Whitepapers - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Whitepapers

Robustness Study for Hydrophilic Matrix Tablets of METOLOSE® SR using QbD Sample Kit

May 6, 2014

A sample kit of Hypromellose having different viscosity levels, hydroxypropoxy content and particle size was applied to a robustness study of a hydrophylic matrix tablet of dipyridamole.

Functional Surfaces To Control Surface-Biomolecule Interaction

April 4, 2014

The tool box material science containing several pathways for selective surface functionalisation 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 optimised protein crystallisation platforms are exemplified.

Functional Surfaces To Control Surface-Biomolecule Interaction

April 23, 2014

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.

Applications In Pharmaceutical Manufacturing

April 23, 2014

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.

Devolatilization/Solvent Extraction via Twin Screw Extrusion

April 23, 2014

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.

The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies

April 11, 2014

Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry.

Tabletting performance of sorbitol excipient

March 5, 2014

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, colour stability, dilution potential and dissolution profile.

Trust the Originator: HPMCAS Technology

April 23, 2014

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.

Validation, Qualification, and Calibration in a Pharmaceutical Facility

April 23, 2014

This paper outlines outsourcing requirements for validation, qualification and calibration activities. These ongoing activities cover development, operation, and maintenance and require a partner with high quality standards that can manage challenging requirements.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
30%
Breakthrough designations
20%
Protecting the supply chain
50%
Expedited reviews of drug submissions
0%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Click here