SOP for Incorporation of Taste-Masking Agents in Nasal Sprays

Standard Operating Procedure for Incorporation of Taste-Masking Agents in Nasal Sprays

1) Purpose

The purpose of this SOP is to outline the process for incorporating taste-masking agents in nasal spray formulations to enhance patient compliance and minimize undesirable aftertastes.

2) Scope

This SOP applies to all personnel involved in the formulation and testing of nasal sprays that require taste-masking at [Company Name].

3) Responsibilities

Operators: Responsible for adding and testing the effectiveness of taste-masking agents during the formulation process.
QA: Verifies the inclusion of taste-masking agents and ensures that the formulation meets taste profile specifications.

4) Procedure

4.1 Selection of Taste-Masking Agents

4.1.1 Suitable Agents

Select appropriate taste-masking agents based on the formulation and API properties (e.g., sweeteners, flavors).
Ensure that all agents are pharmaceutically acceptable and compatible with the nasal spray formulation.

4.1.2 Weighing of Agents

Weigh the required quantity of taste-masking agents as per the formulation specifications.
Record all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Taste-Masking Agents

4.2.1 Mixing

Add the taste-masking agents to the nasal spray solution and mix thoroughly to ensure uniform distribution.

4.2.2 Homogenization

Use a homogenizer if

necessary to ensure proper dispersion of taste-masking agents in the formulation.

4.3 Taste Evaluation

4.3.1 Sensory Testing

Conduct sensory evaluation of the nasal spray to assess the effectiveness of the taste-masking agent.
Adjust the quantity of taste-masking agents if necessary, based on the results of sensory testing.

4.4 Documentation

Document all steps, including the type and amount of taste-masking agent used and the results of sensory evaluation, 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)
Sensory Evaluation Log

7) References, if any

USP 39 – Guidelines on Taste-Masking in Pharmaceutical Products

8) SOP Version

Version 1.0

Annexure

Sensory Evaluation Log Template


  
    Date
    Formulation
    Taste Evaluation
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    Acceptable/Unacceptable
    Operator Name
    QA Name