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,