SOP for Development of Lyophilized Formulations for Sublingual Tablets

Standard Operating Procedure for Development of Lyophilized Formulations for Sublingual Tablets

1) Purpose

This SOP outlines the procedure for the development of lyophilized formulations intended for sublingual tablets, ensuring rapid dissolution, bioavailability, and patient compliance.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the development, preparation, and testing of sublingual lyophilized formulations.

3) Responsibilities

Formulation Scientists: Responsible for developing the sublingual formulation with optimal dissolution and bioavailability characteristics.
Operators: Responsible for preparing the formulation as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying the product’s dissolution time and ensuring documentation accuracy.

4) Procedure

4.1 Formulation Development

4.1.1 Criteria for Sublingual Formulations

4.1.1.1 The formulation should dissolve within 10–30 seconds under the tongue.
4.1.1.2 The active ingredient must be absorbed quickly and efficiently through the mucosal lining.
4.1.1.3 Common excipients include mannitol and gelatin to promote rapid disintegration.

4.2 Preparation and Lyophilization

4.2.1 Solution Preparation

4.2.1.1 Weigh the active ingredients and excipients as per the BMR.
4.2.1.2 Dissolve the ingredients in a suitable solvent (e.g., Water for Injection) and stir until fully dissolved.

4.2.2 Filling and Lyophilization

4.2.2.1 Fill the solution into blister packs designed for sublingual tablets.
4.2.2.2 Transfer the blister packs to the lyophilizer and freeze at -80°C

before running the lyophilization cycle.

4.3 Testing Sublingual Tablets

4.3.1 After lyophilization, test the dissolution time of the tablets to ensure they meet the criteria for rapid disintegration.
4.3.2 Measure the bioavailability of the active ingredient in dissolution testing.

4.4 Documentation

Record all steps in the Sublingual Lyophilized Formulation Logbook, ensuring that the QA team verifies dissolution times and other key metrics.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Sublingual Lyophilized Formulation Logbook

7) References

Pharmacopoeial guidelines for sublingual drug products and disintegration testing

8) SOP Version

Version 1.0

Annexure

Sublingual Lyophilized Formulation Logbook Template


  
    Date
    Formulation Name
    Batch No.
    Disintegration Time
    Bioavailability
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Formulation Name
    Batch Number
    Time (seconds)
    Percentage (%)
    Operator Name
    QA Initials