The present invention relates to a process for the purification of a clay for therapeutic use. This clay can be a clay of smettie, beidellitic montmorillonite or attapulgite type.
Clay is a natural product known for its absorbent and adsorbent power. Thus the clay of smettie type, marketed under the trade-mark Smecta®, is used for example in the symptomatic treatment of the pain linked to oesophago-gastro-duodenal diseases and colics and acute and chronic diarrhea.
The raw material generally only contains approximately 30 to 60% of active ingredient, it is therefore indispensable to purify it in order to obtain a pure clay in the pharmaceutical sense.
A process for the preparation of a clay for therapeutic use is described in the patent FR 2346017. The latter comprises the following main stages: a grinding stage, putting into suspension in water, a chemical treatment of the suspension obtained with an acid until stabilization at pH 2-3, a physical treatment in hydrocyclones and finally drying.
The Applicant has found that the chemical treatment with stabilization at pH 2-3 as described in the patent FR 2346017 was not necessary and that the chemical treatment could be carried out at a less acid pH.
Therefore a subject of the present invention is a process for the purification of a clay for therapeutic use, the process comprising the following successive stages:
The clay thus obtained is a pure clay in the pharmaceutical sense.
Preferably, the process of the invention is carried out for clays containing alkaline-earth carbonates, and more particularly alkaline-earth carbonates selected from K2CO3, Na2CO3, MgCO3 and CaCO3.
Preferably, the chemical treatment of a process according to the present invention is carried out at a pH of the order of 3.5-4.5, and very preferentially at a pH of the order of 4-4.5.
Preferably also, the chemical treatment of a process according to the invention is carried out by adding a strong mineral acid, and very preferentially by adding hydrochloric acid.
Preferably also, the chemical treatment of a process according to the invention is carried out by adding an acid in a ratio (quantity of acid/quantity of raw material) comprised between 0.010 and 0.020.
A process according to the present invention therefore has the advantage of using less acid which allows the limiting and/or elimination of the release of acids and acid vapours. Moreover, this reduction in the consumption of acid which is capable not only of degrading the clay but also the apparatuses used, also has advantages both for the final product but also in terms of cost.
All the technical and scientific terms used in the present text have the meaning known to a person skilled in the art.
After extraction of the raw material (approximately 1 kg) and the mechanical treatment, the clay is put into suspension then subjected to a granulometric treatment in order to reduce the clay to sufficiently fine particles. The suspension (20% in water) is subjected to stirring and 0.010 to 0.020 kg of 36% hydrochloric acid is then added in order to obtain a pH value of the order of 3-5. Initially, the acid is added in excess in order to be sure to eliminate all the carbonates which could be present. Complete neutralization of the carbonates is carried out by monitoring the pH value.
After physical treatment using hydrocyclones and returning to a solid phase, the paste is dried in order to thus obtain a pure clay in the pharmaceutical sense.
Number | Date | Country | Kind |
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0409835 | Sep 2004 | FR | national |