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Topical non-aqueous nanoemulsion of Alpinia galanga extract for effective treatment in psoriasis: In vitro and in vivo evaluation

Non-aqueous nanoemulsion (NANE) of Alpinia galanga extract (AGE) was prepared using Palmester 3595 (MCT oil) as oil phase, Cremophor RH 40-Transcutol P® as surfactant-co-surfactant (Smix), and glycerin as non-aqueous polar continuous phase. The composition was optimized by applying three-level, four factor Box-Behnken design (BBD). The mean droplet size and zeta potential of the optimized AGE NANE was found to be 60.81 ± 18.88 nm and -7.99 ± 4.14 mV, respectively. The ex vivo permeation studies of AGE NANE and AGE per se on porcine skin reported flux of 125.58 ± 8.36 µg/cm2 h-1 and 12.02 ± 1.64 µg/cm2 h-1, respectively. Therefore, the enhancement ratio has shown 10-folds increase in the flux for AGE NANE when compared to extract per se. Later, confocal laser scanning microcopy confirmed that AGE NANE were able to penetrate into skin's stratum by trans-follicular transport mechanism. The stability studies of AGE NANE confirmed its stability at 30 ± 2 °C/75 ± 5 % RH and 5 ± 3 °C. The efficacy of AGE NANE was evaluated in vivo on imiquimod (IMQ) induced mouse model. The mice treated with low and high doses of AGE NANE (groups VI and VII) showed significant (p < 0.05) amelioration of psoriasis. Results of histopathology indicated reduction in psoriasis area severity index in AGE NANE treated mice (group VI and group VII).

 

Comments:

It seems like you have provided a detailed summary of a scientific study involving the preparation and evaluation of a non-aqueous nanoemulsion (NANE) of Alpinia galanga extract (AGE). Let me break down the key points of the study:

### Experimental Setup:

1. **Components Used:**
   - Palmester 3595 (MCT oil) as the oil phase.
   - Cremophor RH 40-Transcutol P® as the surfactant-co-surfactant (Smix).
   - Glycerin as the non-aqueous polar continuous phase.
   - Alpinia galanga extract (AGE) as the active ingredient.

2. **Optimization:**
   - Box-Behnken design (BBD) with three levels and four factors was applied to optimize the composition.

### Nanoemulsion Properties:

1. **Characterization:**
   - Mean droplet size of the optimized AGE NANE: 60.81 ± 18.88 nm.
   - Zeta potential of the optimized AGE NANE: -7.99 ± 4.14 mV.

### Permeation Studies:

1. **Ex Vivo Permeation:**
   - AGE NANE showed a significantly higher flux (125.58 ± 8.36 µg/cm² h⁻¹) compared to AGE alone (12.02 ± 1.64 µg/cm² h⁻¹), indicating a 10-fold increase in permeation.

2. **Mechanism of Permeation:**
   - Confocal laser scanning microscopy confirmed that AGE NANE penetrated the skin's stratum via trans-follicular transport mechanism.

### Stability Studies:

- AGE NANE was found to be stable at 30 ± 2 °C/75 ± 5 % RH and 5 ± 3 °C, indicating its potential for storage and commercial use.

### In Vivo Efficacy:

- **Animal Model:** Imiquimod (IMQ) induced psoriasis mouse model.
- **Treatment Groups:**
  - Group VI: Low dose of AGE NANE.
  - Group VII: High dose of AGE NANE.
- **Results:**
  - Significant (p < 0.05) amelioration of psoriasis observed in mice treated with both low and high doses of AGE NANE.
  - Reduction in psoriasis area severity index in AGE NANE treated mice (Group VI and Group VII).

In summary, the study demonstrates the successful formulation and optimization of a non-aqueous nanoemulsion of Alpinia galanga extract. The nanoemulsion exhibited enhanced permeation through the skin, confirmed by both ex vivo and in vivo studies, and showed promising results in treating psoriasis in a mouse model.

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