Title:  Delayed release coated tablet of bupropion hydrochloride

United States Patent:  6,143,327

Assignee:  Pharma Pass LLC (Irvine, CA)

Filed:  December 13, 1999

The invention provides a delayed release coated tablet, free of stabilizer and free of pore-forming agent comprising: (i) a core consisting essentially of bupropion hydrochloride, a binder and a lubricant; and (ii) a first coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer; and (iii) a second coating consisting essentially of a methacrylic polymer and a plasticizer therefor.

SUMMARY OF THE INVENTION

The invention provides a delayed release coated tablet comprising:

(i) a core comprising bupropion hydrochloride and conventional excipients, free of stabilizer; and

(ii) a first coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer,

(iii) a second coating consisting essentially of a methacrylic polymer and a plasticizer therefor.

The invention thus provides a new bupropion hydrochloride delayed release composition under the form of a coated tablet free of stabilizer of any kind including those with acidic pH or with antioxidant properties. Also, the delayed release is obtained thanks to a semi-permeable release coating, free of (monomeric) pore-forming agent.

The tablets of the invention exhibit specific dissolution profiles.

The invention also provides a tablet comprising the delayed release coated tablet of the invention, coated with a bupropion hydrochloride immediate release coating.

Claim 1 of 19 Claims

What is claimed is:

1. A delayed release coated tablet comprising:

(i) a core comprising bupropion hydrochloride and conventional excipients, free of stabilizer; and

(ii) a first coating consisting essentially of a water-insoluble, water-permeable film-forming polymer, a plasticizer and a water-soluble polymer; and

(iii) a second coating consisting essentially of a methacrylic polymer and a plasticizer therefor;

exhibiting a dissolution profile such that after 2 hours, from 0 up to 30% of the bupropion hydrochloride is released, after 4 hours, from 3 to 22% of the bupropion hydrochloride is released, after 6 hours, from 15 to 38% of the bupropion hydrochloride is released, after 8 hours, more than 40% of the bupropion hydrochloride is released.

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