Natural Tablet Excipients for Flowable, Stable Powder Compression
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Solution Overview
Problem
The challenges in the pharmaceutical and nutraceutical sectors include the need for alternative excipients of natural origin due to regulatory restrictions on synthetic materials, ensuring uniformity and stability of tablets, and addressing defects like non-constant weight, poor mechanical strength, and difficulty in swallowing, while maintaining effective release and absorption of active ingredients.
Innovation Solution
Formulation of tablets using a combination of natural origin ingredients such as fructo-oligosaccharides (FOS) as diluents, mono- and/or diglycerides of fatty acids as lubricants, and optionally arabinogalactan, with specific weight ratios to enhance flowability, compressibility, and stability, replacing conventional excipients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional excipients are used for tablet formulation, then manufacturing process is established, but regulatory restrictions and consumer concerns arise regarding safety and naturalness
Solution Approach 1:
The patent changes the chemical composition parameters of excipients from synthetic to natural origin substances. Specifically, it uses fructo-oligosaccharides instead of conventional diluents, and mono- and/or diglycerides of fatty acids instead of synthetic lubricants, thereby eliminating harmful synthetic ingredients while maintaining functional requirements
Solution Approach 2:
The patent substitutes expensive or controversial synthetic excipients with naturally-derived, consumer-accepted alternatives. These natural excipients are perceived as safer and more acceptable by consumers, effectively replacing the 'harmful' synthetic components with benign natural substances
2Reliability
If natural origin excipients are used to replace conventional excipients, then consumer acceptance and safety improve, but tablet defects such as non-constant weight, poor mechanical strength, and difficulty in swallowing may occur
Solution Approach 1:
The patent optimizes the weight ratio parameters of natural excipients to achieve both safety and manufacturing precision. By carefully controlling the proportion of fructo-oligosaccharides (0.5-3 weight ratio) and mono- and/or diglycerides of fatty acids, the formulation achieves constant weight, good mechanical strength, and proper swallowability while maintaining natural ingredient status
Solution Approach 2:
The patent creates a composite excipient system combining multiple natural origin substances (fructo-oligosaccharides, mono- and/or diglycerides of fatty acids, and optionally arabinogalactan) to achieve synergistic effects that satisfy both safety requirements and manufacturing precision requirements that individual natural excipients cannot achieve alone
3Object-generated harmful factors
If natural origin excipients are used, then consumer appeal and naturalness improve, but flowability and compressibility characteristics may be insufficient
Solution Approach 1:
The patent develops a composite lubricant system using mono- and/or diglycerides of fatty acids that provides superior flowability and compressibility characteristics compared to individual natural excipients. This composite approach combines the naturalness benefit with the manufacturing ease requirement by creating a synergistic mixture that satisfies both consumer appeal and processability needs
Data Source
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AI summary
Tablets obtained by compression of powder mixtures comprising: a) at least one active ingredient, b) at least one diluent; c) at least one lubricating agent d) at least one excipient selected from at least one of the following classes: acidifier, binder, disaggregating agent, anti-caking agent, sweetener, stabilizer wherein: i) the diluent b) is a mixture of at least one conventional diluent and fructooligosaccharides (FOS), ii) the lubricating agent is a mono- and/or diglyceride of a fatty acid; iii) the FOS/conventional diluent ratio is between 0.5 and 3.