A Simplified Extemporaneously Prepared Potassium Chloride Oral Solution

Area of Science:

• Pharmaceutical Sciences
• Clinical Pharmacy
• Pediatric Formulations

Background:

• Commercial oral potassium chloride solutions are not always available.
• Pediatric outpatients requiring liquid potassium supplements face challenges when commercial preparations are out of stock.
• Limited data exists on the stability of extemporaneously prepared potassium chloride oral solutions.

Purpose of the Study:

• To formulate an extemporaneous pediatric oral solution of potassium chloride.
• To assess the physical and chemical stability of the prepared potassium chloride oral solution.
• To establish a reliable beyond-use date for the extemporaneous formulation.

Main Methods:

• A 1 mMoL/mL potassium chloride oral solution was prepared using 14.9% potassium chloride and Ora-Sweet SF.
• The solution was stored under refrigeration (2°C to 8°C) in amber glass bottles.
• Stability was evaluated by measuring potassium concentration, pH, and microbial overgrowth over 28 days.

Main Results:

• The oral potassium chloride solution maintained over 91% of its initial concentration for 28 days.
• No significant changes in pH were observed during the study period.
• The solution remained physically stable with no evidence of microbial contamination.

Conclusions:

• An extemporaneously prepared oral potassium chloride solution (1 mMoL/mL) in Ora-Sweet SF is stable for 28 days when stored refrigerated (2°C to 8°C).
• This formulation provides a viable alternative for pediatric patients needing oral potassium supplementation when commercial products are unavailable.
• The study provides evidence to support assigning a 28-day beyond-use date for this extemporaneous preparation.