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

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.

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