Standard Operating Procedure for Preparing Lyophilized Formulations for Oral Administration

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations intended for oral administration, ensuring stability, bioavailability, and ease of ingestion.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of oral lyophilized formulations.

3) Responsibilities

• Formulation Scientists: Responsible for developing formulations that enhance oral bioavailability.
• Operators: Responsible for preparing the oral formulation as per the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the stability and proper documentation of the oral product.

4) Procedure

4.1 Formulation Design

4.1.1 Criteria for Oral Lyophilized Formulations

• 4.1.1.1 The formulation should be designed to ensure stability in the gastrointestinal tract and enhance absorption.
• 4.1.1.2 Typical excipients include solubility enhancers and disintegrants that ensure rapid release of the active ingredient.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

• 4.2.1.1 Weigh the required ingredients as specified in the BMR.
• 4.2.1.2 Dissolve the ingredients in a suitable solvent, ensuring homogeneity.

4.2.2 Filling and Lyophilization

• 4.2.2.1 Fill the solution into appropriate molds or trays and freeze before lyophilization.
• 4.2.2.2 Run the lyophilization cycle, ensuring the drying phase is optimized for oral formulations.

4.3 Testing Oral Bioavailability

• 4.3.1 After lyophilization, conduct dissolution testing to ensure the formulation dissolves within the gastrointestinal