Liquisoft Capsules Resolving Texture Stability Trade-off
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Solution Overview
Problem
Existing chewable soft gelatin capsules have limitations due to their leathery or rubbery texture, which can be unappealing to users, and tend to harden over time, making them less consumer-friendly.
Innovation Solution
Development of oral pharmaceutical compositions comprising soft gel capsules with flowable fills that can be chewed, sucked, or dissolved in the mouth, utilizing a shell composition that includes film-forming polymers, plasticizers, and sweeteners, and a matrix composition with hydrophilic vehicles, flavors, and active pharmaceutical ingredients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chewable soft gelatin capsules are made with substantial amounts of gelatin in the fill, then the capsule structure is maintained and dosage accuracy is achieved, but the organoleptic properties deteriorate with a leathery or rubbery texture that is unappealing to users
Solution Approach 1:
The patent changes the physical state parameter of the fill from semi-solid to liquid by reducing gelatin content and using liquid carriers (propylene glycol, polyethylene glycol, glycerin). This allows the capsule to maintain structural integrity through the shell while providing a pleasant liquid mouthfeel upon chewing, resolving the contradiction between structure stability and mouthfeel quality.
2Reliability
If chewable soft capsules are designed to release fill contents upon chewing, then active ingredient delivery is achieved, but the capsule shell becomes difficult to consume and creates a distinguishable textural difference between shell and fill
Solution Approach 1:
The patent creates homogeneity between shell and fill textures by making both components soft and pliable. The shell contains plasticizers (glycerin, propylene glycol) and the liquid fill contains compatible carriers, ensuring that both shell and fill have similar soft, non-leathery textures that are easy to consume together without noticeable textural differences.
3Ease of manufacture
If traditional soft gel capsule formulations are used, then manufacturing simplicity is maintained, but the capsules harden over time reducing consumer acceptance
Solution Approach 1:
The patent uses composite materials in both shell and fill formulations. The shell combines gelatin or HPMC with plasticizers (glycerin, propylene glycol, sorbitol), and the fill uses liquid carriers (propylene glycol, polyethylene glycol, glycerin) with active ingredients. This composite approach prevents hardening over time while maintaining manufacturing simplicity, as these materials are readily available and work together synergistically.
4Ease of operation
If liquid fills are used in soft gel capsules, then pleasant tasting and refreshing liquid releases are achieved, but the capsule shell formulation becomes more complex requiring specific plasticizers and polymer modifiers
Solution Approach 1:
The patent applies universality by using the same plasticizers (glycerin, propylene glycol, sorbitol) and liquid carriers in both shell and fill formulations. These materials serve multiple functions: they plasticize the shell for softness, act as liquid carriers in the fill for desired organoleptic properties, and ensure compatibility between shell and fill. This multi-functionality reduces the need for separate specialized ingredients, managing complexity while achieving pleasant liquid releases.
Data Source
AI summary
Described herein are oral pharmaceutical compositions suitable for chewing, sucking, or buccal dissolution comprising soft gel capsules and liquid fills, methods for making the same, and methods for treating subjects in need thereof with such capsules. In particular, oral pharmaceutical compositions comprising chewable, suckable, or dissolvable soft gel capsules with various flowable fill compositions are described.