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