Analytics

Laser diffraction is an important technique for particle size analysis. This article highlights the many advantages this tool has to offer.

Pat Survey

This article provides guidance for developing dissolution testing for poorly soluble compounds. It is the second of a series of articles based on material from a 2003 PhRMA workshop about acceptable analytical practices.

Pharmaceutical Science & Technology Innovations

Pharmaceutical Science & Technology News

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

Pharmaceutical Science & Technology News

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.

Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.

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.

This article describes the quality of highly purified water and its applications, addressing why ultrafiltration (UF) is being used as a downstream purification process. It aims to show that UV is a real alternative for producing pyrogen-free water. This method allows essential cost savings compared with distillation and guarantees a higher safety than other membrane methods such as reverse osmosis.

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In the Spotlight-Pharmaceutical Science & Technology Innovations

Emerging high-tech solutions prepare to cater to industrial automation with promises of increased efficiencies, faster communications, and custom applications.

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

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.

Pharmaceutical Science & Technology News

Pharmaceutical science and technology innovations

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.

Pharmaceutical Science & Technology Innovations

Rapid structural elucidation of compounds in complex mixtures is a powerful technique in metabolite, degradation and process control applications. The ability to follow the fragmentation pathway through sequential MSn transitions provides added confirmation and increases the selectivity for monitoring compounds of interest in a complex mixture. Previously, the limiting factors in applying this technique were sensitivity at MS4 and higher transitions, and the cycle time required to acquire multiple MSn spectra across a narrow LC peak. Recent developments in trapping, detection efficiencies and scan rates have reduced these limitations and enabled rapid characterization of multiple compounds from single chromatographic runs.

Tosoh has developed a new product - Toyopearl Toyoscreen that allows fast identification of the optimal resin for your sample. You can develop the optimal conditions for the separation in addition to the determination of the dynamic binding capacity. All the resins prepacked in these columns are real process resins concerning particle size. Results on the small columns can be scaled up to production.

Automated actuation of nasal sprays removes operator bias during measurement of particle size, spray-plume geometry, and delivered dose.

The authors outline stability studies designed to evaluate the effect of temperature excursions on product quality that may occur during distribution.

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.