Pharmaceutical Engineering & Drug Delivery

QbD for Generic MR Drug Products

Oct 18, 2011

Yue (Helen) Teng

The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among other things),...

Mechanistic Investigation of Drug Release From Asymmetric Membrane Tablets

Oct 18, 2011

Mary T. am Ende

An asymmetric membrane (AM) tablet was developed for a soluble model compound to study the in vitro drug release mechanisms in challenge conditions, including osmotic gradients, concentration gradients, and under potential coating failure modes. Porous, semipermable membrane integrity may be...

Transferring Monitoring Models Between Different Scales Through Multivariate Statistical Techniques

Oct 18, 2011

Emanuele Tomba

The challenge of transferring a process monitoring model across different scales is a different problem than the one addressed in previous studies that have focused on transferring operating procedures looking to produce the same grade of product [1, 2, 3, 4]. In the development of a new...

Optical Coherence Tomography: A New PAT-Tool for Fast and Non-Destructive Analysis of Tablet Coating Quality

Oct 18, 2011

Daniel M. Koller

Optical coherence tomography (OCT) is a non-invasive imaging technique allowing fast and high-quality cross-sectional imaging of semi-transparent and turbid media. Biomedical research and diagnostics have been up to now the main driving forces for the reported applications and progress in OCT. The...

Understanding the Impact of the Properties of Raw Materials Onto Product Quality Using JR-PLS

Oct 18, 2011

Salvador García-Muñoz

Multiple proposals are found in literature to analyze the impact of raw materials onto product using data analysis. From the methods proposed, the L-PLS is the only method that not only considers the ratio in which ingredients are mixed, but also the physical properties of the lots of raw material...

A Model-Centric Solution to Link Content Uniformity Targets with API Particle Size Specifications and Process for a QbD Excercise

Oct 17, 2011

Salvador García-Muñoz

One of the contributing factors in determining targets for the particle size of an API can be the content uniformity of the dosage forms. This work presents a framework established with a model-based specification for particle size of the API that can be used in a bi-directional mode to: a)...

Progress In Quality by Design Implementation In Fda's Office of New Drug Quality Assessment

Oct 17, 2011

Christine Moore

Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, over 40 Quality by Design (QbD) containing applications have been submitted, reviewed, and approved by ONDQA, both within and outside of the pilot. Although challenges still remain, many approaches...

Quality by Design for Generic Drugs

Oct 17, 2011

Yingxu Peng

To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current...

FDA Perspective On QbD for Analytical Methods

Oct 17, 2011

Elaine Morefield

QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and...

QUALITY by Design (QBD), Biopharmaceutical Manufacture

Oct 17, 2011

Kurt Brorson

In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a regulatory structure supporting Quality by Design (QbD) for pharmaceuticals and biopharmaceuticals has been described in International Conference on...

Enhanced Xylitol Production Through Simultaneous Co-Consumption of Cellobiose and Xylose by An Engineered Saccharomyces Cerevisiae Strain

Oct 17, 2011

Eun Joong Oh

Xylitol is a five-carbon sugar alcohol and has been used as a sugar substitute in the food industry because of its low caloric and anti-carcinogenic characteristics. In addition, xylitol is a building block for a variety of commodity chemicals. Biological routes for producing xylitol from...

A QbD Approach to Improve Tablet Coating Uniformity

Oct 17, 2011

Atul Dubey

A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design principles. A solid dosage form product was found to intermittently exhibit bad taste. A suspected cause was the variability in coating thickness which could lead to the...

Process QbD Case Study: An Integrated PAT Approach for a Dynamic Pharmaceutical Co-Precipitation Process Characterization and Process Design Space Development

Oct 17, 2011

Huiquan Wu

Previously we had explored the concepts of developing an integrated PAT approach to monitor and map the state of a dynamic pharmaceutical co-precipitation process in real time, and to determine the nucleation and growth mechanisms occurred during a pharmaceutical co-precipitation process. The aim...

QbD Principles for Packaging Design and Stability: A Regulatory Perspective

Oct 16, 2011

Sharmista Chatterjee

Quality by Design (QbD) is a science and risk based approach for pharmaceutical manufacturing and development. Enhanced product understanding gained from following a QbD based approach, is increasingly being used to select packaging design parameters and to determine optimum storage conditions. The...

Rational Design and Scale-up of Batch Lubrication Processes for Immediate Release Formulations

Oct 16, 2011

Joseph Kushner

Purpose: To provide stepwise guidance for lubrication of pharmaceutical powders through the development of a unifying model which captures lubrication effects during blending and compression. Methods: Literature models of powder properties following lubrication blending over a range of scales and...

Science-Based Stability and Packaging Development Under the Umbrella of QbD

Oct 16, 2011

Rey Chern

Abstract Science-Based Stability and Packaging Development Under The Umbrella of QbD Rey T Chern Global Pharmaceutical Commercialization Merck Sharp & Dohme A systematic approach for characterization of product stability risks, selection of primary packages and utilization of first-principle...

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