Chemical Stability of Progesterone in Compounded Oral Rapid-dissolving Tablets.

Area of Science:

• Pharmaceutical Sciences
• Drug Stability
• Formulation Development

Background:

• Progesterone is a vital female hormone used therapeutically.
• Compounded rapid-dissolving tablets offer alternatives when commercial strengths are unavailable.
• Establishing stability is crucial for safe and effective compounded medications.

Purpose of the Study:

• To evaluate the chemical stability of compounded progesterone in rapid-dissolving tablets.
• To determine an evidence-based beyond-use date (BUD) for this formulation.
• To ensure patient safety and medication efficacy.

Main Methods:

• Progesterone rapid-dissolving tablets were prepared and diluted to 100 µg/mL in methanol.
• Samples were stored under accelerated conditions (60°C, 75% RH).
• Stability-indicating high-performance liquid chromatography (HPLC) was used to assess drug concentration at 0, 6, and 12 months.

Main Results:

• Progesterone samples remained stable for 6 months under accelerated conditions.
• Drug concentrations at 6 months were within the United States Pharmacopeia (USP) accepted limits (±10% of initial).
• The study confirmed the stability of the compounded formulation.

Conclusions:

• The compounded progesterone rapid-dissolving tablet formulation is chemically stable for at least 6 months.
• A 6-month beyond-use date is recommended for this non-aqueous formulation.
• Findings align with USP general guidelines for non-aqueous compounded preparations.