Title:  Method for coating pharmaceutical dosage forms

United States Patent:  6,254,888

Assignee:  Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)

Filed:  January 28, 2000

The invention provides a process for coating a branded pharmaceutical dosage form for the purpose of covering any embossed or printed matter or any colored coating by the application of an amount of a sugar based coating which is sufficient to obscure any identifying indicia without compromising the stability or releasability of the drug that is contained in the dosage form.

SUMMARY OF THE INVENTION

The invention provides a process for coating a branded pharmaceutical dosage form for the purpose of covering any embossed or printed matter or any colored coating by the application of an amount of coating which is sufficient to obscure any identifying indicia without compromising the stability or releasability of the drug that is contained in the dosage form.

The invention also provides a method of coating a micro tablet to form a rounded tablet which may comprise any or all of the following:

(a) sealing said micro tablet by applying a seal coat to form a sealed micro tablet;

(b) applying to said micro tablet an effective amount of a coating which provides a smooth coating over said micro tablet to provide a smoothly coated micro tablet; and (c) polishing the tablet to form a polished and moisture resistant pharmaceutical dosage form.

A method of separating incompatible micro tablets is disclosed which may comprise any or all of the following:

(a) sealing the incompatible micro tablet by applying a seal coat to form sealed incompatible micro tablet;

(b) applying to said micro tablet an effective amount of coating which provides a smooth coating over micro tablet to provide a smoothly coated micro tablet; and

(c) polishing the coated micro tablet to form a polished and moisture resistant pharmaceutical dosage form.

In addition, there is disclosed a method of incorporating additional active ingredients into a micro tablet, said method may comprise any or all of the following:

(a) coating an active ingredient onto a micro tablet using a solution or suspension of said active ingredient to form a coated micro tablet;

(b) sealing said micro tablet by applying a seal coat to form a sealed micro tablet;

(c) applying to said sealed micro tablet an effective amount of a coating which provides a smooth coating over said micro tablet to provide a smoothly coated micro tablet; and

(d) polishing the smoothly coated micro tablet of step (c) to form a polished and moisture resistant pharmaceutical dosage form.

Accordingly, it is a primary object of the invention to provide a novel method of obscuring the identifying indicia on a pharmaceutical dosage form.

It is also an object of the invention to provide a method of obscuring the printed matter or indicia on a pharmaceutical dosage form without compromising the stability or bioavailability of the pharmaceutical dosage form.

It is also an object of the invention to provide a cost efficient process for obscuring the embossed or printed matter on a pharmaceutical dosage form.

These and other objects of the invention will become apparent from the present specification.

Claim 1 of 10 Claims

What is claimed is:

1. A process for blinding a branded pharmaceutical dosage form for the purpose of covering any embossed, printed or colored indicia without compromising the stability or bioavailability of the pharmaceutical dosage form, said process comprising:

(a) sealing the branded pharmaceutical dosage form having thereon embossed, printed or colored indicia by applying a seal coat to the branded pharmaceutical dosage form to form a sealed pharmaceutical dosage form;

(b) applying to said sealed pharmaceutical dosage form an effective amount of a coating which provides a smooth coating over embossed, printed or colored indicia to provide a smoothly coated pharmaceutical dosage form; and

(c) polishing the smoothly coated pharmaceutical dosage form of step (b) to form a polished and moisture resistant pharmaceutical dosage form.

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