Standard Operating Procedure for Preparation of Lyophilized Formulations for Sublingual Delivery

1) Purpose

This SOP outlines the process for preparing lyophilized formulations intended for sublingual delivery, ensuring rapid dissolution, stability, and bioavailability through the sublingual route.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products designed for sublingual delivery, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

• Formulation Scientists: Responsible for designing the sublingual lyophilized formulation for rapid dissolution.
• Operators: Responsible for preparing and lyophilizing the formulation as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying product stability and dissolution characteristics.

4) Procedure

4.1 Preparation of Sublingual Lyophilized Formulation

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment (e.g., mixers, filtration systems) is cleaned, sanitized, and calibrated before use.
• 4.1.1.2 Prepare sterile containers for the sublingual formulation and maintain aseptic conditions during preparation.

4.1.2 Solution Preparation

• 4.1.2.1 Weigh the required active ingredients and excipients using a calibrated balance according to the BMR.
• 4.1.2.2 Dissolve the active ingredient in a suitable solvent (e.g., WFI) and stir until fully dissolved.

4.2 Filtration and Filling

4.2.1 Filtration

• 4.2.1.1 Filter the prepared solution using a sterile 0.22-micron filter to remove particulates.

4.2.2 Filling and Lyophilization

• 4.2.2.1 Fill sterile vials with the filtered solution under