Conducting Pre-formulation Studies for Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting pre-formulation studies during the formulation development process, aiming to gather critical information about the physical and chemical properties of the active pharmaceutical ingredient (API) and excipients.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the entire pre-formulation study process from initial testing to final documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the pre-formulation study process and ensuring alignment with project objectives.
Team Members: Conducting the pre-formulation tests and analyzing the results.
Quality Assurance: Reviewing and approving the pre-formulation study documentation.

4) Procedure

4.1 Planning Pre-formulation Studies

1. Define the objectives and scope of the pre-formulation studies.
2. Select the API and excipients to be tested.
3. Develop a pre-formulation study plan, including testing methods and conditions.
4. Document the pre-formulation study plan.

4.2 Physical Characterization of API and Excipients

1. Determine the physical properties of the API and excipients, including:
   1. Particle size and distribution
   2. Solubility and dissolution rate
   3. Hygroscopicity
   4. Polymorphism
   5. Melting point and thermal behavior
2. Document the physical characterization data.

4.3 Chemical Characterization of API and Excipients

1. Determine the chemical properties of the API and excipients, including:
   1. pH and pKa
   2. Partition coefficient
   3. Stability in various conditions (e.g., temperature, humidity, light)
   4. Potential for chemical interactions
2. Document the chemical characterization data.

4.4 Compatibility Studies

1. Conduct compatibility studies to assess the interaction between the API and selected excipients.
2. Evaluate the stability and performance of the API-excipient combinations under various conditions.
3. Document the results of the compatibility studies in a compatibility assessment report.

4.5 Data Analysis and Interpretation

1. Analyze the test data to determine the suitability of the API and excipients for the intended formulation.
2. Interpret the results to identify any potential stability issues or interactions.
3. Document the analysis and interpretation in a pre-formulation study report.

4.6 Approval and Documentation

1. Submit the pre-formulation study report to senior management and quality assurance for review.
2. Obtain formal approval from senior management and quality assurance.
3. Ensure all documentation related to the pre-formulation studies is complete and accurate.
4. Store the documentation in accordance with organizational record-keeping policies.

5) Abbreviations, if any

API: Active Pharmaceutical Ingredient
SOP: Standard Operating Procedure
pKa: Acid dissociation constant

6) Documents, if any

Pre-formulation Study Plan
Physical Characterization Data
Chemical Characterization Data
Compatibility Assessment Report
Pre-formulation Study Report

7) Reference, if any

– ICH Q8: Pharmaceutical Development
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0