APIs and Excipients

The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.

Creating a kinder, gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy.

Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs.

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

Chemocatalytic and biocatalytic routes show promise for more efficient syntheses of select active ingredients.

The pharmaceutical industry must address the release of nonbiodegradable APIs into the environment.

A changing regulatory environment is on the horizon for excipient suppliers and users.

Moderate growth is projected for the global excipients market. Excipient producers target blends and new grades for improving functionality and performance.

Excipient producers and industry observers share their perspectives on innovation for excipients.

What makes a drug ripe for respiratory delivery?

Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).

The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.

Scientists at The Wistar Institute are taking further steps into understanding a gene regulator that can lead them closer to developing new cancer therapies.

Contract manufacturers expand capabilities in aseptic processing, clinical-trial materials supply, and cytotoxic manufacturing.

An updated book summarizes recent research for formulators and drug-delivery specialists.

Researchers and process chemists share approaches in synthesis of active ingredients and pharmaceutical intermediates.

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.

The permeation of drugs through the skin is compromised by the presence of polar functional groups such as thiols, alcohols, phenols, imides or amides. By transiently masking these polar functional groups as prodrugs the permeability of drugs containing these functional groups through the skin can be improved.

Lipid-based drug delivery systems - such as liposomes, micro-and nanoemulsions, self-emulsified drug delivery systems, and solid lipid micro-and nanoparticles - are becoming more popular because lipid materials are easily characterized, contain a high range of well-defined/tolerated surfactant molecules and can be developed for several administration routes.

Company and People Notes: BASF raises prices on excipients; Verus Pharmaceuticals appoints president and CEO; more.

Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.

Natural gums and mucilage have been widely explored as pharmaceutical excipients. The goal of this study was to extract mucilage from the leaves of Aloe barbadensis Miller and to study its functionality as an excipient in pharmaceutical sustained-release tablet formulations.

The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.

The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

The European Fine Chemicals Group (EFCG) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.