Abstract
Objective: The study is directed towards the development of an orally disintegrating drug delivery system of memantine hydrochloride which can be commercially exploited for the well-being of society for the treatment of Alzheimer’s disease, which is a most common form of dementia.
 Methods: Orally disintegrating immediate-release tablets of memantine hydrochloride were prepared and optimized for disintegration time and in vitro drug release. The top spray granulation method was used for the preparation of granules. Subsequently, these granules were compressed to tablets. The levels of diluent, disintegrant and taste-masking agents were optimized using the design of experiments. The resulting tablets were evaluated for disintegration time and in vitro drug release. The optimized formulation was subjected to accelerated stability study for 3 mo.
 Results: The optimized orally disintegrating tablet formulation exhibited a disintegration time of 2-3 min and complete drug release i.e. more than 85 % drug release within 10 min while performing in vitro drug release study. This is a prerequisite for faster action in the case of patients suffering from Alzheimer’s disease. Accelerated stability studies indicated good physical and chemical stability of the optimized formulation.
 Conclusion: Developed orally disintegrating tablet formulation of memantine hydrochloride could release the drug faster compared to conventional immediate-release tablets which is useful in paediatric, geriatric and psychiatric patients.
Highlights
Dementia is a syndrome in which there is the disturbance of multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language, and judgment [1, 2]
Alzheimer’s disease is the most common form of dementia, which is the major cause of disability in later life and accounts for 11.9 % of the years lived with disability due to a non-communicable disease [3, 4]
Memantine hydrochloride was obtained as a gift sample from Cadila Healthcare Ltd, Mumbai, India; microcrystalline cellulose, mannitol, croscarmellose sodium, silica colloidal anhydrous and magnesium stearate procured from Signet chemicals ltd, Eudragit EPO as a gift sample from Evonik GmbH, India
Summary
Dementia is a syndrome in which there is the disturbance of multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language, and judgment [1, 2]. In the early stages of the disease, people most often notice memory problems that can be severe enough to interfere with their ability for routine tasks and work [5, 6]. In this disease, the change in forgetfulness is more dramatic than normal which commonly gets increased with age. The total number of people with dementia worldwide is projected to nearly double every 20 y, 65.7 million in 2030 and 115.4 million in 2050 [11,12,13]. It is projected that by 2050, people aged 60 and over will account for 22 % of the world’s population with 80 % living in Asia, Latin America or Africa [14]
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