Formulation

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This year's meeting of the Controlled Release Society unveiled a plethora of research insights.

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.

J. Scott Tarrant, executive vice-president of Xceleron, explains the role of microdosing in drug development. He describes how microdose data can be used to predict pharmacological dose absorption, distribution, metabolism, and excretion/pharmacokinetic outcomes using accelerator mass spectrometry.

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Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

This review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.

The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.

A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.

The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.

With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.

Nasal drug delivery depends on many factors, including the conditions of use by the patient, the drug formulation, and the spray pump and aerosol characteristics. In recent years, the types of drug administered via the nasal route have expanded from locally acting drugs, such as those for allergic rhinitis, to delicate molecules for systemic activity, such as vaccines, proteins and peptides, which can be difficult to administer noninvasively. While the nasal cavity provides a delivery pathway for these large molecules, the rate of mucociliary clearance in the nasal cavity may hinder the extent of absorption. Therefore, formulators must develop mechanisms that improve absorption for high molecular weight compounds.

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Letting the public inside the drug development process may increase their faith in what we do.

The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.

The good, the bad, and the ugly about direct-to-consumer advertising.

An ambitious survey of characterization techniques presents current information.