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Development and validation of analytical method for assessment of calcium dobesilate in varied hydrogel compositions

100%
Lisik A., Pilch E., Słowiak L., Musiał W.
Acta Poloniae Pharmaceutica - Drug Research
|
2018
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vol. 75
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issue 4
843-849
EN
Standardized analytical methods for testing pharmaceutical preparations are not readily available in the literature for calcium dobesilate hydrogels. The aim of the study was to develop and validate analytical method for methylcellulose gel containing calcium dobesilate as an active ingredient. Samples from dissolution experiments were assessed via HPLC with UV-VIS detector. The optimal composition of mobile phase included acetonitrile with water 1:1, acidified to 2.5 pH value. The applied column was Standard Purospher Star 18e 250 x 4.6 (5µm), and the maximum wavelength was set on 240 nm, at 25 °C. The total run time of analysis was set at 5 min and acquired retention time was 2.7 and 3.1 min for calcium dobesilate depending on the hydrogel formulation. Validity study of the method revealed that all obtained calibration curves showed good linearity (r2 > 0.9927). Linearity (100% level) was found to be 99.42, 100.12, 99.48, 99.89, 100.70, 100.08, 99.82, 100.23 for A, B, C, D, E, F, G and H formulation, respectively. Accuracy was in the range of 98-102% on three different spike levels for all eight formulations. Precision results was around 100% with RSD lower than 1% in all cases indicating that the method can be used as a validated method. Limit of quantitation (LOQ) was found to be 13.25 μg∙ml-1 for all eight formulations. The method is feasible for evaluation of hydrophilic gels with calcium dobesilate.
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The influence of hydrophylic polymers on the release rate of calcium dobesilate in hydrogel formulation assessed in vitro using porcine ear skin

88%
Wojcik-Pastuszka D., Lisik A., Twarda M., Berkowski R., Musial W.
Current Issues in Pharmacy and Medical Sciences
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2015
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vol. 28
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issue 4
225-230
EN
A shortage of available experimental data exists in the available bibliography on the release rate of calcium dobesilate (CD) from hydrogel formulations. Thus, the aim of the study was to evaluate the effect of selected hydrophilic nonionic polymers and anionic polymers on the release rate of CD from formulation provided for dermal application, as compared to the reference product in the market. The work utilized excised pork skin, while, Methylcellulose (MC), hydroxypropyl methylcellulose (HPMC), and anionic polymers (copolymers of acrylic acid) were used as CD carriers. The release study was executed by the pharmacopoeial paddle method, with extraction cells and fresh excised porcine skin as a membrane. CD in aqueous acceptor fluid was quantified by UV-VIS spectrometry at 300 nm. Subsequently, the kinetic curves were fitted to a zero-order kinetics model, a first-order kinetics model, a second-order kinetics model, as well as to the Higuchi model. The work saw that porcine ear skin influences the release pattern of the CD, compared to the artificial membrane. In the study, the evaluated formulations with MC, polyacrylic acid (PA) and polyacrylate crosspolymer 11 (PC-11) deliver over 60% of the active component (AC), within 250 min, through the excised porcine ear skin, to the acceptor compartment. Moreover, the release observed via porcine ear skin to the aqueous acceptor compartment is congenial to zero-order or first-order kinetics. In addition, the formulations prepared on the basis of MC and PA appear to control AC delivery, independently of actual concentration of AC.
3
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Effect of standard and reversible arrangements of Ph.Eur./USP extraction cells during dissolution tests of calcium dobesilate in hydrogel formulation

88%
Lisik A., Wojcik-Pastuszka D., Twarda M., Berkowski R., Musial W.
Current Issues in Pharmacy and Medical Sciences
|
2015
|
vol. 28
|
issue 2
136-142
EN
The aim of the study was to evaluate, in comparison to the reference product, the effect of the hydrophilic nonionic polymers: methylcellulose (MC) and hydroxypropyl methylcellulose (HPMC), as well as the anionic polymers - copolymers of acrylic acid, on the release kinetics of a calcium dobesilate hydrogel formulation intended for application on the skin. In this work, we used an ointment cell for the release of the active pharmaceutical ingredient (API) from the formulations. This release was performed by employing the paddle method at 100 rpm, with the extraction cells placed in the release vessels in two different positions: with the semipermeable membrane faced to the top, or to the bottom of the vessel. Released API percentage was assessed via the validated spectrophotometric method. In the study with standard placement of the ointment cell, the release rates ranged from 4.45×10-3 min-1 for a formulation containing polyacrylic acid (PA), to 6.96 × 10-3 min-1 for a formulation based on HPMC. In the group of nonionic polymers, the release rate is higher in the case of HPMC, and lower in the case of MC. In the group of anionic polymers, the release rate is higher with the formulation of a modified copolymer of acrylic acid 11 (PC11), while release from a formulation comprising a polymer PA is rather prolonged. We found that the placement of the extraction cell does not affect the alignment of the formulations investigated in terms of the release rates in the group of non-ionic formulations: HPMC > MC, and in the group of preparation of ionic polymers: PC11 > PA.
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