Pharmaceutical Engineering & Drug Delivery

Microengineered Hydrogels for Stem Cell Bioengineering and Tissue Regeneration

SBE Webinar

Aug 23, 2011

Ali Khademhosseini

Micro- and nanoscale technologies are emerging as powerful tools for controlling the interaction between cells and their surroundings for biological studies, tissue eng

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...

An Integrated Quality-by-Design (QbD) Approach towards Design Space Definition of Key Unit Operations In the Manufacturing of Solid Dosage Forms by Discrete Element Method (DEM) and Computational Fluid Dynamics (CFD) Simulation

Nov 10, 2010

Siegfried Adam

Combined Quality-by-Design and computer simulation approaches (discrete element method and computational fluid dynamics) are presented to characterize key unit operations of solid dosage form manufacturing, namely powder blending and tablet coating. The aim is to evaluate the impact of formulation...

Mixture DOE and Design Space

Nov 10, 2010

Patrick J. Whitcomb

Present a case study on mixture DOE involving five components used to formulate a pharmaceutical tablet. The goal is to achieve a sustained release by optimizing the concentration of a hydrophilic polymer in relation to the proportions of a drug and three excipients. Four responses (two related to...

Practical Application of Q8 and Q9 Principles in Pharmaceutical Development

Nov 10, 2010

Erik Gout

The presentation “Practical application of Q8 and Q9 principles in pharmaceutical development” gives an overview of the current practice in pharmaceutical development within the Oral Solid Dosage form Development department of Abbott in Weesp, the Netherlands. The presentation starts at the point...

A Framework for in-Silico Formulation Design and Optimization Using Multivariate Latent Variable Regression Methods

Nov 10, 2010

Salvador García-Muñoz

Quality by Design is a technical exercise that should be performed upstream in the design of the production train for a given product. Although each processing step will have its own inputs and outputs that effect product quality, it is clear that raw materials properties are important for the...

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

Quality by Design Approach to Pharmacokinetic Modeling. A Case Study On Cyclosporin A

Nov 10, 2010

Eric Lueshen

Drug dose response experiments in animals provide invaluable information about the pharmacokinetics and pharmacodynamics of new therapeutic agents. The drug response curves in various organs such as the liver, heart or brain hold quantitative information to ascertain the laws of drug fate in the...

Achieving QM Accuracy at a Fraction of Computational Cost: Lattice Energy Minimization of Organic Crystals Containing Highly Flexible Molecules

Nov 10, 2010

Andrei V. Kazantsev

There is a multitude of possible formulation pathways for pharmaceutical compounds among which polymorph, solvate, salt and cocrystal formation are the most common. Finding the optimal formulation by experimentation alone is often expensive and time consuming. In a quality by design environment,...

Can A Design Space Be Built On Material Attributes Alone?

Nov 10, 2010

James N. Michaels

In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A...

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...

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...

Modelling and Informatics Challenges IN Film-BASED Drug Formulations and Manufacture

Nov 10, 2010

Maria Elisa Luque

Drug-loaded thin films are a novel pharmaceutical administration form that is creating an increasing interest in the pharmaceutical industry due to its versatility of application and the feasibility of continuous manufacture. However, accomplishing this in industrial scale requires addressing the...

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...

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...

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