pediatric-pharmacy/SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md

Standard Operating Procedure: Compounding Pediatric Oral Suspensions

Document ID	SOP-COMP-001
Title	Compounding Pediatric Oral Suspensions from Solid Dosage Forms
Revision	1.0
Effective Date	[DATE]
Author	[AUTHOR]
Approved By	[APPROVER]
Department	Pediatric Pharmacy - Compounding

---

1. Purpose

To establish a standardized process for compounding oral suspensions from tablets or capsules to provide age-appropriate, accurately dosed medications for pediatric patients when commercial liquid formulations are unavailable.

2. Scope

This procedure applies to non-sterile compounding of oral suspensions from solid dosage forms for pediatric patients. It covers:

• Crushing tablets or opening capsules
• Preparing suspensions in appropriate vehicles
• Flavoring for palatability
• Labeling and beyond-use dating
• Quality verification

This procedure does not apply to:

• Hazardous drugs (see USP <800> procedures)
• Sterile preparations
• Commercial liquid formulations

3. Responsibilities

3.1 Pharmacist

• Verifies formulation and calculations
• Selects appropriate vehicle and flavoring
• Determines beyond-use date
• Performs final verification
• Provides counseling on administration and storage

3.2 Pharmacy Technician

• Prepares workspace
• Compounds suspension following procedure
• Labels container appropriately
• Cleans and documents

3.3 Quality Reviewer

• Verifies calculations independently
• Checks final product
• Approves for dispensing

4. Definitions

Term	Definition
Oral Suspension	Liquid dosage form containing solid particles dispersed in liquid vehicle
Vehicle	Liquid base used to suspend active ingredient
Beyond-Use Date (BUD)	Date after which compounded preparation should not be used
Geometric Dilution	Technique for mixing small quantity with larger quantity by doubling proportions
Ora-Plus/Ora-Sweet	Common suspending vehicle and sweetening agent for pediatric suspensions

5. Equipment and Materials

5.1 Equipment

• Mortar and pestle (appropriately sized)
• Graduated cylinder (appropriate volume)
• Amber or light-resistant bottle
• Spatula
• Weighing scale (class III or better)
• Calibrated oral syringes for measuring

5.2 Materials

• Solid dosage form (tablets or capsules)
• Suspending vehicle (Ora-Plus, SyrSpend SF, methylcellulose, etc.)
• Sweetening agent (Ora-Sweet, Ora-Sweet SF, syrup, etc.)
• Flavoring (if needed)
• Appropriate label
• Compounding log

6. Procedure

6.1 Preparation and Planning

1. Review Prescription

   • Verify medication, strength, and quantity
   • Calculate total amount needed plus overage (typically 10-20%)
   • Determine final concentration
   • Check for drug-vehicle compatibility

2. Select Vehicle and Flavoring

   • Choose appropriate vehicle for medication stability
   • Consider patient age and preferences
   • Select sugar-free vehicles if appropriate (diabetic patients)
   • Choose flavoring (see Appendix A for flavor recommendations)

3. Calculate Beyond-Use Date

   • Reference stability data (published studies, manufacturers)
   • Apply USP <795> guidelines if no data available:
     • Aqueous formulations: Maximum 14 days refrigerated
     • Non-aqueous formulations: Maximum 30 days
   • Use most conservative date if multiple sources

4. Gather Materials

   • Obtain correct tablets/capsules (verify NDC)
   • Obtain vehicle and flavoring
   • Select appropriate bottle size
   • Prepare workspace

6.2 Compounding Process

1. Hand Hygiene and Garbing

   • Wash hands thoroughly
   • Don lab coat and gloves
   • No jewelry on hands/wrists

2. Clean Workspace

   • Disinfect compounding area
   • Ensure equipment is clean and dry
   • Remove unnecessary items

3. Preparation of Solid Dosage Form

   For Tablets:

   • Count correct number of tablets
   • Place in mortar
   • Crush to fine, uniform powder
   • Triturate until no large particles remain

   For Capsules:

   • Count correct number of capsules
   • Empty capsule contents into mortar
   • Discard empty capsule shells appropriately
   • Mix powder thoroughly

4. Geometric Dilution with Vehicle

   • Measure small amount of vehicle (approximately equal volume to powder)
   • Add to powder in mortar
   • Triturate to form smooth paste (no lumps)
   • Add another equal portion of vehicle
   • Mix thoroughly
   • Continue doubling portions until all powder incorporated
   • Transfer to graduated cylinder

5. Add Remaining Vehicle

   • Rinse mortar with vehicle to capture all medication
   • Transfer to graduated cylinder
   • Add vehicle to desired final volume
   • Add flavoring if using separate flavoring agent

6. Mix Thoroughly

   • Cap bottle securely
   • Shake vigorously for 30 seconds
   • Visually inspect for uniform suspension
   • No clumps or settling immediately after shaking

6.3 Quality Checks

1. Visual Inspection

   • Color appropriate for ingredients
   • Smooth consistency (no large particles)
   • Uniform suspension when shaken
   • No visible contamination

2. Volume Verification

   • Final volume matches calculated volume (±5%)
   • Adequate overage to allow for bottle hold-up

3. Concentration Verification

   • Independent pharmacist verifies calculation
   • Example: 30 tablets × 100 mg = 3000 mg in 150 mL = 20 mg/mL

6.4 Labeling

Apply pharmacy label with following information:

• Patient name and date of birth
• Medication name and strength per volume (e.g., "20 mg/mL")
• Directions for use
• "SHAKE WELL BEFORE EACH USE"
• Beyond-use date
• Storage instructions (e.g., "Refrigerate" or "Store at room temperature")
• "For Oral Use Only"
• Flavor (if added)
• Auxiliary labels as appropriate
• Pharmacist initials
• Compounding date

6.5 Final Verification

Pharmacist verifies:

• Correct medication and strength
• Accurate calculation
• Appropriate concentration for patient age and weight
• Correct labeling
• BUD appropriate
• Storage instructions clear
• Oral syringe provided for accurate dosing

6.6 Counseling Points

Provide to patient/caregiver:

• Shake well before each use
• Use provided oral syringe for measuring (never household spoon)
• Storage requirements (refrigerate if required)
• Beyond-use date
• What to do if dose missed
• Possible side effects
• Complete full course even if feeling better

6.7 Documentation

Complete compounding log with:

• Date and time
• Patient name
• Medication and strength
• Lot numbers of all ingredients
• Expiration dates of ingredients
• Calculations
• Final concentration and volume
• BUD assigned
• Compounding pharmacist/technician
• Verifying pharmacist

6.8 Cleanup

• Wash all equipment with hot soapy water
• Rinse thoroughly and dry
• Disinfect work surface
• Dispose of waste appropriately
• Return ingredients to storage

7. Common Pediatric Suspensions

Medication	Typical Concentration	Vehicle	Stability (refrigerated)
Atenolol	2 mg/mL	Ora-Plus/Ora-Sweet (1:1)	60 days
Captopril	1 mg/mL	Ora-Plus/Ora-Sweet (1:1)	56 days
Clonidine	0.1 mg/mL	Ora-Plus/Ora-Sweet SF (1:1)	91 days
Enalapril	1 mg/mL	Ora-Plus/Ora-Sweet SF (1:1)	60 days
Propranolol	1 mg/mL	Ora-Plus/Ora-Sweet (1:1)	42 days
Spironolactone	5 mg/mL	Ora-Plus/Ora-Sweet SF (1:1)	60 days

Always verify stability data from current references before compounding

8. Appendix A: Pediatric Flavoring Guide

Age Group	Preferred Flavors
Infants (< 1 year)	Minimize flavoring; consider mother's diet if breastfeeding
Toddlers (1-3 years)	Cherry, grape, bubblegum, strawberry
Children (4-12 years)	Watermelon, grape, cherry, bubblegum, chocolate
Adolescents (13-18 years)	Fruit flavors, vanilla, chocolate

Medication Type	Flavoring Recommendation
Bitter medications	Chocolate, vanilla, or cream flavors
Salty medications	Citrus or fruit flavors
Acidic medications	Fruit punch or grape

9. Related Documents

• FRM-COMP-001 Compounding Record
• Master Formulation Records (if established)
• USP <795> Pharmaceutical Compounding - Nonsterile Preparations
• Pediatric dosing references

10. References

• USP <795> Pharmaceutical Compounding - Nonsterile Preparations
• ASHP Guidelines on Compounding Sterile Preparations
• Trissel's Stability of Compounded Formulations
• Paddock Laboratories Flavoring Guide
• State Board of Pharmacy compounding regulations
• Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients (ASHP)

---

Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]