Pharmaceutical Tablet Binder with Plasticizer for Strength and Disintegration
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Solution Overview
Problem
Tablets produced by direct compression with existing binders lack sufficient mechanical strength and immediate disintegrability, affecting their stability and dissolution rates.
Innovation Solution
A pharmaceutical tablet using a polyvinyl alcohol resin as a binder, combined with a polyhydric alcohol plasticizer other than water, is produced through a direct compression method, ensuring high tensile strength and rapid disintegration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a polyvinyl alcohol resin is used as a binder in direct compression method, then mechanical strength of the tablet is improved, but disintegration time increases
Solution Approach 1:
The patent applies parameter changes by carefully controlling the degree of saponification of the polyvinyl alcohol resin within 70-100 mol% and the average degree of polymerization within 500-4000. These specific parameter ranges optimize the balance between mechanical strength (improved by higher saponification and polymerization) and disintegration rate (maintained by not exceeding these values), resolving the contradiction between strength and disintegration time
Solution Approach 2:
The patent uses a composite binder system combining polyvinyl alcohol resin with specific additives (0.1-10 wt% of crosslinking agents, 1-50 wt% of pore-forming agents, and 1-50 wt% of disintegrants). This composite approach creates a material that simultaneously provides mechanical strength through the PVA resin network while incorporating disintegration-promoting components, thus resolving the contradiction between strength and disintegration rate
2Productivity
If direct compression method is used, then manufacturing efficiency is improved, but tablet mechanical strength deteriorates
Solution Approach 1:
The patent changes the parameters of the binder material by using polyvinyl alcohol resin with specific degree of saponification (70-100 mol%) and average degree of polymerization (500-4000). These parameter adjustments enable the resin to provide sufficient binding strength for direct compression without requiring granulation, thus maintaining high manufacturing efficiency while achieving adequate mechanical strength
Solution Approach 2:
The patent creates a composite binder material by combining polyvinyl alcohol resin with crosslinking agents (0.1-10 wt%), pore-forming agents (1-50 wt%), and disintegrants (1-50 wt%). This composite formulation enhances the mechanical strength of tablets produced by direct compression, allowing the method to achieve both high productivity and satisfactory tablet strength
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 tablet exhibits enhanced mechanical strength, preventing breakage during handling and transportation, and facilitates easy dissolution due to improved disintegrability.
Implementation Method 1
the binder is added to bind powder particles of raw materials and has large impact on the mechanical strength of the tablet
Implementation Method 2
a polyvinyl alcohol resin and a plasticizer other than water, wherein the plasticizer is a polyhydric alcohol which is liquid at 25 °C
Data Source
AI summary
An object of the present invention is to provide a pharmaceutical tablet having high tensile strength and excellent in immediate disintegrability. The pharmaceutical tablet of the present invention is obtained by a direct compression method, and contains an active ingredient, a polyvinyl alcohol resin, and a plasticizer other than water, wherein a content of the plasticizer is 1 to 8 parts by weight with respect to 100 parts by weight of the polyvinyl alcohol resin.