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Related Experiment Video

Updated: Jun 2, 2026

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Dissolution testing of sublingual tablets: a novel in vitro method.

Ousama Rachid¹, Mutasem Rawas-Qalaji, F Estelle R Simons

¹Faculty of Pharmacy, University of Manitoba, Apotex Centre, Winnipeg, Canada. umrachid@cc.umanitoba.ca

AAPS Pharmscitech

|April 28, 2011

Summary

A new in vitro dissolution method accurately simulates sublingual (SL) conditions, unlike standard USP methods. This novel approach is crucial for developing rapidly disintegrating SL tablets.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems

Background:

Sublingual (SL) tablets face unique challenges, including minimal agitation and limited saliva, unlike the gastrointestinal tract.
Existing compendial dissolution apparatuses do not accurately replicate SL physiological conditions.

Purpose of the Study:

To develop and evaluate a novel in vitro dissolution method that simulates sublingual conditions.
To assess the performance of this new method compared to the official US Pharmacopeia (USP) dissolution method.

Main Methods:

A custom-made dissolution apparatus was designed to mimic the SL environment.
The method used 2 mL of distilled water at 25°C, measuring dissolution at 60 and 120 seconds.
Several epinephrine 40 mg SL formulations and commercial isosorbide dinitrate and nitroglycerin SL tablets were tested.

Main Results:

The novel in vitro method demonstrated accuracy, reproducibility, and discrimination capability.
It effectively detected formulation changes missed by standard in vitro tests.
Significant differences were observed between the novel method and the official USP dissolution method (p < 0.05).

Conclusions:

The developed in vitro method accurately reflects dissolution under simulated SL conditions.
This novel method is valuable for evaluating rapidly disintegrating sublingual tablets.
It offers a more physiologically relevant approach for SL drug product development.