Digital UV/VIS imaging: A rapid PAT tool for crushing strength, drug content and particle size distribution determination in tablets.

The Process Analytical Technology (PAT) and the Quality-by-Design (QbD) approaches can efficiently facilitate the shift to the desired continuous manufacturing and real time release testing (RTRT). By this, it is vital to develop new, in-line analytical methods which fulfil the pharmaceutical requirements. The fast-developing digital imaging-based machine vision systems can provide revolutionary solutions not just in the automotive industry but in the pharmaceutical technology, as well. This study aimed to explore the capabilities of UV/VIS-based machine vision in tablet inspection as a PAT tool for the determination of compression force and crushing strength, drug content and drug distribution in tablets using meloxicam a yellow model drug. In the case of determining the compression force and crushing strength, the application of multivariate wavelet texture analysis (MWTA) based models provided relatively low prediction errors. To predict the drug content of meloxicam tablets CIELAB or RGB colorspace based algorithms were successfully developed and validated. UV/VIS imaging was also used to map the particle size distribution and spatial distribution of meloxicam, the results were compared to chemical maps obtained by Raman microscopy. Digital imaging combined with multivariate data analysis might be a valuable, high throughput, in-line PAT tool for automated inspection of pharmaceutical tablets.

[Current problems in the quality control of pharmaceutical preparations manufactured in pharmacies III. Investigation of theophilline containing suppositories]. / Magisztrális gyógyszerkészítmények minoségellenorzésének aktuális kérdései III. Teofillin tartalmú kúpok vizsgálata.

In the present part of our series of papers a study on theophilline containing suppositories prepared in pharmacies is described. From the possible methods for assay of theophilline two nonaqueous titrations are compared. In first, theophilline is measured as a very weak base in a mixture of glacial acetic acid and acetic anhydride with perchloric acid using Sudan-III indicator, in second, the compound is measured as medium strong acid in dimethylformamide solvent with sodium-hydroxide titrant using phenolphtalein indicator. These methods were validated and the first was found more appropriate for regulatory control. We investigated suppositories prepared in our laboratory and in different pharmacies. The study revealed the poor quality of the preparations due to the difficulties in the technology and the importance of the applied vehicle. A guideline for the good preparation practice and an alternative technology are proposed.

[Example for a new alternative application of NIR spectroscopy in the parallel determination of active ingredients and an excipient in powders and tablets]. / Példa a NIR spektroszkópia alternatív alkalmazhatóságára: porkeverékek es tabletták komponenseinek egyideju meghatározása.

Near infrared reflectance (NIR) spectroscopy was used to determine paracetamol, caffeine and lactose based excipient content of powders for direct compression and in intact tablet formulations as well. The nominal concentrations of the active moiety was different in each sample set, and calibration was carried out by multiple linear regression calculations from the reflectance spectral data. The results obtained with NIR spectroscopy were comparable with those obtained with high-performance liquid chromatography (HPLC) used as reference method. The non-destructive NIR method applied is thus suitable for the alternative quantitative determination of paracetamol, caffeine and additionally the excipient in intact tablets and have the advantage over HPLC of being rapid and can be simply carried out without sample preparation and without the use of any reagent.