Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Methods
2.2.1. Preparation of SCG Topical Formulations
2.2.2. Physicochemical Stability Studies
2.2.3. SCG Quantification by HPLC
2.2.4. Physicochemical Characterization of SCG Formulations
2.2.5. In Vitro Permeation Studies Using Franz Cells
2.2.6. In Vitro Permeation Studies Using Porcine Skin
2.2.7. Data Analysis
3. Results
3.1. Physicochemical Stability
3.2. Permeability Assays
3.3. Physicochemical Properties: Particle Size and Viscosity
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Formulation ID | SCG (%) | Propylene Glycol | Eucrinum® | Acofar Creamgel | Beeler’s Base |
---|---|---|---|---|---|
TLCG | 0.2 | - | - | Yes | - |
TLE | 0.2 | - | Yes | - | - |
TM1CG | 1 | - | - | Yes | - |
TM1BB | 1 | - | - | - | Yes |
TM2CG | 2 | Yes | - | Yes | - |
TM2BB | 2 | Yes | - | - | Yes |
Formulation | Membrane | Jss (µg/cm2/h) | Lag Time (h) |
---|---|---|---|
TM1CG | S.M. | 0.666 ± 0.123 | 0.6 ± 0.1 |
TM1BB | S.M. | 0.420 ± 0.104 | 1.1 ± 0.2 |
TM2CG | S.M. | 0.894 ± 0.25 | 0.6 ± 0.2 |
TM2BB | S.M. | 0.504 ± 0.113 | 1.1 ± 0.2 |
TM2CG | P.S. | 3.042 ± 0.487 | 0.8 ± 0.2 |
TM2BB | P.S. | 0.672 ± 0.264 | 1.2 ± 0.5 |
MV | Population 1 | Population 2 | SPAN | Viscosity (cP) * | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Formulation | D10 | D50 | D90 | Diameter (µm) | Volume (%) | Diameter (µm) | Volume (%) | |||||||||
Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | |||
TM1CG | 1.7 | 0.0 | 8.8 | 0.3 | 27.2 | 10.6 | 14.2 | 0.3 | 68.8 | 0.7 | 2.2 | 0.0 | 31.2 | 0.7 | 2.89 | 13,631 |
TM1BB | 35.3 | 0.5 | 96.0 | 2.2 | 235.5 | 3.0 | 177.9 | 1.1 | 46.2 | 1.0 | 58.6 | 0.4 | 53.8 | 1.0 | 4.89 | 19,005 |
TM2CG | 1.7 | 0.0 | 10.1 | 0.3 | 51.1 | 9.8 | 16.5 | 0.2 | 69.4 | 0.6 | 2.1 | 0.0 | 30.6 | 0.6 | 2.08 | 24,910 |
TM2BB | 23.0 | 2.8 | 80.5 | 2.2 | 231.0 | 4.8 | 165.9 | 5.9 | 50.7 | 2.2 | 39.9 | 3.6 | 49.2 | 2.2 | 2.58 | 20,030 |
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González-González, O.; Leal, E.; Martín-Martínez, M.; Bautista, L.; Ballesteros, M.P.; Torrado, J.J.; Serrano, D.R. Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance. Pharmaceutics 2023, 15, 1609. https://doi.org/10.3390/pharmaceutics15061609
González-González O, Leal E, Martín-Martínez M, Bautista L, Ballesteros MP, Torrado JJ, Serrano DR. Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance. Pharmaceutics. 2023; 15(6):1609. https://doi.org/10.3390/pharmaceutics15061609
Chicago/Turabian StyleGonzález-González, Olga, Enrique Leal, Mercedes Martín-Martínez, Liliana Bautista, Maria Paloma Ballesteros, Juan J. Torrado, and Dolores R. Serrano. 2023. "Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance" Pharmaceutics 15, no. 6: 1609. https://doi.org/10.3390/pharmaceutics15061609
APA StyleGonzález-González, O., Leal, E., Martín-Martínez, M., Bautista, L., Ballesteros, M. P., Torrado, J. J., & Serrano, D. R. (2023). Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance. Pharmaceutics, 15(6), 1609. https://doi.org/10.3390/pharmaceutics15061609