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Tablet Formulation of a Polymeric Solid Dispersion Containing Amorphous Alkalinized Telmisartan.

Jun Soo Chae¹, Bo Ram Chae¹, Dong Jun Shin¹

¹College of Pharmacy, Chung-Ang University, 84 Heuksuk-ro, Dongjak-gu, Seoul, 06974, Republic of Korea.

AAPS Pharmscitech

|July 26, 2018

Summary

Amorphous alkalinized telmisartan (AAT) solid dispersions were developed to improve drug dissolution. The AAT-SOL formulation demonstrated enhanced supersaturation and dissolution, showing promise as a superior alternative to existing telmisartan products.

Keywords:

alkalizer amorphous form dissolution solid dispersion telmisartan

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Materials Science

Background:

Telmisartan (TMS) exhibits poor dissolution in weakly acidic environments, limiting its bioavailability.
Developing amorphous solid dispersions can enhance the solubility and dissolution rate of poorly soluble drugs.
Polymers like Soluplus offer potential for creating stable amorphous formulations.

Purpose of the Study:

To enhance the dissolution of telmisartan (TMS) by creating amorphous alkalinized TMS (AAT) solid dispersions.
To evaluate the supersaturation and dissolution characteristics of AAT formulations with various polymers.
To develop and assess an AAT-SOL tablet for improved therapeutic efficacy.

Main Methods:

Preparation of AAT-containing polymeric solid dispersions (AAT-PEG, AAT-PVP, AAT-POL, AAT-SOL) via solvent evaporation.
Characterization of formulations using differential scanning calorimetry, powder X-ray diffraction, FTIR, and SEM.
Dissolution testing in simulated intestinal fluid under plain and limited volume conditions.
Formulation of AAT-SOL into tablets using direct compression and evaluation against Micardis.

Main Results:

AAT-SOL exhibited superior dissolution and enhanced supersaturation maintenance, particularly in limited volume conditions.
Solid dispersions prevented recrystallization, maintaining the amorphous state of telmisartan.
The AAT-SOL tablet demonstrated improved supersaturation compared to the reference product, Micardis.

Conclusions:

Amorphous alkalinized telmisartan (AAT) formulated with Soluplus (AAT-SOL) significantly improves telmisartan dissolution and supersaturation.
The AAT-SOL formulation is a promising candidate for developing improved telmisartan-based medications.
This approach offers a potential strategy to enhance the therapeutic performance of poorly soluble drugs like telmisartan.