Stability of propranolol hydrochloride suspension compounded from tablets

Area of Science:

• Pharmaceutical Sciences
• Drug Stability Studies

Background:

• Extemporaneous compounding of medications is crucial for patient-specific dosing.
• Propranolol hydrochloride is a widely used beta-blocker requiring stable formulations.
• Assessing the stability of compounded suspensions is essential for ensuring therapeutic efficacy.

Purpose of the Study:

• To evaluate the stability of propranolol hydrochloride suspensions compounded from commercial tablets.
• To determine the shelf-life of extemporaneously prepared propranolol hydrochloride oral suspensions.
• To assess the impact of storage conditions (room temperature vs. refrigeration) on suspension stability.

Main Methods:

• Propranolol hydrochloride 10-mg tablets were triturated and incorporated into a suspension vehicle (1 mg/mL theoretical concentration).
• Samples were stored at room temperature (25°C) and refrigerated (2°C) for four months.
• Propranolol hydrochloride concentration was quantified using a stability-indicating HPLC assay at various time points (0-120 days).
• pH, visual inspection for microbial growth, and ease of resuspension were also assessed.

Main Results:

• Propranolol hydrochloride concentration remained within 90% of the initial concentration throughout the 120-day study period.
• No significant changes in pH were observed.
• No visible microbial growth was detected in any of the samples.
• Ease of resuspension was maintained.

Conclusions:

• Extemporaneously compounded propranolol hydrochloride suspensions from commercial tablets are stable for at least four months.
• The suspension maintains its integrity under both room temperature and refrigerated storage conditions.
• This formulation offers a viable option for providing propranolol hydrochloride in a liquid dosage form.