Pharmaceutical Engineering & Drug Delivery

Pragmatic Application of Crystallization Design Basics for a Pharmaceutical Compound

Nov 10, 2010

James Wertman

An API crystallization can be sufficiently developed to provide a robust process utilizing basic design principles and simplified modeling techniques. Such an approach is presented as an example of the typical methods for an industrial application, where resource and time are becoming increasingly...

Drop-On-Demand Dispensing of Pharmaceutical Suspensions: Correlation of Material Attributes and Operating Conditions to Process Performance

Nov 10, 2010

Sara Holt

The ability to produce drops on demand is critical to microdosing applications, such as dispensing inks, polymers, and other biological fluids. In the pharmaceutical industry microdosing can be used to reliably fill capsules with multiple materials at strictly controlled ratios, under full closed...

Computational Predictive Models Applied to Scale-up of Solid Oral Drug Products

Nov 10, 2010

Mary T. am Ende

The budget-restricted pharmaceutical environment is countered by the heightened expectations for drug products to be developed using science-based principles. These two opposing factors have created a crucial opportunity for engineering principles to be applied and implemented across the industry...

Plantwide Dynamic Simulation and Model-Based Control of a Continuous Pharmaceutical Process

Nov 10, 2010

Dimitrios I. Gerogiorgis

Spray Drying Process Design: Establishing Links Between Process Parameters and Product Performance

Nov 10, 2010

Scott R. Ellis

Spray drying or spray congealing is typically used to manufacture a powder for further processing into a final dosage form. Although this operation can profoundly influence the properties and quality of the final product, its contribution is subtle and often incompletely understood due to the...

Impact of API Particle Size On a Sustained Release Oral Tablet Formulation

Nov 10, 2010

Sarina G. Harris Ma

The objective of this study was to understand the impact of API particle size on various blend and tablet quality attributes of a sustained release oral tablet formulation produced via a direct compression process. The API primary particle size and agglomerate size were identified as critical...

A High Throughput, Parallel, Microscale, Fully Automated Approach to Biologics Formulation Development and Stress Test Studies

Nov 9, 2010

Eric Carlson

Developing robust formulations for biological materials (proteins, antibodies, vaccines, etc.) requires the screening and analysis of a comprehensive matrix of formulation compositions and stress conditions. This talk will focus on the development and use of a fully-automated workflow for stressing...

Raman Spectroscopy Combined with Small and Wide Angle X-Ray Scattering as a Non Destructive Quality Control Tool for Powder Compression Analytics in Pharmaceutical Applications

Nov 9, 2010

Nicolas Heigl

This study evaluates the feasibility of a combined use of small-wide angle X-ray scattering (SWAXS) and Raman spectroscopy as a non-invasive process analytical tool (PAT) for the analysis of pharmaceutical granulation and compression procedures. Placebo formulations containing Lactose monohydrate (...

Optimizing and Controlling High Value Processes Using the Principles of Quality-by-Design (QbD) Advanced Tools Such as Real-Time in-Situ Particle Characterization, in-Situ Mid-Infrared Spectrometry, and Reaction Calorimetry

Nov 9, 2010

Leen Schellekens

Quality by Design (QbD) is a concept applied to gain true process understanding utilizing tools such as Design of Experiment (DoE), Risk Management, and Process Analytical Technology (PAT). Utilization of these principles and tools not only allow the chemist, engineer, or formulator to optimize a...

On-Line Blend Monitoring of Pharmaceutical Materials Using Multiple NIR Sensors

Nov 9, 2010

Benoit Igne

In recent years, powder blend monitoring and control systems using process analytical technologies (PAT) have become increasingly popular in the pharmaceutical industry. Among them, spectroscopic techniques allow for real-time evaluation of blend homogeneity and powder behaviors necessary for both...

Desensitizing near-Infrared Calibration Models for Physical Interferences in Tablets During Formulation/Process Development

Nov 9, 2010

Benoit Igne

During formulation/process developments, experimental designs are often used to minimize the number of experiments and maximize the necessary information on the chemical and physical stability of the drug, the flow properties, the process parameters, and the process monitoring tools, etc. As a...

Quality-by-Design (QbD): Integration of Design of Experiments (DOE) and Real-Time PAT Monitoring for Pharmaceutical Powder Blending Process Evaluation

Nov 9, 2010

Huiquan Wu

Although pharmaceutical powder blending process as an important unit operation has received significant attention, our understanding to some of the critical issues such as blending homogeneity assessment and blending kinetics evaluation is limited. As highlighted in the FDA's PAT Guidance,...

Real-Time Monitoring of Pharmaceutical Manufacturing Processes with a Multiplexed Optical Fiber Probe NIR-Setup

Nov 9, 2010

Nikolaus Balak

Diffuse reflectance near-infrared (NIR) spectroscopy is a non-invasive and widely used technology with the potential for a wide range of applications in the pharmaceutical industry, ranging from raw material identification to final product qualification. Especially powder blending processes, as one...

Imaging Pharmaceutical Fluidised Bed Multi-Processes with Electrical Capacitance Tomography

Nov 9, 2010

Haigang Wang, Lubomir Gradinarsky, Wuqiang Yang

The fluidised bed process (drying, granulation and coating) is an important procedure in pharmaceutical industry and the end point of product quality is strongly depended on the properly setting of operation parameters. However, due to the complex gas-solid two phases flow behavior in these...

Implementation of a Normalization Risk Assessment Tool to Link Design Space Inputs

Nov 9, 2010

Diana S. Hou

Risk analysis and assessment tools are a key component of Quality by Design (QbD) because they facilitate understanding, identifying, and documenting of risks affecting drug product quality attributes. As stated in the ICH Q8 guidelines, the “design space” is where a process generates a product...

Risk Based Roadmap for the Approval of Biosimilar Biologics

Nov 9, 2010

Henry Y. Wang

The development of biologics has grown significantly in recent years, due in part to the profitability for innovator companies, which currently enjoy exclusivity in the absence of “generic” biologics. In the U.S. There is currently no guideline in place for the approval of “biosimilar” biologics...

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