Elixir Department: SOP for Pre-formulation Studies of Elixirs – V 2.0

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Elixir Department: SOP for Pre-formulation Studies of Elixirs – V 2.0

Standard Operating Procedure for Conducting Pre-formulation Studies in Elixir Development

Department Elixir Department
SOP No. SOP/ELX/049/2025
Supersedes SOP/ELX/049/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standardized procedure for conducting pre-formulation studies for elixir dosage forms in order to assess the physicochemical compatibility, stability, and performance of the drug and excipients before formulation development.

2. Scope

This SOP applies to all pre-formulation activities conducted in the Elixir Department for new product development, including solubility profiling, pH-dependent behavior, compatibility studies, and viscosity evaluations.

3. Responsibilities

  • Formulation Scientist:
    • Design and execute pre-formulation studies.
    • Interpret results and document findings.
  • Analytical Development Scientist:
    • Perform supporting analysis such as assay, pH, and stability testing.
  • QA Department:
    • Review and approve reports and protocols for compliance with regulatory standards.
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4. Accountability

The Head of R&D is accountable for ensuring that pre-formulation studies are performed as per defined procedures and that results are properly evaluated before formulation initiation.

5. Procedure

5.1 Selection of Materials

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  • Collect required samples of the drug substance and proposed excipients from approved vendors.
  • Verify material identity using CoA and label information.

    • 5.2 Solubility Studies

    1. Perform solubility screening in various solvents (e.g., water, alcohol, glycerin, propylene glycol).
    2. Record solubility as:
      • Freely soluble: <1 part solvent to dissolve 1 part solute
      • Sparingly soluble: 30–100 parts solvent
      • Practically insoluble: >10,000 parts solvent

    5.3 pH Stability Profile

    1. Prepare drug solutions at different pH values (pH 3, 5, 7, 9) using appropriate buffers.
    2. Store at 25°C and 40°C for 7 days and monitor changes in color, precipitation, and assay.
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    5.4 Drug-Excipient Compatibility

    1. Prepare physical mixtures of drug and each excipient in 1:1 ratio.
    2. Store at 40°C/75% RH and 25°C/60% RH for 14 days.
    3. Analyze for physical changes, assay, and any degradation products.

    5.5 Viscosity and Rheology

    1. Evaluate the effect of excipients like glycerin and sorbitol on viscosity.
    2. Use a viscometer to measure at 25°C and record in cP (centipoise).

    5.6 Documentation and Reporting

    1. Document all data in the Pre-Formulation Study Report (Annexure-1).
    2. Prepare a summary report with conclusions and recommendations (Annexure-2).
    3. QA to review and approve before initiating formulation development.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • RH: Relative Humidity
    • CoA: Certificate of Analysis

    7. Documents

    1. Pre-Formulation Study Report (Annexure-1)
    2. Summary and Conclusion Sheet (Annexure-2)
    3. Material Verification Checklist (Annexure-3)

    8. References

    • ICH Q8 (R2) – Pharmaceutical Development
    • WHO Technical Report Series – Annex on Pharmaceutical Pre-formulation
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    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Pre-Formulation Study Report

    Parameter Observation Remarks
    Solubility in Water Sparingly soluble Requires solubilizer
    pH Stability (pH 3–9) Stable at pH 5–6 Suitable for oral liquid

    Annexure-2: Summary and Conclusion Sheet

    Study Outcome Recommendation
    Solubility Low in water, high in PG Use PG as vehicle
    Drug-Excipient Compatibility No major interaction Proceed with formulation

    Annexure-3: Material Verification Checklist

    Material Batch No. Expiry Date Verified By
    Active Ingredient A A12345 12/2026 Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Issue New SOP Creation QA Head
    11/04/2025 2.0 Included Annexures and Study Templates Standardization QA Head
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