Indian researchers have developed and validated a headspace gas chromatography method for analysing residual solvents in the active pharmaceutical ingredient (API) omeprazole.
“The developed method is specific, accurate, precise and rugged as per ICH (International Conference on Harmonisation) guidelines”, researchers write in the Brazilian Journal of Pharmaceutical Sciences .
A method for using near-infrared chemical imaging (NIR-CI) to quickly estimate the concentration and distribution of the API and excipients in paracetamol has been developed. The US Pharmacopeia recommends liquid chromatography for this task but researchers claim NIR-CI has advantages.
“It is believed that using this methodology it is possible to study particle size, interferences detection, quality process, as well as, global information in the samples”, the researchers write in the Journal of Molecular Structure .
Using NIR-CI clustering of two different crystal groups was observed. Knowing how often these crystal clusters form and what impact they have on bioavailability could benefit final product quality.
UK researchers have used a modified microwave oven to formulate ibuprofen with either stearic acid or polyvinylpyrrolidone. Microwaves have been used to dry pharmaceutical products but applications in formulation have been limited by the difficulty in controlling temperature.
A modified microwave with direct temperature measurement and computerised power control was developed to overcome these problems, write researchers in AAPS Pharm SciTech . Using the oven a product was formed, although dissolution kinetics changed when polyvinylpyrrolidone was included.
Researchers in Argentina have proposed using micro-spectrometers to determine moisture content of lyophilised mannitol through intact glass. As a micro-spectrometer is relatively inexpensive the team think it could take at-line and in-line measurements as a process analytical technology (PAT).
Having tested the system researchers, writing in the Brazilian Journal of Pharmaceutical Sciences , conclude that “after minor adaptations, micro-spectrometers similar…could be readily introduced in a production environment within the PAT framework”.
Moisture content measurements were taken through the bottom of rotating glass vials using a reflective probe. Development of an effective system is reliant on researchers overcoming inferior resolution of micro-spectrometers, the low signal intensity of mannitol and glass vial reflections.