Coating composition and therapeutic preparation incorporating same

• US 3,939,259 A
• Filed: 05/24/1974
• Issued: 02/17/1976
• Est. Priority Date: 05/24/1974
• Status: Expired due to Term

• Current Assignee: Anthony Pescetti
• Original Assignee: Anthony Pescetti
• Inventors: Pescetti, Anthony
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US05/473,289
• Time in Patent Office: 634 Days
• Field of Search: 424/19-23, 424/31-38
• US Class Current: 424/460
• CPC Class Codes: A61K 9/5078 with drug-free core

Abstract

A therapeutic preparation consisting of particles containing a therapeutically active material are coated with a disintegratable coating comprising zein and shellac. A first group of particles contains no coating or a coating subject to rapid disintegration upon ingestion to release an initial dose of therapeutic material and remaining groups of particles are coated with increasingly thicker coatings for delayed disintegration to release subsequent doses of therapeutic material. The coating composition may include disintegration modifiers so that thinner coatings of the zein-shellac coating material can be employed than would be required for zein shellac alone to obtain the delayed disintegration of the coating.

Claims

1. A therapeutic preparation comprising a pharmaceutical gelatin capsule containing a blend of three groups of particles containing a pharmaceutically active material, said first group containing a unit dose amount of said material for release thereof within a period of one hour after ingestion, a second group of said particles containing a unit dose amount of said material being provided with a coating comprising a major proportion of zein and shellac in a weight/weight ratio of between 1:

7 and about 1;

14 and minor proportions of ethyl cullulose, bees wax and a plasticizer, said coating having an effective thickness for disintegration and relase of said material in a period of about 4 hours after ingestion, and a third group of said particles containing a unit dose amount of said material being provided with a coating comprising a major proportion of zein and shellac in a weight/weight ratio of between about 1;

7 and about 1;

14 and minor proportions of ethyl cellulose, bees wax, polyvinylpyrrolidone and a plasticizer, said coating having an effective thickness for disintegration and relase of said material in about a period of about 8 hours after ingestion.

2. The therapeutic preparation of claim 1 wherein said pharmaceutically active material is digitoxin.