SOP for Incorporating Anti-Inflammatory Agents in Nasal Sprays

Standard Operating Procedure for Incorporating Anti-Inflammatory Agents in Nasal Sprays

1) Purpose

The purpose of this SOP is to outline the process for incorporating anti-inflammatory agents into nasal spray formulations to ensure consistent dosage and therapeutic efficacy.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays containing anti-inflammatory agents at [Company Name].

3) Responsibilities

Operators: Responsible for incorporating anti-inflammatory agents into the formulation and ensuring even distribution.
QA: Verifies the concentration of anti-inflammatory agents and checks for uniformity in the formulation.

4) Procedure

4.1 Selection of Anti-Inflammatory Agents

4.1.1 Types of Anti-Inflammatory Agents

Select appropriate anti-inflammatory agents based on the therapeutic requirements of the formulation (e.g., corticosteroids, NSAIDs).

4.1.2 Weighing of Agents

Weigh the required amount of anti-inflammatory agents according to the formulation specifications.
Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Anti-Inflammatory Agents

4.2.1 Mixing

Mix the anti-inflammatory agent into the nasal spray solution under constant stirring to ensure uniform distribution.

4.2.2 Homogenization

Use a homogenizer if required to ensure even distribution of the active agent in the formulation.

4.3 Testing

4.3.1 Assay Testing

Test the formulation to verify that the concentration of the anti-inflammatory agent meets the specified range.

4.3.2 pH and Osmolality Testing

Test the pH and osmolality of the formulation to ensure it falls within the required range for nasal sprays.

4.4 Filtration and Filling

4.4.1 Filtration

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

4.4.2 Filling

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

4.5 Documentation

Document all steps, including the amount of anti-inflammatory agent used, assay results, and pH and osmolality values in the batch manufacturing record (BMR).

5) Abbreviations, if any

NSAIDs: Non-Steroidal Anti-Inflammatory Drugs
QA: Quality Assurance
BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)
pH and Osmolality Log

7) References, if any

USP 39 – Anti-Inflammatory Drugs in Nasal Sprays

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