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@article{203023,
        author = {Abhijeet Sunil Shinde and Miss. Priti Ambhore},
        title = {FORMULATION AND EVALUATION OF NASAL DROPS OF PRAMIPEXOLE TO TREAT PARKINSON'S DISEASE},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {9744-9757},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=203023},
        abstract = {Parkinson's disease is a progressive, chronic neurodegenerative disorder characterized by the selective and irreversible loss of dopaminergic neurons in the substantia nigra pars compacta of the midbrain, leading to a profound depletion of dopamine in the striatum. This dopamine deficiency manifests clinically as the cardinal motor features of Parkinson's disease resting tremor, bradykinesia, muscular rigidity, and postural instability that together severely impair the patient's ability to perform activities of daily living and dramatically reduce quality of life. With a global prevalence of over 10 million individuals and no currently available disease-modifying therapy, Parkinson's disease represents one of the most significant unmet medical needs in neurology.
Pramipexole dihydrochloride is a highly selective, potent non-ergot dopamine receptor agonist with preferential affinity for the D2 and D3 receptor subtypes located in the striatum and substantia nigra. It is approved for the treatment of both early and advanced Parkinson's disease and is widely used in clinical practice for its efficacy in reducing motor fluctuations, prolonging on-time, and providing significant symptomatic relief. However, conventional oral pramipexole therapy is significantly limited by first-pass hepatic metabolism, erratic gastrointestinal absorption, gastrointestinal adverse effects including nausea and vomiting, and the need for frequent dosing all of which reduce therapeutic consistency and patient compliance.
The intranasal route of drug delivery has emerged as a highly promising and scientifically well-supported alternative pathway for the administration of drugs targeting the central nervous system. The nasal cavity provides unique and privileged access to the brain through the olfactory and trigeminal nerve pathways the so-called nose-to-brain transport that can deliver drugs directly to the CNS while effectively bypassing the blood-brain barrier, hepatic first-pass metabolism, and gastrointestinal degradation. This nose-to-brain pathway is particularly relevant for drugs like pramipexole that target the dopaminergic system of the brain.
The present work focuses on the formulation and evaluation of Pramipexole Dihydrochloride Nasal Drops (20 mL, Higher Strength 1% w/v) for the treatment of Parkinson's disease. The formulation contains Pramipexole Dihydrochloride (0.20 g) as the active drug, Sodium Chloride IP (0.18 g) as a tonicity adjuster for isotonicity with nasal mucosa, Phosphate Buffer (pH 5.5–6.5) as pH regulator, Glycerine IP (0.6 g) as a humectant to prevent nasal irritation, Benzalkonium Chloride (0.004 g) as an antimicrobial preservative, and Distilled Water q.s. to 20 mL as the vehicle.
The prepared nasal drops were evaluated for organoleptic properties, pH, clarity, isotonicity, drug content, nasal mucociliary toxicity, antimicrobial preservative efficacy, in-vitro drug permeation, and stability. Results demonstrated a clear, isotonic, pH-compatible, stable, and well-preserved nasal drop formulation with promising potential for improving the systemic and brain-targeted delivery of pramipexole in Parkinson's disease patients with reduced adverse effects compared to conventional oral therapy.},
        keywords = {Pramipexole Dihydrochloride, Parkinson's Disease, Nasal Drops, Intranasal Drug Delivery, Nose-to-Brain Transport, Dopamine Agonist, Blood-Brain Barrier Bypass, Isotonicity, Benzalkonium Chloride, Indian Pharmacopoeia.},
        month = {May},
        }