Description
Risperidone Orally Disintegrating Tablets (ODT) (1 mg / 2 mg / 4 mg)
Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, central nervous system (CNS), and behavioral health therapeutics. We provide ultra-high-purity, kinetically advanced Risperidone Orally Disintegrating Tablets (1 mg / 2 mg / 4 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Second-Generation Atypical Antipsychotic” is a highly lucrative, massive-volume export to psychiatric hospitals, behavioral health NGOs, geriatric care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for Schizophrenia, Bipolar Mania, and severe Autism-related irritability.
Product Overview
This highly advanced formulation combines a potent, broad-spectrum neuro-receptor antagonist with a sophisticated “flash-melt” delivery system, delivering rapid psychiatric stabilization while completely eliminating patient non-compliance.
The “Anti-Cheeking & Dual-Antagonism” Specialist:
- Mechanism 1 (The Flash-Melt Compliance Advantage): In acute psychiatric settings, patients frequently refuse medication or hide tablets in their cheeks to spit out later (“cheeking”). The Orally Disintegrating Tablet (ODT) completely neutralizes this issue. The moment it is placed on the tongue, the superdisintegrant matrix rapidly draws in saliva and dissolves the tablet into a micro-particulate suspension in under 30 seconds. It cannot be spat out, and it requires zero water to swallow, guaranteeing full clinical dosing in uncooperative, agitated, or dysphagic (difficulty swallowing) patients.
- Mechanism 2 (D2 & 5-HT2A Receptor Blockade): Risperidone is a powerful Atypical Antipsychotic. It works by aggressively blocking both Dopamine (D2) and Serotonin (5-HT2A) receptors in the brain. Blocking dopamine severely reduces the “positive” symptoms of schizophrenia (hallucinations, delusions, and severe agitation). Simultaneously, blocking the serotonin receptors helps alleviate the “negative” symptoms (social withdrawal, emotional flatness) while drastically reducing the severe motor side effects typically caused by older drugs like Haloperidol.
Product Composition & Strength
We supply this product as a Precision-Engineered Orally Disintegrating Tablet (ODT) / Mouth Dissolving Tablet (MDT), packed exclusively in highly secure, moisture-resistant Alu-Alu or specialized Peelable Blister strips to protect the incredibly fragile, highly porous tablet structure.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Risperidone INN/Ph.Eur. | 1 mg / 2 mg | Base titration units for acute agitation and pediatric/geriatric initiation. |
| Risperidone INN/Ph.Eur. | 4 mg | Global Clinical Standard: High-dose therapy for severe, acute schizophrenic or manic exacerbations. |
| Excipients | Mannitol / Crospovidone / Aspartame / Peppermint Flavor / Magnesium Stearate | Lyophilized Matrix Base / Superdisintegrant / Sweetener (Engineered to mask the bitter API and melt within seconds on the tongue) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict psychiatric ward dispensing and outpatient compliance regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Psychiatric Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Psychotropics/Antipsychotics) |
| CAS Number | 106266-06-2 |
| Dosage Form | Orally Disintegrating Tablet (ODT) / Mouth Dissolving Tablet |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). The highly porous ODT matrix acts like a sponge. It is extremely sensitive to ambient humidity and physical crushing. Strict barrier packaging guarantees structural integrity and rapid disintegration times across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. Handle with dry hands. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Flash-Melt Matrix Engineering: Manufacturing a stable ODT requires advanced pharmaceutical engineering. Our facilities utilize specialized Lyophilization (freeze-drying) or highly compressed superdisintegrant matrices (using Crospovidone and Mannitol). This ensures the tablet is strong enough to survive international shipping logistics, yet porous enough to instantaneously draw in saliva and shatter into a liquid suspension in under 30 seconds, leaving no gritty residue.
Therapeutic Indications (Human Use)
Indicated for the targeted management of severe psychiatric and behavioral dysfunction:
- Schizophrenia: Treatment of acute and chronic schizophrenia in adults and adolescents.
- Bipolar I Disorder: Short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
- Autism Spectrum Disorder: Treatment of severe irritability (including symptoms of aggression towards others, deliberate self-injuriousness, and temper tantrums) associated with autistic disorder in children and adolescents.
Dosage & Administration
Recommended Dosage (Strictly as per Psychiatrist Guidelines):
- Administration (THE DRY HANDS RULE): The tablet must not be pushed through the foil, as it will crush. The blister foil must be peeled back with dry hands. The tablet should be immediately placed on the tongue. It will dissolve in seconds and can be swallowed with saliva. No water is required.
- Adult Schizophrenia: Usually initiated at 2 mg per day, titrated upward to 4 mg – 8 mg daily depending on clinical response.
- Geriatric/Renal Impairment: Must be initiated at a severely reduced dose (0.5 mg twice daily) due to increased sensitivity and slower clearance.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Elderly Patients with Dementia): Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at a significantly increased risk of death (mostly from cardiovascular events like heart failure or infectious events like pneumonia). Risperidone is strictly not approved for the treatment of dementia-related psychosis.
- Extrapyramidal Symptoms (EPS) & Tardive Dyskinesia: While safer than older drugs, high doses of Risperidone can cause severe, sometimes irreversible movement disorders, including tremors, severe muscle stiffness, and involuntary facial twitches (Tardive Dyskinesia).
- Hyperprolactinemia (Hormonal Shift): Risperidone dramatically elevates prolactin levels in the blood. This can cause male breast enlargement (gynecomastia), lactation in non-pregnant women (galactorrhea), and complete absence of menstrual periods (amenorrhea).
- Metabolic Syndrome: Can cause significant weight gain, dyslipidemia, and new-onset Type 2 Diabetes. Blood glucose and weight must be monitored regularly.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Psychiatric and ODT Formulations. Whether you need a reliable Hospital Tender Supplier for behavioral health clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery of WHO-GMP certified products.









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