Description
Ondansetron Orally Disintegrating Tablets (ODT) / Film-Coated Tablets (4 mg / 8 mg)
Healthy Inc is a specialized global supplier and exporter of advanced anti-emetic, oncology-support, and post-operative therapeutics. We provide ultra-high-purity, kinetically optimized Ondansetron Hydrochloride Film-Coated Tablets & Orally Disintegrating Tablets (4 mg / 8 mg), manufactured in WHO–GMP certified, high-precision rapid-dissolution oral solid dosage facilities. This “5-HT3 Receptor Antagonist” is a massive-volume, highly lucrative export to oncology centers, surgical wards, emergency rooms, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, gold-standard intervention for Chemotherapy-Induced Nausea and Vomiting (CINV), Radiation-Induced Nausea and Vomiting (RINV), and Post-Operative Nausea and Vomiting (PONV).
Product Overview
This highly advanced formulation contains Ondansetron, an incredibly potent, highly selective serotonin blocker that fundamentally shut downs the brain’s vomiting center, allowing patients to endure aggressive cancer treatments and complex surgeries without debilitating nausea.
The “5-HT3 Blockade & Flash-Dispersion” Specialist:
- Mechanism 1 (The Vagus Nerve & Central Blockade): Cytotoxic chemotherapy drugs and abdominal radiation physically damage the cells lining the small intestine. These damaged cells release massive amounts of serotonin (5-HT), which binds to 5-HT3 receptors on the vagus nerve, sending a violent “vomit” signal directly to the Chemoreceptor Trigger Zone (CTZ) in the brain. Ondansetron aggressively and competitively blocks these exact 5-HT3 receptors both in the gut and in the brain, completely severing the nausea signal at its source.
- Mechanism 2 (The Orally Disintegrating Advantage – CRITICAL): When a patient is actively experiencing hyperemesis (severe vomiting), asking them to swallow a pill with water frequently triggers another vomiting episode. Our Orally Disintegrating Tablet (ODT) is engineered to melt instantly upon contact with saliva. The patient simply places the tablet on their tongue; it flashes into a liquid in under 5 seconds and is swallowed effortlessly, ensuring 100% dose retention and rapid systemic absorption.
- The Surgical & ER Workhorse: Beyond cancer care, Ondansetron is the undisputed first-line therapy in emergency rooms for severe viral gastroenteritis, and in surgical recovery rooms to counteract the intense nausea caused by general anesthesia and opioid painkillers.
Product Composition & Strength
We supply this product as a Precision-Engineered Flash-Dispersion ODT or Standard Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant peelable Alu-Alu blister strips to ensure the absolute chemical stability of the highly hygroscopic ODT matrix.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Ondansetron (as HCl Dihydrate) Ph.Eur./USP | 4 mg (ODT / FCT) | Pediatric & PONV Standard: Base therapeutic unit for post-operative nausea, severe pediatric gastroenteritis, and mild emetic triggers. |
| Ondansetron (as HCl Dihydrate) Ph.Eur./USP | 8 mg (ODT / FCT) | Global Oncology Standard: High-dose adult maintenance therapy for highly emetogenic chemotherapy (CINV) and radiation therapy (RINV). |
| Excipients (ODT Formulation) | Mannitol / Crospovidone / Aspartame / Colloidal Silicon Dioxide / Premium Mint Flavoring | Lyophilized Matrix / Superdisintegrant / Sweetener / Saliva-Stimulating Flavor (Engineered specifically to draw saliva into the tablet matrix, forcing a violent, sub-5-second structural collapse on the tongue without a bitter aftertaste) |
*Pack Sizes: 10×10 Peelable Alu-Alu Blisters (Optimized specifically for strict oncology and surgical dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Gastrointestinal/Anti-emetics) |
| CAS Number | 103639-04-9 (Ondansetron Hydrochloride Dihydrate) |
| Dosage Form | Orally Disintegrating Tablet (ODT) / Film-Coated Tablet |
| Packaging | Peelable Alu-Alu Blisters (STRICTLY MANDATORY FOR ODT). ODTs are extremely fragile and highly sensitive to ambient humidity. They cannot be pushed through standard foil, or they will crumble. We utilize specialized peel-back Alu-Alu barrier packaging to guarantee absolute physical and chemical stability across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Flash-Dispersion ODT Engineering (CRITICAL COMPLIANCE): Manufacturing an Orally Disintegrating Tablet requires entirely different technology than standard tableting. If the compression force is too high, the tablet won’t melt; if it’s too low, the tablet turns to dust during shipping. Our facilities utilize advanced low-compression rotary presses combined with elite superdisintegrants (like Crospovidone) and highly porous Mannitol matrices. This guarantees a rock-solid tablet in the blister that instantly and flawlessly liquifies the moment it touches human saliva, masking the bitter API with premium flavor profiles.
Therapeutic Indications (Human Use)
Indicated for the targeted management of severe, centrally and peripherally mediated emesis:
- CINV & RINV: Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy and radiotherapy.
- PONV: Prevention and treatment of post-operative nausea and vomiting following general anesthesia.
- Severe Gastroenteritis: Rapid cessation of uncontrollable vomiting in emergency room settings to prevent severe dehydration (especially in pediatrics).
- Hyperemesis Gravidarum (Off-Label): Management of severe, refractory nausea and vomiting during pregnancy (used cautiously under strict obstetric supervision).
Dosage & Administration
Recommended Dosage (Strictly as per Oncologist/Physician Guidelines):
- Chemotherapy (CINV): Typically, 8 mg is administered 30 minutes before the start of chemotherapy, followed by 8 mg every 12 hours for 1 to 2 days after completion of the treatment.
- Administration (THE PEEL & MELT RULE – ODT ONLY): The blister pack must be peeled open with dry hands (never pushed through the foil). The tablet must be immediately placed on the top of the tongue. It will dissolve in seconds and can be swallowed with saliva. No water is required.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Dose-Dependent QT Prolongation: Ondansetron significantly prolongs the QT interval on an ECG, which can lead to a fatal, chaotic heart rhythm known as Torsades de Pointes. Use with extreme caution in patients with congenital long QT syndrome, congestive heart failure, or severe hypokalemia/hypomagnesemia.
- Serotonin Syndrome: Because it heavily interacts with the serotonin system, combining Ondansetron with other serotonergic drugs (like SSRI antidepressants e.g., Paroxetine, or SNRIs) can trigger fatal Serotonin Syndrome (hyperthermia, seizures, coma, extreme agitation).
- Masking Progressive Ileus: In patients undergoing abdominal surgery, Ondansetron will stop the vomiting, but it may mask the clinical signs of a severe, life-threatening bowel obstruction (progressive ileus) or gastric distension.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anti-Emetic and Orally Disintegrating Formulations. Whether you are looking for a reliable Government Tender Supplier for cancer hospitals in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.
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