Trust the Originator: HPMCAS Technology
Author: Sakae Obara
Sponsored By: SE Tylose USA
HPMCAS (Hypromellose Acetate Sucinate) has been used for enteric coating and solubility enhancement for over 30 years. The white paper shows basic data of this polymer for solubility enhancement using melt-extrusion process.

Tableting Performance of Sorbitol Excipient
Author: Marjorie Lejeune
Sponsored By: Tereos Syral
Tereos Syral has conducted a formulation study to assess the tableting performance of sorbitol excipient (spray-dried and crystalline) against lactose when associated with ascorbic acid at 25%. It shows that sorbitol ensures high quality, while providing competitive advantages in terms of hardness, friability, color stability, dilution potential, and dissolution profile.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Author: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot-melt mixed ASDs of FLD.

What is Quality by Design (QbD) – and Why Should You Care?
Sponsored By: DPT Laboratories
Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.

Validation, Qualification, and Calibration in a Pharmaceutical Facility
Authors: Marco Benvenuti
Sponsored By: SGS Life Science Services
This paper outlines outsourcing requirements for v alidation, q ualification and c alibration activities. These ongoing activities cover development, operation, and maintenance and require a partner with high quality standards that can manage challenging requirements.

Critical Issues to Explore When Choosing Your Humidity Calibration Lab
Sponsored By: Charles River Laboratories
An auditor is entitled to determine the scope of its own audit and surely quality personnel have the best intentions when developing paper-based questionnaires, but auditing activities are not a one-size-fits-all exercise. With risk assessment being at the forefront of the FDA’s focus, more supplier evaluations should be incorporating risk at the level of the audit process.

Improving Product Quality with Risk Assessment Tools
Authors: Brenda Percy
Sponsored By: EtQ Inc.
With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is Risk Management. Learn the elements of Risk Management and how they help to identify, prevent, and mitigate risk throughout an organization.

Industry Report on Viral Destruction: Smooth thermal processes consistently and effectively destroy these germs
Author: John Miles
Sponsored By: MicroThermics
This Q&A report includes information on viral inactivation and sterilization; integration  and scale up; and advantages of high temperature short-time (HTST) and ultra-high temperature (UHT) processes.

How to Control the Nutraceutical Supply Chain
Author: Jonathan Feinbaum and Anthony Harnack
Sponsored By: Aptean
Myriad regulations pose compliance challenges for drug manufacturers, but if done successfully, business opportunities can arise.

Applications In Pharmaceutical Manufacturing
Author: Malcolm McLaughlin
Sponsored By: Alconox
This comprehensive white paper covers how to approach critical cleaning in the pharmaceutical industry.  This tool enables one to ask and answer the logical issues that arise when performing one of the most important aspects of pharmaceutical manufacturing: the clean-out.

Functional Surfaces To Control Surface-Biomolecule Interaction
Author: Dr. Heinrich Jehle
Sponsored By: Greiner Bio-One GmbH
The toolbox material science containing several pathways for selective surface functionalization enables the development of novel biological assays and applications. These new functional materials give the chance to overcome existing limitations in biotechnology. Cell -based assays, microarrays as well as optimized protein crystallization platforms are exemplified.

Keeping Relative Humidity Calibrated
Author: Rotronic
Sponsored By: Keeping Relative Humidity Calibrated
Many processes in pharmaceutical science require controlled humidity to produce the desired product and preserve the necessary quality control. To maintain a humidity- controlled environment, manufacturers must keep instruments calibrated. Pharmaceutical Technology talked with David Love, vice president of Rotronic Instrument Corporation, to answer the question: Do you really know your relative humidity calibration vendor?.

Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin
Sponsored By: Leistritz
Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water, or other undesirable volatile contaminants are removed from a polymer melt.  A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance.  Oftentimes, there are chase impurities in the polymeric system that needs to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties.