guidelines for the incorporation of mucoadhesive agents in nasal formulations to enhance drug retention and improve efficacy.

2) Scope

This SOP applies to all personnel involved in the formulation, preparation, and testing of nasal formulations containing mucoadhesive agents at [Company Name].

3) Responsibilities

• Operators: Responsible for accurately adding mucoadhesive agents into nasal formulations.
• QA: Ensures the proper concentration of mucoadhesive agents and overall formulation quality.

4) Procedure

4.1 Preparation of Mucoadhesive Nasal Formulations

4.1.1 Selection of Mucoadhesive Agents

• Select appropriate mucoadhesive agents based on the formulation’s properties (e.g., chitosan, carbopol, HPMC).
• Ensure that the selected agents meet pharmacopeial standards and are compatible with the formulation.

4.1.2 Weighing of Agents

• Weigh the required amount of mucoadhesive agents as per the formulation specifications.
• Ensure all weights are documented in the batch manufacturing record (BMR).

4.2 Incorporation of Mucoadhesive Agents

4.2.1 Mixing

• Slowly incorporate the mucoadhesive agents into the nasal spray solution while stirring continuously.
• Maintain the temperature of the solution as required by the formulation specifications.

4.2.2 Homogenization

• Use a homogenizer to ensure even distribution of the mucoadhesive agents throughout the formulation.
• Monitor the homogenization process to avoid the formation of clumps or uneven mixing.

4.3 Testing

4.3.1 Viscosity and pH Testing

• After mixing, test the viscosity of the formulation to ensure it falls within the desired range for nasal application.
• Check the pH of the formulation and adjust if necessary to meet the target pH range.

4.4 Filtration and Filling

4.4.1 Filtration

• Filter the formulation through a 0.22-micron filter to ensure sterility, especially if the formulation is preservative-free.

4.4.2 Filling

• Transfer the sterilized formulation into nasal spray containers using aseptic filling techniques.

4.5 Documentation

• Document all steps, including the amount of mucoadhesive agents added, mixing conditions, pH, and viscosity values in the batch manufacturing record (BMR).

5) Abbreviations, if any

• HPMC: Hydroxypropyl Methylcellulose
• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Viscosity and pH Log

7) References, if any

• USP 39 – Mucoadhesive Polymers in Drug Delivery

8) SOP Version

Version 1.0

Annexure

Viscosity and pH Log Template

  

    
Date
    
Formulation
    
pH
    
Viscosity (cP)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Viscosity
    
Operator Name
    
QA Name