Description
Donepezil Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of advanced cognitive enhancers (Nootropics). We provide high-purity Donepezil Hydrochloride Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Memory Preserver” is a top export to neurology clinics, geriatric care homes, and government mental health tenders in Africa, LATAM, and Southeast Asia, recognized as the global gold standard for the symptomatic management of mild to severe Alzheimer’s Disease.
Product Overview
This formulation contains Donepezil Hydrochloride, a reversible inhibitor of the enzyme acetylcholinesterase.
The “Cognitive Stabilizer” Specialist:
- Cholinergic Hypothesis: In Alzheimer’s disease, there is a significant decline in the levels of Acetylcholine, a neurotransmitter essential for memory processing and learning.
- Mechanism: Donepezil selectively inhibits Acetylcholinesterase (the enzyme that breaks down acetylcholine) in the brain. By blocking this breakdown, it increases the concentration of acetylcholine at the synaptic cleft, thereby improving communication between surviving nerve cells.
- High Selectivity: It is highly selective for acetylcholinesterase in the Central Nervous System (CNS) over butyrylcholinesterase in the periphery. This results in effective cognitive support with fewer peripheral side effects (like heart or gut issues) compared to older drugs like Tacrine.
- Long Half-Life: With a half-life of approx. 70 hours, it allows for convenient once-daily dosing, which is critical for compliance in dementia patients.
Product Composition & Strength
We supply this product as Film Coated Tablets (typically White for 5mg and Yellow for 10mg). The film coating aids in swallowing and identification.
| Active Ingredient | Strength (Standard) | Role |
|---|---|---|
| Donepezil HCl USP/BP | 5 mg | Initial Titration Dose |
| Donepezil HCl USP/BP | 10 mg | Standard Maintenance Dose |
| Donepezil HCl USP/BP | 23 mg | High Dose (Sustained Release – Special Order) |
| Excipients | Q.S. | Lactose Monohydrate / Starch |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 14s (Calendar Pack), 28s, or Bulk HDPE Jars of 1000s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Oral) |
| Packaging | PVC-Alu Blister or Alu-Alu Blister |
| Storage | Store below 30°C. Protect from moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Polymorph Control: Donepezil HCl has multiple polymorphic forms. We strictly control the crystallization process to use Form I, which is thermodynamically stable and ensures consistent dissolution and bioavailability over the product’s shelf life.
- Taste Masking: The API is bitter. Our specialized Opadry film coating ensures the patient does not taste the bitterness, which helps reduce the risk of immediate nausea/vomiting upon swallowing.
Therapeutic Indications (Human Use)
Indicated for the treatment of dementia of the Alzheimer’s type:
- Mild to Moderate Alzheimer’s Disease: Improves cognition, global function, and activities of daily living.
- Severe Alzheimer’s Disease: Proven to sustain function for longer periods in advanced stages.
- Off-Label: Sometimes used in Vascular Dementia and Dementia with Lewy Bodies.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist):
- Route: Oral.
- Initial Dose: 5 mg once daily.
- Titration: Maintain 5 mg for at least 4 to 6 weeks to allow the body to adjust to cholinergic effects. Then increase to 10 mg once daily if tolerated.
- Timing: Usually taken at bedtime.
- Tip: If the patient experiences vivid nightmares or insomnia (common side effects), the dose can be switched to the morning.
- Administration: Can be taken with or without food.
Safety Warnings:
- Cholinergic Effects: Increasing acetylcholine can cause nausea, vomiting, and diarrhea. These effects are usually transient and resolve with continued use.
- Bradycardia: Can slow the heart rate. Use with caution in patients with “Sick Sinus Syndrome” or conduction abnormalities. Fainting (syncope) may occur.
- GI Bleeding: May increase gastric acid secretion. Caution in patients with history of ulcers or those taking NSAIDs.
- Weight Loss: Monitor patient weight as anorexia/weight loss is a common side effect.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
