Pharmaceutical composition for use as a laxative
a technology of pharmaceutical compositions and laxatives, applied in the field of new compositions, can solve the problems of inability or inability to directly process these mixtures to powder ready for administration, inability to optimally adjust the flow and suspendability in water, and the formation of lumps of granules. , to achieve the effect of facilitating the manufacture of complete compositions, reducing the risk of hazards, and reducing the risk of adverse effects
Inactive Publication Date: 2008-12-18
ASTA WERKE AG CHEM FAB
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- Description
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- Application Information
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Benefits of technology
[0041]The pharmaceutical composition of the invention is advantageously in the form of granules. A number of advantages are associated therewith. The granule form facilitates administration in several ways: firstly, dosage is facilitated (e.g. the granule form makes teaspoon dosage possible), and secondly the granule form increases on the one hand the storage stability of the composition, and on the other hand its suspendability or solubility in water for the relevant administration (i.e. stated more accurately the psyllium seed constituents go into suspension, while the other constituents, especially the senna fruit dry extract and, where appropriate, further ingredients such as, for example, granule formers, go into solution). It is also possible in this way to increase the stability of the prepared suspension or solution. In addition, the granule form ensures that the composition of the invention is dust-free, which facilitates in particular the usability and minimizes the risks (e.g. inhalation on inappropriate use) connected therewith.
Problems solved by technology
However, the flowability and suspendability in water cannot be optimally adjusted with such mixtures, but this would be desirable for oral administration.
Processing of these mixtures to powders ready for administration is moreover impossible or not directly possible.
Otherwise there is the risk on inappropriate oral intake or administration, i.e. on oral intake or administration with amounts of water which are too small, that swollen lumps of the granules may form and may, in the worst cases, lead to blockage of the esophagus or else even of the gastrointestinal tract.
Laxatives which are based on plantains or Indian plantains (psyllium) or their constituents and which are on the market often do not have a sufficient cathartic effect and, after suspension in water, because of the rapid onset of the swelling effect of the plantain, do not remain drinkable for long, so that they must be taken immediately after pre-paring the aqueous suspension.
In addition, with most of the products there is very rapidly at least a two-layer phase separation which no longer ensures homogeneous distribution of the active components in the stirred product.
These products must also be taken with copious water because, otherwise, there is a risk of the possible formation of swollen agglomerates which, in the worst cases, may lead to blockage of the esophagus or else even of the gastrointestinal tract.
Further disadvantages of these products are also the insipid taste and the artificial appearance.
Method used
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OF THE PRESENT INVENTION
Manufacture of Pharmaceutical Compositions of the Invention for Use as Purgatives
[0099]The following weights were chosen to manufacture a composition of the invention:
Senna fruit dry extract (10%)506.67gPlantago seeds (maximum particle size: 140 μm)7,000gColorant76gAromatizing substance400gSweetener28gGranule former (maltodextrin)836gAcidifier (citric acid, anhydrous)1,153gWater (granulating liquid)4kg
A powdered mixture was produced from the plantago seeds, the senna fruit dry extract and the aromatizing substance. The other raw materials were dissolved in water; the solution was clear and was subsequently used as granulating liquid.
[0100]A fluidized-bed granulation was subsequently carried out. For this purpose, the powdered mixture was transferred into the fixed-bed granulation. 200 to 300 m3 / h was used for fluidization. After the inlet air temperature reached 70° C., spraying was started. The inlet air temperature rose during the process up to 85° C. The p...
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Abstract
The invention relates to a pharmaceutical composition which is suitable in particular for use as purgative (cathartic), where the composition comprises in combination and in each case in pharmaceutically effective amounts (A) senna fruit dry extract and (B) plantago seeds (plantaginis ovatae semen). The composition can advantageously be manufactured by fluidized bed granulation. The composition is in particular free of guar gum, is dust-free, is dispersible in water and has a pleasant taste and can be supplemented straightforwardly with vitamins, minerals, trace elements and the like.
Description
CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority to German Patent Application No. DE 10 2007 020 842.3, filed May 2, 2007, and also claims priority to German Patent Application No. DE 10 2007 023 397.5, filed May 18, 2007, both entitled “NEW PHARMACEUTICAL COMPOSITION FOR USE AS A LAXATIVE”. Both references are expressly incorporated by reference herein, in their entirety.BACKGROUND OF THE PRESENT INVENTION[0002]The present invention relates to a novel composition, in particular pharmaceutical composition, for use as laxative (also referred to synonymously as “cathartic” or “purgative”) and to a method for its manufacture, and to the use of this composition as laxative (i.e. cathartic or purgative).[0003]Laxatives—also referred to synonymously as “purgatives” or “cathartics”—exist in very diverse forms, including numerous herbal cathartics.[0004]Thus, for example, the use of plantago seed (plantaginis ovatae semen or semen plantaginis ovatae, also calle...
Claims
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IPC IPC(8): A61K36/68A61K9/14A61K31/05
CPCA61K31/704A61K36/482A61K36/68A61K2300/00A61P1/10A61P43/00A61K9/16A61K31/7034
InventorMORICK, WOLFGANGPRENNER, LARS-NORBERTHUBBERT, MICHAELGEBHART, KURT N.BEHM, WOLF
OwnerASTA WERKE AG CHEM FAB