Drug Development

Freeze pelletization is a new and simple technique for producing spherical pellets for pharmaceutical use.

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Using dimensionless analytical models, the authors establish the relationships among the essential parameters of a kneading complexation process.

FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.

By enhancing stability and in vitro drug-release characteristics, limonene enantiomers are a natural-source alternative for developing and characterizing self-nanoemulsified drug delivery systems.

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

Transdermal drug technology specialists are meeting demands for methods that can painlessly deliver larger molecules in therapeutic quantities.

Steaming-in-place (SIP) is a widely adopted method for the in-line sterilization of processing equipment. The main advantage of SIP relies on manipulation reduction and aseptic connections that might compromise the integrity of the downstream equipment.

Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.

FDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.

The process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.

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FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

Pharmaceutical Science & Technology News

The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.

Customers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.

The author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.

This article reviews various physicochemical approaches that may be employed to enhance absorption following oral administration of solid dosage forms in humans. This article also examines strategies based on capitalizing or neutralizing physiological processes.

A novel probe design can reduce the powder-sample density variance such that moisture and solvent levels can be accurately modeled and predicted in process.

A new generation of drug delivery devices is being developed. Smart skin patches, it is claimed, will provider a safer and more user-friendly method of taking medication. This article highlights some recent developments in the field and analyses some of the many benefits the patches will provide to patients.

FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.

The use of stable isotopic analyses to characterize drug products before they leave the manufacturer is explored as a means to identify counterfeit products.

The results of forced degradation studies indicate the need for alternatives to valerophenone as an internal standard calibration for quantifying ibuprofen in bulk drug and tablet assay samples.