Coated Orally Disintegrating Tablet Using Hydrolyzed Graft Polymer
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Solution Overview
Problem
Existing orally disintegrating tablets struggle to maintain a short disintegration time when coated, as film coatings typically extend the disintegration time due to their dissolution in saliva, hindering the rapid disintegration required for these dosage forms.
Innovation Solution
A rapidly disintegrating, solid coated dosage form comprising a solid core with a film coating made of a rapidly water-soluble polyether-vinyl ester graft polymer, where the vinyl esters have been completely or partially hydrolyzed, and a finely divided crospovidone, allowing for disintegration within 45 seconds or less, even when coated.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a film coating is applied to an orally disintegrating tablet, then protection against external influences, improved appearance, and concealed bitter flavor are achieved, but the disintegration time in the mouth is extended
Solution Approach 1:
The patent applies parameter changes by selecting specific polymer characteristics (molecular weight, composition ratio of water-soluble to water-insoluble portions) and coating thickness (1-20 μm, preferably 2-12 μm) to achieve rapid dissolution of the film coating within the required disintegration time while maintaining protective functions
Solution Approach 2:
The film coating uses composite materials consisting of both water-soluble and water-insoluble polymer portions, where the water-soluble portion (20-80% by weight) enables rapid dissolution and the water-insoluble portion provides mechanical strength and protective barrier function, resolving the contradiction between protection and rapid disintegration
2Ease of operation
If a film coating is applied to an orally disintegrating tablet, then appearance and swallowability are improved, but the disintegration time is extended
Solution Approach 1:
The patent optimizes coating thickness parameters (1-20 μm, preferably 2-12 μm) and polymer composition ratios to ensure the film coating provides improved swallowability and appearance while dissolving rapidly enough not to extend the disintegration time beyond acceptable limits
3Object-affected harmful factors
If a film coating is applied to an orally disintegrating tablet, then bitter flavor is concealed, but the disintegration time is extended
Solution Approach 1:
The film coating employs composite materials with both water-soluble and water-insoluble polymer portions, where the coating material itself can be formulated with pleasant flavor characteristics, providing bitter flavor concealment while the water-soluble portion ensures rapid dissolution within the required disintegration time
4Ease of manufacture
If direct tableting is used instead of wet granulation, then production ease is improved, but mechanical strength may be insufficient
Solution Approach 1:
The patent utilizes parameter changes in the polymer components (molecular weight, composition ratio) to achieve adequate mechanical strength through direct tableting without requiring wet granulation, maintaining production simplicity while ensuring sufficient mechanical strength for packaging and handling
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The dosage form achieves rapid disintegration in the mouth within 45 seconds or less, maintaining mechanical strength and avoiding a sandy mouth feel, while also providing protection against external influences and allowing for customizable flavor and color, enhancing usability and stability.
Implementation Method 1
where the vinyl acetate has been completely or partially hydrolyzed after the polymerization
Data Source
AI summary
Rapidly disintegrating, solid coated dosage form comprising a solid core consisting of at least 60% by weight of an auxiliary mixture, up to 40% by weight of at least one active ingredient, and optionally further auxiliaries, coated with at least one film coating comprising completely or partially hydrolyzed, rapidly water-soluble polyether-vinyl ester graft polymers, methods for the production thereof, and their use.