Clay compositions

Patent metadata

Field	Value
Publication number	US-9511023-B2
Application number	US-201113695593-A
Country	US
Kind code	B2
Filing date	Apr 29, 2011
Priority date	Apr 29, 2010
Publication date	Dec 6, 2016
Grant date	Dec 6, 2016

Abstract

The present invention relates to liquid or semi-solid pharmaceutical compositions, more specifically to aqueous pharmaceutical suspension or semi-solid paste containing natural mineral clays as active ingredients. These compositions are particularly useful for the treatment of acute and chronic diarrhea.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising:
(i) 30% to 35% by weight (w/w) natural dioctahedral smectite as the only active ingredient;
(ii) about 0.1% to about 5% by weight (w/w) xanthan gum;
(iii) a pH adjuster;
(iv) 0.01% to 5% by weight (w/w) preservative selected from citric acid, potassium sorbate, ascorbic acid, and mixtures thereof;
(v) 0.5% to 2% by weight (w/w) flavoring agent;
(vi) about 0.02% to 0.5% by weight (w/w) sweetener selected from sodium saccharin, sucralose, a natural sweetener from plant extract, and mixtures thereof; and
(vii) water;
wherein the pH of the composition is between 4 and 6, the composition has a viscosity of between about 1100 mPa·s and about 2500 mPa·s, and the composition is an aqueous suspension or in a semi-solid state.

2. A pharmaceutical composition comprising:
(i) 30% to 40% by weight (w/w) natural dioctahedral smectite as the only active ingredient;
(ii) about 0.1% to about 5% by weight (w/w) xanthan gum;
(iii) a pH adjuster;
(iv) 0.01% to 5% by weight (w/w) preservative selected from citric acid, potassium sorbate, ascorbic acid, and mixtures thereof;
(v) 0.5% to 2% by weight (w/w) flavoring agent;
(vi) about 0.02% to 0.5% by weight (w/w) sweetener selected from sodium saccharin, sucralose, a natural sweetener from plant extract, and mixtures thereof; and
(vii) water;
wherein the pH of the composition is between 4 and 6, the composition has a viscosity of between about 1100 mPa·s and 2500 mPa·s, and the composition is an aqueous suspension or in a semi-solid state.

3. The pharmaceutical composition according to claim 2 , wherein: xanthan gum is present in an amount of from 0.1% to 2% by weight (w/w); the preservative is present in an amount of from 0.1% to 1% by weight (w/w); the pH adjuster is present in an amount that adjusts the composition to a pH of from 4 to 6; the flavoring agent is present in an amount of from 0.5% to 1.5% by weight (w/w); and the sweetner is present in an amount of from 0.03% to 0.3% by weight (w/w).

4. The pharmaceutical composition according to claim 2 , wherein xanthan gum is present in an amount of from about 0.1 to about 2% by weight (w/w).

5. The pharmaceutical composition according to claim 2 , wherein the preservative is present in an amount of from about 0.1 to about 1% by weight (w/w).

6. The pharmaceutical composition according to claim 2 , wherein the sweetener is present in an amount of from about 0.03% to about 0.3% by weight (w/w).

7. The pharmaceutical composition according to claim 2 , wherein the flavoring agent is present in an amount of from 0.5% to 1.5% by weight (w/w) and provides a caramel/cacao flavor.

8. The pharmaceutical composition according to claim 2 , wherein the viscosity is between about 1300 mPa·s and about 2500 mPa·s.

9. The pharmaceutical composition according to claim 2 , which is a ready-to-use formulation.

10. The pharmaceutical composition according to claim 2 , which is a ready-to-use formulation in a sachet.

11. The pharmaceutical composition according to claim 2 , which is a ready-to-use formulation in a tubular sachet.

12. The pharmaceutical composition according to claim 2 , wherein the dioctahedral smectite is sieved.

Assignees

• Hacher Béatrice
• Kubiak Didier
• Harnett Jeremiah
• Mondoly Nathalie
• Ipsen Pharma Sas

Inventors

• Hacher Béatrice
• Kubiak Didier
• Harnett Jeremiah
• Mondoly Nathalie

Classifications

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61K47/32

  Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} · CPC title

• A61K9/00

  Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)} · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title