In the pharmaceutical industry, Donepezil Hydrochloride is a centrally acting Reversible Acetylcholinesterase Inhibitor. As a pharmacist and manufacturer, I view this molecule as a “Cognitive Bridge”—it does not stop the neurodegenerative progression of Alzheimer’s, but it optimizes the remaining neural pathways to improve the quality of daily life and memory.

At your WHO-GMP facility in Mumbai, where you likely manufacture the 5 mg, 10 mg, and potentially 23 mg tablets, this is a core SKU for your CNS and Geriatric Portfolio.

Primary Clinical Utility

Donepezil is the “Gold Standard” for the symptomatic treatment of dementia in patients with Alzheimer’s disease.

• Memory and Attention: It improves cognitive functions, including thinking, remembering, and speaking.

• Daily Activities: It helps patients maintain the ability to perform regular tasks (like dressing or eating) for a longer period.

• Behavioral Stability: It has been shown to reduce some of the neuropsychiatric symptoms of dementia, such as agitation or confusion.

Mechanism: The “Cholinergic Boost”

Alzheimer’s patients suffer from a significant deficit of Acetylcholine (ACh), a neurotransmitter essential for learning and memory.

Enzyme Inhibition: Donepezil binds to the enzyme acetylcholinesterase, which is responsible for breaking down ACh in the synaptic cleft.

Increased Concentrations: By blocking this “clean-up” enzyme, Donepezil allows higher levels of ACh to remain available for brain cell communication.

The Result: It enhances the efficiency of the remaining cholinergic neurons, providing a modest but measurable improvement in mental function.

The Pharmacist’s “Technical Warning”

• The “Bedtime” Rule: Donepezil should ideally be taken at night, just before retiring. This helps minimize the impact of gastrointestinal side effects (nausea/dizziness) which are most common during the first few weeks of therapy.

• Vagotonic Effects: As a cholinomimetic, it can cause bradycardia (slow heart rate). Caution is required for patients with a history of heart block or “Sick Sinus Syndrome.”

• The “Dose-Response” Risk: The 23 mg dose is associated with a significantly higher incidence of severe vomiting and weight loss compared to the 10 mg dose. Close monitoring of body weight is essential.

• Abrupt Discontinuation: Stopping treatment suddenly can lead to a rapid decline in cognitive function. Always follow a tapering schedule if discontinuation is necessary.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “ODT” Advantage: On your digital marketplace, highlight your Orally Disintegrating Tablet (ODT) capability. For Alzheimer’s patients who may have difficulty swallowing (dysphagia), ODTs that dissolve on the tongue provide a major competitive advantage.

• Stability for Export: Donepezil is stable but must be protected from light and moisture. For export to Zone IVb tropical regions, utilizing Alu-Alu or high-grade PVC/PVDC blister packaging is essential to ensure a 36-month shelf life.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international tenders for government-funded elderly care programs.