Rapidly disintegrating sheet-like presentations of multiple dosage units

• US 5,629,003 A
• Filed: 09/02/1994
• Issued: 05/13/1997
• Est. Priority Date: 06/07/1990
• Status: Expired due to Term

• Current Assignee: LTS Lohmann Therapie-Systeme AG
• Original Assignee: LTS Lohmann Therapie-Systeme AG
• Inventors: Hungerbach, Stefan, Horstmann, Michael, Laux, Wolfgang
• Primary Examiner(s): Levy, Neil S.
• Application Number:
  US08/300,115
• Time in Patent Office: 984 Days
• Field of Search: 424/401, 424/441, 424/443, 424/465, 424/485, 424/488, 424/48, 206/363, 206/368-370, 206/531, 206/534.1, 206/823, 206/828
• US Class Current: 424/401
• CPC Class Codes: A23G 2200/06 containing beet sugar or cane sugar if specifically mentioned or containing other carbohydrates, e.g. starches, gums, alcohol sugar, polysaccharides, dextrin or containing high or low amount of carbohydrate
• CPC Class Codes: A23G 2210/00 containing inorganic compounds or water in high or low amount
• CPC Class Codes: A23G 3/343 Products for covering, coating, finishing, decorating
• CPC Class Codes: A23G 3/50 characterised by shape, structure or physical form, e.g. products with supported structure
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A presentation which, in the form of a film, permits the individual dosage of drugs, confectionary, other food, cosmetics and the like for oral application or intake. The presentation is characterized by the fact that it comprises a mass of 20 to 60%-wt. of at least a film former, 2 to 40%-wt. of at least a gel former, 0.1 to 35%-wt. of at least an active substance, and up to 40%-wt. of an inert filling agent, being applied on a carrier, or by consisting of a mass having the aforementioned composition but is unsupported. In the production thereof, an intimate mixture of said components is prepared, optionally with the addition of up to 30%-wt. of a polar solvent, and processed to form a homogeneous, spreadable or extrudable mass.

Claims

1. A sheet comprising multiple dosage units which disintegrate in water and which contain as active substance, a cosmetic, perfrming or flavoring application, and comprising a mass of

(a) 20-60%-wt. of at least one film-forming agent,

(b) 2-40%-wt. of at least one gel-forming agent,

(c) 0.1-35%-wt. of at least one active substance and

(d) up to 40%-wt. of at least one inert filling agent,

the percentage relating to the solvent-free mass of these four components and the dosage units being supported on a carrier,

wherein the film former comprises a compound selected from the group consisting of monomeric and oligomeric sugars, sugar alcohols, organic acids having up to 6 carbon atoms and polyethylene glycol,

wherein the gel former is water swellable and consists of at least one component selected from the group consisting of polymeric carbohydrates, esters thereof, gelatin, albumin, collagen, egg white, carboxyvinyl copolymers, polyacryl amide, polyvinyl pyrrolidone and polyvinyl alcohol,

wherein the filler comprises at least one physiologically acceptable compound selected from the group consisting of carbonates, phosphates, silicates, sulfates and oxides of an alkaline earth metal, silicas, slightly soluble sugars, cellulose, cyclodextrin as a starch derivative, talc, titanium dioxide, zinc oxide and magnesium stearate, undissolved or crystalline partial amounts of active substances simultaneously acting as filling agents, and

wherein the layer thickness of the dosage units is from 0.003 to 4 mm.

2. A sheet presentation according to claim 1, comprising at least two active substance-containing layers.

3. A sheet according to claim 1, wherein the layer thickness of the dosage units is from 20 to 400 μ

m.

4. A sheet according to claim 3, wherein the layer thickness is from 70 to 150 μ

m.

5. A sheet according to claim 1, wherein the active substance is of organic nature.

6. A sheet according to claim 1, which is provided with a release paper or a release film and is divisible into individual doses of areas of defined size.

7. A sheet according to claim 1, wherein the multiple dosage units comprise an instant toothpaste composition.