SOP for Formulating Nasal Sprays for Allergic Rhinitis

Standard Operating Procedure for Formulating Nasal Sprays for Allergic Rhinitis

1) Purpose

The purpose of this SOP is to provide guidelines for formulating nasal sprays specifically designed for treating allergic rhinitis, ensuring effectiveness in reducing inflammation and nasal congestion.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays for allergic rhinitis at [Company Name].

3) Responsibilities

Operators: Responsible for following the formulation guidelines to ensure correct dosage and formulation of active ingredients.
QA: Ensures that the formulation meets the required specifications for safety and efficacy.

4) Procedure

4.1 Selection of Active Ingredients

4.1.1 Anti-Inflammatory Agents and Decongestants

Select appropriate anti-inflammatory agents (e.g., corticosteroids) and decongestants (e.g., oxymetazoline) based on the formulation’s requirements.

4.2 Formulation Process

4.2.1 Weighing of Active Ingredients

Weigh the required amount of anti-inflammatory agents and decongestants as per the formulation guidelines.

4.2.2 Mixing

Mix the active ingredients into the nasal spray base solution using a magnetic stirrer or homogenizer.
Ensure homogeneity in the mixture to avoid dosage inconsistencies.

4.3 pH and Osmolality Testing

4.3.1 Testing Procedures

Test the pH and osmolality of the formulation to ensure they fall within

the required range for nasal spray administration.

4.4 Filtration and Filling

4.4.1 Sterilization and Filtration

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

4.4.2 Aseptic Filling

Fill the sterile solution into nasal spray containers using aseptic techniques.

4.5 Documentation

Document all formulation steps, including ingredient amounts and test results, 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)
pH and Osmolality Log

7) References, if any

FDA Guidance on Nasal Spray Drug Products

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template


  
    Date
    Formulation
    pH
    Osmolality (mOsm/kg)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    pH Value
    Osmolality
    Operator Name
    QA Name