Drug-loaded vegan gummies for personalized dosing of simethicone: A feasibility study of semi-solid extrusion-based 3D printing of pectin-based low-calorie drug gummies.

Chewable gummies are an attractive dosage form for all age groups because of their appearance and texture. Although, this dosage form has been highly preferred administering nutraceuticals, its application in the pharmaceutical sector is worth exploring. In this study, simethicone (SMT), an OTC drug prescribed for anti-flatulence was incorporated in pectin- based, low-calorie, 3D printed gummies. Semi-solid extrusion (SSE)-based 3D printing was used to dispense personalized dose of SMT i.e 40 mg for children and 125 mg for adults. Formulation optimization was carried out based on the texture profile of the gummies, using a texture analyzer. The inks were thoroughly characterized for their rheological behavior since it is a critical attribute for SSE-based 3D printing. Printing parameters like the printing speed, layer height and the type of the nozzle were optimized based on the printing accuracy achieved. The printed gummies were further evaluated for their disintegration time, drug content, weight variation, water activity and total microbial count. SSE-based 3D printing was found to be an effective tool to print pectin-based shear thinning gels for accurate drug dispensing. The texture profile of the printed gummies was comparable to the gummies prepared by conventional method as well as the marketed samples.

A case study: Correlation of the nutrient composition in Chinese Hamster Ovary cultures with cell growth, antibody titre and quality attributes using multivariate analyses for guiding medium and feed optimization in early upstream process development.

In this case-study, we demonstrate an approach for identifying correlations between nutrients/metabolites in the spent medium of CHO cell cultures and cell growth, mAb titre and critical quality attributes, using multivariate analyses, which can aid in selection of targets for medium and feed optimization. An extensive LC-MS-based method was used to analyse the spent medium composition. Partial least squares (PLS) model was used to identify correlations between nutrient composition and cell growth and mAb titre and orthogonal projections to latent structures (OPLS) model was used to determine the effect of the changing nutrient composition during the culture on critical quality attributes. The PLS model revealed that the initial concentrations of several amino acids as well as pyruvic acid and pyridoxine, governed the early cell growth, while the concentrations of TCA cycle intermediates and several vitamins highly influenced the stationary phase, in which mAb production was maximum. For the first time, with the help of the OPLS model, we were able to draw correlations between nutrients/metabolites during the culture and critical quality attributes, for example, optimizing the supply of certain amino acids and vitamins could reduce impurities while simultaneously increasing desirable glycoforms. The unique correlations obtained from such an exploratory analysis, utilizing conditions that are commonly adopted in early process development, present opportunities for optimizing the compositions of the growth media and the feed media for enhancing cell growth, mAb production and quality, thereby proving to be a useful preliminary step in bioprocess optimization. Supplementary Information: The online version contains supplementary material available at 10.1007/s10616-022-00561-z.

Analytical methods for 25-hydroxyvitamin D: advantages and limitations of the existing assays.

Vitamin D plays an important role in the absorption of calcium and phosphorus, bone metabolism. Various analytical methods are being used to measure the circulating vitamin D levels in the blood. Among all vitamin D metabolites, 25 hydroxyvitamin (25(OH) D) is the most well-known member of the vitamin D family. It is available in two forms, viz. 25 hydroxyvitamin D3 (25(OH)D3) and 25 hydroxyvitamin D2(25(OH)D2). These are stable and available in ample amounts in serum and hence are the most commonly measured during estimation of vitamin D. Although, immunoassay was the most common analytical technique, it could not differentiate between 25(OH) D2 and 25(OH) D3. HPLC is another low-cost technique but lacks sufficient sensitivity for determining trace amounts of 25(OH) D2 and D3. Further, more advanced techniques like liquid chromatography-mass spectrometry have been developed to provide better specificity, higher degree of separation and identification of different forms of vitamin D. However, this technique is not very user friendly. Thus, standardization of these analytical methods in clinical and research laboratories is essential for developing and implementing evidence based clinical guidelines. This will also enable achievement of comparable results via different methods, based on diverse principles. In this manuscript, we have presented a comprehensive overview of the efforts for standardization in vitamin D assessment, along with latest advances in methods used for 25(OH) D2 and 25(OH) D3 analysis. Finally, a summary of clinical trials associated with vitamin D has been presented to discuss all the analytical methods employed for measuring 25(OH) D2 and D3.

Menthol based hydrophobic deep eutectic solvent for extraction and purification of ergosterol using response surface methodology.

Vitamin D deficiency has been linked to various diseases, but could be rectified via fortified food stuffs or supplementation. In this study 39 different hydrophobic deep eutectic solvents were evaluated for green extraction of ergosterol from mushroom. Extraction parameters (e.g. time, solvent volume) were optimized using response surface methodology (RSM) and a maximum extraction yield of 6995.00 µg ergosterol/g dry weight mushroom was attained with menthol: pyruvic acid. The extracted ergosterol was purified using a novel methodology and the extraction solvent was reused for six cycles, while retaining extraction efficiency (up to 28%). The ergosterol was exposed to ultra-violet radiation for conversion to ergocalciferol (vitamin D2) resulting in a yield of ergocalciferol that was equivalent to 2142.01 µg/g dry weight mushroom.

Penetration study of oils and its formulations into the human hair using confocal microscopy.

BACKGROUND: Laser scanning confocal microscopy (LSCM) is a nondestructive method for observing the samples in three dimensions as well in their natural environment. Therefore, it is well suited for studying human hair. This investigation is focused on evaluating the comparative penetration ability of vegetable vs mineral oils and their formulations with excipient, in human hair. AIMS: Laser scanning confocal microscopy was employed to assess thin cross sections of human hair, treated with oils and their formulations, to comprehend their penetration capability and pattern. METHODS: Hair incubated with individual oils or their formulations were labeled with the fluorescent dye was cross-sectioned into thin fragments and visualized under the LSCM. RESULTS: The mineral oil demonstrated better penetration through the hair than the vegetable oils. Combination of these oils with excipient, in an appropriate ratio, had a substantial influence on oil penetration in terms of the depth of penetration. CONCLUSIONS: Our investigation proved the suitability of fluorescent-based imaging for studying the penetration of oils across human hair. This method can be employed as a potential analytical tool to study the penetration of various hair-care formulations and/or their additives, to estimate their effects on human hair.

Curcumin-loaded hydrogel nanoparticles: application in anti-malarial therapy and toxicological evaluation.

The present investigation involved preparation of hydrogel nanoparticles using a combination of hydroxyl propyl methyl cellulose and polyvinyl pyrrolidone. The objective was to exploit the size and hydrophilic nature of the formulated nanocarriers to enhance absorption and prolong the rapid clearance of curcumin due to possible evasion of the reticulo-endothelial system. Reproducible nanoparticles of size around 100 nm, a fairly narrow distribution and encapsulation efficiency of 72%, were produced by the solvent emulsion-evaporation technique. This optimized system was further subjected to freeze-drying. The freeze-dried product was readily reconstituted with distilled water. The reconstituted product exhibited a size and distribution similar to that before freeze-drying, drug content of greater than 99% and presence of amorphous drug when analyzed by differential scanning calorimetry (DSC) which may result in possible improved absorption of curcumin. In vivo anti-malarial studies revealed significant superior action of nanoparticles over curcumin control suggesting the possibility of the formulation being employed as an adjunct anti-malarial therapy along with the standard therapy. Acute and subacute toxicity studies confirmed the oral safety of the formulation. A battery of genotoxicity studies was conducted to evaluate the nongenotoxic potential of the developed formulation thus indicating the possibility of the formulation being employed for prolonged duration.