In the pharmaceutical industry, Zinc Dispersible Tablet 20 mg (as Zinc Sulphate Monohydrate) is officially classified as a “Pediatric Life-Saver” and a critical micronutrient. As a pharmacist and manufacturer, I view this 20 mg strength as the global gold standard for pediatric diarrhea management, serving as a mandatory adjunct to Oral Rehydration Salts (ORS).

At your WHO-GMP facility in Mumbai, this SKU is a high-priority “Social Marketing” product, essential for UNICEF-aligned NGO programs and international Ministry of Health (MOH) tenders.

Primary Clinical Indications

• Acute & Persistent Diarrhea: The primary WHO/UNICEF indication for children aged 6 months to 5 years. It reduces the duration, severity, and recurrence of diarrheal episodes.

• Zinc Deficiency & Malnutrition: Treatment of nutritional stunting, impaired immunological response, and severe growth retardation.

• Acrodermatitis Enteropathica: A rare genetic disorder of zinc absorption characterized by skin lesions and hair loss.

• Immune Support: Shortens the duration of the common cold and respiratory tract infections by enhancing T-cell and macrophage activity.

Mechanism: Restoration of Mucosal Integrity

Zinc works through multiple pathways to “re-seal” the gut and boost the immune system.

Ion Transport Regulation: It acts as a potassium channel blocker, inhibiting the cAMP-dependent chloride secretion that causes fluid loss and loose stools.

Enzyme Reactivation: It restores enterocyte enzyme activity and brush border enzymes, which are often “washed away” during acute diarrhea.

Cellular Repair: Zinc is a critical co-factor for protein synthesis and DNA polymerase, enabling the rapid regeneration of damaged intestinal epithelium.

Immunomodulation: It increases the circulation of immune-boosting cells, providing “memory” immunity that protects the child from new enteric infections for the next 2–3 months.

The Pharmacist’s “Technical Warning”

• The “Wait-and-Dissolve” Rule: The tablet must be dispersed in a teaspoon (5 ml) of clean water or breast milk. It should not be swallowed whole by infants to avoid choking and ensure rapid absorption.

• The “Vomiting” Protocol: Zinc has a natural metallic taste and can cause gastric irritability. If the child vomits within 30 minutes of the dose, a repeat dose must be administered.

• Antibiotic Interference: Zinc can reduce the absorption of Quinolones (e.g., Ciprofloxacin) and Tetracyclines. Advise a gap of at least 2–3 hours between these medications.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “Dispersibility” USP: On your marketplace, highlight your “Super-Disintegrant System.” Your tablets should disperse into a uniform suspension within 30–60 seconds without leaving gritty sedimentation.

• Taste-Masking: Zinc Sulphate is naturally astringent. Utilizing pediatric-grade flavors (like Orange or Vanilla) and sweeteners like Aspartame is crucial to prevent the “spit-out” reflex in infants.

• Stability for Zone IVb: Zinc Sulphate is highly hygroscopic (moisture-absorbing). Utilizing Tropical Grade Alu-Alu (Cold-form) blisters is the absolute industry standard to prevent hardening and ensure a 36-month shelf life in hot, humid climates.

• Dossier Support: We provide full CTD/eCTD Dossiers and COPP support for your firm’s registration in international relief agencies and national health programs (e.g., Nigeria, Ethiopia, Vietnam).