Protamine sulfate API active pharmaceutical ingredient

Protamine sulfate is an active pharmaceutical ingredient (API) used primarily as an antidote for heparin overdose. It works by neutralizing the anticoagulant effects of heparin, a commonly used blood thinner. Protamine sulfate is a positively charged protein that binds to negatively charged heparin, forming a stable complex that inhibits its anticoagulant activity.

Here are some key points about protamine sulfate:

Chemical Properties:

Molecular Formula: C30H57N17O17S
Molecular Weight: ~1230 g/mol (varies based on the exact composition of the protamine molecule, which is derived from fish sperm or other sources).
Protamine is a low-molecular-weight protein, often derived from fish, and is rich in arginine residues.
Mechanism of Action:

It binds to heparin and forms an inactive complex, neutralizing its anticoagulant effects.
The effect is almost immediate when administered intravenously.
Medical Use:

Heparin Reversal: Used to reverse the effects of heparin during surgeries, such as cardiac or vascular procedures.
Dosing: The dose of protamine sulfate depends on the amount of heparin to be neutralized. The typical ratio is 1 mg of protamine sulfate per 100 units of heparin.
Side Effects:

Protamine sulfate can cause allergic reactions, especially in patients with fish allergies.
It may also lead to hypotension, bradycardia, or anaphylaxis in some cases.
Formulation:

Protamine sulfate is commonly available in injectable forms, usually as a sterile solution for intravenous administration.
It plays a critical role in clinical settings, especially when managing anticoagulation therapy during and after surgery.

Protamine sulfate  API     Protamine sulfate active pharmaceutical ingredient