Development of Dermal Films Containing Miconazole Nitrate
Abstract
:1. Introduction
2. Results and Discussion
2.1. Products Obtained in Form of Polymeric Matrix Films
2.2. Mechanical Properties of MN Dermal Films
2.2.1. Tensile Strength and Elongation Capacity
2.2.2. Adhesive Capacity and Behaviour towards Vapour Moisture
2.3. In Vitro Availability of Miconazole Nitrate Dermal Films
2.3.1. Analysis of In Vitro Release Profiles
2.3.2. Analysis of In Vitro Release Profiles
3. Materials and Methods
3.1. Preparation of MN-Dermal Films
3.1.1. Materials
3.1.2. Films Preparation Technique
3.2. Evaluation of Physicochemical and Mechanical Parameters
3.2.1. Measurement of Physical Parameters
3.2.2. Mechanical Resistance Test
3.2.3. Stickiness (Adhesion) Test (St)
3.2.4. Water Vapour Absorption Test (Aw)
3.2.5. Water Vapour Loss by Desiccation Test (Lw)
3.2.6. Water Vapour Permeability Test (Pw)
3.3. Evaluation of Dermal films In Vitro Availability
3.3.1. Determination of In Vitro Release Profiles
3.3.2. The Release Profile
3.3.3. Kinetic of Release Modelling
3.4. Statistical Analysis
4. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Sample Availability: Samples of the compounds are not available from the authors. |
Ingredient | Code | Formula/Quantity (% m/m) | Function | ||
---|---|---|---|---|---|
FI | FII | FIII | |||
Miconazole nitrate | MN | 1.25 | 5.00 | 5.00 | Active pharmaceutical ingredient |
Hydroxyethyl cellulose 250 M | HEC | - | 3.00 | 2.00 | Film forming agent, non-ionic, water highly viscous soluble polymer |
Polyethylene glycol 400 | PEG400 | - | 1.00 | 1.00 | Permeation enhancer, solubilizer, plasticizer |
Hydroxypropyl methylcellulose 15,000 | HPMC | 1.00 | - | - | Film forming agent, non-ionic, water highly viscous soluble polymer, water retention agent |
Propylene glycol | PG | 10.00 | - | - | Humectant agent, solubilizer, plasticizer |
Polysorbate 20 | PSB20 | 1.00 | - | - | Surfactant, non-ionic, oil in water emulsifier, permeation enhancer, solubilizer |
Ethanol | - | 30.00 | 10.00 | 10.00 | Co-solvent |
Ultrapure water | - | 56.75 | 81.00 | 82.00 | Solvent |
Total | 100 | 100 | 100 |
Parameter | Dermal Film Formula | ||
---|---|---|---|
FI | FII | FIII | |
Appearance | Translucent film | Opaque film | Opaque film |
Surface | Slightly rough | Shiny smooth | Shiny smooth |
Thickness (mm ± SD 1) | 0.20 ± 0.009 | 0.30 ± 0.004 | 0.23 ± 0.007 |
MN theoretical content | |||
mg in 63.585 cm2 film: | 250 | 1000 | 1000 |
mg in 2.54 cm2 film: | 10 | 40 | 40 |
mg·cm−2: | 3.931 | 15.726 | 15.726 |
Model | Kinetic Function/Equation 1 [41] | Parameter 2 | FII | FIII |
---|---|---|---|---|
1 | First-order | 0.0071 | 0.0072 | |
0.9361 | 0.9750 | |||
2 | First-order with | 0.0516 | 0.0543 | |
−0.3832 | −0.0765 | |||
0.9848 | 0.9774 | |||
3 | First-order with | 0.0903 | 0.0374 | |
10.8379 | 21.6643 | |||
0.9872 | 0.9794 | |||
4 | First-order with and | 0.0799 | 0.0200 | |
−0.1667 | −0.3614 | |||
11.5726 | 35.9946 | |||
0.9864 | 0.9795 |
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Bîrsan, M.; Apostu, M.; Todoran, N.; Antonoaea, P.; Rusu, A.; Ciurba, A. Development of Dermal Films Containing Miconazole Nitrate. Molecules 2018, 23, 1640. https://doi.org/10.3390/molecules23071640
Bîrsan M, Apostu M, Todoran N, Antonoaea P, Rusu A, Ciurba A. Development of Dermal Films Containing Miconazole Nitrate. Molecules. 2018; 23(7):1640. https://doi.org/10.3390/molecules23071640
Chicago/Turabian StyleBîrsan, Magdalena, Mihai Apostu, Nicoleta Todoran, Paula Antonoaea, Aura Rusu, and Adriana Ciurba. 2018. "Development of Dermal Films Containing Miconazole Nitrate" Molecules 23, no. 7: 1640. https://doi.org/10.3390/molecules23071640