In the pharmaceutical industry, Isosorbide-5-Mononitrate (ISMN) 20 mg is a potent organic nitrate and the active metabolite of Isosorbide Dinitrate. As a pharmacist, I classify this as a “long-acting vasodilator.” Unlike nitroglycerin, which is used for emergency relief of a heart attack (acute angina), ISMN is used for daily maintenance to prevent chest pain from occurring.
Primary Clinical Uses
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Prophylaxis of Angina Pectoris: It is primarily indicated for the long-term prevention of angina pectoris (chest pain) due to coronary artery disease.
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Chronic Heart Failure: Often used as an adjunctive therapy (frequently in combination with hydralazine) to reduce the workload on the heart.
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Vasodilation in Portal Hypertension: Occasionally used in specialized settings to reduce pressure in the portal vein.
Mechanism of Action: The Nitric Oxide Pathway
ISMN works by relaxing the smooth muscles of the blood vessels, particularly the veins.
Nitric Oxide Release: Once in the body, the nitrate group is converted into nitric oxide (NO).
cGMP Activation: NO stimulates the enzyme guanylate cyclase, which increases the levels of cyclic guanosine monophosphate (cGMP).
Vasodilation: Increased cGMP leads to the dephosphorylation of myosin light chains, causing the smooth muscle in blood vessels to relax.
Reduced Preload: By dilating the veins, it reduces the amount of blood returning to the heart (preload), which lowers the heart’s oxygen demand and prevents angina.
The Manufacturer’s Perspective: Formulation & Export
From a production and global trade standpoint, ISMN 20 mg is a high-demand cardiovascular product:
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Avoidance of “Nitrate Tolerance”: A key technical challenge with nitrates is that the body can become “immune” to them if they are in the system 24/7. As a manufacturer, we design the dosing schedule (often “twice daily, 7 hours apart”) to allow for a “nitrate-free interval” to maintain efficacy.
Sustained Release (SR) vs. Immediate Release: While 20 mg is often an immediate-release strength, we also manufacture SR/ER versions (30mg, 60mg). For your B2B marketplace, offering both formats is essential for capturing different international clinical preferences.
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Stability for Global Trade: ISMN is relatively stable but sensitive to moisture. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, SE Asia)
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B2B & Dossier Support: Our Mumbai facility provides the necessary CTD/eCTD Dossiers to support international registration against the innovator (Imdur/Ismo).