Dear Rishabh,

The factors to be considered are:

1-Vaginal Secretions: The vaginal discharge is a mixture of multiple secretions that collect in the vagina from peritoneal, follicular tubal, uterine, Bartholin's and Skene's glands. In presence of moisture, solid dosage formulations should ideally disperse in the vaginal canal immediately after insertion to avoid inconvenience to the users.

2-Enzyme Activity: The specific enzymatic activity of four different amino peptidases in vaginal homogenates decreases in the order: sheep > guinea pig > rabbit ≥ human ≥ rat . The human genital tract has lower enzymatic activity leading to less degradation of protein and peptide drugs in the vagina than the gastrointestinal tract .

3-Vaginal pH: The pH of the healthy female genital tract is acidic (pH 3.5–4.5) and is maintained within that range by bacterial conversion of glycogen from exfoliated

epithelial cells to lactic acid  The pH changes with age, stage in the menstrual cycle, infections, estrogen levels and variations in the levels of cervical mucus. The

control of vaginal pH is a critical factor for successful vaginal delivery of drugs.

The change in hormone levels with age, during intercourse and various phases of the menstrual cycle leads to alteration in vaginal secretion, pH, enzyme activity as well as changes in the thickness and permeability of the epithelium all of which complicate the problem of achieving consistent drug delivery.

For more information, see attached file.

Hoping this will be helpful,

Rafik

Risk involved is great

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