Whitepapers - Pharmaceutical Technology

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PharmTech Europe

Whitepapers

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.

Trust the Originator: HPMCAS Technology

April 10, 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.

Keeping Relative Humidity Calibrated: To find the right vendor you need to ask the right questions

March 26, 2014

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. Do you really know your relative humidity calibration vendor?

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.

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.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution

March 26, 2014

The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD.

2014 QMS Health Check

March 26, 2014

Time to take a look at your QMS. Time for an overdue Health Check. With increasing numbers of FDA 483 warning letters, consent decrees, and recalls, it's time to evaluate your QMS. Time to take NSF Health Sciences Pharma Biotech's QMS Health Check to ensure your business is ready for 2014.

Transfer the USP method for Ceftizoxime from a Traditional 5-um Column to an Agilent Poroshell 120

March 26, 2014

A USP method for ceftizoxime is transferred to a superficially porous Agilent Poroshell 120 column for significant time and solvent savings.

Modernizing the USP Monograph for Acetaminophen

March 26, 2014

A USP method for Acetaminophen is transferred to superficially porous Agilent Poroshell 120 columns for significant time and solvent savings. Several phases of Poroshell 120 are compared.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
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