Dietary Supplements with Proline-A Comprehensive Assessment of Their Quality.

Dietary supplements are food products commonly used worldwide to obtain nutritional and physiological effects. They can contain a wide variety of active substances and can be administered for health and disease. Their use can be beneficial if justified, and their quality is adequate. Unfortunately, data on the quality of supplements is scarce. As part of this work, we assess the quality of seven dietary supplements containing proline. The preparations were produced in the EU and the USA. The quality assessment consisted of the detection of potential impurities, the determination of the content of the main ingredient, and the release of proline. The technique used to analyse impurities and proline (Pro) content was liquid chromatography coupled with tandem mass spectrometry. We detected five contaminants. The main ingredient content was in the range of 73-121% in capsules and 103-156% in tablets. Five of the seven analysed dietary supplements released below 80% Pro (for each tablet/capsule at pH 1.2). One of the supplements may be inactive because a very low release of Pro was reported. The results, we hope, will increase consumer awareness of the quality of these preparations and result in a change in the regulations governing the marketing of these preparations, at least by making release testing mandatory.

Application of Liquid Chromatography Coupled to Mass Spectrometry in Quality Assessment of Dietary Supplements-A Case Study of Tryptophan Supplements: Release Assay, Targeted and Untargeted Studies.

Dietary supplements are widely consumed in the EU and the USA. Based on their similarity to pharmaceuticals, consumers mistakenly believe that dietary supplements have also been approved for safety and efficacy. However, in the absence of mandatory testing, data on supplement quality is scarce. Thus, we applied liquid chromatography coupled with tandem mass spectrometry to analyse the quality of dietary supplements containing tryptophan (Trp). We examined 22 supplements in tablets or capsules, produced in the USA, Great Britain, Germany, France, Czech Republic, and Poland. Trp release, crucial for bioavailability and efficiency, was assessed. Additionally, we performed a qualitative analysis of the main ingredient and screened for contaminants. Among the contaminants, we detected Trp's metabolites, condensation products of Trp and carbonyl compounds, Trp degradation products, degradation products of kynurenine, and other contaminants such as glucosamine and melatonin. The main ingredient content was in the range of 55-100% in capsules and 69-87% in tablets. Surprisingly, almost no Trp release was noted from some supplements. Our study confirms the need to advance research on supplements. We believe that the high-quality analysis of supplements based on reliable analytical techniques will be an important contribution to the discussion on the regulatory framework of these products.

Embedded 3D Printing of Novel Bespoke Soft Dosage Form Concept for Pediatrics.

Embedded three-dimensional printing (e-3DP) is an emerging method for additive manufacturing where semi-solid materials are extruded within a solidifying liquid matrix. Here, we present the first example of employing e-3DP in the pharmaceutical field and demonstrate the fabrication of bespoke chewable dosage forms with dual drug loading for potential use in pediatrics. LegoTM-like chewable bricks made of edible soft material (gelatin-based matrix) were produced by directly extruding novel printing patterns of model drug ink (embedded phase) into a liquid gelatin-based matrix (embedding phase) at an elevated temperature (70 °C) to then solidify at room temperature. Dose titration of the two model drugs (paracetamol and ibuprofen) was possible by using specially designed printing patterns of the embedded phase to produce varying doses. A linearity [R2 = 0.9804 (paracetamol) and 0.9976 (ibuprofen)] was achieved between percentage of completion of printing patterns and achieved doses using a multi-step method. The impact of embedded phase rheological behavior, the printing speed and the needle size of the embedded phase were examined. Owning to their appearance, modular nature, ease of personalizing dose and geometry, and tailoring and potential inclusion of various materials, this new dosage form concept holds a substantial promise for novel dosage forms in pediatrics.