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SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md
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SOPs/Compounding/SOP-COMP-001-Pediatric-Oral-Suspensions.md
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# Standard Operating Procedure: Compounding Pediatric Oral Suspensions
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| Document ID | SOP-COMP-001 |
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| Title | Compounding Pediatric Oral Suspensions from Solid Dosage Forms |
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| Revision | 1.0 |
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| Effective Date | [DATE] |
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| Author | [AUTHOR] |
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| Approved By | [APPROVER] |
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| Department | Pediatric Pharmacy - Compounding |
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---
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## 1. Purpose
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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.
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## 2. Scope
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This procedure applies to non-sterile compounding of oral suspensions from solid dosage forms for pediatric patients. It covers:
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- Crushing tablets or opening capsules
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- Preparing suspensions in appropriate vehicles
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- Flavoring for palatability
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- Labeling and beyond-use dating
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- Quality verification
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This procedure does not apply to:
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- Hazardous drugs (see USP <800> procedures)
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- Sterile preparations
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- Commercial liquid formulations
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## 3. Responsibilities
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### 3.1 Pharmacist
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- Verifies formulation and calculations
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- Selects appropriate vehicle and flavoring
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- Determines beyond-use date
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- Performs final verification
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- Provides counseling on administration and storage
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### 3.2 Pharmacy Technician
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- Prepares workspace
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- Compounds suspension following procedure
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- Labels container appropriately
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- Cleans and documents
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### 3.3 Quality Reviewer
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- Verifies calculations independently
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- Checks final product
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- Approves for dispensing
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## 4. Definitions
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| Term | Definition |
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|------|------------|
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| Oral Suspension | Liquid dosage form containing solid particles dispersed in liquid vehicle |
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| Vehicle | Liquid base used to suspend active ingredient |
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| Beyond-Use Date (BUD) | Date after which compounded preparation should not be used |
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| Geometric Dilution | Technique for mixing small quantity with larger quantity by doubling proportions |
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| Ora-Plus/Ora-Sweet | Common suspending vehicle and sweetening agent for pediatric suspensions |
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## 5. Equipment and Materials
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### 5.1 Equipment
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- Mortar and pestle (appropriately sized)
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- Graduated cylinder (appropriate volume)
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- Amber or light-resistant bottle
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- Spatula
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- Weighing scale (class III or better)
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- Calibrated oral syringes for measuring
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### 5.2 Materials
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- Solid dosage form (tablets or capsules)
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- Suspending vehicle (Ora-Plus, SyrSpend SF, methylcellulose, etc.)
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- Sweetening agent (Ora-Sweet, Ora-Sweet SF, syrup, etc.)
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- Flavoring (if needed)
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- Appropriate label
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- Compounding log
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## 6. Procedure
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### 6.1 Preparation and Planning
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1. **Review Prescription**
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- Verify medication, strength, and quantity
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- Calculate total amount needed plus overage (typically 10-20%)
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- Determine final concentration
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- Check for drug-vehicle compatibility
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2. **Select Vehicle and Flavoring**
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- Choose appropriate vehicle for medication stability
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- Consider patient age and preferences
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- Select sugar-free vehicles if appropriate (diabetic patients)
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- Choose flavoring (see Appendix A for flavor recommendations)
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3. **Calculate Beyond-Use Date**
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- Reference stability data (published studies, manufacturers)
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- Apply USP <795> guidelines if no data available:
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- Aqueous formulations: Maximum 14 days refrigerated
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- Non-aqueous formulations: Maximum 30 days
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- Use most conservative date if multiple sources
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4. **Gather Materials**
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- Obtain correct tablets/capsules (verify NDC)
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- Obtain vehicle and flavoring
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- Select appropriate bottle size
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- Prepare workspace
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### 6.2 Compounding Process
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1. **Hand Hygiene and Garbing**
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- Wash hands thoroughly
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- Don lab coat and gloves
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- No jewelry on hands/wrists
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2. **Clean Workspace**
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- Disinfect compounding area
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- Ensure equipment is clean and dry
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- Remove unnecessary items
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3. **Preparation of Solid Dosage Form**
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**For Tablets:**
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- Count correct number of tablets
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- Place in mortar
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- Crush to fine, uniform powder
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- Triturate until no large particles remain
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**For Capsules:**
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- Count correct number of capsules
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- Empty capsule contents into mortar
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- Discard empty capsule shells appropriately
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- Mix powder thoroughly
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4. **Geometric Dilution with Vehicle**
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- Measure small amount of vehicle (approximately equal volume to powder)
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- Add to powder in mortar
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- Triturate to form smooth paste (no lumps)
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- Add another equal portion of vehicle
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- Mix thoroughly
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- Continue doubling portions until all powder incorporated
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- Transfer to graduated cylinder
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5. **Add Remaining Vehicle**
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- Rinse mortar with vehicle to capture all medication
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- Transfer to graduated cylinder
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- Add vehicle to desired final volume
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- Add flavoring if using separate flavoring agent
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6. **Mix Thoroughly**
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- Cap bottle securely
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- Shake vigorously for 30 seconds
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- Visually inspect for uniform suspension
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- No clumps or settling immediately after shaking
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### 6.3 Quality Checks
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1. **Visual Inspection**
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- Color appropriate for ingredients
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- Smooth consistency (no large particles)
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- Uniform suspension when shaken
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- No visible contamination
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2. **Volume Verification**
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- Final volume matches calculated volume (±5%)
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- Adequate overage to allow for bottle hold-up
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3. **Concentration Verification**
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- Independent pharmacist verifies calculation
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- Example: 30 tablets × 100 mg = 3000 mg in 150 mL = 20 mg/mL
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### 6.4 Labeling
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Apply pharmacy label with following information:
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- Patient name and date of birth
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- Medication name and strength per volume (e.g., "20 mg/mL")
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- Directions for use
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- "SHAKE WELL BEFORE EACH USE"
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- Beyond-use date
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- Storage instructions (e.g., "Refrigerate" or "Store at room temperature")
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- "For Oral Use Only"
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- Flavor (if added)
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- Auxiliary labels as appropriate
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- Pharmacist initials
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- Compounding date
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### 6.5 Final Verification
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Pharmacist verifies:
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- Correct medication and strength
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- Accurate calculation
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- Appropriate concentration for patient age and weight
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- Correct labeling
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- BUD appropriate
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- Storage instructions clear
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- Oral syringe provided for accurate dosing
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### 6.6 Counseling Points
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Provide to patient/caregiver:
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- Shake well before each use
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- Use provided oral syringe for measuring (never household spoon)
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- Storage requirements (refrigerate if required)
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- Beyond-use date
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- What to do if dose missed
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- Possible side effects
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- Complete full course even if feeling better
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### 6.7 Documentation
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Complete compounding log with:
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- Date and time
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- Patient name
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- Medication and strength
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- Lot numbers of all ingredients
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- Expiration dates of ingredients
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- Calculations
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- Final concentration and volume
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- BUD assigned
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- Compounding pharmacist/technician
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- Verifying pharmacist
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### 6.8 Cleanup
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- Wash all equipment with hot soapy water
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- Rinse thoroughly and dry
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- Disinfect work surface
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- Dispose of waste appropriately
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- Return ingredients to storage
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## 7. Common Pediatric Suspensions
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| Medication | Typical Concentration | Vehicle | Stability (refrigerated) |
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|------------|----------------------|---------|--------------------------|
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| Atenolol | 2 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 60 days |
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| Captopril | 1 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 56 days |
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| Clonidine | 0.1 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 91 days |
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| Enalapril | 1 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 60 days |
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| Propranolol | 1 mg/mL | Ora-Plus/Ora-Sweet (1:1) | 42 days |
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| Spironolactone | 5 mg/mL | Ora-Plus/Ora-Sweet SF (1:1) | 60 days |
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*Always verify stability data from current references before compounding*
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## 8. Appendix A: Pediatric Flavoring Guide
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| Age Group | Preferred Flavors |
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|-----------|-------------------|
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| Infants (< 1 year) | Minimize flavoring; consider mother's diet if breastfeeding |
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| Toddlers (1-3 years) | Cherry, grape, bubblegum, strawberry |
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| Children (4-12 years) | Watermelon, grape, cherry, bubblegum, chocolate |
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| Adolescents (13-18 years) | Fruit flavors, vanilla, chocolate |
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| Medication Type | Flavoring Recommendation |
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|-----------------|--------------------------|
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| Bitter medications | Chocolate, vanilla, or cream flavors |
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| Salty medications | Citrus or fruit flavors |
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| Acidic medications | Fruit punch or grape |
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## 9. Related Documents
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- FRM-COMP-001 Compounding Record
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- Master Formulation Records (if established)
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- USP <795> Pharmaceutical Compounding - Nonsterile Preparations
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- Pediatric dosing references
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## 10. References
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- USP <795> Pharmaceutical Compounding - Nonsterile Preparations
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- ASHP Guidelines on Compounding Sterile Preparations
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- Trissel's Stability of Compounded Formulations
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- Paddock Laboratories Flavoring Guide
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- State Board of Pharmacy compounding regulations
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- Extemporaneous Formulations for Pediatric, Geriatric, and Special Needs Patients (ASHP)
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---
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## Revision History
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||||
|
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| Rev | Date | Description | Author |
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||||
|-----|------|-------------|--------|
|
||||
| 1.0 | [DATE] | Initial release | [AUTHOR] |
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