Dosage Forms

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.

The electronic tongue technology provides a technically suitable and cost-effective method for screening and directing taste formulation, while eliminating both safety concerns and subjective bias.

Pharmaceutical Science & Technology News

In part two of a series of three articles, mixing rates and mechanisms are examined using rectangular bin blenders and two free-flowing mixtures.

The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.

The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology Innovations

pharmaceutical science and technology news

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques.

Currently, high-production rates and continuous production processes favor existing tableting technologies. However, if tablet development becomes rate-limiting in the future, alternative technologies may prove attractive.

Some of the common problems faced by formulators and how using ion exchange resins may be able to solve them are discussed.

Recent advances in spray-drying technology have led to the production of new directly compressible lactose grades with distinct advantages.

Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets.

In this series of articles, bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures. In part 1, an introduction to tools and techniques is presented, followed by an examination of parameter effects, mixing mechanisms, and the effects of cohesion on mixing.

The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.

Pharmaceutical science and technology innovations

Bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures.

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

In spite of regulatory uncertainties, the industry continues to develop improved aseptic processing technologies.

A new active dry powder inhaler has been developed using vibration frequencies to aerosolize powders.

Dry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.

The bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.

The authors establish a quantitative framework for understanding the correlation between the segregation of pharmaceutical powders and various physical and process parameters.

This article describes the use of a one-pot processor for the cleaning and cleaning validation of two drug compounds - water-soluble theophylline and water-insoluble mebendazole. Both substances were produced using wet granulation and microwave drying, after which the processor was cleaned using its clean-in-place (CIP) system. Swab samples were taken from areas considered critical during processing and analysed for remains of active ingredient. It was concluded from the results that the processor's CIP system is capable of removing both moieties to a level well within accepted regulations.

The authors examine the development and performance of coprocessed excipients, including testing them for flowability, compressibility, amd dilution potential.

This article reflects on the challenges that predicting powder flowability currently pose to the pharmaceutical manufacturing industry and considers some of the benefits that can accrue when companies overcome these issues.

The use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.