SOP for Formulation of Sustained Release Nasal Sprays

Standard Operating Procedure for Formulation of Sustained Release Nasal Sprays

1) Purpose

The purpose of this SOP is to provide guidelines for the formulation of sustained-release nasal sprays to ensure prolonged drug release and effective therapeutic action.

2) Scope

This SOP applies to all personnel involved in the formulation and testing of sustained-release nasal sprays at [Company Name].

3) Responsibilities

Operators: Responsible for preparing the sustained-release formulation according to the specified protocol.
QA: Verifies the release profile and ensures the formulation meets quality standards.

4) Procedure

4.1 Selection of Release-Controlling Agents

4.1.1 Polymers and Excipients

Select suitable polymers and excipients (e.g., hydroxypropyl methylcellulose, carbopol) that provide sustained drug release.
Ensure the excipients meet pharmacopeial standards for sustained-release applications.

4.1.2 Weighing of Ingredients

Weigh the required amount of polymers and excipients as per the formulation guidelines.
Document all weights in the batch manufacturing record (BMR).

4.2 Formulation Process

4.2.1 Mixing

Mix the polymers, excipients, and active pharmaceutical ingredients in the formulation base, ensuring even distribution.

4.2.2 Homogenization

Use a homogenizer to ensure uniform particle size and dispersion in the sustained-release formulation.

4.3 Release Profile Testing

4.3.1 Dissolution Testing

Test the sustained-release formulation

using a dissolution apparatus to determine the release profile.

4.3.2 Adjustment

If the release profile does not meet the target, adjust the polymer concentration and repeat the testing.

4.4 Sterilization and Filling

4.4.1 Filtration

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

4.4.2 Filling

Fill the formulation into nasal spray containers under aseptic conditions.

4.5 Documentation

Document all formulation steps, including ingredient amounts, release profile testing, and final release data in the batch manufacturing record (BMR).

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20. SOP for Formulation of Sustained Release Nasal Sprays (continued)
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5) Abbreviations, if any

QA: Quality Assurance
BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)
Dissolution Test Results

7) References, if any

FDA Guidance for Industry – Dissolution Testing of Immediate and Sustained-Release Dosage Forms

8) SOP Version

Version 1.0

Annexure

Dissolution Test Results Log Template


  
    Date
    Formulation
    Initial Release (%)
    Sustained Release (over time)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    Release at 1 hour
    Release over 12/24 hours
    Operator Name
    QA Name

Date	Formulation	Initial Release (%)	Sustained Release (over time)	Operator Initials	QA Approval
DD/MM/YYYY	Formulation Name	Release at 1 hour	Release over 12/24 hours	Operator Name	QA Name