Pharmaceutical chewing gum containing acetylsalicylic acid

• US 5,922,347 A
• Filed: 01/29/1993
• Issued: 07/13/1999
• Est. Priority Date: 01/30/1991
• Status: Expired due to Fees

• Current Assignee: Bayer AG
• Original Assignee: Bayer AG
• Inventors: Maasz, Joachim, Hausler, Franz, Valeri, Thomas
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US08/011,074
• Time in Patent Office: 2,356 Days
• Field of Search: 424/441, 424/440, 424/439
• US Class Current: 424/441
• CPC Class Codes: A61K 31/60 Salicylic acid; Derivatives thereof
• CPC Class Codes: A61K 9/0058 Chewing gums non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00

Abstract

The invention relates to stable, pharmaceutically usable chewing gum formulations which contain acetylsalicylic acid (ASA) as the active compound, and to a process for their preparation.

Claims

1. An acetylsalicyclic acid-salt releasing chewing gum comprising acetylsalicylic acid, and a basic substance capable of reacting with said acetylsalicylic acid to form an acetylsalicylic acid salt, said gum containing not more than about 2% of water and said acetylsalicylic acid and said basic substance being bound in said chewing gum apart from each other sufficiently to prevent them from reacting with each other until said chewing gum is chewed, which gum when chewed in the presence of saliva brings said acetylsalicylic acid into contact with said basic substance so that they react to form said acetylsalicylic acid salt which is then rapidly released to the saliva, said basic substance being selected from the group consisting of an alkaline earth metal carbonate, calcium hydroxide, magnesium hydroxide, light magnesium carbonate, heavy magnesium carbonate or magnesium oxide, tris-(hydroxymethyl)-aminomethane, alkali metal phosphates or alkaline earth metal phosphates and basic amino acids, the amount of basic substance being such that together with the amount of acetylsalicylic acid emploved there results a buffer capacity of between 5 and 15 mEg.

2. Chewing gum formulation according to claim 1, having the following composition:

space="preserve" listing-type="tabular">______________________________________Acetylsalicylic acid 2-30 parts by weight corresponding to 30-1500 mgBasic buffer substances corresponding to 0.1-17 meq buffer capacityChewing gum base 15-50 parts by weightPlasticiser 0-30 parts by weightSugar and/or 0-55 parts by weightsugar substitutesSweetener 0-2 parts by weightAroma substances 0-5 parts by weightFillers 0-30 parts by weightwaxes, emulsifiers, 0-20 parts by weightstabiliserswater- 0-30 parts by weight.soluble polymer______________________________________

3. Chewing gum formulation according to claim 1, per 100 parts by weight consisting essentially of

4. Chewing gum formulation according to claim 1, characterized in that the spatial separation between the components acetylsalicylic acid and the basic buffer substance is ensured by one or more of the following measures:

a) the two components are incorporated independently of one another and individually into the chewing gum matrix,

b) one or both components are coated with a protective separating layer of a water-soluble polymer film,

c) the two components are in each case incorporated independently of one another into the chewing gum composition and these compositions are mixed just before shaping or coextruded via multiple dies, or

d) the two components are in each case incorporated independently of one another into different chewing gum bases or polymer compositions which are only partly compatible with one another, a two-phase system being formed during joint compounding and shaping of the two matrices.

5. Process for the preparation of chewing gum formulations according to claim 1, characterized in that the acetylsalicylic acid, the chewing gum base, and additives and the basic component, which is optionally coated and/or worked into a chewing gum base which is optionally partly compatible, are converted into application form continuously or discontinuously in a mixing unit at temperatures between 20 and 85°

C.