Peer-Reviewed Research

The authors propose an approach for qualification-target selection and show how it can be applied to blister-filling and packaging systems.

Hot-melt extrusion offers many advantages compared with conventional solid dosage form manufacturing, and has consequently received considerable attention from both the pharmaceutical industry and academia as a novel drug delivery technology. The possibility of forming solid dispersions with improved bioavailability renders hot-melt extrusion an excellent alternative to other conventionally employed techniques.

The authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.

The authors review the current regulatory framework for the selection of drug substance starting materials.

This review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.

The authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility.

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

The authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.

This article summarizes the classification systems for topical liquid and semisolid dosage forms used for dermatological application and notes some differences between FDA and USP classification.

Cycle design and robustness testing using advanced process analytical technology.

Criticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.

This tutorial paper is meant to aid in dielectric-sensor selection

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.

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

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

Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.

The author provides an overview of key regulatory issues facing companies seeking to market their biopharmaceutical agents globally.

The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.

Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.

The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.

The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

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).

Using a handheld Raman spectrometer, the authors developed methods for 28 commonly used excipients and active ingredients.

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.

In this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.

This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.

FDA is modernizing and streamlining current good manufacturing practices. The author examines FDA's evolving approach to quality systems and how a manufacturer can implement a quality system framework.

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.