1. Features and parameters (Feature)

2. Application scenarios and advantages (Advantage & Benefit)

Formulation development support:

Oral tablets: optimize particle size distribution (D90≤50μm), improve dissolution (30min dissolution>85%)

Orally disintegrating tablets: provide micronized models (D50≤10μm), improve taste and rapid release effect

Patent avoidance: develop amorphous solid dispersion (ASD) technology solutions to bypass crystal patent restrictions

Compliance guarantee:

DMF documents: US FDA DMF (number #XXXXX) and EU ASMF have been submitted to support customers to quickly declare

Stability data: Accelerated test (40℃/75%RH, 6 months) shows that the content change is <0.5%

3. Customer Benefits

Cost optimization: Direct supply prices are 8-12% lower than the Indian market (based on 2024 Q2 quotations)

Supply security: Own factory + CDMO dual-source production to ensure supply chain continuity

Technical support: Provide preformulation research (Preformulation) data package (solubility/hygroscopicity/compatibility)

Indications

Tadalafil is used to treat male erectile dysfunction (ED) and pulmonary hypertension.

Preparation

Using D-tryptophan as raw material, the methyl esterification reaction is first performed, and the generated D-tryptophan methyl ester hydrochloride undergoes Pictet-spengler reaction with piperonal in isopropanol to obtain cis-tetrahydrocarboline compound, which is then reacted with chloroacetyl chloride and methylamine in sequence, with a total yield of 56%. After screening, glacial acetic acid is used as the recrystallization solvent for further purification. The specific reaction equation is as follows:

Uses

Phosphodiesterase 5 inhibitors, used to treat male erectile dysfunction, second-generation phosphodiesterase 5 inhibitors, used to treat male erectile dysfunction

Team Presentation