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RELATED APPLICATIONS The present application is a continuation of U.S. Patent application Ser.
11/658,702, filed Oct. 8, 2007, now U.S. 8,193,196, issued on Jun. Bug fix release karma m3 2.2.2 for mac. 5, 2012, which in turn is filed under 35 U.S.C. §371 as the U.S. National application of International Patent Application No.
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PCT/EP2006/001755, filed Feb. 27, 2006, which in turn claims priority to the European Patent Application No. EP 05004695.2, filed Mar. 3, 2005, the entire disclosure of all of which is hereby incorporated by reference herein, including the drawings. BACKGROUND OF THE INVENTION The rifaximin (INN; see The Merck Index, XIII Ed., 8304) is an antibiotic pertaining to the rifamycin class, exactly it is a pyrido-imidazo rifamycin described and claimed in the Italian Patent IT 1154655, while the European Patent EP 0161534 describes and claims a process for its production starting from the rifamycin O (The Merck Index, XIII Ed., 8301). Both these patents describe the purification of the rifaximin in a generic way saying that the crystallization can be carried out in suitable solvents or solvent systems and summarily showing in some examples that the product coming from the reaction can be crystallized from the 7:3 mixture of ethyl alcohol/water and can be dried both under atmospheric pressure and under vacuum without saying in any way neither the experimental conditions of crystallization and drying, nor any distinctive crystallographic characteristic of the obtained product.
The presence of different polymorphs had not been just noticed and therefore the experimental conditions described in both patents had been developed with the goal to get a homogeneous product having a suitable purity from the chemical point of view, apart from the crystallographic aspects of the product itself. It has now be found, unexpectedly, that some polymorphous forms exist whose formation, in addition to the solvent, depends on the conditions of time and temperature at which both the crystallization and the drying are carried out. These orderly polymorphous forms will be, later on, conventionally identified as rifaximin δ ( FIG. 1) and rifaximin ε ( FIG. 2) on the basis of their respective specific diffractograms reported in the present application. The polymorphous forms of the rifaximin have been characterized through the technique of the powder X-ray diffraction. The identification and characterization of these polymorphous forms and, contemporarily, the definition of the experimental conditions for obtaining them is very important for a compound endowed with pharmacological activity which, like the rifaximin, is marketed as medicinal preparation, both for human and veterinary use.
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In fact it is known that the polymorphism of a compound that can be used as active principle contained in a medicinal preparation can influence the pharmaco-toxicologic properties of the drug. Different polymorphous forms of an active principle administered as drug under oral or topical form can modify many properties thereof like bioavailability, solubility, stability, color, compressibility, flowability and workability with consequent modification of the profiles of toxicological safety, clinical effectiveness and productive efficiency.