WO2008080809A2 - Pharmaceutical composition containing psyllium and senna - Google Patents

Pharmaceutical composition containing psyllium and senna Download PDF

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Publication number
WO2008080809A2
WO2008080809A2 PCT/EP2007/064038 EP2007064038W WO2008080809A2 WO 2008080809 A2 WO2008080809 A2 WO 2008080809A2 EP 2007064038 W EP2007064038 W EP 2007064038W WO 2008080809 A2 WO2008080809 A2 WO 2008080809A2
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Prior art keywords
weight
psyllium
pharmaceutical composition
senna
composition
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PCT/EP2007/064038
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French (fr)
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WO2008080809A3 (en
Inventor
Assumpta Bruna Floris
Cesar Molinero Egea
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Madaus SA
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Madaus SA
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482—Cassia, e.g. golden shower tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Definitions

  • the present invention relates to a pharmaceutical composition comprised of pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna.
  • the invention also relates to the use of said composition for the manufacture of laxative medicines; and to a production procedure thereof.
  • Plantago ovata or Plantago psyllium L. fruits generally the seeds and husks, have been used in the field of laxative medicines.
  • the laxative properties of senna fruits, or Cassia angustifolia are also well known.
  • a laxative composition containing both components In an effort to produce a laxative composition containing both components,
  • Patent GB2067402 disclosed a laxative composition which could be produced by dry- mixing granulated psyllium seeds and senna fruits and then rapidly moistening the mixture. The resulting mixture was granulated and dried in a manner preventing swelling. Finally, a granulated product with a residual moisture content of no more than 3.5% by weight is produced, which is then coated with a pharmaceutically acceptable material, thereby forming dragees. Specifically, the particle size of the grains produced is from 2.0 to 2.5 mm.
  • the dragee product is prepared in a manner that the senna fruits are enveloped or coated by the psyllium component, thus retarding the release of the senna fruit sennosides, and therefore their oxidation, which has a certain convulsant and pain producing action.
  • the product in dragee form disclosed in GB2067402 is difficult to swallow and must be administered with water in order to facilitate the descent of the granules along the oesophagus.
  • the administration method is always indicated, some users, due to the product's presentation in small, more or less regular spheres, normally swallow them dry, without water, which causes the granules to swell in the oesophagus on contact with the humidity of the digestive system.
  • This incorrect administration of the product can produce, and in fact produces a bezoar or the appearance of a foreign object in the oesophagus or stomach which, apart from causing an unpleasant feeling, is also very dangerous.
  • the inventors have developed a new manufacturing method and a new galenic form of the pharmaceutical composition with psyllium and senna, which surprisingly offers many advantages with respect to current laxative compositions, which at the same time solves the aforementioned problems.
  • the pharmaceutical composition represents an improved galenic form with respect to the compositions containing psyllium and senna, not only making it more pleasant and attractive for consumption, but also increasing tolerability.
  • the pharmaceutical composition to which the invention relates comprises pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna.
  • the pharmaceutical composition is characterized in that it has a powder format, comprising of finely ground psyllium seeds and husks and finely ground senna fruits or fruits extract, with a water content of less than 5% by weight with respect to the total composition.
  • the pharmaceutical composition, according to the invention is also characterized in that powder grain size is less than 1 ,000 microns.
  • the weight ratio of the mixture of active ingredients and pharmaceutically accepted additives is in the range of 1.8:1 to 2.2:1.
  • the pharmaceutically accepted additives contain at least one binding agent.
  • the pharmaceutical composition is also characterized in that the binding agent represents a percentage by weight of between 1 1% and 25% with respect to the total composition.
  • the pharmaceutical composition is characterized in that it comprises, with respect to the total dry composition, of 40% to 60% by weight of psyllium seeds; 1.0% to 3.0% by weight of psyllium husks; and either 10.0% to 13.2% by weight of senna fruits or 4% to 8% by weight of senna fruits extract.
  • the pharmaceutical composition comprises 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 10.0% to 13.2% by weight of senna fruits, with respect to the total dry composition.
  • the pharmaceutical composition comprises 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 4.0% to 8.0% by weight of senna fruits extract, with respect to the total dry composition.
  • the final product which represents the preferred embodiment, consists essentially in:
  • Anhydrous citric acid 9.00% by weight with respect to the total dry composition.
  • a second preferred embodiment consists in: Senna fruits 10.72% by weight
  • a third preferred embodiment consists in:
  • Senna fruits extract 5% 6% by weight - A -
  • An additional object of the present invention is the use of the pharmaceutical composition, according to the previous description, for the preparation of a laxative medicine.
  • the present invention is also aimed at establishing a procedure for the preparation of a pharmaceutical composition comprising pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna.
  • the procedure is characterized in that it comprises the following phases: a) Homogenization of a mixture of powdered active ingredients in a fluidized bed device, said mixture comprising finely ground psyllium seeds and husks and either finely ground senna fruits or senna fruits extract, together with a binding agent; b) spraying of the mixture resulting from phase a) with an aqueous additive solution containing an additional binding agent, water content of 40% by weight of the total mixture and temperature maintained between 40 Q C and 45 9 C; and c) drying of the powdered mixture produced in phase b) to a water content of no more than 5% by weight.
  • compositions are comprised of a combination of active ingredients containing at least psyllium and senna, specifically psyllium seeds and husks and either senna fruits or senna fruits extract, said active ingredients having been previously shredded and ground to fine powder.
  • Table 1 below lists the ingredients that comprise the pharmaceutical composition according to the invention. Specifically, the table lists the ingredients and quantities of a single-dose sachet containing approximately 5 grams of product.
  • Table 3 below also lists the ingredients that comprise a single-dose sachet containing approximately 5 grams of product, which is orange-flavoured, contains senna fruits extract and which can be dissolved in water.
  • Table 3 orange-flavoured powder composition with senna fruit extract
  • the powder compositions of examples 1 , 2 and 3 are expected to contain at least 5% by weight of water or relative humidity upon completion and packaging of the finished product.
  • the preparation of the sachets of examples 1 , 2 and 3 is based on a procedure according to which a mixture of finely ground psyllium seeds and husks, a binding agent and, either finely ground senna fruits as described in examples 1 and 2, or senna fruits extract as described in example 3, are firstly homogenized in a fluidized bed device. During this preliminary phase all the ingredients are added dry, using half of the binding agent required for the composition. The resulting mixture thereof is then finely ground and added to the aqueous solution containing the remaining additional binding agent. In this way an intermediate product is produced with a moisture content of 40% by weight of water. Throughout the grinding phase, mixing tank temperature is maintained in the range of 40 Q C to 45 Q C. Finally, the mixture produced in the second phase is dried to a residual moisture content of no more than 5% by weight of water with respect to the total composition.
  • flavourings or flavourings in addition to the acidulants, are generally added during the grinding phase, either dissolved or suspended in the water.
  • any of the flavouring or colouring components creates problems upon mixture with the water, said components may be added together with the active principle powder mixture.
  • the whole procedure is expected to last between 2 and 3 hours, which makes it fast and therefore profitable, even more considering that said procedure does not require extreme pressure or temperature conditions, and that the raw materials or ingredients are added in large quantities.
  • the pharmaceutical composition produced according to the aforementioned procedure has a powder grain size of less than 1 ,000 microns and an active principle and pharmaceutical additive mixture weight ratio in the range of 1.8:1 to 2.2:1. Its finished appearance is that of fine powder which is easily dissolved in water for oral administration.
  • the binding agent is of exceptional importance, and usually consists of a combination of ingredients with said binding capacity, for example, acesulfame and maltodextrin.
  • the binding agent represents a percentage by weight of 1 1.0% to 25.0% with respect to the total dry composition, i.e. the composition excluding the water content.
  • the pharmaceutically accepted additives used consist of acidulants, diluents, aromatic essences and sweeteners, which may in turn carry out several of these functions due to their chemical nature.
  • the water-soluble powder composition of the present invention is particularly advantageous because it avoids ingestion problems, such as dragees becoming stuck to the palate, especially in elderly patients. Additionally, having to dissolve the powder in water ensures that the patient swallows the medicine with the adequate amount of water, which facilitates the product's descent to the stomach and intestines, thus avoiding swelling in the oesophagus. That is, the powder composition of the present invention avoids a serious risk of impaction (bezoar) in the upper digestive tract (oesophagus), with the consequent emergency medical situation created. Said composition is useful as a laxative.
  • the pharmaceutical composition produced following the previously described procedure and detailed in examples 1 , 2 and 3, is comprised of both psyllium seeds and husks. Specifically, the seeds represent a percentage by weight of 40% to 60%, preferably 52%; and the husks represent a percentage by weight of 1.0% to 3.0%, preferably 2.2%. All of these quantities are considered in relation to total composition weight, excluding the 5% of water content.
  • the composition also contains either finely ground senna fruits, representing a percentage by weight with respect to the total dry composition of 10.0% to 13.2%; or senna fruits extract, representing a percentage by weight with respect to the total dry composition of 4.0% to 8.0%.
  • the percentage added depends on the sennosides content of the fruits.
  • the powdered aspect of the medicine is also worth mentioning, in addition to its administration method, which is more pleasant for patients than the compositions containing psyllium and senna known to date, producing a pleasant feeling upon being swallowed or even when the users think about the medicine, thus encouraging patients to follow the therapeutic guidelines recommended by their doctors.
  • compositions prepared in single-dose sachet format are described in examples 1 , 2 and 3, said compositions can also be prepared in multi- dose bottles.
  • orange and cherry-flavoured compositions are described in examples 1 , 2 and 3, other flavours and aromatic essences can also be added.
  • the pharmaceutical composition in powder form containing psyllium seeds and husks and senna using either the fruits or the fruits extract, in addition to being produced through a simple manufacturing procedure, due to the fact that the senna components do not have to be coated with psyllium to avoid their undesirable side effects, said composition is effective as a laxative medicine, easier to swallow than dragees and more pleasant for the user, not only due to its flavour or aroma, but also due to its texture or taste on the palate.

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Abstract

Pharmaceutical composition comprised of pharmaceutically accepted additives and a combination of active ingredients containing finely ground psyllium seeds and husks and finely ground senna fruits or fruits extract, comprising a powder composition with water content of less than 5% by weight with respect to the total composition and powder grain size of less than 1,000 microns. The invention also describes a procedure for the preparation of a powdered pharmaceutical composition containing finely ground psyllium seeds and husks and finely ground senna fruits or fruits extract, in addition to its use for the preparation of a laxative medicine.

Description

D E S C R I P T I O N
"PHARMACEUTICAL COMPOSITION CONTAINING PSYLLIUM AND SENNA"
Technical field of the invention
The present invention relates to a pharmaceutical composition comprised of pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna. The invention also relates to the use of said composition for the manufacture of laxative medicines; and to a production procedure thereof.
Background of the invention
For some time now, Plantago ovata or Plantago psyllium L. fruits, generally the seeds and husks, have been used in the field of laxative medicines. The laxative properties of senna fruits, or Cassia angustifolia, are also well known. In an effort to produce a laxative composition containing both components,
Patent GB2067402 disclosed a laxative composition which could be produced by dry- mixing granulated psyllium seeds and senna fruits and then rapidly moistening the mixture. The resulting mixture was granulated and dried in a manner preventing swelling. Finally, a granulated product with a residual moisture content of no more than 3.5% by weight is produced, which is then coated with a pharmaceutically acceptable material, thereby forming dragees. Specifically, the particle size of the grains produced is from 2.0 to 2.5 mm.
In GB2067402, the dragee product is prepared in a manner that the senna fruits are enveloped or coated by the psyllium component, thus retarding the release of the senna fruit sennosides, and therefore their oxidation, which has a certain convulsant and pain producing action.
However, the product in dragee form disclosed in GB2067402 is difficult to swallow and must be administered with water in order to facilitate the descent of the granules along the oesophagus. Although the administration method is always indicated, some users, due to the product's presentation in small, more or less regular spheres, normally swallow them dry, without water, which causes the granules to swell in the oesophagus on contact with the humidity of the digestive system. This incorrect administration of the product can produce, and in fact produces a bezoar or the appearance of a foreign object in the oesophagus or stomach which, apart from causing an unpleasant feeling, is also very dangerous.
Another drawback of the product's dragee format derives from the need to coat the granules with a pharmaceutically accepted compound in order to make their ingestion more pleasant.
Additionally, in order to ensure a rapid and uniform moistening of the granulated product mixture, the manufacturing procedure of the dragees must successively combine small quantities of granulated product and water, which are subjected to intensive stirring. This lengthens the procedure and inevitably raises costs.
The inventors have developed a new manufacturing method and a new galenic form of the pharmaceutical composition with psyllium and senna, which surprisingly offers many advantages with respect to current laxative compositions, which at the same time solves the aforementioned problems.
Explanation of the invention
The pharmaceutical composition, according to the invention, represents an improved galenic form with respect to the compositions containing psyllium and senna, not only making it more pleasant and attractive for consumption, but also increasing tolerability.
In this way, the pharmaceutical composition to which the invention relates comprises pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna.
In essence, the pharmaceutical composition is characterized in that it has a powder format, comprising of finely ground psyllium seeds and husks and finely ground senna fruits or fruits extract, with a water content of less than 5% by weight with respect to the total composition. The pharmaceutical composition, according to the invention, is also characterized in that powder grain size is less than 1 ,000 microns.
According to another characteristic of the invention, the weight ratio of the mixture of active ingredients and pharmaceutically accepted additives is in the range of 1.8:1 to 2.2:1. According to another characteristic of the pharmaceutical composition to which the invention relates, the pharmaceutically accepted additives contain at least one binding agent.
The pharmaceutical composition is also characterized in that the binding agent represents a percentage by weight of between 1 1% and 25% with respect to the total composition. The pharmaceutical composition, according to the invention, is characterized in that it comprises, with respect to the total dry composition, of 40% to 60% by weight of psyllium seeds; 1.0% to 3.0% by weight of psyllium husks; and either 10.0% to 13.2% by weight of senna fruits or 4% to 8% by weight of senna fruits extract. Preferably, the pharmaceutical composition comprises 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 10.0% to 13.2% by weight of senna fruits, with respect to the total dry composition.
According to another preferred embodiment, the pharmaceutical composition comprises 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 4.0% to 8.0% by weight of senna fruits extract, with respect to the total dry composition.
The final product, which represents the preferred embodiment, consists essentially in:
Senna fruits 10.72% by weight Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight
Allura red (FD&C RED 40) 0.60% by weight
Orange nuclearoma 32 N-3 4.00% by weight Acesulfame-K 0.52% by weight
Maltodextrin 20.44% by weight
Anhydrous citric acid 9.00% by weight with respect to the total dry composition.
A second preferred embodiment consists in: Senna fruits 10.72% by weight
Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight
Cochineal extract 1.00% by weight Cherry flavouring 650083 3.20% by weight
Acesulfame-K 0.52% by weight
Maltodextrin 20.44% by weight
Anhydrous citric acid 9.00% by weight with respect to the total dry composition. A third preferred embodiment consists in:
Senna fruits extract 5% 6% by weight - A -
Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight
Acesulfame-K 0.52% by weight Maltodextrin 25.46% by weight (**)
Anhydrous citric acid 2.25% by weight
Nuclearoma orange 32N-3 1% by weight
Sunset yellow (FD&C Yellow 6) 0.3% by weight with respect to the total dry composition. An additional object of the present invention is the use of the pharmaceutical composition, according to the previous description, for the preparation of a laxative medicine.
The present invention is also aimed at establishing a procedure for the preparation of a pharmaceutical composition comprising pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna.
In essence, the procedure, according to the present invention, is characterized in that it comprises the following phases: a) Homogenization of a mixture of powdered active ingredients in a fluidized bed device, said mixture comprising finely ground psyllium seeds and husks and either finely ground senna fruits or senna fruits extract, together with a binding agent; b) spraying of the mixture resulting from phase a) with an aqueous additive solution containing an additional binding agent, water content of 40% by weight of the total mixture and temperature maintained between 40QC and 459C; and c) drying of the powdered mixture produced in phase b) to a water content of no more than 5% by weight.
Detailed description of the invention For illustrative purposes and according to the present invention, three pharmaceutical compositions are described below in detail.
In addition to the pharmaceutically accepted additives (excipients), said compositions are comprised of a combination of active ingredients containing at least psyllium and senna, specifically psyllium seeds and husks and either senna fruits or senna fruits extract, said active ingredients having been previously shredded and ground to fine powder. EXAMPLE 1
Table 1 below lists the ingredients that comprise the pharmaceutical composition according to the invention. Specifically, the table lists the ingredients and quantities of a single-dose sachet containing approximately 5 grams of product.
Table 1 : Orange-flavoured powder composition
Figure imgf000006_0001
EXAMPLE 2 Table 2 below also lists the ingredients that comprise a single-dose sachet containing approximately 5 grams of product which can be dissolved in water, cherry- flavoured in this case.
Table 2: Cherry-flavoured powder composition
Figure imgf000006_0002
EXAMPLE 3
Table 3 below also lists the ingredients that comprise a single-dose sachet containing approximately 5 grams of product, which is orange-flavoured, contains senna fruits extract and which can be dissolved in water.
Table 3: orange-flavoured powder composition with senna fruit extract
Figure imgf000007_0001
(*): The quantity depends on the content of the senna fruits extract used (**): The quantity will be adjusted to maintain the dose of 5g/sachet
The powder compositions of examples 1 , 2 and 3 are expected to contain at least 5% by weight of water or relative humidity upon completion and packaging of the finished product.
The preparation of the sachets of examples 1 , 2 and 3 is based on a procedure according to which a mixture of finely ground psyllium seeds and husks, a binding agent and, either finely ground senna fruits as described in examples 1 and 2, or senna fruits extract as described in example 3, are firstly homogenized in a fluidized bed device. During this preliminary phase all the ingredients are added dry, using half of the binding agent required for the composition. The resulting mixture thereof is then finely ground and added to the aqueous solution containing the remaining additional binding agent. In this way an intermediate product is produced with a moisture content of 40% by weight of water. Throughout the grinding phase, mixing tank temperature is maintained in the range of 40QC to 45QC. Finally, the mixture produced in the second phase is dried to a residual moisture content of no more than 5% by weight of water with respect to the total composition.
In order to produce specifically flavoured and/or coloured compositions, the colourings or flavourings, in addition to the acidulants, are generally added during the grinding phase, either dissolved or suspended in the water. Obviously, if any of the flavouring or colouring components creates problems upon mixture with the water, said components may be added together with the active principle powder mixture. The whole procedure is expected to last between 2 and 3 hours, which makes it fast and therefore profitable, even more considering that said procedure does not require extreme pressure or temperature conditions, and that the raw materials or ingredients are added in large quantities.
The pharmaceutical composition produced according to the aforementioned procedure has a powder grain size of less than 1 ,000 microns and an active principle and pharmaceutical additive mixture weight ratio in the range of 1.8:1 to 2.2:1. Its finished appearance is that of fine powder which is easily dissolved in water for oral administration.
Amongst the pharmaceutically accepted additives, the binding agent is of exceptional importance, and usually consists of a combination of ingredients with said binding capacity, for example, acesulfame and maltodextrin. The binding agent represents a percentage by weight of 1 1.0% to 25.0% with respect to the total dry composition, i.e. the composition excluding the water content.
In addition to the binding agent, the pharmaceutically accepted additives used consist of acidulants, diluents, aromatic essences and sweeteners, which may in turn carry out several of these functions due to their chemical nature.
The water-soluble powder composition of the present invention is particularly advantageous because it avoids ingestion problems, such as dragees becoming stuck to the palate, especially in elderly patients. Additionally, having to dissolve the powder in water ensures that the patient swallows the medicine with the adequate amount of water, which facilitates the product's descent to the stomach and intestines, thus avoiding swelling in the oesophagus. That is, the powder composition of the present invention avoids a serious risk of impaction (bezoar) in the upper digestive tract (oesophagus), with the consequent emergency medical situation created. Said composition is useful as a laxative.
The pharmaceutical composition produced following the previously described procedure and detailed in examples 1 , 2 and 3, is comprised of both psyllium seeds and husks. Specifically, the seeds represent a percentage by weight of 40% to 60%, preferably 52%; and the husks represent a percentage by weight of 1.0% to 3.0%, preferably 2.2%. All of these quantities are considered in relation to total composition weight, excluding the 5% of water content.
In order for the composition to be effective as a laxative, the composition also contains either finely ground senna fruits, representing a percentage by weight with respect to the total dry composition of 10.0% to 13.2%; or senna fruits extract, representing a percentage by weight with respect to the total dry composition of 4.0% to 8.0%. The percentage added depends on the sennosides content of the fruits.
The powdered aspect of the medicine is also worth mentioning, in addition to its administration method, which is more pleasant for patients than the compositions containing psyllium and senna known to date, producing a pleasant feeling upon being swallowed or even when the users think about the medicine, thus encouraging patients to follow the therapeutic guidelines recommended by their doctors.
Although pharmaceutical compositions prepared in single-dose sachet format are described in examples 1 , 2 and 3, said compositions can also be prepared in multi- dose bottles. In the same way, although orange and cherry-flavoured compositions are described in examples 1 , 2 and 3, other flavours and aromatic essences can also be added.
In conclusion, it is worth noting that the pharmaceutical composition in powder form containing psyllium seeds and husks and senna, using either the fruits or the fruits extract, in addition to being produced through a simple manufacturing procedure, due to the fact that the senna components do not have to be coated with psyllium to avoid their undesirable side effects, said composition is effective as a laxative medicine, easier to swallow than dragees and more pleasant for the user, not only due to its flavour or aroma, but also due to its texture or taste on the palate.

Claims

C L A I M S
1 .- Pharmaceutical composition comprising pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna, characterized in that it includes finely ground psyllium seeds and husks and finely ground senna fruits or fruits extract, forming a powder composition with water content of less than 5% by weight with respect to the total composition.
2.- Pharmaceutical composition, according to claim 1 , characterized in that powder grain size is less than 1 ,000 microns.
3.- Pharmaceutical composition, according to claim 1 or 2, characterized in that the active principle and pharmaceutically accepted additive mixture weight ratio is in the range of 1.8:1 to 2.2:1.
4.- Pharmaceutical composition, according to any of claims 1 to 3 above, characterized in that the pharmaceutically accepted additives comprise at least one binding agent.
5.- Pharmaceutical composition, according to claim 4 above, characterized in that the binding agent represents a percentage by weight in the range of 1 1.0% and 25.0%, with respect to the total dry composition.
6.- Pharmaceutical composition, according to any of the previous claims, characterized in that it comprises, with respect to the total dry composition, 40% to 60% by weight of psyllium seeds; 1.0% to 3.0% by weight of psyllium husks; and 10.0% to 13.2% by weight of senna fruits.
7.- Pharmaceutical composition, according to claim 6, characterized in that it comprises, with respect to the total dry composition, 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 10.0% to 13.2% by weight of senna fruits.
8.- Pharmaceutical composition, according to any of claims 1 to 7 above, characterized in that it consists in:
Senna fruits 10.72% by weight Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight
Allura red (FD&C RED 40) 0.60% by weight Orange nuclearoma 32 N-3 4.00% by weight
Acesulfame-K 0.52% by weight
Maltodextrin 20.44% by weight
Anhydrous citric acid 9.00% by weight with respect to the total dry composition.
9.- Pharmaceutical composition, according to any of claims 1 to 7 above, characterized in that it consists in:
Senna fruits 10.72% by weight Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight
Cochineal extract 1.00% by weight
Cherry flavouring 650083 3.20% by weight Acesulfame-K 0.52% by weight
Maltodextrin 20.84% by weight
Anhydrous citric acid 9.00% by weight with respect to the total dry composition.
10.- Pharmaceutical composition, according to claims 1 to 5, characterized in that it comprises, with respect to the total dry composition, 40% to 60% by weight of psyllium seeds; 1.0% to 3.0% by weight of psyllium husks; and 4.0% to 8.0% by weight of senna fruits extract.
1 1.- Pharmaceutical composition, according to claim 10, characterized in that it comprises, with respect to the total dry composition, 52% by weight of psyllium seeds; 2.2% by weight of psyllium husks; and 4.0% to 8.0% by weight of senna fruits extract.
12- Pharmaceutical composition, according to the claim 1 1 , characterized in that it consists in: Senna fruits extract 5% 6% by weight (*)
Psyllium husks 2.20% by weight
Psyllium seeds 52.00% by weight
Aspartame 0.52% by weight Acesulfame-K 0.52% by weight
Maltodextrin 25.46% by weight (**)
Anhydrous citric acid 2.25% by weight
Nuclearoma orange 32N-3 1% by weight
Sunset yellow (FD&C Yellow 6) 0.3% by weight with respect to the total dry composition.
13.- Use of the pharmaceutical composition, according to any of claims 1 to 12 above, for the preparation of a laxative medicine.
14.- Procedure for the preparation of a pharmaceutical composition containing pharmaceutically accepted additives and a combination of active ingredients containing psyllium and senna, characterized in that it comprises the following phases:
a) Homogenization of a mixture of powdered active ingredients in a fluidized bed device, said mixture comprising finely ground psyllium seeds and husks and finely ground senna fruit or fruits extract, together with a binding agent;
b) spraying of the mixture resulting from phase a) with an aqueous additive solution containing an additional binding agent, water content of 40% by weight of the total mixture and temperature maintained between 40QC and 45QC; and
c) drying of the powdered mixture produced in phase b) to a water content of no more than 5% by weight of water.
PCT/EP2007/064038 2006-12-29 2007-12-17 Pharmaceutical composition containing psyllium and senna Ceased WO2008080809A2 (en)

Applications Claiming Priority (2)

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ESP200603305 2006-12-29
ES200603305A ES2320827B1 (en) 2006-12-29 2006-12-29 "PHARMACEUTICAL COMPOSITION CONTAINING PSYLLIUM AND SENNA".

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WO2008080809A2 true WO2008080809A2 (en) 2008-07-10
WO2008080809A3 WO2008080809A3 (en) 2008-10-23

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008135115A2 (en) 2007-05-02 2008-11-13 Madaus Gmbh Novel pharmaceutical composition for use as a laxative
ITMI20111925A1 (en) * 2011-10-25 2013-04-26 Apharm Srl COMPOSITIONS BASED ON HYALURONIC ACID AND NATURAL FIBERS FOR ORAL USE TO INCREASE INTESTINAL PERISTALTIC ACTIVITY.

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4511561A (en) * 1980-01-16 1985-04-16 Dr. Madaus & Co. Laxative composition comprising psyllium seeds and senna fruits
DE3001357C2 (en) * 1980-01-16 1986-08-21 Dr. Madaus & Co, 5000 Koeln Granulated laxative based on plantago seeds and senna pods and process for the manufacture of the same
JPS6026375B2 (en) * 1980-01-16 1985-06-24 ドクトル・マ−ダウス・ウント・コンパニイ A laxative made from pusillium and senna seeds
US4548806A (en) * 1982-07-23 1985-10-22 G. D. Searle & Co. Psyllium hydrophilic mucilloid composition
US5232699A (en) * 1990-07-26 1993-08-03 The Proctor & Gamble Company Laxative compositions
AU9052791A (en) * 1990-11-16 1992-06-11 Procter & Gamble Company, The Compositions containing psyllium
US5232698A (en) * 1992-06-12 1993-08-03 The Proctor & Gamble Company Psyllium drink mix compositions
US5320847A (en) * 1993-05-13 1994-06-14 Valentine Enterprises, Inc. Agglomerated psyllium hydrophilic mucilloid combinates
CN1288730A (en) * 1999-09-07 2001-03-28 麦克内尔-Ppc股份有限公司 Slight-purgitive composition
US6986901B2 (en) * 2002-07-15 2006-01-17 Warner-Lambert Company Llc Gastrointestinal compositions
DE20315266U1 (en) * 2003-09-05 2004-10-14 Madaus Ag Powdered laxative composition based on plantago seeds and sennoside compounds, also containing polygalactomannan to facilitate suspension in water and improve activity
US20050053676A1 (en) * 2003-09-05 2005-03-10 Madaus Ag Powdered composition for use as laxative

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008135115A2 (en) 2007-05-02 2008-11-13 Madaus Gmbh Novel pharmaceutical composition for use as a laxative
WO2008135115A3 (en) * 2007-05-02 2009-04-02 Madaus Gmbh Novel pharmaceutical composition for use as a laxative
ITMI20111925A1 (en) * 2011-10-25 2013-04-26 Apharm Srl COMPOSITIONS BASED ON HYALURONIC ACID AND NATURAL FIBERS FOR ORAL USE TO INCREASE INTESTINAL PERISTALTIC ACTIVITY.

Also Published As

Publication number Publication date
ES2320827A1 (en) 2009-05-28
WO2008080809A3 (en) 2008-10-23
ES2320827B1 (en) 2010-03-03

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