In the pharmaceutical industry, Ranitidine Hydrochloride 150 mg is a classic $H_2$-receptor antagonist ($H_2$ blocker). While the proton pump inhibitor (PPI) class has become more common, Ranitidine remains a preferred choice for many due to its rapid onset of action and its specific effectiveness in controlling “nocturnal acid breakthrough.”
Primary Clinical Uses
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GERD (Gastroesophageal Reflux Disease): Relief of heartburn and acid indigestion.
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Peptic Ulcer Disease: Treatment and maintenance of gastric and duodenal ulcers.
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Zollinger-Ellison Syndrome: Management of pathological hypersecretory conditions where the stomach produces extreme amounts of acid.
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Prophylaxis of Aspiration Pneumonitis: Given before surgery to reduce the acidity of gastric contents, protecting the lungs during anesthesia.
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Erosive Esophagitis: Healing and relief of pain from acid-damaged esophageal lining.
Mechanism of Action: Competitive $H_2$ Blockade
Ranitidine works by selectively blocking the histamine receptors located on the parietal cells in the stomach lining.
Histamine Inhibition: Histamine is one of the primary triggers for acid production. Ranitidine competes with histamine for $H_2$ receptors.
Reduction of Basal Acid: It is particularly effective at reducing “basal” acid secretion (the acid produced when the stomach is empty), which is why it is often taken at bedtime.
Volume & Acidity Reduction: It reduces both the total volume of gastric juice and the concentration of hydrogen ions (acidity).
The Manufacturer’s Perspective: Technical & Regulatory
From a production and global trade standpoint at your WHO-GMP facility in Mumbai, there are critical technical aspects to consider for this molecule:
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The NDMA Context: As a pharmacist and firm owner, you are aware of the global regulatory history regarding NDMA (N-Nitrosodimethylamine) impurities in Ranitidine. For your digital platform, emphasizing “NDMA-Free Certified API” and rigorous stability testing is the single most important factor for building B2B trust and securing export contracts.
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tability & Storage: Ranitidine is sensitive to moisture and light. At our facility, we utilize Alu-Alu blister packaging to ensure the 150 mg dose maintains its integrity for 36 months, even in Zone IVb climates.
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Formulation Versatility: While 150 mg is the standard, manufacturing a 75 mg OTC strength and a 300 mg intensive strength allows your trading firm to cover both the retail and hospital segments.
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Dossier Support: Despite regulatory shifts, there is still high demand for Ranitidine in many international markets. We provide full CTD/eCTD Dossiers with updated impurity profiling to support your export registrations.