Natural Disintegrant Pre-mixes for Oral Tablets
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current formulations of all-natural solid dosage forms face challenges with tablet hardness, friability, dissolution profiles, and processing characteristics, particularly in using natural ingredients, which result in reduced flowability and compressibility, and batch-to-batch variations.
Innovation Solution
A natural disintegrant pre-mix composition comprising 30-90% Psyllium Husk, 20-40% Oat Fiber, and 1-20% additional natural fibers or gums, such as Apple Fiber, Wheat Fiber, or Guar Gum, blended physically without chemical reactions, enhancing disintegration properties and homogeneity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If natural ingredients are used in solid dosage forms, then consumer acceptance and clean label requirements are improved, but tablet hardness, friability, and processing characteristics deteriorate
Solution Approach 1:
The patent uses a composite disintegrant system combining multiple natural ingredients (Psyllium Husk, Oat Fiber, and additional natural fibers or gums) to achieve both disintegration functionality and processing stability. This composite approach allows the formulation to maintain natural ingredient purity while improving mechanical properties like tablet hardness and friability through synergistic effects of the different natural materials.
Solution Approach 2:
The patent optimizes the composition ratios of natural disintegrant ingredients (Psyllium Husk 30-90%, Oat Fiber 20-40%, and additional components 1-20%) to achieve the desired balance between disintegration performance and processing characteristics. By carefully controlling these parameters, the formulation maintains natural integrity while improving manufacturability and product reliability.
2Ease of manufacture
If natural disintegrants are used, then clean label and consumer acceptance are improved, but flowability and compressibility deteriorate
Solution Approach 1:
The composite disintegrant formulation combines Psyllium Husk with Oat Fiber and additional natural fibers or gums to achieve a balance between flowability and compressibility. The synergistic interaction of these natural materials provides both lubricating effects for flowability and structural integrity for compressibility, overcoming the limitations of single natural ingredient systems.
Solution Approach 2:
The patent applies different natural ingredients to different functional requirements within the formulation: Psyllium Husk provides primary disintegration, Oat Fiber contributes to bulk and flow characteristics, and additional natural fibers or gums are selected based on specific needs to enhance either flowability or compressibility in the powder blend.
3Reliability
If natural ingredients are used, then clean label requirements are met, but batch-to-batch variation increases
Solution Approach 1:
The composite disintegrant system combines multiple natural ingredients with complementary properties that work synergistically to stabilize batch-to-batch variation. The combination of Psyllium Husk, Oat Fiber, and additional natural fibers or gums creates a more robust formulation that is less sensitive to variations in individual ingredient performance, thereby improving batch consistency while maintaining clean label status.
Solution Approach 2:
The patent establishes specific composition ranges (Psyllium Husk 30-90%, Oat Fiber 20-40%, additional components 1-20%) that have been optimized to minimize batch-to-batch variation. By controlling these parameters within defined ranges, the formulation achieves reliable and consistent performance across batches while maintaining the natural ingredient profile required for clean label products.
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 composition provides super disintegrant properties, improving tablet disintegration times and maintaining excellent flowability and compressibility, making it a suitable alternative to synthetic disintegrants while ensuring batch consistency and consumer acceptance.
Implementation Method 1
The pre-mixes promote the break-up of the tablet (and capsule 'slugs') into smaller fragments in an aqueous environment thereby increasing the available surface area and promoting the release of the active nutraceutical/pharmaceutical substance
Implementation Method 2
disintegration of direct compression tablets
Implementation Method 3
Tablets are manufactured by compressing a suitable powder mixture in a die at high compression force
Data Source
AI summary
The present invention relates The invention relates to the field of natural disintegrant pre-mixes which are useful for formulating solid dosage forms for oral administration of drugs, vitamins, food supplements, etc. The composition comprises a blend about 20% to about 90% by weight of Psyllium Husk and about 5% to about 60% by weight of Oat Fiber (all weight percentages being based on the dry weight of the disintegrant composition). The composition may further comprise about 1% to about 25% by weight of at least one further component selected from guar gum, Locust bean gum, gum karaya, Aegle marmelose gum, Mangifera indica gum, and a combination thereof and/or about 1% to about 20% by weight of at least one further component selected Apple Fiber, Wheat Fiber, Pea Fiber, Cellulose Powder, Agave Powder, Bamboo Fiber, and a combination thereof (all weight percentages being based on the dry weight of the disintegrant composition). The natural disintegrant composition provides super disintegrant properties to the tablet, while maintaining excellent properties of homogeneity, flowability and compressibility during the manufacture of the solid oral dosage form. Tablets made with the conventional/organic super disintegrant composition may be labelled as "natural". The composition may replace conventional super disintegrants like croscarmellose or crospovidone.