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 | |