Manufacturing

Pharmaceutical science and technology innovations

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

Pharmaceutical Science & Technology News

Total organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.

This article describes the formulation of a tablet for a specific purpose, primarily using fractional or full factorial designs. The formulation work generated a matrix that was processed by two software packages based on neural networks. When the dataset was divided into smaller subsets, the agreement between the predicted and observed tablet properties of the optimized formulations was reasonable.

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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 this article, the authors describe a study into the factorial effect of selected process parameters on the pharmaceutical characteristics of poly(DL-lactide-co-glycolide) microspheres containing methotrexate. A study of the microspheres' stability at refrigerated temperatures is also examined.

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

Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.

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

FDA relies on e-chips to thwart bogus products, and drops paper pedigrees and unit-of-use packaging.

pharmaceutical science and technology news

Protecting a product from temperature abuse is gaining importance as regulators seek proof of product stability throughout the distribution process.

The author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.

Electrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.

Hydrogen peroxide has become the compound of choice for gaseous biodecontamination in the pharmaceutical industry. As some processes operate at vapour concentrations below the dew point, to avoid condensation, and others actually form dew, it is important to understand the relationship between the vapours and to have a method of establishing the dew point.

Though recognized by the public since freeze-dried coffee hit the market 30 years ago, lyophilization remains far from mature and deserves more research.

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.

With new features such as servo-controlled operations and modularity, today's packaging machines offer enhanced flexibility, increased uptime, and reduced product waste.

Based on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.

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.

One of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.

Organic solvents are frequently used in the manufacture of active pharmaceutical ingredients. They have, therefore, normally also been used for process cleaning. However, a number of factors have encouraged the industry to change from solvent-based to aqueous cleaning. This article considers current cleaning practices, related issues and the author's experience of switching from one cleaning method to another.