Colorimetry as Quality Control Tool for Individual Inkjet-Printed Pediatric Formulations

Abstract

Printing technologies were recently introduced to the pharmaceutical field for manufacturing of drug delivery systems. Printing allows on demand manufacturing of flexible pharmaceutical doses in a personalized manner, which is critical for a successful and safe treatment of patient populations with specific needs, such as children and the elderly, and patients facing multimorbidity. Printing of pharmaceuticals as technique generates new demands on the quality control procedures. For example, rapid quality control is needed as the printing can be done on demand and at the point of care. This study evaluated the potential use of a handheld colorimetry device for quality control of printed doses of vitamin Bs on edible rice and sugar substrates. The structural features of the substrates with and without ink were also compared. A multicomponent ink formulation with vitamin B, B, B, and B was developed. Doses (4 cm) were prepared by applying 1-10 layers of yellow ink onto the white substrates using thermal inkjet technology. The colorimetric method was seen to be viable in detecting doses up to the 5th and 6th printed layers until color saturation of the yellow color parameter (b*) was observed on the substrates. Liquid chromatography mass spectrometry was used as a reference method for the colorimetry measurements plotted against the number of printed layers. It was concluded that colorimetry could be used as a quality control tool for detection of different doses. However, optimization of the color addition needs to be done to avoid color saturation within the planned dose interval.

Quantification of Inkjet-Printed Pharmaceuticals on Porous Substrates Using Raman Spectroscopy and Near-Infrared Spectroscopy

“…Vakili et al used near-infrared chemical imaging for content analysis of IJP theophylline using copy paper as the model substrate (10). Researchers from the same group have used a colorimetric technique for content determination of IJP propranolol with colorant added, using edible rice paper and edible icing sheets as the substrates (11) and was also used for quantitative determination of IJP vitamin B2 doses on edible rice paper and copy paper (12). More recently, a handheld near-infrared spectrometer has been reported for API quantification on the IJP dosage forms, containing levothyroxine sodium and prednisolone.…”

Application of data mining and adaptive neuro-fuzzy structureto predict color parameters of walnuts (Juglans regia L.)

“…Color measurement instruments, usually colorimeters, are used to measure the color characteristics of agricultural products (Van Roy et al, 2017). Colorimeters also use CIELab color space and these instruments are used in quality assurance applications (Wickström et al, 2017). In CIELab color space, L* represents lightness and ranges between absolute black (L* = 0) and absolute white (L* = 100).…”

Shaping the future: recent advances of 3D printing in drug delivery and healthcare

“…In fact, the use of multiple production sites adds further technical and logistic challenges, wherein it is difficult to ensure that the end-products are of consistent quality, due to the multiple variables affecting the process including different settings, hardware, raw material suppliers and operator training [3]. Thus, this instigates the need for quality control (QC) measurements, such as the use of non-destructive characterisation methods, including process analytical technologies (PAT), such as near-infrared (NIR) spectroscopy [10,110,111], Raman spectroscopy [76,112,113] or colourimetry [114,115], to monitor drug performance and ensure requirements imposed by regulatory bodies are being fulfilled.…”