Title:  Elegant film coating system

United States Patent:  6,274,162

Inventors:  Steffenino; Rita M. (Green Lane, PA); Vesey; Charles F. (Hatfield, PA); Fegely; Kurt A. (Limerick, PA); Korchok; Brian D. (Lansdale, PA); Porter; Stuart C. (Hatfield, PA)

Appl. No.:  480969

A dry film coating composition for forming a coating suspension for film coating pharmaceuticals, food, confectionery forms, agricultural seeds, and the like, comprises (1) a primary film former, the primary film former comprising low bloom strength gelatin, or hydroxyethyl cellulose, or a combination thereof, and (2) a secondary film former, or a plasticizer, or a surfactant, or a glidant, or a suspension aid, or a colorant, or a flavorant, or a combination thereof.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the invention, our dry film coating composition for use in forming a coating suspension for film coating pharmaceuticals, food, confectionery forms, agricultural seeds, and the like, comprises gelatin and/or hydroxyethyl cellulose (HEC), and one or more of the following components: a secondary film former(s), a plasticizer(s), a surfactant(s), a glidant(s), a suspension aid(s), a colorant(s), and/or a flavorant(s).

In accordance with the invention, a method of coating substrates such as pharmaceutical tablets, food, confectionery forms, agricultural seed, and the like, comprises mixing gelatin and/or HEC into water to form our inventive aqueous coating suspension, applying the inventive coating suspension onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates. Optionally, but preferably, one or more of the following components may be mixed into water with the gelatin and/or HEC to form the inventive coating suspension: a secondary film former(s), a plasticizer(s), a surfactant(s), a glidant(s), a suspension aid(s), a colorant(s), and/or a flavorant (s).

Our invention also includes the film coating formed on said substrates, the coated substrates, and the methods of making the dry film coating composition and of making our coating suspension.

The film former of the coating is hydroxyethyl cellulose (HEC), or low bloom strength, non-gelling gelatin (preferably, fish gelatin), or combinations thereof.

The secondary film former may be sodium alginate, sodium carboxymethylcellulose (NaCMC), pectin, gelatin, propylene glycol alginate, methylcellulose, polydextrose, polyvinylpyrrolidone, or combinations thereof.

The plasticizer may be glycerin, maltitol solution, propylene glycol, polyethylene glycol, triethyl citrate, glyceryl triacetate, or any other material of similar plasticizing ability, or combinations thereof.

The surfactant may be soya lecithin, sodium lauryl sulfate, polysorbate 80, or polyoxyethylene polyoxypropylene block copolymers, or combinations thereof.

The glidant may be talc, colloidal silicon dioxide, or stearic acid, or combinations thereof.

The suspension aid may be xanthan gum, propylene glycol alginate, or pectin, or combinations thereof.

The colorants may be FD&C and D&C lakes, titanium dioxide, iron oxides, natural pigments, or dyes approved for ingestion by the U.S. Federal Drug Administration, or combinations thereof.

The flavorant(s), which is used primarily for taste- and/or odor-masking, may be vanillin, sodium citrate, citric acid, mint, orange, lemon oil, or any other pharmaceutically approved flavorant or tastemasking agent, and combinations thereof. Vanillin and citric acid are preferred.

The ranges for each component of the dry coating composition are as follows, by weight:

Claim 1 of 81 Claims

What is claimed is:

1. A dry film coating composition for forming a coating suspension for film coating pharmaceuticals, food, confectionery forms, and agricultural seeds, consisting essentially of

(1) a primary film former, the primary film former comprising low bloom strength gelatin, or hydroxyethyl cellulose, or a combination thereof, and

(2) a secondary film former, or a plasticizer, or a surfactant, or a glidant, or a suspension aid, or a colorant, or a flavorant, or a combination thereof.

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