Clay compositions
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.
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.