Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Plan of Reformulation
2.3. Preparation of the Samples
2.4. Methods
2.4.1. Microbiological Quality of Non-Sterile Pharmaceutical and Cosmetic Preparations for Dermal Use
- Pseudomonas aeruginosa;
- Staphylococcus aureus;
- Aspergillus brasiliensis; and
- Candida albicans.
2.4.2. Rheological and pH Measurements
2.4.3. Hydration and Transepidermal Water Loss Tests
2.4.4. Statistical Analysis
3. Results and Discussion
3.1. Reformulation Phase 1
3.2. Reformulation Phase 2
3.3. Reformulation Phase 3
4. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Component | Concentration [w/w%] | Function |
---|---|---|
Phase A | ||
Polysorbate 60 | 4 | nonionic o/w emulsifier |
Liquid paraffin | 4 | oil phase and consistency softener |
Cetostearyl alcohol | 12 | nonionic w/o emulsifier and consistency-increasing agent |
White petrolatum | 20 | base of the cream |
Phase B | ||
Purified water | 58 | water phase of the cream |
Phase C | ||
Methyl parahydroxybenzoate | 0.2 | preservative |
Ethanol 96% | 1.8 | solvent of preservative |
Not Infected | Pseudomonas aeruginosa | Staphylococcus aureus | Aspergillus brasiliensis | Candida albicans | Mixed 25–25% Reinfected | |
---|---|---|---|---|---|---|
Control A | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 1.75 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 1 × 105 | 1 day: 2 × 105 | 1 day: 1 × 105 | 1 day: 7 × 104 | 1 day: 1.2 × 105 | |
1–6 weeks: 0 | 1–6 weeks: 2 × 101 | 1–6 weeks: 6 × 104 | 1–6 weeks: 3 × 103 | |||
Control B | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 1.75 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 1 × 105 | 1 day: 2 × 105 | 1 day: 1 × 105 | 1 day: 7 × 104 | 1 day: 1.2 × 105 | |
1–6 weeks: 0 | 1–6 weeks: 2 × 101 | 1–6 weeks: 6 × 104 | 1–6 weeks: 3 × 103 |
Not Infected | Pseudomonas aeruginosa | Staphylococcus aureus | Aspergillus brasiliensis | Candida albicans | Mixed 25–25% Reinfected | |
---|---|---|---|---|---|---|
Sample1 A | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | |
Sample1 B | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | |
Sample2 A | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 1.75 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day: 4 × 104 | 1 day: 1 × 105 (Candida!) | |
1–6 weeks: 2 × 104 | 1–6 weeks: 1 × 103(Candida!) | |||||
Sample2 B | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 1.75 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day: 4 × 104 | 1 day: 1 × 105 (Candida!) | |
1–6 weeks: 2 × 104 | 1–6 weeks: 1 × 103(Candida!) | |||||
Sample3 A | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | |
Sample3 B | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | |
Sample4 A | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | |
Sample4 B | Initial time: 0 | Initial time: 2 × 105 | Initial time: 3 × 105 | Initial time: 1 × 105 | Initial time: 1 × 105 | Initial time: 2–3 × 105 |
1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 | 1 day–6 weeks: 0 |
Components | Original Cream [w/w %] | Composition 1 [w/w %] | Composition 2 [w/w %] | Composition 3 [w/w %] | Composition 4 [w/w %] |
---|---|---|---|---|---|
Phase A | |||||
Polysorbate 60 | 4 | 4 | 4 | 4 | 4 |
Liquid paraffin | 4 | - | - | - | - |
Cetostearyl alcohol | 12 | 12 | 12 | 12 | 12 |
White petrolatum | 20 | - | - | - | - |
Sunflower oil | - | 4 | 4 | 4 | 8 |
White beeswax | - | 20 | 15 | 10 | 5 |
Phase B | |||||
Purified water | up to 100 | up to 100 | up to 100 | up to 100 | up to 100 |
Phase C | |||||
Methyl parahydroxy-benzoate | 0.2 | - | - | - | - |
Ethanol 96% | 1.8 | - | - | - | - |
Phenoxyethanol | - | 0.5 | 0.5 | 0.5 | 0.5 |
Rheological Data | Original Cream | Composition 1 | Composition 2 | Composition 3 | Composition 4 |
---|---|---|---|---|---|
η100 (Pa *s) | 4.07 ± 0.31 | 3.38 ± 0.50 | 2.84 ± 0.27 | 3.26 ± 0.08 | 3.98 ± 0.15 |
SR Pa s−s mL−1 | 39,639 ± 4631 | 21,028 ± 6683 | 21,973 ± 2593 | 26,504 ± 6561 | 18,341 ± 4618 |
Original Cream | Composition 1 | Composition 2 | Composition 3 | Composition 4 |
---|---|---|---|---|
4.52 | 4.81 | 4.76 | 4.89 | 4.88 |
Components | Original Cream [w/w%] | Composition 5 [w/w%] | Composition 6 [w/w%] | Composition 7 [w/w%] | Composition 8 [w/w%] |
---|---|---|---|---|---|
Phase A | |||||
Polysorbate 60 | 4 | 4 | 4 | 4 | 4 |
Liquid paraffin | 4 | - | - | - | - |
Cetostearyl alcohol | 12 | 6 | 12 | 6 | 12 |
White petrolatum | 20 | - | - | - | - |
Sunflower oil | - | 4 | 4 | 4 | 4 |
White beeswax | - | 10 | 10 | 10 | 8 |
Cocoa butter | - | 6 | - | 6 | 8 |
Phase B | |||||
Urea | - | - | 1 | 1 | - |
Glycerol (85%) | - | - | - | - | 5 |
Purified water | up to 100 | up to 100 | up to 100 | up to 100 | up to 100 |
Phase C | |||||
Methyl parahydroxy-benzoate | 0.2 | - | - | - | - |
Ethanol 96% | 1.8 | - | - | - | - |
Phenoxyethanol | - | 0.5 | 0.5 | 0.5 | 0.5 |
Rheological Data | Original Cream | Composition 5 | Composition 6 | Composition 7 | Composition 8 |
---|---|---|---|---|---|
η100 (Pa*s) | 4.07 ± 0.31 | 1.94 ± 0.12 | 3.54 ± 0.38 | 2.11 ± 0.14 | 3.50 ± 0.05 |
SR Pa s−s mL−1 | 39,639 ± 4631 | 11,696 ± 643 | 24,218 ± 2811 | 6051 ± 28 | 15,698 ± 1104 |
Original Cream | Composition 5 | Composition 6 | Composition 7 | Composition 8 |
---|---|---|---|---|
4.52 | 4.65 | 5.07 | 5.02 | 4.60 |
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Kovács, A.; Péter-Héderi, D.; Perei, K.; Budai-Szűcs, M.; Léber, A.; Gácsi, A.; Csányi, E.; Berkó, S. Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care. Pharmaceutics 2020, 12, 729. https://doi.org/10.3390/pharmaceutics12080729
Kovács A, Péter-Héderi D, Perei K, Budai-Szűcs M, Léber A, Gácsi A, Csányi E, Berkó S. Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care. Pharmaceutics. 2020; 12(8):729. https://doi.org/10.3390/pharmaceutics12080729
Chicago/Turabian StyleKovács, Anita, Dóra Péter-Héderi, Katalin Perei, Mária Budai-Szűcs, Attila Léber, Attila Gácsi, Erzsébet Csányi, and Szilvia Berkó. 2020. "Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care" Pharmaceutics 12, no. 8: 729. https://doi.org/10.3390/pharmaceutics12080729
APA StyleKovács, A., Péter-Héderi, D., Perei, K., Budai-Szűcs, M., Léber, A., Gácsi, A., Csányi, E., & Berkó, S. (2020). Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care. Pharmaceutics, 12(8), 729. https://doi.org/10.3390/pharmaceutics12080729