020
In pharmaceutical manufacturing of solid formulations, blending with a lubricant is a key process in preventing sticking during compression. Sticking not only results in tablets with a disfigured appearance but also brings about the interruption of continuous operations.
Hirotaka Ando   +5 more
openaire   +2 more sources

Evaluation of the effect of granule size of raw tableting materials on critical quality attributes of tablets during the continuous tablet manufacturing process using near-infrared spectroscopy

Drug Development and Industrial Pharmacy, 2023
The effects of granule size of raw materials on tablet hardness (TH) and weight (TW) in the continuous tablet manufacturing process (CTMP) were investigated using near-infrared spectroscopy (NIRS).Granule materials of different sizes were prepared by extrusion granulation from a standard granule formula powder containing lactose/starch and 4.5 ...
Makoto, Otsuka   +3 more
openaire   +2 more sources

Quality by Design in Action 2: Controlling Critical Material Attributes during the Synthesis of an Active Pharmaceutical Ingredient

Organic Process Research & Development, 2015
Quality by Design (QbD) is of paramount importance not only for patient safety but also for the timely and uninterrupted supply of products at affordable prices into the market. Both of these objectives can be achieved only through a robust process, and one of the major obstacles for developing a robust process is the quality of input materials and ...
Abdul Qayum Mohammed   +4 more
openaire   +1 more source

Elucidating molecular properties of kappa-carrageenan as critical material attributes contributing to drug dissolution from pellets with a multivariate approach

International Journal of Pharmaceutics, 2019
Multivariate data analysis (MVDA) and artificial neural networks (ANN) are supporting statistical methodologies required for successful development and manufacturing of drug products. To address this purpose, a complex dataset from 49 industrially produced capsules filled with pellets was first analyzed through the development of a multiple linear ...
Vidović, Sara   +10 more
openaire   +4 more sources

Critical Material Attributes of Strip Films Loaded With Poorly Water-Soluble Drug Nanoparticles: II. Impact of Polymer Molecular Weight

Journal of Pharmaceutical Sciences, 2017
Recent work established polymer strip films as a robust platform for delivery of poorly water-soluble drug particles. However, a simple means of manipulating rate of drug release from films with minimal impact on film mechanical properties has yet to be demonstrated.
Scott M, Krull   +5 more
openaire   +2 more sources

Critical attributes of fine excipient materials in carrier-based dry powder inhalation formulations: The particle shape and surface properties

International Journal of Pharmaceutics
The potential of fine excipient materials to improve the aerodynamic performance of carrier-based dry powder inhalation (DPI) formulations is well acknowledged but not fully elucidated. To improve the understanding of this potential, we studied two fine excipient materials: micronized lactose particles and silica microspheres.
Mustafa M.A. Elsayed   +6 more
openaire   +4 more sources

Importance of Raw Material Attributes for Modeling Ribbon and Granule Properties in Roller Compaction: Multivariate Analysis on Roll Gap and NIR Spectral Slope as Process Critical Control Parameters

Journal of Pharmaceutical Innovation, 2007
This work is an extension of the earlier work from this laboratory aimed at identifying raw material properties critical to the modeling of granule and ribbon properties as part of the optimization of roller (RC) compaction processes. The utility of roll gap (RG) and near-infrared (NIR) signal, specifically, the spectral slope, as process critical ...
Josephine L. P. Soh   +5 more
openaire   +1 more source

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