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