Starch-Free Soft Chew for Veterinary Drug Delivery
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Solution Overview
Problem
Current soft chew pharmaceutical products for animals often have high water content, hard texture, and poor dissolution properties, failing to meet regulatory requirements for in-vitro dissolution and being unsuitable for moisture-sensitive drugs due to the presence of starch as an excipient.
Innovation Solution
A starch-free soft chew composition and process that uses non-starch solid excipients like dibasic calcium phosphate and microcrystalline cellulose, combined with non-water liquid excipients such as glycerin and triglycerides, eliminating the need for added water and maintaining low water content, ensuring stability and bioavailability for moisture-sensitive active ingredients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If starch-based excipients are used in soft chew formulations, then the product achieves desirable texture and malleability, but the water content increases and dissolution performance deteriorates
Solution Approach 1:
The patent removes starch from the formulation entirely, extracting the problematic excipient that caused high water content and poor dissolution. This is achieved by replacing starch with alternative excipients like microcrystalline cellulose, dicalcium phosphate, and pre-gelatinized starch alternatives that provide necessary texture without the harmful water retention effects
Solution Approach 2:
The patent changes the physical and chemical parameters of the formulation by using pre-gelatinized starch alternatives and modified excipient combinations. This allows the soft chew to achieve desired malleability through controlled gelatinization and binding mechanisms rather than relying on starch's natural water-retention properties
2Shape
If starch-based excipients are used in soft chew formulations, then the product achieves desirable texture, but the dissolution performance and regulatory compliance deteriorate
Solution Approach 1:
The patent extracts starch from the formulation to eliminate the dissolution barrier it creates. By removing starch, the formulation achieves compliance with FDA dissolution requirements while maintaining acceptable texture through alternative excipient systems
Solution Approach 2:
The patent uses composite excipient systems combining microcrystalline cellulose, dicalcium phosphate, and pre-gelatinized starch alternatives in specific ratios. This composite approach provides both the desired texture and the dissolution performance needed for regulatory compliance
3Shape
If water is added during extrusion to improve flexibility, then the malleability improves, but the stability of moisture-sensitive active ingredients deteriorates
Solution Approach 1:
The patent removes water from the formulation process entirely, eliminating the source of moisture that compromises active ingredient stability. Flexibility is achieved through alternative mechanisms using hydrophilic excipients and controlled binding rather than water addition
Solution Approach 2:
The patent introduces hydrophilic excipients like microcrystalline cellulose and pre-gelatinized starch as intermediaries that provide flexibility and binding functions without requiring free water. These intermediaries enable the formulation to achieve desired physical properties while maintaining a low water activity environment
4Ease of manufacture
If starch is used as an excipient, then the formulation achieves ease of manufacture, but the water activity control and microbial stability deteriorate
Solution Approach 1:
The patent removes starch from the formulation to eliminate the substrate that supports microbial growth. By extracting this harmful element, the formulation achieves improved microbial stability while maintaining manufacturability through alternative excipient systems
Data Source
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AI summary
The present invention relates to a starch-free soft chew formulation for oral delivery of at least one active ingredient to an animal, and a starch-free soft chew containing the formulation and at least one active ingredient. The starch-free soft chew includes one or more active ingredients and excipients, such as a bulking agent, a flavoring agent, a humectant, a preservative, an antioxidant, and a lubricant, but no added water. In addition, the invention relates to a composition of starch-free, non-water excipients for use in the final dosage form of a soft chew for oral administration of at least one active ingredient to an animal. Also provided are processes for making the starch-free soft chew formulation and the starch-free soft chew.