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 |

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## 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)

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## Revision History

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