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Validation of Oral/Topical Liquids and Semi-Solids
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Solutions are drug active pharmaceutical ingredient(s) dissolved molecularly in a solvent system. Elixirs contain some alcohol in the solvent system and are for oral administration. Tinctures are alcohol based and are used for topical administration. Syrups, intended for oral administration, contain sugars or artificial sweeteners. The nature of properly mixed low viscosity solutions provides assurance they are uniform. Validation concerns focus on assurance of the adequacy of the mixing and bioburden. Manufacturing processes may involve premixes or “side pots” to facilitate dissolving solids. The premix is then diluted/added into a final bulk mixture that is tested and held prior to filling and packaging. Typical CPPs for the premix are evidence of dissolution (particle size) and refractive index. Excessive sampling of the premix can affect the final concentration of the bulk batch. The number and size of the samples must be considered in protocol preparation. The final mix may be sampled at any point, given the assumption of homogeneity. Syringe-based and bottle-based sampling thieves (Figure 43.1) have been developed by GlobePharma, New Brunswick, New Jersey (www.globepharma.com) to facilitate location-based sampling of low viscosity materials within final mix vessels and/or bulk holding tanks. Sample sizes for uniformity should follow the solid dosage blend edict of no more than a three-unit dose size, when possible. It is not uncommon to sample solutions from a sampling port intermittently while they are agitated. In this case, subdivision to the assay quantity must be performed in the laboratory. Primary packages are easily obtained during the course of filling and packaging operations. It is important to obtain the very first and very last containers filled to assure that these historic “problem areas” are included in the validation testing. All of the filling nozzles should be represented in sampling and testing. Bulk manufacturing CPPs include mixing speed, configuration of mixing blade, position of mixing blade, tank and /or kettle volume and geometry, pumping mechanisms and rates, temperature, pressures and pipe or hose diameters. All of these should have appropriate definition/specification and be properly measured and documented during validation. Filling should fully specify the equipment, especially the dispensing- and container-sealing systems, along with other mechanical settings. The presence of mixing and/or agitation of the bulk liquid within the filling system should be documented. Form-fill and seal-unit dose packages will require the documentation of the many parameters associated with the packaging equipment. Container crimping/capping parameters and container closure integrity should also be evaluated.
Iodine tomographic images derived from a small number of X-ray transmission measurements using material thickness distributions
Published in Journal of Nuclear Science and Technology, 2022
The PMMA distributions showed 1.1–1.3 times greater values than the theoretical ones. The solid lines for PMMA include the POM and iodine regions: the geometrical lengths of POM and iodine regions through which X-rays passed were summed up with the thickness of the PMMA. Dashed lines were drawn taking into account the densities of POM and iodine regions: the ratios of the densities of POM (1.41 gcm−3) and iodine regions (0.92 and 0.85 gcm−3 for thin and thick regions) to PMMA (1.18 gcm−3) were multiplied to the solid lines. The thick iodine region was filled with neat iodine tincture (consisting of 30 mg iodine, 20 mg KI per 1 ml solution with 70% ethanol and 30% water). The same amount of water was added to the neat iodine tincture to fill the thin iodine region. As a result, the solution of thin iodine region had higher density than the solution of thick iodine region. Although the agreements for the PMMA thickness distributions are not very good, the shapes are similar to the theoretical ones.
Potential production of biodiesel from green microalgae
Published in Biofuels, 2020
Samuel Kofi Tulashie, Siisu Salifu
A Gilson pipette was used to sample cell suspension containing iodine tincture. The hemocytometer was carefully filled by gently placing the end of the Gilson tip at the brink of the chamber. Maximum care was taken in the process not to exceed the capacity of the chamber.
Filter-based energy-resolved X-ray computed tomography with a clinical imager
Published in Journal of Nuclear Science and Technology, 2019
Tien-Hsiu Tsai, Takumi Hamaguchi, Hiraku Iramina, Mitsuhiro Nakamura, Ikuo Kanno
In Figures 5, 7, and 8, the spatial distribution of noise in each image is not uniform, and the lower part is noisier than the upper part. This can be explained by the projection data, i.e. the sinogram, after material decomposition. Figure 9 is the iodine sinogram of the case of ‘Sn/none’ and iodine tincture (A). Due to the iodine content in the contrast agent, a bright part appears at the center of the sinogram. On the right and the left, where iodine should not exist, the values are not completely zero because of detection noise. In addition, the non-zero values on the left are much more than those on the right, which results in nonuniform noise distribution in the CT image after a half-scan image reconstruction. The reason for this is considered to be the spatial variance of the X-ray beam quality. In two-channel imaging, the iodine result will be overestimated if the output of the high-energy channel is higher than expected. In other words, the noisy left part in Figure 9 may imply that the real spectrum there is harder (i.e. the energy is higher) than expected. In Sections 2.1 and 2.2, we assumed that the X-ray spectrum is spatially uniform as was obtained at the center of the detector. However, the beam quality of a real X-ray beam may be not completely uniform due to, for example, the heel effect of the X-ray tube [1,2]. For verification, we divided the detector into three parts (left, center, and right), estimated the correction factors for each part, and then performed the material decomposition separately. The resulting virtual monochromatic images are shown in Figure 10. After dividing the detector into three parts, the distribution of noise became more uniform (Figure 10(b)). Also, during the analysis, the corrected spectrum of the left part was slightly harder than that of the central part, which matches the expectation. Although the image noise in Figure 10(b) is not completely eliminated, this result demonstrates the influence of the spatially variant beam quality on the material decomposition. In practical use, dividing the detector into three parts may be insufficient. A spatially fine spectrum correction would be necessary, especially when imaging with a bowtie filter [1,2,15], which can drastically change the spatial uniformity of the beam quality. With the proposed beam-quality correction method described in Section 2.1, obtaining such fine data should be achievable within a reasonable length of time because of the reduction in required measurements.