Process for producing an administration or dosage form for drugs, reagents or other active ingredients

• US 4,849,246 A
• Filed: 06/09/1987
• Issued: 07/18/1989
• Est. Priority Date: 10/09/1985
• Status: Expired due to Term

• Current Assignee: LTS Lohmann Therapie-Systeme AG
• Original Assignee: Desitin Arzneimittel GmbH
• Inventors: Schmidt, Wolfgang
• Primary Examiner(s): Lusignan, Michael
• Application Number:
  US07/060,689
• Time in Patent Office: 770 Days
• Field of Search: 427/2, 427/3, 424/478, 424/479
• US Class Current: 427/2.21
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence

Abstract

A process for producing an administration or dosage form of drugs, reagents or other active ingredients. A watersoluble foil composed of starch, gelatin, glycerin and/or sorbit and if necessary other additives is coated by a roll coating process with a layer containing the active ingredients and composed of the samebasic ingredients. After a corresponding prefragmentation, the administration form thus produced is particularly useful as an oral administration drug.

Claims

1. In a process for the production of an administration and dosage form for drugs, reagents or other active ingredients in the form of a film with an active ingredient-containing coating, in which process

(a) a water-soluble support film is produced from an aqueous composition based on an effective amount of a compound selected from starches, gelatins, and their mixtures and an effective amount of a compound selected from glycerol, sorbitol and their mixtures,

(b) an aqueous coating material is prepared from an effective amount of the active ingredient, as well as an effective amount of a compound selected from starches, gelatins, and their mixtures and an effective amount of a compound selected from glycerol, sorbitol and their mixtures, and

(c) the coating material is continuously applied by means of a roll coating process and in a precisely predetermined quantity to at least one side of the support film,

the improvement that the basic composition of the support film corresponds to that of the coating material.

2. Process according to claim 1, characterized in that the support film and the coating material also comprises a substance selected from the group comprising natural and synthetic resins and gums and their mixtures.

3. Process according to claim 1, characterized in that the composition of the support film contains further additives selected from the group consisting of inert soluble and insoluble fillers, sugar and other sweeteners, plasticizers such as polyols, waxes and dyes, flavouring substances and preservatives.

4. Process according to claim 1, characterized in that the coating material contains further additives selected from the group consisting of soluble and insoluble fillers, sugar and other sweeteners, plasticizers such as polyols, waxes and dyes, flavouring substances and preservatives.

5. Process according to claim 1, characterized in that the coating compound is applied to the support film in a continuous manner by means of grooved rollers, which absorb a clearly defined quantity of coating material and then transfer it to the support film.

6. Process according to claim 1, characterized in that the coating material is continuously applied to the support film by means of smooth roller pairs, which in speed-displaced synchronism absorb the material and transfer it to the support film in a clearly defined quantity.

7. Process according to claim 1, characterized in that the composition of the support film and of the coating material comprises 8 to 10 parts by weight of gelatin, 4 to 8 parts by weight of starch, 1 to 2 parts by weight of glycerol and 20 to 50 parts by weight of water.

8. Process according to claim 7, characterized in that the coating material comprises up to 10 parts by weight of the active ingredient.

9. Process according to claim 1, characterized in that different active ingredients are applied to the top and bottom surfaces of the support film for producing a combination product.

10. Process according to claim 1, characterized in that a coating material is used which comprises more than one active ingredient.

11. Process according to claim 1, characterized in that mutually incompatible active ingredients are applied in the form of separate coatings to the support film and an ingredient-free intermediate coating is provided between the two ingredient-containing coatings.

12. Process according to claim 1, characterized in that an active ingredient coating is placed between at least two further coatings, which control the active ingredient resorption in the gastrointestinal tract and one of the coatings can be the support film.

13. Process according to claim 1, characterized in that a further coating is placed over the active ingredient coating and protects the active ingredient against contact with the atmosphere, against light or against both.

14. Process according to claim 1, characterized in that the active ingredient-coated water-soluble film is subdivided into portions by perforation or punching and said portions contain defined dosage units of the active ingredient.

15. Process according to claim 1, characterized in that the back of the support material is printed with the active ingredient composition or information relating to its medical application.