14 Chapter 14: Adaptation of Formulation Records

Formulation records need to be evaluated regularly to ensure quality and safety of the compounded preparation. These changes need to be made by regulated pharmacy personnel with adequate experience and broad scientific knowledge.  Follow Provincial regulations as not all provinces allow pharmacy technicians to create or modify Master Formulation Records.  When changes are made, they need to be updated using appropriate references and rationale for the change.  All compounding personnel need to be informed of these changes.

Reasons for Adapting Formulation Records Pharmacy Compounding

1. Customization for Patient Needs

• Allergy or Sensitivity Considerations
  • Removal of allergens (e.g., lactose, gluten, dyes, preservatives).
  • Substitution with alternative excipients.
• Dose and Strength Modifications
  • Adjusting formulations for pediatric, geriatric, or special-needs patients.
  • Personalized hormone therapy or pain management compounds.
• Alternative Dosage Forms
  • Creating liquid suspensions for patients who cannot swallow tablets.
  • Converting oral medications into topical or transdermal formulations.

2. Availability of Ingredients

• Substituting unavailable or discontinued ingredients while ensuring bioequivalence.
• Ensuring pharmaceutical-grade excipients are used in place of non-compendial alternatives.

3. Stability and Compatibility Adjustments

• Reviewing data from stability studies and modifying storage conditions or BUDs.
• Reformulating to improve compatibility with APIs and excipients.

Examples of Formulation Adaptation:

•  Use of improved technique or superior technology or equipment, e.g., use of electronic mortar and pestle (EMP), ointment mill
•  Use of superior ingredients, e.g., reduced settling and increased redispersion with Suspendit vs OraPlus; use of Diffusimax-10 vs Diffusimax for high concentrations of diclofenac or other APIs

Challenges in Adapting Formulation Records

1. Lack of Comprehensive Stability Data

• Many compounded medications lack extensive long-term stability testing.
• Pharmacists rely on USP guidelines, supplier recommendations, and published literature.

2. Regulatory and Documentation Burden

• Adapting a formulation requires extensive documentation and justification.
• Provincial regulators may require audits and approval before modifications.

3. Quality Control and Verification

• In-house testing (e.g., pH, viscosity, particle size) may be required.
• Third-party testing for potency and sterility in sterile compounding settings.

Best Practices for Formulation Record Adaptation

1. Follow a Standardized Process

• Use validated references (e.g., USP, BC Cancer Drug Manual, SickKids Formulary).
• Ensure compliance with provincial and national guidelines.

2. Document Every Change

• Justify ingredient substitutions with scientific or regulatory support.
• Update Beyond-Use Dating (BUD) based on stability data.

3. Conduct Quality Control Checks

• Perform pH testing, particle size evaluation, and microbial testing when needed.
• Maintain batch records and documentation for audits.

4. Collaborate with Healthcare Providers

• Ensure formulation adaptations align with prescriber intent and patient safety.
• Communicate any limitations or risks of modifications.