Chewable softgel capsules

Abstract

A chewable softgel capsule configured for encasing orally ingestible articles. The chewable soft capsule is provided with an outer shell composition which comprises at least one gelatin in a range of 20% to 60% of the total weight of the shell composition, at least one plasticizer in an amount selected to render flexible the outer shell composition, an anti-tacking agent in an amount selected to render the outer shell composition non-sticky, and water. In one embodiment the chewable soft capsule further comprises at least one starch in a range of 0.1% to 35% of the total weight of the shell composition. The chewable softgel capsule is suitable for encasing therein medicines, pharmaceutical compositions, nutraceuticals, vitamins, nutritional supplements, and the like.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of our prior application Ser. No. 12 / 200,850 filed Aug. 28, 2008 currently pending.FIELD OF THE INVENTION[0002]The present invention relates generally to soft gelatin capsules and in particular, to soft gelatin capsules having a chewable consistency.BACKGROUND OF THE INVENTION[0003]Common routes for the administration of pharmacologically active agents, nutraceuticals, and vitamins are exemplified by a variety of oral dosage forms such as tablets, pills, and capsules. Additionally, a wide range of foodstuffs and oral hygiene products, such as breath fresheners are also orally dispensed. Such dosage forms are generally convenient, stable in storage and transport, and familiar to the user. However, they are not without problems, and these problems are often significant. It is extremely difficult for most people to swallow any of these oral dosage forms without supplemental water. It is frequently i...

AI Technical Summary

Benefits of technology

The formulation results in softgel capsules that are non-sticky and soft during storage, maintaining these properties under high temperature and humidity conditions, and can be produced using conventional machinery, addressing the challenges of stickiness and stability in existing softgel capsules.

Problems solved by technology

However, they are not without problems, and these problems are often significant.

It is extremely difficult for most people to swallow any of these oral dosage forms without supplemental water.

It is frequently inconvenient or messy to have to take supplementary water with oral medicaments.

Such difficulties are compounded for those with swallowing difficulties such as, for example, children and the elderly.

Certain medical conditions, such as Parkinsons' disease and other neurological states, make it difficult to swallow oral dosage forms, even with supplemental water.

Children and the elderly often experience difficulty in swallowing and ingesting medicines in solid forms such as tablets, pills, and capsules.

Recently, with diversification of personal preferences in food and textures of food within the mouth, the texture of oral dosage forms of pharmaceuticals is an additional complication in oral medicaments.

Conventional soft gelatin capsules commonly available are often hard and tough because they are designed to dissolve after reaching the intestines so as to release their contents therein.

Such capsules are not easily broken by teeth and are not suitable for chewing.

In addition, twisting the capsule with the fingers to open the capsule is often a difficult practice, and generally opening the capsule requires a tool such as scissors.

However, this often makes a soft gelatin capsule more likely to stick to another soft gelatin capsule or to a container, thereby causing deterioration in storage stability.

Increasing plasticizer content is further problematic in high-temperature, high-humidity regions.

Such capsules are distinguished by particular fabrication problems, such as excessive stickiness during encapsulation and sticking of the end product to other capsules during post-encapsulation handling.

Further, chewable softgels with high end water content typically have poor storage performance, sticking to one another in packaging and often melting or leaking during storage.

However, such formulations can be problematic when stored at high temperatures or high humidity.

For example, it is very difficult to formulate a fish gelatin capsule that will be stable at a storage temperature above 35° C. Capsules made with such low melting point gelatins tend to become sticky during storage, and may even burst or melt, releasing their contents.

On the other hand, it is known that mammalian gelatins, some of which have melting temperatures above 60° C., tend to be much more stable at higher storage temperatures, but too often have poorer organoleptic qualities.