The specification of the drug in the form of dermatological ointment provides for pH measurement to be performed by potentiometric method (FP XI)-Polish Pharmacopoeia 11-th edition, 2017 by direct immersion of a glass electrode in a semi-solid dosage form [26 ]. An InLab Expert Pro-ISM electrode (Part No. 30014096, Mettler-Toledo AG, Greifensee, Switzerland) was used for the examination. The measurements were taken for the ointment formulation: Glycerol ointment (F-control), ointment containing respectively15 mg/g ACTH, 20 mg/g ACTH and 25 mg/g ACTH at the temperature 25.0 ± 0.5 °C, assumed at the storage or application temperature of the preparations on the skin. Each measurement was carried out five times and average pH was calculated. pH values are presented as the mean ± standard deviation (SD).
Inlab expert pro ism electrode
Manufactured by Mettler Toledo
Sourced in Switzerland
The InLab® Expert Pro-ISM electrode is a high-quality pH electrode designed for laboratory applications. It features an integrated temperature sensor and is suitable for a wide range of measurements in various sample types. The electrode provides reliable and accurate pH readings to support scientific research and analysis.
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5 protocols using inlab expert pro ism electrode
1
Potentiometric pH Measurement of ACTH Ointments
2
Reconstitution and Characterization of SPIONs
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To reconstitute the SPIONs from the electrospun products and reference dry products (i.e., oven-dried and lyophilized products), 10 mL of purified water was added to the sample (~10 mg) in a 20 mL glass vial and mixed well by 3 min vortex mixing. The dispersion was visually inspected to confirm the reconstitution. Next, the hydrodynamic size and zeta potential of SPIONs were evaluated, as described in Section 2.3 . The short-term physical stability of the SPION dispersions after reconstitution was evaluated by measuring the hydrodynamic size and zeta potential of SPIONs every 30 min in the first hour after the reconstitution. The pH value of the reconstituted SPION dispersions was measured with the pH meter SevenCompactTM pH/Ion S220 equipped with InLab® Expert Pro-ISM electrode (Mettler-Toledo; Greifensee, Switzerland). All reconstitution experiments were performed in triplicates, and the results are expressed as an average with the corresponding standard deviation.
Additionally, a drop of the reconstituted SPION dispersion was placed on a carbon-coated copper TEM grid, air-dried at room temperature, and evaluated by transmission electron microscopy (TEM; Jem 2100; Jeol, Akishima, Japan). TEM imaging was performed using an accelerating voltage of 200 kV.
Additionally, a drop of the reconstituted SPION dispersion was placed on a carbon-coated copper TEM grid, air-dried at room temperature, and evaluated by transmission electron microscopy (TEM; Jem 2100; Jeol, Akishima, Japan). TEM imaging was performed using an accelerating voltage of 200 kV.
3
Bortezomib Stability in Aqueous Solutions
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An excess of bortezomib (10 mg) was added to 2 mL of acidic or basic aqueous solutions and titrated to the desired pH using 200 mM HCl and NaOH. The experiment was repeated using 500 mM aqueous D-mannitol. D-Mannitol dilution was minimal due to the use of 200 mM HCl and NaOH needed for pH adjustments. Each sample was left in an orbital shaking incubator at 25 C and 50 rpm, over 24 h. The second day aliquots of 1 mL were taken, placed in 2 mL polypropylene tubes, and centrifuged at 13,200 rpm for 10 min at 25 C, using a Hettich Mikro 22R cooling centrifuge with fixed-angle rotor 1153 (LabMakelaar Benelux BV, Zevenhuizen, The Netherlands). The supernatant, 400 mL, of each sample was taken and placed in a 2 mL polypropylene tube. The pH of these solutions was monitored with a Mettler Toledo pH meter model SevenExcellence™ combined with a Mettler-Toledo InLab® Expert Pro-ISM electrode (Milan, Italy). Each aliquot was then diluted with purified water. Each sample was then analyzed by HPLC as described above.
4
Reconstitution and Characterization of Electrospun MNPs
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After the drying of MNP dispersions via electrospinning, the reconstitution of MNPs was performed as follows. The dry product (~10 mg) was weighed into 20 mL glass vial and 10 mL of 0.9 % (w/v) NaCl solution was added. The sample in the glass vial was mixed well by a vortex mixer for 3 min to achieve the reconstitution, which was confirmed by a visual inspection of the sample. After the reconstitution, the samples were diluted to the final concentration of 0.1 mg MNPs/mL with 0.9 % (w/v) NaCl solution, and average hydrodynamic size and zeta potential were determined (Zetasizer Ultra, Malvern Panalytical Ltd.; Worcestershire, UK). The hydrodynamic size, size distribution, and zeta potential of MNPs were expressed relative to values measured fot MNPs in the initial dispersions diluted with 0.9 % (w/v) NaCl solution.
To assess the short-term physical stability of the MNP dispersion after reconstitution, the measurements of hydrodynamic size and zeta potential were performed every 15 min in the first hour after the reconstitution. The pH value of the dispersions right after the reconstitution of MNPs was measured with pH meter SevenCompact TM pH/Ion S220 equipped with InLab® Expert Pro-ISM electrode (Mettler-Toledo; Greifensee, Switzerland). All experiments were performed in triplicates.
To assess the short-term physical stability of the MNP dispersion after reconstitution, the measurements of hydrodynamic size and zeta potential were performed every 15 min in the first hour after the reconstitution. The pH value of the dispersions right after the reconstitution of MNPs was measured with pH meter SevenCompact TM pH/Ion S220 equipped with InLab® Expert Pro-ISM electrode (Mettler-Toledo; Greifensee, Switzerland). All experiments were performed in triplicates.
5
Stability Testing of Insulin Hydrogels
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Hydrogels stability was tested by the stability test of biotechnological/biological products under conditions specified by ICH, Q5C: 25 ± 1 °C and 5 ± 3 °C. The samples were stored for 4 weeks [27 (link)]. Hydrogels were controlled by visual examination, drug content, pH, and viscosity. The pH of hydrogels was tested with the SevenCompactTM S210 device (Mettler Toledo, Switzerland) using the InLab®Expert Pro–ISM electrode with a solid polymeric electrolyte (Mettler Toledo, Switzerland). The measurement accuracy was ±0.01 pH. The analysis for color, homogeneity, and phase separation was performed in daylight in glass beakers placed against a white matte background [24 ]. The amount of insulin was determined by spectrophotometry using a CECIL apparatus (CE 3021, Cambridge, United Kingdom) at a wavelength λ = 271 nm. Rotational rheometry was used for viscosity tests using the Lamy RM 200 Touch laboratory rheometer (Lamy Rheology Instruments, Champagne au Mont d’Or, France) equipped with the MK-CP 2445 measuring system and the CP-1 Plus laboratory thermostat. All prepared formulations were found to be stable. API content was within the acceptable limit of 90% of the initial value [28 ].
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