Pharmaceutical compositions containing an effervescent acid-base couple

• US 6,667,056 B2
• Filed: 08/20/2001
• Issued: 12/23/2003
• Est. Priority Date: 07/23/1997
• Status: Expired due to Fees

• Current Assignee: Chiesi Farmaceutici SPA (Valline Srl)
• Original Assignee: Chiesi Farmaceutici SPA (Valline Srl)
• Inventors: Chiesi, Paolo, Brambilla, Gaetano, Acerbi, Daniela, Ventura, Paolo, Mezzadri, Rosa
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Pulliam, Amy E
• Application Number:
  US09/932,097
• Publication Number:
  US 20020051752A1
• Time in Patent Office: 855 Days
• Field of Search: 424/464, 424/466, 514/282, 514/226.5, 514/284
• US Class Current: 424/466
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence

Abstract

A pharmaceutical formulation in the form of a fast dissolving tablet comprising an active ingredient, sodium glycine carbonate and an acid capable of reacting rapidly with sodium glycine carbonate to release carbon dioxide.

Claims

1. A pharmaceutical composition in form of effervescent or fast-dissolving tablet of a water-soluble blend comprising an active ingredient and an effervescent couple, the couple comprising an acidic component and an alkaline component, wherein the active ingredient is selected from the group consisting of piroxicam-β

-cyclodextrin complex, ambroxol hydrochloride, piroxicam combined with a cyclodextrin as an excipient, and apomorphine hydrochloride, the acidic component is selected from the group consisting of fumaric acid, maleic acid and their salts and the alkaline component is sodium glycine carbonate.

2. A pharmaceutical composition according to claim 1, further comprising at least one additional excipient selected from the group consisting of ligands, lubricants, sweeteners, solubilizers, colourings, flavourings, diluents, disintegrants, wetting agents and mixtures thereof.

8. A pharmaceutical composition according to claim 1 further comprising a diluent, wherein the diluent is spray-dried lactose.

10. A pharmaceutical composition according to claim 1 wherein the pharmaceutical composition comprises cyclodextrin as the component of an inclusion complex or as an excipient.

12. A pharmaceutical composition according to claim 1, wherein the active ingredient is piroxicam-β

-cyclodextrin.

13. A pharmaceutical composition according to claim 1 wherein the active ingredient is ambroxol hydrochloride.

3. A pharmaceutical composition in form of effervescent or fast-dissolving tablet of a water-soluble blend comprising an active ingredient and an effervescent couple, the couple comprising an acidic component and an alkaline component, wherein the active ingredient is selected from the group consisting of piroxicam-β

-cyclodextrin complex, ambroxol hydrochloride and piroxicam combined with a cyclodextrin as an excipient, the acidic component is selected from the group consisting of fumaric acid, maleic acid and their salts and the alkaline component is sodium glycine carbonate.

4. A pharmaceutical composition according to claim 3, further comprising at least one additional excipient selected from the group consisting of ligands, lubricants, sweeteners, solubilizers, colourings, flavourings, diluents, disintegrants, wetting agents and mixtures thereof.

7. A pharmaceutical composition according to claim 3 comprising a water-soluble lubricant.

11. A pharmaceutical composition according to claim 3, wherein the pharmaceutical composition comprises cyclodextrin as the component of an inclusion complex or an excipient.

5. A pharmaceutical composition in form of effervescent or fast-dissolving tablet of a water-soluble blend comprising an active ingredient and an effervescent couple, the couple comprising an acidic component and an alkaline component, wherein the active ingredient is apomorphine hydrochloride, the acidic component is selected from the group consisting of fumaric acid, maleic acid and their salts and the alkaline component is sodium glycine carbonate.

6. A pharmaceutical composition according to claim 5, further comprising at least one additional excipient selected from the group consisting of ligands, lubricants, sweeteners, solubilizers, colourings, flavourings, diluents, disintegrants, wetting agents and mixtures thereof.

9. A pharmaceutical composition in form of effervescent or fast-dissolving tablet comprising an active ingredient and an effervescent couple, the couple comprising an acidic component and an alkaline component, wherein the active ingredient is apomorphine hydrochloride, the acidic component is fumaric acid, or its salts and the alkaline component is sodium glycine carbonate and further comprising mannitol, crosspovidone and magnesium stearate.