In the pharmaceutical industry, Donepezil Hydrochloride 5 mg is the leading reversible acetylcholinesterase inhibitor. As a pharmacist, I view this 5 mg strength as the critical initiation dose. Because this molecule has a long half-life (roughly 70 hours), the 5 mg dose is typically maintained for at least 4–6 weeks to reach steady-state plasma levels and assess gastrointestinal tolerance before any dose escalation.

Primary Clinical Uses

• Alzheimer’s Disease: Indicated for the symptomatic treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

• Vascular Dementia: Frequently used off-label to improve cognitive function in patients with dementia resulting from stroke or small vessel disease.

• Lewy Body Dementia: Used to manage cognitive fluctuations and hallucinations associated with this specific neurodegenerative condition.

• Cognitive Impairment: Occasionally prescribed for mild cognitive impairment (MCI) to potentially delay the progression to clinical dementia.

Mechanism of Action

Donepezil works by increasing the concentration of acetylcholine—a neurotransmitter essential for memory, learning, and overall cognitive function—at the synaptic cleft.

Enzyme Inhibition: It binds reversibly to the enzyme acetylcholinesterase, which is responsible for breaking down acetylcholine.

Increased Signaling: By inhibiting this enzyme, Donepezil ensures more acetylcholine remains available to stimulate the post-synaptic receptors.

Neurotransmission Enhancement: This stabilizes or slightly improves cognitive symptoms, though it does not “cure” the underlying neurodegeneration.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Donepezil 5 mg is a high-precision CNS product:

• Film-Coating & Palatability: Donepezil API has a notably bitter taste. As a WHO-GMP manufacturer, we utilize advanced film-coating technology to ensure the tablets are palatable and easy to swallow for geriatric patients.

• Orally Disintegrating Tablets (ODT): For patients with dysphagia (difficulty swallowing), we also manufacture Donepezil in MD (Mouth Dissolving) formats, which disintegrate on the tongue without water.

• Stability for Global Trade: We utilize Alu-Alu or high-grade PVC/PVDC blister packaging to protect against moisture and light, ensuring a stable 36-month shelf life for export to Zone IVb climates (Africa, SE Asia).

• B2B & Institutional Supply: Donepezil is a core item for geriatric clinics and specialized B2B distributors. Our Mumbai facility provides full CTD/eCTD Dossiers and bioequivalence data against the innovator (Aricept) to support international registration.