Distigmine Bromide is a long-acting reversible cholinesterase inhibitor and parasympathomimetic agent. It increases the availability of acetylcholine by inhibiting cholinesterase activity and is used in pharmaceutical applications involving urinary bladder dysfunction and, in selected markets, myasthenia gravis.
Distigmine Bromide is an organic bromide salt of distigmine. It has the molecular formula C₂₂H₃₂Br₂N₄O₄, molecular weight 576.32 g/mol, and CAS No. 15876-67-2.
Distigmine Bromide belongs to the cholinesterase inhibitor class. Its pharmacological activity results from reversible inhibition of acetylcholinesterase, increasing acetylcholine activity at cholinergic sites.
Distigmine Bromide is a long-acting carbamate cholinesterase inhibitor. Increased acetylcholine activity can enhance cholinergic transmission and stimulate smooth-muscle activity, including detrusor muscle activity in the urinary tract.
Distigmine Bromide inhibits acetylcholinesterase, reducing the breakdown of acetylcholine. Increased acetylcholine concentration enhances cholinergic neurotransmission.
In the urinary tract, this activity can improve detrusor contraction and support bladder emptying in patients with appropriate bladder dysfunction.
Distigmine Bromide is associated with pharmaceutical treatment of:
The exact approved indication varies by country and regulatory authority.
Distigmine Bromide is relevant to pharmaceutical manufacturers and formulation-development organizations working on cholinergic medicines, urinary-system therapies and neuromuscular pharmaceutical products.
It is particularly associated with oral pharmaceutical formulations such as tablets.
Important quality-control parameters for Distigmine Bromide include:
The Japanese Pharmacopoeia specifies loss on drying NMT 0.5%, residue on ignition NMT 0.20%, and a defined titrimetric assay procedure.
Distigmine Bromide intended for pharmaceutical manufacturing should comply with applicable GMP, pharmacopoeial and regulatory requirements.
The Japanese Pharmacopoeia identifies the compound as:
3,3'-[Hexane-1,6-diylbis(methyliminocarbonyloxy)]bis(1-methylpyridinium) dibromide.
The Japanese Pharmacopoeia specifies tight containers and light-resistant storage for Distigmine Bromide.
Distigmine Bromide is suitable for pharmaceutical organizations involved in the development and manufacture of cholinesterase-inhibitor and urinary-system formulations.
For commercial procurement, the API should be evaluated for identity, assay, purity, related substances, water content and applicable pharmacopoeial compliance.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 168°C – 172°C |