Abstract
The present invention relates to a pharmaceutical composition which contains activated charcoal, Carum carvi extract, papain and, optionally, α-galactosidase and β-galactosidase for the treatment of gastrointestinal disorders.
Claims
1. A method for treating diarrhoea, or a symptom thereof, in a subject, comprising orally administering to the subject an effective amount of a composition comprising the following components: a) 3000 mg-5000 mg activated charcoal; b) 30 mg-50 mg Carum carvi extract; and c) 20 mg-50 mg papain, extracted from Carica papaya.
2. The method according to claim 1, wherein the composition further comprises: d) α-galactosidase; e) β-galactosidase; or f) α-galactosidase and β-galactosidase.
3. The method according to claim 1, wherein the composition further comprises α-galactosidase is present in an amount from 5 mg to 100 mg or, if present, β-galactosidase is present in an amount from 5 mg to 100 mg, or combinations thereof.
4. The method according to claim 1, wherein the composition is in the form of a tablet, a capsule, a powder, a granulate, a syrup, a solution, a suspension or a gel, each being suitable for oral administration.
5. The method according to claim 1, wherein the composition further comprises at least one pharmaceutically acceptable excipient, food grade excipient or technological additive, or combinations thereof.
Description
(1) Results
(2) FIG. 1: Effect of papain (0.3-30 mg/kg) on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals. “p<0.01 vs control.
(3) FIG. 2: Effect of the activated charcoal (28-2800 mg/kg) on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals. *p<0.05 vs control.
(4) FIG. 3: Effect of Carum carvi (1.7-170 mg/kg) on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals.
(5) FIG. 4: Effect of α-galactosidase (0.3-30 mg/kg) on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals.
(6) FIG. 5: Effect of 3-galactosidase (0.3-30 mg/kg) on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals.
(7) FIG. 6: Effect of the total formulation [obtained from the combination of papain (3 mg/kg), Carum carvi (1.7 mg/kg), α-galactosidase (3 mg/kg) and β-galactosidase (3) and charcoal (280 mg/kg) or papain (30 mg/kg), Carum carvi (17 mg/kg), α-galactosidase (30 mg/kg) β-galactosidase 30 mg/kg) and charcoal (2800 mg/kg)] and of the partial formulation [obtained from the combination of papain (3 mg/kg), Carum carvi (1.7 mg/kg) and charcoal (280 mg/kg) or papain (30 mg/kg), Carum carvi (17 mg/kg) and charcoal (2800 mg/kg)] on diarrhoea induced by the administration of the cathartic agent, castor oil (0.2 ml/mouse). The effect was evaluated 2 hours after the administration of castor oil. Each bar represents the mean±S.E.M. of 10-12 animals. “p<0.01 and ***p<0.001 vs control; ° p<0.01 vs total mixture 30.
(8) Papain (administered orally at the doses comprised between 0.3 and 30 mg/kg) and charcoal (administered orally at the doses comprised between 28 and 2800 mg/kg) significantly reduced diarrhoea 2 hours after the administration of castor oil, the effect being significant at the dose of 30 mg/kg in the case of papain (FIG. 1) and 2800 mg/kg in the case of charcoal (FIG. 2). In contrast, Carum carvi (1.7-170 mg/kg), α-galactosidase (0.3-30 mg/kg) and β-galactosidase (0.3-30 mg/kg), administered orally (at all the doses used) were not capable of modifying the cathartic effect of the castor oil (FIG. 3-5). The total formulation [obtained from the combination of papain (3 and 30 mg/kg), Carum carvi (1.7 and 17 mg/kg), α-galactosidase (3 and 30 mg/kg) β-galactosidase (3 and 30 mg/kg) and charcoal (280 and 2800 mg/kg)] and the partial formulation [obtained from the combination of papain (3 and 30 mg/kg), Carum carvi (1.7 and 17 mg/kg) and charcoal (280 and 2800 mg/kg)], (used at doses that were inactive in themselves) significantly reduced, in a dose-dependent manner, diarrhoea induced by castor oil (FIG. 6). The partial formulation, at the highest dose used (30 mg/kg of papain, 17 mg/kg of Carum carvi extract and 2800 mg/kg of charcoal), was much more active than the total formulation at the same doses of papain, Carum carvi extract and activated charcoal (FIG. 6).
