Pharmaceutical Engineering & Drug Delivery

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...

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...

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...

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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