Semi-moist oral delivery system
AssigneeEZ-Med Company
InventorEdwin H. Christensen
Life of this patent
Estimating the term…
Abstract
The subject invention is a carrier or product formed of a matrix having starch, sugar, fat, polyhydric alcohol and water in suitable ratios such that there exists a water activity of 0.6-0.75. The water activity of the product matrix may be adjusted up or down so that the availability of water in the finished product is not detrimental to the included active ingredient, be it pharmaceutical, nutraceutical, or a vitamin mineral complex.
Claims23
A composition for the oral administration of an additive selected from the group consisting of pharmaceutical, nutritional supplements, vitamins and minerals, and mixtures thereof mammals in a discrete dosage form, said discrete dosage from comprising:
- said additive,
- an extrudate comprising a matrix having about 10 to about 50% wt starch,
- a sweetener consisting essentially of sucrose, corn syrup and sorbitol, said sucrose being in an amount of at least 10%, and
- at least about 5% wt water,
- said composition having Aw of about 0.60 to about 0.75, and a soft and chewy texture, and said Aw being adjusted to permit an appropriate amount of free water in the presence of the additive.
A method of making a carrier and additive mixture for use in an oral administration of a therapeutically effective amount of the additive in a discrete dosage form, comprising the steps of:
- a) forming a matrix and additive admixture by mixing, in a one-step procedure additive,
- about 10 to about 50% wt starch,
- 0 to about 40% wt fat or oil,
- a sweetener consisting of sucrose, corn syrup and sorbitol, said sucrose being in an amount of at least 10%,
- and water,
- and mixing;
- adjusting the relative amounts of polyhydric alcohol and water to control the Aw of said admixture to adjust the level of moisture in the carrier to be a level not inimical to the additive and extruding said admixture to form an extrudate.
A composition for the oral administration of a pharmaceutical additive to mammals in a discrete dosage form, said discrete dosage form comprising:
- an extrudate having a matrix, and comprising:
- 10-50% starch,
- 0-40% fat or oil,
- a sweetener consisting essentially of sucrose, corn syrup and sorbitol, said sucrose being in an amount of least 10%,
- at least about 5% water,
- said composition having an Aw of about 0.60 to about 0.75, and a soft and chewy texture, and said Aw being adjusted to permit an appropriate amount of free water in the presence of the additive.
Dependencies are inferred from the claim text.