How to compound omeprazole (proton pump inhibitor) tablets into a suspension?

Compounding Omeprazole Tablets into Suspension

The recommended method for compounding omeprazole tablets into suspension is to prepare a 2 mg/mL suspension using 8.4% sodium bicarbonate solution as the vehicle, with the intact tablets or pellets shaken (not crushed) to dissolve, and storing the final preparation refrigerated for optimal stability.

Preparation Method

Materials Needed:

• Omeprazole tablets or capsules containing enteric-coated pellets
• 8.4% sodium bicarbonate solution
• Amber glass bottle (to protect from light)
• Measuring devices
• Oral syringes for dispensing

Step-by-Step Procedure:

1. Calculate the required amount:

   • Standard concentration: 2 mg/mL omeprazole 1, 2, 3
   • Determine volume needed based on patient's dose and duration of therapy

2. Preparation method (shaking method preferred):

   • Place intact omeprazole tablets or open capsules containing enteric-coated pellets into a container
   • Add appropriate volume of 8.4% sodium bicarbonate solution to achieve 2 mg/mL concentration
   • Shake gently to aid dissolution - DO NOT CRUSH the pellets 2
   • Allow pellets to dissolve completely (may take 20-30 minutes with intermittent gentle shaking)
   • Transfer to amber glass bottle for dispensing

Stability Considerations

• Storage conditions:

  • Refrigeration (4°C): Stable for up to 8 weeks when prepared by shaking method 2
  • Room temperature (25°C): Stable for only 14 days when prepared by shaking method 3
  • If prepared by grinding method: Stable for only 1 week at room temperature 2

• Critical factors affecting stability:

  • Method of preparation (shaking is superior to grinding) 2
  • Storage temperature (refrigeration significantly extends shelf life)
  • Protection from light (use amber containers)
  • pH maintenance (sodium bicarbonate provides alkaline environment needed for stability)

Administration Considerations

• Dosing recommendations:

  • For pediatric patients: 0.7-3.3 mg/kg/day 4, 5
  • Shake well before each use to ensure uniform distribution
  • Administer immediately after preparation of each dose

• For nasogastric/gastric feeding tube administration:

  • Can be administered through feeding tubes positioned in the stomach 5
  • Flush tube with water before and after administration
  • Avoid administration distal to the stomach as absorption may be reduced

Important Cautions

• DO NOT use the grinding method as it significantly reduces stability (1 week vs. 4 weeks at room temperature) 2
• DO NOT store at room temperature for extended periods - refrigeration is essential for maintaining stability beyond 14 days 2, 3
• Label with appropriate beyond-use date based on storage conditions
• Include "Shake well before use" on the label
• Include "Refrigerate" on the label

Alternative Commercial Options

For patients requiring liquid omeprazole formulations, consider that some commercially prepared oral suspension formulations may be available in certain markets 6, which may provide greater consistency and stability than extemporaneously compounded preparations.