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Related Experiment Video

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Formation of Dispersible Taohong Siwu Tablets

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Development and Optimization of a Biphasic-Release Acetazolamide Tablet-in-Tablet Formulation.

Si-Kai Wang^1,2, Wei Li^1,2, Miao-Miao Guo³

¹School of Pharmacy, Hubei University of Chinese Medicine, Wuhan, 430065, China.

|June 9, 2026

Summary

A novel acetazolamide (ACZ) tablet-in-tablet formulation offers both immediate and extended release for high-altitude illness (HAI) prevention. This biphasic delivery system aims to improve upon existing ACZ options.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
High-Altitude Medicine

Background:

High-altitude illness (HAI) presents significant health risks.
Acetazolamide (ACZ) is the sole FDA-approved prophylactic medication for HAI.
Current ACZ formulations (immediate-release and extended-release) have limitations in providing both rapid onset and sustained drug availability.

Purpose of the Study:

To develop and characterize a biphasic-release acetazolamide tablet-in-tablet (ACZ-TIT) formulation.
To create a proof-of-concept oral dosage form integrating immediate-release (IR) and extended-release (ER) properties.
To assess the potential of ACZ-TIT to overcome limitations of existing ACZ delivery systems.

Main Methods:

Excipient compatibility assessed using FTIR, DSC, and PXRD.
Solubility evaluated in relevant physiological media.
Formulation optimized using single-factor studies and response surface methodology (RSM).
In vitro dissolution studies and drug release kinetic analysis (Ritger-Peppas model).

Main Results:

ACZ-TIT demonstrated a biphasic release profile: 25.3% at 0.5 h and 86.5% at 10 h.
Physical properties met pharmacopeial standards, with no significant ACZ-excipient incompatibilities observed.
Release kinetics best fit the Ritger-Peppas model, indicating diffusion-controlled extended release.

Conclusions:

The developed ACZ-TIT formulation shows promise for providing rapid initial drug release followed by sustained exposure.
This biphasic delivery could address shortcomings of current acetazolamide dosage forms for HAI prophylaxis.
Further in vivo pharmacokinetic and clinical studies are necessary to confirm clinical utility.