In the pharmaceutical industry, Pyridoxine Hydrochloride 40 mg is the medicinal form of Vitamin B6. As a pharmacist and manufacturer, I classify this specific 40 mg strength as a “therapeutic dose,” distinct from the lower doses found in standard multivitamins.
It is primarily used to treat and prevent Vitamin B6 deficiency, which can lead to neurological issues, skin conditions, and anemia.
Primary Clinical Uses
-
Drug-Induced Neuropathy (INH Supplementation): This is the most critical use in the Indian and export markets. When patients are treated for Tuberculosis with Isoniazid (INH), the drug depletes Vitamin B6, leading to peripheral neuropathy. A 40 mg daily dose is the standard preventative measure.
-
Pregnancy-Induced Nausea & Vomiting: Often used as a first-line therapy (sometimes combined with Doxylamine) to treat morning sickness.
-
Sideroblastic Anemia: Used to treat certain types of hereditary anemia where the body cannot incorporate iron into hemoglobin effectively.
Premenstrual Syndrome (PMS): Sometimes prescribed at this dosage to alleviate mood swings and bloating associated with the menstrual cycle.
-
Metabolic Disorders: Treatment of pyridoxine-dependency seizures in infants or cases of homocystinuria.
Mechanism of Action: The Essential Co-Enzyme
Pyridoxine is a precursor to Pyridoxal Phosphate (PLP), which is a cofactor for over 100 enzymes in the human body.
Neurotransmitter Synthesis: It is vital for the synthesis of Serotonin, Norepinephrine, and GABA. This explains its role in mood regulation and seizure prevention.
Heme Production: It acts as a co-enzyme in the first step of porphyrin synthesis, which is essential for creating hemoglobin.
Metabolic Regulation: It facilitates the breakdown of homocysteine. High levels of homocysteine are linked to cardiovascular disease, so Pyridoxine helps maintain heart health.
Peripheral Nerve Protection: It maintains the myelin sheath (the protective coating of nerves), preventing the “pins and needles” sensation characteristic of neuropathy.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Pyridoxine 40 mg is a high-demand “Essential Medicine”:
-
API Stability: Pyridoxine Hydrochloride is relatively stable but is light-sensitive. In our manufacturing process, we ensure the use of Amber-colored PVC/PVDC or Alu-Alu blister packaging to prevent degradation and ensure a 36-month shelf life.
-
The “TB-Kit” Demand: For your export firm, Pyridoxine 40 mg is a major B2B asset when bundled with anti-TB medications. It is a staple in government health tenders across Africa and Southeast Asia.
-
Solubility and Formulation: Pyridoxine is highly water-soluble. At our Mumbai facility, we ensure a rapid In-Vitro Dissolution profile, ensuring the tablet disintegrates quickly for maximum bioavailability.
-
Dossier Support: We maintain full CTD/eCTD Dossiers to support international registrations, highlighting its safety profile and manufacturing compliance.