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Pilot Formulation Study of Ph-sensitive Gels Cover

Pilot Formulation Study of Ph-sensitive Gels

European Pharmaceutical Journal
Volume 70 (2023): Issue s1 (December 2023)
By: T. Wolaschka,  S. Rohaľová,  I. Želinská,  Ľ. Balážová,  M. Bačkorová and  S. Kurhajec  
Open Access
|Aug 2023

Figures & Tables

Figure 1.

Appearance of formulation C940-0.1 (a) solution, (b) gel, PCP-0.225 (c) solution, (d) gel, CHM-2.5 (e) solution.
Appearance of formulation C940-0.1 (a) solution, (b) gel, PCP-0.225 (c) solution, (d) gel, CHM-2.5 (e) solution.

Figure 2.

Dissolution profiles and Korsmeyer-Peppas fitting lines of formulations C940-0.1 (○, – • –), PCP-0.225 (▲, ‒‒‒) and CHM-2.5 (□, - - -).
Dissolution profiles and Korsmeyer-Peppas fitting lines of formulations C940-0.1 (○, – • –), PCP-0.225 (▲, ‒‒‒) and CHM-2.5 (□, - - -).

Composition of polymeric solutions (in grams)_

FormulationC940PCPCHLCHMPWAA 1%
C940-0.100.100---99.900-
C940-0.700.700---99.300-
C940-1.301.300---98.700-
PCP-0.200-0.200--99.800-
PCP-0.225-0.225--99.775-
PCP-0.250-0.250--99.750-
PCP-0.300-0.300--99.700-
PCP-0.400-0.400--99.600-
PCP-0.600-0.600--99.400-
PCP-1.000-1.000--99.000-
CHL-3000--3.000--97.000
CHL-3.50.--3.500--96.500
CHM-200.---2.000-98.000
CHM-2.50---2.500-97.500
CHM-30.0---3.000-97.000

Injectability of polymeric solutions_

FormulationInjection needle diameter
0.50.60.70.8
C940-0.10++++
C940-0.70−−−−
C940-1.30−−−−
PCP-0.200++++
PCP-0.225++++
PCP-0.250++++
PCP-0.300++++
PCP-0.400++++
PCP-0.600++++
PCP-1.000++++
CHL-3000−−−−
CHL-3.50.−−−−
CHM-200.−−−−
CHM-2.50−−−−
CHM-30.0−−−−

Appearance of polymeric solutions and gels, pH of polymeric solutions, and pH of the gelation_

FormulationAppearancepH
polymeric solutiongelpolymeric solutiongelation
C940-0.10+++++3.57 ± 0.056.74 ± 0.47
C940-0.70+++++2.93 ± 0.103.01 ± 0.14
C940-1.30+++++2.66 ± 0.032.81 ± 0.02
PCP-0.200+−3.68 ± 0.02−
PCP-0.225++++3.59 ± 0.056.61 ± 0.21
PCP-0.250++++3.56 ± 0.036.02 ± 0.06
PCP-0.300++++3.39 ± 0.035.36 ± 0.30
PCP-0.400++++3.35 ± 0.044.19 ± 0.33
PCP-0.600+++3.26 ± 0.044.03 ± 0.08
PCP-1.000++3.32 ± 0.243.36 ± 0.37
CHL-3000+np4.62 ± 0.097.00 ± 0.00
CHL-3.50.+np5.05 ± 0.026.50 ± 0.00
CHM-200.++np4.33 ± 0.029.00 ± 0.00
CHM-2.50+np4.52 ± 0.016.00 ± 0.00
CHM-30.0+np4.85 ± 0.016.00 ± 0.00

Dissolution parameters of the Korsmeyer–Peppas model and released amount of the drug after 60 min dissolution_

FormulationkKPnTlagT50Q60
C940-0.1022.98 ± 4.950.31 ± 0.032.72 ± 0.2116.54 ± 05.3777.04 ± 5.94
PCP-0.22519.70 ± 2.860.24 ± 0.044.04 ± 0.2761.01 ± 20.4848.85 ± 5.74
CHM-2.5016.52 ± 3.420.39 ± 0.041.45 ± 0.6119.29 ± 04.8877.35 ± 4.98

Calculated adjusted coefficient of determination (R2adj) of different mathematical models, fitted to released data in whole dissolution time (0–60 min)_

FormulationR2adj of mathematical models
Zero orderFirst orderKorsmeyer–Peppas
C940-0.100.741 ± 0.0460.975 ± 0.0030.999 ± 0.001
PCP-0.2250.637 ± 0.0770.993 ± 0.0020.990 ± 0.003
CHM-2.500.792 ± 0.0320.956 ± 0.0080.969 ± 0.004

Process parameters of preparation for individual polymers_

PolymerPrimary stirring (rpm)Secondary stirring (rpm)Homogenization time (min)
Carbomer30033030
Polycarbophil30035045
Chitosan50070045
DOI: https://doi.org/10.2478/afpuc-2023-0005 | Journal eISSN: 2453-6725
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Language: English
Page range: 28 - 33
Submitted on: Jun 14, 2023
|
Accepted on: Jun 23, 2023
|
Published on: Aug 24, 2023
Published by: Comenius University in Bratislava, Faculty of Pharmacy
In partnership with: Paradigm Publishing Services
Publication frequency: 2 issues per year
Keywords:
in situ,
pH-sensitive,
gel,
polycarbophil,
chitosan,
carbomer 940
Related subjects:
Pharmacy,
Pharmacy, other

© 2023 T. Wolaschka, S. Rohaľová, I. Želinská, Ľ. Balážová, M. Bačkorová, S. Kurhajec, published by Comenius University in Bratislava, Faculty of Pharmacy
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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