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Edible PGA coating composition

a coating composition and prompt release technology, applied in the direction of pectin coatings, starch coatings, fertiliser forms, etc., can solve the problems of increasing the disintegration time of tablets, difficult or inconvenient application to the soil, and the loss of active ingredients in the process, and achieve the effect of low viscosity and low viscosity

Inactive Publication Date: 2005-05-05
FMC CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] It has been found that these and other advantages may be achieved in accordance with the present invention by a coating composition which comprises a low viscosity propylene glycol alginate as the principle or only film-forming component of the coating composition, preferably in combination with a surface active agent. The coating composition of the present invention utilizes as the primary film former a low viscosity propylene glycol alginate (PGA), a 1% aqueous solution of which has a viscosity in the range of about 1 to 500 mPa·s at 25° C. The PGA preferably is used in combination a surface active agent, and optionally such additional ingredients as a filler, a coloring agent, or combination of these, and may also contain a small amount of a secondary film former and / or a strengthening polymer as an additional ingredient. More specifically, the present invention provides a prompt release, edible, hardenable PGA coating composition, as well as dry coatings and aqueous dispersions thereof and solid dosage forms coated therewith.

Problems solved by technology

Uncoated tablets are often subject to being abraded or chipped, causing a loss of active ingredient in the process.
Fertilizers, in either granular or tableted forms, may be coated to retain the integrity of the form and, especially, to protect the fertilizer from moisture which can cause agglomeration during storage, which could make rapid, even application to the soil difficult or inconvenient.
A particular disadvantage of coatings based primarily on HPMC is that the coating may harden over time and therefore increase tablet disintegration times. An increase in disintegration time delays the bioavailability of the active ingredient at least in proportion to the increase in disintegration time.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0034] In a Patterson-Kelly twin shell blender were placed 250 grams of low viscosity propylene glycol alginate (Profoam, Pronova / FMC Corporation) and 10 grams of hydroxylated soy lecithin (Precept 8120, Central Soya). After the dry components had been thoroughly blended, the blend was added slowly to the vortex of 3450 grams deionized water which was stirred with a Lightnin' mixer. The suspension was stirred for 3 hours at ambient temperature to fully hydrate the composition. To this dispersion was added 40 grams of Chroma-Kote red liquid dispersion (Crompton and Knowles). A 24″ Acella Comp-U-Coat coater was charged with 12 Kg of ibuprofen caplets. The coater was operated at an inlet temperature of 40-55° C., an outlet temperature of 35-39° C., and 8-9 rpm. During the spraying, which required 85 minutes, a 2-3% by weight coating, based on the weight of the caplets, was applied. The composition of the coating and the physical properties of the coated caplets are shown as Example 1 o...

examples 2 and 3

[0035] In a Patterson-Kelly twin shell blender were placed 292 grams of low viscosity propylene glycol alginate (Profoam, Pronova / FMC Corporation) and 45 grams of hydroxyethylcellulose 250 L, 22.5 grains of hydroxylated soy lecithin (Precept 8120, Central Soya), 45 grams of maltodextrin M1 80 (Maltrin M1 80, GPC) and 45 grams of Color Blend Pigment (Croma-tone, Warner Jenkinson). After the dry components had been thoroughly blended, the blend was added slowly to the vortex of 5175 grains deionized water which was stirred with a Lightnin' mixer. The suspension was stirred for 2 hours at ambient temperature to fully hydrate the composition. To this dispersion was added 40 grams of Chroma-Kote red liquid dispersion (Crompton and Knowles). A 24″ Acella Comp-U-Coat coater was charged with 12 Kg of ibuprofen caplets. The coater was operated at an inlet temperature of 53-55° C., an outlet temperature of 32-39° C., and 8-11 rpm. During the spraying, which required 63-69 minutes, a 3% by wei...

example 4

[0036] In a Patterson-Kelly twin shell blender were placed 65 grams of low viscosity propylene glycol alginate (Profoam, Pronova / FMC Corporation), 22.5 Crams of hydroxylated soy lecithin (Precept 8120, Central Soya), and 45 grams of maltodextrin M1 80 (Maltrin M1 80, GPC). After the dry components had been thoroughly blended, the blend was added slowly to the vortex of 1150 grams deionized water which was stirred with a Lightnin' mixer. The suspension was stirred for 2 hours at ambient temperature to fully hydrate the composition. A Vector LDCD 15″ coater was charged with 2 Kg of chlorpheniramine 4 mg tablets. The coater was operated at an inlet temperature of 74-83° C., an outlet temperature of 34-39° C., and 13-16 rpm. During the spraying, which required 67 minutes, a 3% by weight coating, based on the weight of the caplets, was applied. The composition of the coating and the physical properties of the coated caplets are shown as Example 4 of Table 1, below.

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Abstract

An edible, hardenable coating composition is disclosed which comprises high levels of low viscosity propylene glycol alginate and a surfactant, which may additionally contain a filler, a pigment, and optionally a small amount of a secondary film former and / or a strengthening polymer. The coating composition of the present invention may be applied to pharmaceutical and veterinary solid dosage forms, confectionery, seeds, animal feed, fertilizers, pesticide tablets, and foods and provides an elegant prompt release coating which does not retard the release of active ingredients from the coated substrate.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation in part of U.S. patent application Ser. No. 09 / 994,252, filed Nov. 26, 2001, which claims the benefit of U.S. Provisional Application No. 60 / 284,778, filed Apr. 19, 2001; U.S. Provisional Application No. 60 / 268,608, filed Feb. 14, 2001; and U.S. Provisional Application No. 60 / 253,406, filed Nov. 28, 2000.FIELD OF INVENTION [0002] This invention relates to edible, hardenable prompt release coating compositions comprising a film forming amount of low viscosity propylene glycol alginate that serves as the principle, primary or sole film former of the coating composition. The coatings of the present invention can be applied to pharmaceutical, including neutraceutical, and veterinary solid dosage forms, such solid substrates such as seeds, animal feed, fertilizers, pesticide tablets and granules, and also to confectionery and foods. They are readily dispersed in aqueous media, and, when applied as a coating...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A23G3/34A23L1/00A61K9/20A61K9/28A61K9/36A61K47/24A61K47/36A61K47/38C05G5/00C08L1/28C08L3/02C08L5/00C08L71/02C09D105/04C09D105/06C09K3/00
CPCC08L3/02A23V2002/00A23L1/0052C09D105/06C09D105/04C08L71/02C08L5/00A61K9/2072C08L1/284A61K9/286A61K9/282A23G3/343A23G2200/00C08L2666/26C08L2666/02A23V2200/22A23V2250/5026A23V2250/1842A23V2250/5114A23V2250/612A23P20/105
Inventor AUGELLO, MICHAEL
Owner FMC CORP
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