Oral liquid compositions of rhein or diacerein
The invention relates to liquid pharmaceutical compositions for oral administration comprising rhein or diacerein, or salts or esters or prodrugs thereof and processes for preparing such compositions.
1. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1.
Diacerein
0.5-3.75%
2.
Poloxamer
0.01-0.5%
3.
Magnesium aluminium silicate
0.25-10%
4.
Acesulfame
0.1-5%
5.
Colloidal silicon dioxide
0.1-5%
6.
Sodium benzoate
0.01-15
7.
Sodium citrate
0.01-1%
8.
Flavours
0.01-5%
9.
Sucrose
q.s,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.
2. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1.
Diacerein
0.5-3.75%
2.
Poly vinyl pyrrolidone
0.05-8.0%
3.
Docusate sodium
0.001-0.5%
4.
Mannitol
0.1-30%
5.
Sucrose
1.0-95.0%
6.
Colloidal silicon dioxide
0.01-5%
7.
Sodium benzoate
0.001-0.5%
8.
Sodium citrate
0.001-0.5%
9.
Xanthan gum
0.1-10%
10.
Sweetener
0.001-1.0%
11.
Flavoring agent
0.001-1.0%,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.
3. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1.
Diacerein
0.5-3.75%
2.
Polysorbate
0.01-0.5%
3.
Sucrose
1.0-95.0%
4.
Colloidal silicon dioxide
0.01-5%
5.
Sodium benzoate
0.001-0.5%
6.
Sodium citrate
0.001-0.5%
7.
Microcrystalline cellulose
0.01-0.5%
8.
Flavours
0.01-0.5%
9.
Sucrose
q.s,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.
4. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1
Diacerein
0.5-3.75%
2
Polysorbate
0.01-0.5%
3
Xanthan Gum
0.25-10%
4
Aspartame
0.1-5%
5
Colloidal Silicon dioxide
0.1-5%
6
Sodium Citrate
0.01-1%
7
Flavours
0.01-5%
8
Sucrose
q.s.,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.
5. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1.
Diacerein
0.5-3.75%
2.
Poloxamer
0.01-0.5%
3.
Microcrystalline cellulose
0.25-10%
4.
Aspartame
0.01-5%
5.
Colloidal silicon dioxide
0.1-5%
6.
Sodium citrate
0.01-1%
7.
Sodium Phosphate
0.01-1%
8.
Flavours
0.01-5%
9.
Sucrose
q.s,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.
6. A pharmaceutical composition in the form of dry syrups or solid ready mix comprising:
Sr. No.
Ingredients
% Composition
1
Diacerein
0.5-3.75%
2
Polysorbate
0.01-0.5%
3
Sodium carboxymethyl cellulose
0.25-10%
4
Sucralose
0.1-5%
5
Colloidal Silicon dioxide
0.1-5%
6
Sodium Citrate
0.01-1%
7
Flavours
0.01-5%
8
Sucrose
q.s.,
wherein said composition exhibits a dissolution profile such that more than 75% of diacerein is released within 30 minutes, wherein the release profile is measured in Apparatus 2 (USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 phosphate buffer at 37° C.±0.5° C.; and,
wherein said composition results in a reduction of undesirable effects of soft stools.