Itopride Hydrochloride (Itopride HCl) is a gastroprokinetic agent used primarily for the management of symptoms associated with impaired gastrointestinal motility. It combines dopamine D₂-receptor antagonism with acetylcholinesterase inhibition, enhancing cholinergic activity in the gastrointestinal tract.
Itopride HCl promotes gastric motility and facilitates gastric emptying, making it relevant to the treatment of functional upper gastrointestinal disorders.
Itopride HCl is a specialized gastrointestinal pharmaceutical API manufactured through controlled chemical synthesis, purification and hydrochloride salt formation.
Important quality attributes include identity, assay, related substances, water content, residual solvents, chloride content, residue on ignition and stability.
CAS Number: 122892-31-3
Molecular Formula: C20H26N2O2·HCl
Molecular Weight: 394.89 g/mol
Drug Class: Gastroprokinetic Agent
Pharmacological Class: Dopamine D₂ Antagonist / Acetylcholinesterase Inhibitor
Therapeutic Class: Gastrointestinal Motility Agent
Therapeutic Area: Gastroenterology
Itopride has a dual mechanism of action:
1. Dopamine D₂-receptor antagonism
It blocks dopamine D₂ receptors in the gastrointestinal tract, reducing dopamine-mediated inhibition of gastrointestinal motility.
2. Acetylcholinesterase inhibition
It inhibits acetylcholinesterase, increasing the availability of acetylcholine at cholinergic nerve endings.
Together, these actions can result in:
Itopride HCl is primarily used for symptomatic management of upper gastrointestinal motility disorders, including:
Specific indications depend on the approved formulation and regulatory market.
Itopride differs from conventional dopamine-antagonist prokinetics because it combines D₂ receptor blockade and acetylcholinesterase inhibition.
This pharmacological profile supports its action on gastric motility and gastric emptying.
Typical API manufacturing may involve:
Itopride HCl API quality evaluation may include:
Itopride HCl should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should be established from validated stability studies.
Itopride HCl is relevant to research involving:
Itopride HCl is a gastroprokinetic agent with CAS Number 122892-31-3, molecular formula C20H26N2O2·HCl, and molecular weight 394.89 g/mol. It enhances gastrointestinal motility through combined dopamine D₂-receptor antagonism and acetylcholinesterase inhibition and is primarily associated with functional upper gastrointestinal disorders.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 2.0% |