Strategy for streamlined release identity testing of chromatography media

Afonina, N. D.; Bhattacharyya, Lokesh; Hennessey, John P.

doi:10.1039/b404899g

Cited by 7 publications

(4 citation statements)

References 9 publications

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“…Measurement of viscosity allows the fluidity of a cream to be gauged when it is actually applied by humans. These 2 techniques are a useful way to identify differences in forms of preparations [16] . The current findings suggested a correlation between assessment of physical properties and results of a sensory test, so determining a preparation’s physicochemical properties is a useful indicator of how the preparation will feel to humans [17] .…”

Section: Discussionmentioning

confidence: 99%

Evaluation of formulation properties and skin penetration in the same additive-containing formulation

Inoue

Suzuki

Maeda

et al. 2014

Results in Pharma Sciences

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The aim of this study is to examine the physicochemical properties of the external preparation, the effect on the skin permeability and the human senses. Miconazole nitrate cream formulation (MCZ-A: bland name and MCZ-B, −C, −D: generics) to measure the physicochemical properties, was performed by the skin permeation test and human sensory test. The flattening, viscoelasticity, and water content of each cream were measured and each cream was subjected to near-infrared (NIR) absorption spectroscopy and human sensory testing. The yield value was calculated based on measured flattening and was 734.8 dynes/cm2 for MCZ-A, 1198.9 dynes/cm2 for MCZ-B, 461.3 dynes/cm2 for MCZ-C and 3112.3 dynes/cm2 for MCZ-D. Measurement of viscoelasticity and viscosity revealed that MCZ-C had a smaller tanδ than the other 3 creams at 25 °C. NIR absorption spectroscopy revealed that MCZ-A had the highest absorption peak due to hydroxyl groups, followed by MCZ-C, −B, and then −D. Measurement of water content revealed that MCZ-A had a water content of 65.9%, MCZ-B, −C, and −D had a water content of around 56.3%. Human sensory testing revealed differences between MCZ-A and MCZ-C and between MCZ-B and MCZ-D in terms of spreadability and feel. These findings indicate that differences in water and oil content and emulsification resulted in the creams having different physical properties, such as flattening, internal structure, and dynamic viscoelasticity. NIR absorption spectroscopy, which allows non-destructive measurement of a sample’s physicochemical properties, and measurement of viscoelasticity and viscosity, which allows measurement of a sample’s dynamic viscoelasticity, revealed differences in the physical properties of creams. The skin permeation test, skin MCZ amount was 7.48 µg/cm2 for MCZ-A, 5.11 µg/cm2 for MCZ-B, 12.08 µg/cm2 for MCZ-C and 3.75 µg/cm2 for MCZ-D. In addition, since the drug spread is good about the skin migration, spreadability is affecting the potential dermal transfer.

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Section: Discussionmentioning

confidence: 99%

Evaluation of formulation properties and skin penetration in the same additive-containing formulation

Inoue

Suzuki

Maeda

et al. 2014

Results in Pharma Sciences

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“…In other words, differences in fl attening lead to different amounts applied by patients in clinical settings and different feel on the skin, and these variations may affect the therapeutic effectiveness of the preparation. Near-infrared absorption spectroscopy, a nondestructive method of analysis, is a useful method of identifying differences in preparations (14). As the current study indicated, differences may affect skin penetration since preparations are used on areas with a thin layer of skin, like the face, to treat conditions like acne.…”

Section: Discussionmentioning

confidence: 89%

Comparison of the Properties of Brand-Name and Generic Nadifloxacin Creams

et al. 2011

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Background and Objective. In external preparations, types and ratios of additives are not necessarily the same for brand-name drugs and generic drugs. Thus, the physicochemical properties of preparations may differ despite the fact that they contain the same ingredients or additives. This study examined differences in brand-name and generic versions of nadifloxacin (NFX) creams. Material and Methods. Three types of NFX creams (NFX-A, NFX-B, and NFX-C) were used. The viscosity of each preparation was determined, its yield value was calculated, and each preparation was subjected to light microscopy, x-ray powder diffraction, and near-infrared absorption spectroscopy. Results. Comparison of viscosity of different preparations revealed that NFX-B had a lower viscosity than NFX-A and NFX-C (14.5 vs. 24.6 and 17.9 Pa·s). NFX-B also had a lower yield value than NFX-A and NFX-C. Microscopy revealed that NFX-A and NFX-B had satisfactory emulsification although crystallization was observed with NFX-C. Near-infrared absorption spectroscopy revealed changes in the absorption spectra of NFX-B in comparison with those of NFX-A and NFX-C that were due to differences in water content and differences in fat and oil content. Conclusions. These findings confirmed that there were differences in the viscosity and flattening of NFX-A, NFX-B, and NFX-C. In addition, microscopy revealed differences in emulsification and it revealed the precipitation of NFX crystals in NFX-C. Near-infrared absorption spectroscopy revealed that differences in the type and amount of additives and water content in the creams had contributed to differences in the preparations.

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“…Differences in physical properties are surmised to cause differences in feel when ointments are actually applied. In such instances, NIR absorption spectroscopy, a non-destructive method of analysis, is a useful way to identify differences in preparations [21]. Physical assessment based on NIR absorption spectra leads to information on how preparations feel to patients and should provide indications of individual preferences.…”

Section: Discussionmentioning

confidence: 99%

Relationship between the usability and physicochemical properties of triamcinolone acetonide ointments

Inoue

Maeda

Furuya

et al. 2013

Results in Pharma Sciences

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The purpose of this study was to examine the physicochemical properties of TA ointments and conduct a human sensory test to assess the properties of those ointments. Physicochemical assessment was done via near-infrared (NIR) absorption spectroscopy, measurement of water content, microscopy, and measurement of viscoelasticity. The human sensory test examined 5 aspects (texture, cohesiveness, spreadability, smell, and feel). Three TA ointments were used: TA-A, a brand-name preparation, and TA-B and TA-C, two generics. The sensory test revealed significant differences between TA-A and TA-B and TA-C in terms of cohesiveness and spreadability. Significant differences between TA-A and TA-C and between TA-B and TA-C in terms of feel were noted. Microscopic examination revealed that TA-C had good dispersibility while TA-A and TA-B produced crystallization. NIR spectroscopy revealed differences in absorption spectra attributed to oil and water content in TAA, TA-B, and TA-C. Measurement of water content indicated water content of 0.06 ± 0.02% for TA-A, 0.08 ± 0.08% for TA-B, and 36.7 ± 1.19% for TA-C. Assessment of viscoelasticity indicated that stress decreased for all 3 ointments at 35 °C compared to that at 25 °C. TA-A and TA-B were found to have a higher percent decrease in stress than was TA-C. These findings indicate that differences in the types and content of additives caused differences in the physicochemical properties of individual ointments. In addition, differences in physicochemical properties presumably resulted in the close correlation between cohesiveness and spreadability in the sensory test.

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Strategy for streamlined release identity testing of chromatography media

Cited by 7 publications

References 9 publications

Evaluation of formulation properties and skin penetration in the same additive-containing formulation

Evaluation of formulation properties and skin penetration in the same additive-containing formulation

Comparison of the Properties of Brand-Name and Generic Nadifloxacin Creams

Relationship between the usability and physicochemical properties of triamcinolone acetonide ointments

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