Storage-stable, quick-disintegrating pressed shapes containing pharmaceutical active substances

• US 4,666,703 A
• Filed: 03/13/1985
• Issued: 05/19/1987
• Est. Priority Date: 03/23/1984
• Status: Expired due to Fees

• Current Assignee: Ciba-Geigy Corporation (Novartis Ag)
• Original Assignee: Ciba-Geigy Corporation (Novartis Ag)
• Inventors: Kopf, Helmut
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/711,137
• Time in Patent Office: 797 Days
• Field of Search: 424/19-22, 424/32, 424/35
• US Class Current: 424/470
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/5026 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Abstract

Storage stable, quick-disintegrating pressed shapes containing pharmaceutical active substances, which shapes consist substantially of a compressed mixture of

(a) an effective amount of a pharmaceutical active substance in granular form, which is coated with a coating material comprising essentially a homogeneous mixture of a poly(H+meth)-acrylic acid-(methyl+ethyl) ester insoluble but dispersible in water and an ethyl cellulose insoluble but dispersible in water, the weight ratio of the acrylic acid ester to ethyl cellulose being 2.5:1 to 5:1;

(b) talcum; and

(c) colloidal silicon dioxide, and crosslinked polyvinylpolypyrrolidone as the disintegrating agent having a high disintegrating capacity and good binding properties.

Claims

1. Storage-stable, quick-disintegrating pressed shapes containing pharmaceutical active substances, which shapes consist substantially of a compressed mixture of

(a) an effective amount of a pharmaceutical active substance in granular form, which is coated with a coating material comprising essentially a homogeneous mixture of a poly(H+meth)-acrylic acid-(methyl+ethyl) ester insoluble but dispersible in water and an ethyl cellulose insoluble but dispersible in water, the weight ratio of the acrylic acid ester to ethyl cellulose being 2.5:

1 to 5;

1;

(b) talcum; and

(c) colloidal silicon dioxide, and crosslinked polyvinylpolypyrrolidone as the disintegrating agent having a high disintegrating capacity and good binding properties.

2. Pharmaceutical active-substance pressed shapes according to claim 1, wherein the mixture ratio of the coating materials is 3:

1.

3. Pharmaceutical active-substance pressed shapes according to claim 1, wherein the disintegrating agent consists of a mixture of polyvinylpolypyrrolidone and microcrystalline cellulose.

4. Pharmaceutical active-substance pressed shapes according to claim 1, wherein the pharmaceutical active substance is potassium chloride having a particle size of 0.3-1.2 mm diameter.

5. Pharmaceutical active-substance pressed shapes according to claim 1, wherein the pharmaceutical active substance is potassium chloride having a particle size of 0.5-1.2 mm diameter.