Impact of the Preparation Method on the Formulation Properties of Allantoin Hydrogels: Evaluation Using Semi-Solid Control Diagram (SSCD) Principles
Abstract
:1. Introduction
2. Results and Discussion
2.1. The Hydrogel Evaluation Using SSCDs
2.1.1. Organoleptic Properties
Homogeneity
Color
Flow through a Tube or Cannula
Air Absence
Texture
2.1.2. Viscosity
2.1.3. Extensibility (Spreadability)
2.1.4. Loss on Drying
2.1.5. Stability through Centrifugation
2.2. SSCDs Applied for the Hydrogels’ Evaluation
- Parameter Index (PI—Table 1). It was noticed that all the gels respected the minimum admitted limit of 0.5 regarding the PI, with the formulation obtaining values higher than 0.8 for all four hydrogels.
- Parameter Profile Index (PPI—Table 1). The PPI ranged between 7.27 for M2 and 8.6 for M01. It can be noticed that the M1, M01, and M02 presented values higher than 8 of these indexes, with the only gels that received a lower score of this index being M2. Even though the hydrogels can be differentiated using this index, all four hydrogels fulfilled the average limit of 5 proposed for this index.
- Good Quality Index (GQI—Table 1). The final and most important index calculated using this method is GQI, whose limit was set at 5. The values of GQI ranged between 5.45 (M3) and 6.45 (M01), all of them respecting the minimum admitted limit of 5. It was noticed that GQI was lower in comparison to PPI, a fact that can be explained by the low value of the reliability factor of 0.75.
2.3. Penetrometry (Consistency) Study
2.4. Rheology and Flow Behavior
2.5. Drug Content Analysis Using the UV-Vis Spectrophotometric Method
3. Conclusions
4. Materials and Methods
4.1. Blank and Allantoin Gel Preparation
4.2. The Evaluation of the Proposed Hydrogel Using SSCDs
- ○
- Parametric Index (PI).PI = nr of parameters > 5/number of total parameters (5)
- ○
- nr of parameters > 5—the number of parameters that are equal to or higher than 5; the limit of acceptance is 0.5, whilst the maximum value that can be obtained is 1.
- ○
- The Parametric Profile Index (PPI) represents the average value of the radius of all parameters.
- ○
- Good Quality Index (GQI) can be calculated using the formula:GQI = PPI × f
- ○
- f = reliability factor = polygon area/circle area, which was set at f = 0.75.
4.2.1. Organoleptic Properties
4.2.2. Viscosity/Rheology/Flow Behavior
4.2.3. Extensibility (Spreadability)
4.2.4. Loss on Drying
4.2.5. Stability through Centrifugation
4.3. Penetrometry (Consistency) Study
4.4. Drug Content Analysis Using the UV-Vis Spectrophotometric Method
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Index | M1 | M2 | M01 | M02 |
---|---|---|---|---|
PI | 1 | 0.8 | 1 | 0.8 |
PPI | 8.36 | 7.27 | 8.6 | 8.5 |
GQI | 6.27 | 5.45 | 6.45 | 6.38 |
GQIa | 8.36 | 7.26 | 8.6 | 8.51 |
Ingredient | Role | Formulation Code | |||
---|---|---|---|---|---|
M01 | M02 | M1 | M2 | ||
Allantoin | Active ingredient | - | - | 1 | 1 |
Xanthan gum | Gel-forming agent | 1 | 1 | 1 | 1 |
Citric acid | Keratin softener | 1 | 1 | 1 | 1 |
Glycerol | Humectant | 5 | 5 | 5 | 5 |
Preservative solution | Preservative/Dispersion media | ad 100 | ad 100 | ad 100 | ad 100 |
Parameters/Test | Limit Values | ||
---|---|---|---|
0 | 1 | 2 | |
Homogeneity (on a glass plate) | Discontinuities that can be noticed visually (inhomogeneous dispersion) | Small discontinuities can be noticed with a microscope (partially homogenous) | No physical discontinuities can be noticed (homogenous) |
Color (visual evaluation) | Different shades can be noticed | Non-uniform parts are almost imperceptible | Uniform |
Flow through a cannula (Ø = 4.8 mm; length of 40 mm, using manual force) | Excessive force is required for flowing | Flows with difficulty | Passes smoothly |
Air absence (visual evaluation) | Air bubbles are observed by visual evaluation | Air bubbles can be noticed with the help of a microscope | Air absence through microscope visualization |
Texture (on glass) | Difficult to spread | - | It can spread properly |
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Vlad, R.-A.; Dudici, T.-C.; Syed, M.A.; Antonoaea, P.; Rédai, E.M.; Todoran, N.; Cotoi, C.-T.; Bîrsan, M.; Ciurba, A. Impact of the Preparation Method on the Formulation Properties of Allantoin Hydrogels: Evaluation Using Semi-Solid Control Diagram (SSCD) Principles. Gels 2024, 10, 58. https://doi.org/10.3390/gels10010058
Vlad R-A, Dudici T-C, Syed MA, Antonoaea P, Rédai EM, Todoran N, Cotoi C-T, Bîrsan M, Ciurba A. Impact of the Preparation Method on the Formulation Properties of Allantoin Hydrogels: Evaluation Using Semi-Solid Control Diagram (SSCD) Principles. Gels. 2024; 10(1):58. https://doi.org/10.3390/gels10010058
Chicago/Turabian StyleVlad, Robert-Alexandru, Teodora-Cătălina Dudici (Vlăgea), Muhammad Ali Syed, Paula Antonoaea, Emöke Margit Rédai, Nicoleta Todoran, Cornelia-Titiana Cotoi, Magdalena Bîrsan, and Adriana Ciurba. 2024. "Impact of the Preparation Method on the Formulation Properties of Allantoin Hydrogels: Evaluation Using Semi-Solid Control Diagram (SSCD) Principles" Gels 10, no. 1: 58. https://doi.org/10.3390/gels10010058