SOP for Preparation of Liposomal Nasal Spray Formulations

Standard Operating Procedure for Preparation of Liposomal Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to outline the process for preparing liposomal nasal spray formulations, ensuring encapsulation efficiency and stability of the liposomes.

2) Scope

This SOP applies to all personnel involved in the formulation, characterization, and testing of liposomal nasal sprays at [Company Name].

3) Responsibilities

Operators: Responsible for preparing liposomal formulations and ensuring proper encapsulation of the drug.
QA: Verifies the encapsulation efficiency and ensures the liposomal suspension meets the quality specifications.

4) Procedure

4.1 Liposome Preparation

4.1.1 Lipid Selection

Select the appropriate lipids (e.g., phospholipids, cholesterol) for the formulation.

4.1.2 Solvent Preparation

Dissolve the lipids in an organic solvent such as chloroform or ethanol.

4.1.3 Lipid Film Formation

Evaporate the organic solvent under vacuum using a rotary evaporator to form a thin lipid film.
Hydrate the lipid film with a drug-containing aqueous phase under constant stirring.

4.2 Liposome Size Reduction

4.2.1 Sonication or Extrusion

Use sonication or extrusion to reduce the size of liposomes to the desired range (e.g., 100-300 nm).

4.3 Encapsulation Efficiency Testing

4.3.1 Drug Loading

Determine the encapsulation efficiency by separating free drug from liposome-encapsulated drug using dialysis or ultracentrifugation.

4.4 Sterilization and Filling

4.4.1 Sterilization

Filter the liposomal suspension through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

Fill the sterilized suspension into nasal spray containers under aseptic conditions.

4.5 Documentation

Document all steps, including lipid types, particle size, and encapsulation efficiency in the batch manufacturing record (BMR).

5) Abbreviations, if any

QA: Quality Assurance
BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)
Encapsulation Efficiency and Particle Size Log

7) References, if any

ICH Q8(R2) – Pharmaceutical Development Guidelines

8) SOP Version

Version 1.0

Annexure

Encapsulation Efficiency and Particle Size Log Template


  
    Date
    Formulation
    Encapsulation Efficiency (%)
    Particle Size (nm)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    Efficiency
    Size
    Operator Name
    QA Name