Standard Operating Procedure for Formulating Nanoparticles for Pulmonary Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles for pulmonary drug delivery, where the formulation is optimized for inhalation and targeting the lungs, ensuring rapid drug absorption and minimal systemic exposure.
2) Scope
This SOP applies to personnel responsible for the preparation and characterization of nanoparticles designed for pulmonary delivery via inhalation routes.
3) Responsibilities
- Operators: Responsible for the formulation of nanoparticles for pulmonary drug delivery as per this SOP.
- QA: Ensures that the nanoparticles meet size, stability, and aerodynamic requirements for inhalation.
4) Procedure
4.1 Selection of Materials
4.1.1 Polymer or Lipid Selection
- 4.1.1.1 Select suitable materials for nanoparticle formulations for pulmonary delivery, such as biodegradable polymers (PLGA) or lipids (lecithin).
4.2 Nanoparticle Preparation
4.2.1 Solvent Evaporation or Nanoprecipitation Method
- 4.2.1.1 Prepare nanoparticles using either the solvent evaporation or nanoprecipitation method, optimizing the formulation for particle size suitable for inhalation (100–300 nm).
4.3 Spray Drying for Powder Formulation
4.3.1 Conversion to Dry Powder
- 4.3.1.1 Use a spray drying process to convert the nanoparticle suspension into a dry powder suitable for pulmonary delivery.
4.4 Aerodynamic Particle Size Measurement
4.4.1 Cascade Impactor
- 4.4.1.1 Measure the aerodynamic particle size distribution using a cascade impactor to confirm that the nanoparticles are suitable for inhalation and can deposit in the lung’s alveolar regions.
4.5 Drug Loading and Release Studies
4.5.1 Drug Incorporation
- 4.5.1.1 Incorporate the therapeutic agent (e.g., antibiotics, steroids) during nanoparticle formation or through post-loading techniques.
4.5.2 In Vitro Release
- 4.5.2.1 Perform in vitro release studies to evaluate the release profile of the drug from the nanoparticles.
4.6 Storage
4.6.1 Storage Conditions
- 4.6.1.1 Store the dry powder formulation in sealed containers under controlled humidity to maintain stability and prevent agglomeration.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- QA: Quality Assurance
6) Documents, if any
- Pulmonary Nanoparticle Formulation Logbook
7) References, if any
- Protocols for nanoparticle formulations for pulmonary drug delivery
8) SOP Version
Version 1.0
Annexure
Pulmonary Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer/Lipid Type | Particle Size | Aerodynamic Size | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer/Lipid Type | Size in nm | Aerodynamic Size | Operator Name | QA Name |