Independent Third-Party Testing

Franz Cell Diffusion Study
HINNAO High-Stability Liposomal Glutathione

An independent absorption study conducted by CC Research (P) Ltd. using the Franz Cell Diffusion method with HPLC analysis, measuring the percentage of glutathione diffused through biological mucosal membrane under physiological conditions.

82.63%
Absorbed at 90 seconds
79.82%
Absorbed at 60 seconds
37°C
Physiological temperature
0.998
Linearity correlation coefficient
Study Design

Methodology

The study used a vertical Franz-type diffusion cell with a biological sheep mucosal membrane, replicating the conditions of sublingual absorption in the human buccal cavity. Samples were collected at 10-second intervals from 0 to 90 seconds and analysed by High-Performance Liquid Chromatography (HPLC).

Materials

  • PBS buffer solution (pH 7.4)
  • Franz diffusion apparatus
  • Sheep mucosal membrane
  • HPLC instrument
  • Syringe

HPLC Conditions

ColumnINERTSIL ODS C18 150×4.6mm
Wavelength215 nm
Flow rate0.8 ml/min
Injection vol.10 µl
Mobile phaseAcetonitrile:water (50:50)

Cell Parameters

Temperature37°C ± 1°C
Stirring50 rpm
Receptor vol.60 ml
Diffusion area10.18 cm²
Sample dose5 ml at 1 mg/ml
Table 1 — D50 Diffusion Results

Absorption Over Time

Percentage of glutathione diffused through biological mucosal membrane at each time point.

0s
 
0%
10s
28.95%
28.95%
20s
29.95%
29.95%
30s
30.63%
30.63%
40s
54.06%
54.06%
50s
56.60%
56.60%
60s
79.82%
79.82%
70s
80.06%
80.06%
80s
80.29%
80.29%
90s
82.63%
82.63%
Table — Flux Values

Flux and Permeation Data

Flux (J) measures the rate of glutathione permeation through the mucosal membrane per unit area. Higher flux values indicate faster and more efficient delivery into systemic circulation.

Time (sec) Dose (mg/ml) Concentration % Drug Release Flux
102005038.0625.95%66.99
202005131.7628.29%136.48
302005225.4630.64%208.46
402006162.4554.06%327.79
502006264.4056.61%416.52
602007193.0479.83%573.91
702007202.4080.06%670.44
802007211.6780.29%767.20
902007305.2882.63%874.30
Table 3 — Linearity Results

HPLC Linearity Verification

Five concentration levels of L-glutathione were tested to confirm a linear relationship between concentration and HPLC peak area. A correlation coefficient at or above 0.99 is required for analytical validity.

20 ppm
26,979
Level I
40 ppm
46,891
Level II
60 ppm
66,745
Level III
80 ppm
88,889
Level IV
100 ppm
109,990
Level V
Correlation coefficient: R² = 0.998  —  exceeds the 0.99 acceptance threshold
Study Conclusion

What the data confirms

HINNAO High-Stability Liposomal Glutathione demonstrated rapid and high-efficiency permeation through biological mucosal membrane under physiological conditions. Absorption reached 79.82% at 60 seconds and 82.63% at 90 seconds, confirming that the liposomal delivery system enables near-immediate systemic availability of glutathione via the buccal mucosa.

This is clinically significant for glutathione specifically, as the molecule is a fragile tripeptide that is rapidly degraded by digestive enzymes in standard oral formats. The Franz Cell data confirms that HINNAO's sublingual liposomal technology protects the molecule and delivers it intact, bypassing hepatic first-pass metabolism entirely.

The HPLC linearity study returned a correlation coefficient of 0.998, confirming full analytical validity of the measurement method across all tested concentration levels.

Analysis conducted by: CC Research (P) Ltd.  |  20 White Church Lane, London, E1 7QR
Commissioned by: HINNAO Technology
Method: Franz Cell Diffusion Study with HPLC Analysis  |  Membrane: Sheep mucosal membrane  |  Temperature: 37°C ± 1°C

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