High-Purity Trimebutine Maleate API | CAS 34140-59-5

Trimebutine Maleate (CAS No. 34140-59-5) is a highly effective, non-competitive spasmolytic agent and a unique dual-action modulator of gastrointestinal (GI) motility. Manufactured under rigorous GMP-compliant conditions, Xi'an Tihealth supplies premium pharmaceutical-grade Trimebutine Maleate powder engineered for industrial formulation. By exhibiting strict control over residual solvents (Toluene) and elemental impurities, our API ensures superior crystalline stability and dissolution profiles. It serves as the gold-standard active ingredient for the manufacturing of solid oral dosage forms targeting Irritable Bowel Syndrome (IBS), chronic gastritis, and functional dyspepsia.

To guarantee seamless compliance with international pharmacopeial monographs, our Trimebutine Maleate undergoes exhaustive analytical profiling. The following parameters represent our stringent release criteria:

Trimebutine Maleate stands out among antispasmodics due to its "enkephalinergic" agonist activity, functioning as a true dual-action modulator of the enteric nervous system:

• Peripheral Opiate Receptor Agonism: It acts as an agonist at peripheral mu (μ), kappa (κ), and delta (δ) opiate receptors situated within the gastrointestinal tract. This avoids central nervous system side effects while specifically targeting gut motility.
• Dual-Action Modulation: Depending on the physiological state of the gut, it restores normal motility. It stimulates hypomotile smooth muscle (relieving constipation) and relaxes hypermotile spasms (relieving diarrhea and abdominal cramps).
• Local Anesthetic Properties: Additionally, it exerts a mild local anesthetic effect on the gastric mucosa, which contributes to its efficacy in alleviating functional abdominal pain.

• Solid Oral Dosage Forms: The primary API utilized in formulating immediate-release tablets, capsules, and extended-release matrices prescribed for Irritable Bowel Syndrome (IBS) and post-operative paralytic ileus.
• Pediatric & Liquid Formulations: Suitable for suspension formulations aimed at pediatric gastroenterological care due to its favorable safety profile and targeted localized action.

Trimebutine Maleate (CAS 34140-59-5) is the salt form of the molecule. It is vastly preferred in pharmaceutical formulations because the maleate salt significantly improves the molecule's stability and dissolution rate in the gastrointestinal tract, leading to more predictable bioavailability compared to the free base.

How do you control residual solvents like Toluene in this API?

Our GMP-certified facility utilizes advanced vacuum drying and solvent recovery technologies. Every batch is rigorously tested via Gas Chromatography (GC) to ensure Toluene levels remain well below 0.01%, strictly complying with ICH Q3C guidelines for residual solvents.

Is this API suitable for sustained-release formulations?

Yes. Our Trimebutine Maleate powder features excellent crystalline stability and consistent particle size distribution, making it an ideal candidate for integration into hydrophilic polymer matrices for sustained-release (SR) tableting.