Table of Contents
- 1. Product Overview & Specifications
- 2. Clinical Applications
- 3. Mechanism of Action
- 4. Pharmaceutical Formulations
- 5. Clinical Case Studies
- 6. Approved Manufacturers
- 7. Contact for Technical Support
1. Trimebutine Maleate Specifications (CAS 34140-59-5)
Chemical Profile
| Parameter | Specification | Testing Method |
|---|---|---|
| CAS Number | 34140-59-5 | USP |
| Chemical Name | 3,4,5-Trimethoxybenzoic acid (2-dimethylamino-2-phenyl)butyl ester maleate | IUPAC |
| Molecular Formula | C26H35NO9 | Elemental Analysis |
| Molecular Weight | 505.56 g/mol | Mass Spectrometry |
| Purity | ≥99.5% (Pharmaceutical Grade) | HPLC |
| Storage | 2-8°C in airtight container | ICH Q7 |
Comparative Analysis
| Parameter | Trimebutine Maleate | Mebeverine HCl | Dicyclomine HCl |
|---|---|---|---|
| Receptor Action | Dual μ/κ opioid agonist | Selective antispasmodic | Muscarinic antagonist |
| GI Motility Effect | Normalization | Reduction | Complete inhibition |
| Bioavailability | 96-98% | 30-40% | 60-70% |
| Half-life | 2.5-3.5 hours | 2-3 hours | 1.8 hours |
2. Therapeutic Applications
Approved Indications
- Irritable Bowel Syndrome (IBS-D/C/M subtypes)
- Postoperative ileus management
- Functional gastrointestinal disorders
- Chronic intestinal pseudo-obstruction
Off-label Uses
- Gastroparesis management in diabetics
- Adjunct in endoscopic procedures
- Pediatric functional abdominal pain
3. Pharmacodynamic Profile
Key Mechanisms
- Modulates calcium channels in smooth muscle cells
- Enhances colonic propagating contractions
- Reduces visceral hypersensitivity
- Balances ENS neurotransmitter release
4. Commercial Formulations
| Dosage Form | Strength | Excipients | Release Profile |
|---|---|---|---|
| Immediate Release Tablets | 100mg/200mg | Lactose, MCC, Mg stearate | Tmax: 1.5h |
| Modified Release Capsules | 300mg | HPMC, Ethylcellulose | 12h sustained release |
| Pediatric Suspension | 50mg/5ml | Xanthan gum, Sorbitol | Rapid absorption |
5. Clinical Evidence
Case Study 1: IBS Management
Patient: 38yo female with IBS-M
Regimen: 200mg TID for 12 weeks
Outcome: 68% reduction in pain episodes, normalized bowel frequency
Case Study 2: Postoperative Recovery
Setting: Colorectal surgery cohort (n=120)
Protocol: 300mg BID starting POD1
Results: 40% faster return of bowel function vs placebo
6. Qualified Suppliers
| Manufacturer | Certifications | Batch Capacity | API Source |
|---|---|---|---|
| ABC Pharma Ltd. | USFDA, EDQM | 500kg/month | In-house synthesis |
| XYZ Biotech | WHO-GMP, PIC/S | 200kg/month | EU-sourced intermediates |
7. Technical & Commercial Support
For formulation development support or bulk API procurement:
- Email: info@vivalr.com
- Tel: (86) 15866781826
Request following documentation:
- Certificate of Analysis (CoA)
- Drug Master File (DMF)
- Stability Package (ICH Conditions)
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