Ingredients

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

A recent study of computer-created and natural proteins suggests the number of sites where small-molecule drugs can bind to proteins is limited, thereby narrowing how to mitigate side effects through drug design.

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

Access to extremely low and consistently controlled reaction temperatures can improve product yields and selectivities while also reducing costs.

The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.

Solid-state chemistry is an important part of drug development, and public research is advancing the field.

Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.

Because peptoids are relatively easy to synthesize, have tremendous sequence diversity, and are more proteolytically stable than peptides and proteins, they have significant potential for use as APIs, drug-delivery agents, and in numerous biomedical applications.

Access to simpler and more direct methodologies for the incorporation of fluorinated substituents remains an unmet need in pharmaceutical synthesis. An analysis of recent trends in fluorination chemistry.

Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.

Contract API manufacturers proceed with select investment in capacity and service additions.

As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.

FDA's requirements for API manufacturers in regards to ICH Q7.

Visual mapping can provide a particle-size distribution estimate.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

Pharmaceutical Technology brought together a panel of industry experts for a special forum to discuss solubilizing polymers and the related formulation strategies for poorly soluble drugs.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

As contract API manufacturers, fine-chemical producers, and pharmaceutical companies prepare to attend Informex in Anaheim this month, the state of the industry shows improving conditions in certain sectors.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.

Researchers use inorganic catalysts as an alternative to biocatalysts in the selective conversion of sugars to produce chiral building blocks.

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

As 2012 comes to a close, Pfizer leads among Big Pharma companies for FDA approvals of new molecular entities and biologics.

The promise of antibody drug conjugates is creating a network of partners among large pharma companies and specialized players.

Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.

Recent research on elucidating the structure and sequence of proteins involves examining the effect of microgravity on protein crystallization and a computational model for protein elucidation.

The authors examine the use of various grades of direct-compression mannitol in direct-compression tableting process to evaluate the content uniformity of micronized APIs and excipients in a solid-dosage formulation.

Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug.