SOP for Preparing Lyophilized Formulations for Nasal Delivery

Standard Operating Procedure for Preparing Lyophilized Formulations for Nasal Delivery

1) Purpose

This SOP outlines the procedure for preparing lyophilized formulations intended for nasal delivery, ensuring product stability, effective delivery, and compatibility with nasal administration devices.

2) Scope

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

3) Responsibilities

Formulation Scientists: Responsible for designing the nasal lyophilized formulation and ensuring it is compatible with nasal delivery devices.
Operators: Responsible for preparing the solution and lyophilization according to the Batch Manufacturing Record (BMR).
QA: Responsible for verifying product stability and ensuring proper documentation.

4) Procedure

4.1 Preparation of Nasal Lyophilized Formulation

4.1.1 Equipment Setup

4.1.1.1 Ensure that all equipment (e.g., mixers, pH meters) is cleaned, sanitized, and calibrated before use.
4.1.1.2 Maintain aseptic conditions throughout the preparation process.

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 ingredients 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 nasal delivery vials with the filtered solution under aseptic conditions, ensuring the correct volume as per the BMR.
4.2.2.2 Freeze the filled vials at -80°C before transferring them to the lyophilizer.
4.2.2.3 Lyophilize the vials according to the parameters specified in the BMR.

4.3 Testing for Nasal Delivery

4.3.1 After lyophilization, test the reconstitution properties by spraying the reconstituted solution using the nasal delivery device to ensure uniform dispersion.
4.3.2 Measure the particle size distribution and spray pattern to confirm effective nasal delivery.

4.4 Documentation

Record all steps, including solution preparation, filtration, filling, lyophilization, and nasal delivery testing in the Nasal Lyophilized Formulations Logbook. All entries must be verified by QA personnel.

5) Abbreviations

BMR: Batch Manufacturing Record
WFI: Water for Injection

6) Documents

Nasal Lyophilized Formulations Logbook

7) References

Pharmacopoeial guidelines for nasal drug products and delivery devices

8) SOP Version

Version 1.0

Annexure

Nasal Lyophilized Formulations Logbook Template


  
    Date
    Formulation Name
    Batch No.
    Spray Pattern
    Particle Size Distribution
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Formulation Name
    Batch Number
    Spray Pattern Result
    Particle Size Result
    Operator Name
    QA Initials