Memantine Melatonin Orally Disintegrating Tablet Formulation
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Solution Overview
Problem
Current pharmaceutical compositions of memantine and melatonin lack stability and dissolution rate studies, and there is a need for improved orally disintegrating tablet forms with enhanced safety and storage stability for treating mental, behavioral, and cognitive disorders.
Innovation Solution
A novel pharmaceutical composition in an orally disintegrating tablet form comprising 2.0 to 15.0 wt% memantine, 1.5 to 10.0 wt% melatonin, and 75.0 to 96.5 wt% excipients, with preferred components including mannitol, crospovidone, sorbitol, and flavoring agents, optimized for improved stability and dissolution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pharmaceutical compositions of memantine and melatonin are used, then the basic therapeutic effect is achieved, but the storage stability and dissolution rate are insufficient
Solution Approach 1:
The patent changes the physical and chemical parameters of the pharmaceutical composition by incorporating specific excipients (mannitol, crospovidone, sorbitol) in optimized ratios. This modifies the dissolution characteristics and storage stability of the tablet formulation, transforming the original composition into one with improved performance parameters without changing the active ingredients.
Solution Approach 2:
The patent creates a composite pharmaceutical formulation by combining memantine, melatonin, and multiple excipients (mannitol, crospovidone, sorbitol, flavoring agents) in specific proportions. This composite material approach allows the formulation to simultaneously achieve good storage stability and rapid dissolution rate, resolving the contradiction between these two properties.
2Ease of operation
If the composition is made to disintegrate quickly in the mouth, then patient compliance is improved, but the chemical purity and stability during storage may be compromised
Solution Approach 1:
The patent introduces disintegrating agents (crospovidone) and effervescent agents (sodium bicarbonate, citric acid) as intermediaries that facilitate rapid oral disintegration. These excipients act as mediators between the active ingredients and the dissolution medium, enabling quick breakdown of the tablet in the mouth while the optimized formulation maintains chemical purity during storage by protecting the active ingredients from degradation.
Data Source
AI summary
The invention relates to the chemical-pharmaceutical industry, and specifically to a pharmaceutical composition in a tablet form comprising: 2.0 to 15.0 wt% of memantine; 1.5 to 10.0 wt% of melatonin; 65.0 to 80.0 wt% of a filler selected from mannitol or a mannitol and copovidone mixture; 4.0 to 15.0 wt% of a disintegrant selected from crospovidone; 1.0 to 2.0 wt% of a binder selected from sorbitol; 1.0 to 2.5 wt% of a sweetener selected from maltitol, sodium saccharinate or a mixture thereof; 0.5 to 1.0 wt% of a glidant selected from colloidal silicon dioxide, stearic acid, magnesium stéarate, talc or mixtures thereof; and 1.5 to 3.0 wt% of a flavoring agent; and to a method for preparing the pharmaceutical composition. The invention provides for broadening the range of pharmaceutical compositions comprising a combination of memantine and melatonin, and for increasing the storage stability and dissolution rate thereof.