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(12) United States Patent (10) Patent No.: US 7,569.274 B2 Besse Et Al

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(12) United States Patent (10) Patent No.: US 7,569.274 B2 Besse Et Al US007569274B2 (12) United States Patent (10) Patent No.: US 7,569.274 B2 Besse et al. (45) Date of Patent: Aug. 4, 2009 (54) IMPREGNATED POWDER IMPROVING (52) U.S. Cl. ....................... 428/403; 428/404; 428/405: BOAVAILABILITY AND/OR SOLUBILITY 428/406; 428/407; 427/212; 427/213.3 AND METHOD OF PRODUCTION (58) Field of Classification Search ................. 428/403, 428/404, 405, 406, 407; 427/212, 213.3 (75) Inventors: Jérôme Besse, Listrac Medoc (FR): See application file for complete search history. Laurence Besse, Listrac Medoc (FR); (56) References Cited Myriam Alphonse, Bordeaux (FR) FOREIGN PATENT DOCUMENTS (73) Assignee: SAS Galenix Innovations, Saint-Jean DIllac (FR) WO WOO3,051334 * 6, 2003 (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 638 days. * cited by examiner Primary Examiner Leszek Kiliman (21) Appl. No.: 10/547,797 (74) Attorney, Agent, or Firm Arent Fox LLP (22) PCT Filed: Mar. 5, 2004 (57) ABSTRACT (86). PCT No.: PCT/FR2004/OOO541 This invention relates to an impregnated powder for increas S371 (c)(1), ing the bioavailabilty and/or the solubility of at least one (2), (4) Date: Sep. 6, 2005 active principle comprising a solid, inert Support in a particle form impregnated by a liquid medium comprising a hydro (87) PCT Pub. No.: WO2004/080381 phobic phase and optionally a hydrophilic phase, at least one Surfactant and at least one active principle dissolved in at least PCT Pub. Date: Sep. 23, 2004 one of said phases, wherein said active principle(s) is(are) also present in at least one of said phases in the form of a (65) Prior Publication Data Suspension. US 2006/O182691 A1 Aug. 17, 2006 Such an impregnated powder is used as a base for various (30) Foreign Application Priority Data preparations in the pharmaceutical, parapharmaceutical and cosmetic field, in the food complement field and in the food Mar. 6, 2003 (FR) ................................... O3 O28O2 processing industry. (51) Int. Cl. B32B5/66 (2006.01) 31 Claims, 12 Drawing Sheets U.S. Patent Aug. 4, 2009 Sheet 1 of 12 US 7,569.274 B2 Mixture of components having a lipophilic nature (fatty bodies, surfactant, Co-Surfactant...) Stirring Solubilization of the hydrophobic active principle Stirring Incorporation of the aqueous phase Making of an active principle saturated Solution Stirring Addition of the hydrophobic active principle amount until making of the desired percentage = active principle rich Suspension Granulation impregnation of the obtained suspension on a solid inert Support Active principle filled powder for increasing the bioavailability FIGURE 1 U.S. Patent Aug. 4, 2009 Sheet 2 of 12 US 7,569.274 B2 Mixture of components having a lipophilic nature (fatty bodies, surfactant, co-surfactant...) Stirring Incorporation of the aqueous phase Making of an active principle saturated solution Stirring Addition of the hydrophobic active principle amount Making of the suspension or the active principle filled Suspension Stirring Impregnation of the obtained suspension on a solid inert support Granulation Active principle filled powder for increasing the bioavailability FIGURE 2 U.S. Patent Aug. 4, 2009 Sheet 3 of 12 US 7,569.274 B2 Mixture of components having an aqueous nature Stirring Solubilization of the hydrophile active principle Stirring Incorporation of the hydrophobic phase Making of an active principle saturated solution Stirring Addition of the hydrophobic active principle amount until obtention of the desired percentage = active principle rich Suspension Granulation Impregnation of the obtained suspension on a Solid inert Support Active principle filled powder for increasing the bioavailability FIGURE 3 U.S. Patent Aug. 4, 2009 Sheet 4 of 12 US 7,569.274 B2 Mixture of components having an aqueous nature Stirring Incorporation of the hydrophobic phase Making of an active principle saturated solution Stirring Addition of the hydrophile active principle amount Making of the active principle filled suspension Stirring Impregnation of the obtained suspension on a solid inert support Granulation Active principle filled powder increasing the bioavailabilty FIGURE 4 U.S. Patent Aug. 4, 2009 Sheet 5 of 12 US 7,569.274 B2 -0- Utrogestan (R) 100mg -A- mpregnated powder of the invention O O 50 100 150 200 250 300 350 400 Time (minutes) FIGURE 5 120 . --Lipanthyl(R) 160mg -- mpregnated powder of the invention O O 1 O 20 30 40 50 60 70 Time (minutes) FIGURE 6 U.S. Patent Aug. 4, 2009 Sheet 6 of 12 US 7,569.274 B2 -0- Commercial formulation K-Progesterone based impregnated 5 O powder O 10 20 30 40 50 60 Time (minutes) FIGURE 7 U.S. Patent Aug. 4, 2009 Sheet 7 of 12 US 7,569.274 B2 100 -h- Utrogestan -e-Progesterone based impregnated powder -O-Impregnated powder based tablet 10 20 30 40 50 60 Time (minutes) FIGURE 8 U.S. Patent Aug. 4, 2009 Sheet 8 of 12 US 7,569.274 B2 Particule size (um) FIGURE 9 U.S. Patent Aug. 4, 2009 Sheet 9 of 12 US 7,569.274 B2 5 0 - - A - Zovirax 200mg -- Acyclovir based impregnated powder O I I I 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Time (minutes) FIGURE 10 U.S. Patent Aug. 4, 2009 Sheet 10 of 12 US 7,569.274 B2 -A-Zovirax200mg 5 O -- Acyclovir based impregnated powder 30 -HImpregnated powder based tablet - f ri------- O 2 4 6 8 10 12 14 16 1820 22 24 26 28 30 Time (minutes) FIGURE 11 U.S. Patent Aug. 4, 2009 Sheet 11 of 12 US 7,569.274 B2 Volume 4.5 um in (% Particule size (um) FIGURE 12 U.S. Patent Aug. 4, 2009 Sheet 12 of 12 US 7,569.274 B2 100 - 5 O -A-Lipanthyl --Fenofibrate based impregnated powder 4 6 8 10 12 14 16 18 20 Temps (minutes) FIGURE 13 US 7,569,274 B2 1. 2 MPREGNATED POWDER IMPROVING increase the absorption, the solubility and/or the protection of BOAVAILABILITY AND/OR SOLUBILITY the active principle in order to facilitate the administration of AND METHOD OF PRODUCTION liposoluble and/or hydrosoluble molecules (generally with a low bioavailability), easy and cheap to manufacture, in con CROSS-REFERENCE TO RELATED trast to the lyophilization and spraying method generally used APPLICATION in the prior art for adsorbing fat bodies on a Solid Support. An object of the invention is a powder for increasing the This application is a National Stage entry of International bioavailability and/or the solubility of at least one active Application Number PCT/FR2004/000541, filed Mar. 5, principle comprising a solid inert Support, in a particle form 2004. The disclosure of the prior application is hereby incor 10 impregnated by a liquid medium comprising a hydrophobic porated herein in its entirety by reference. phase and a hydrophilic phase, at least one surfactant and at least one active principle wherein said active principle is (are) FIELD OF THE INVENTION dissolved in one of said hydrophilic or hydrophobic phases, and in the form of a suspension in the other one of said phases. This invention relates to a method for producing an impreg 15 Another object of the present invention is to provide a nated powder for increasing the bioavailability and/or the method for producing an impregnated powder allowing to solubilization of one or more active principle(s) or making increase the bioavailability and/or the solubility and in par easier the administration mode thereof, cheap to manufacture ticular allowing to increase the absorption, the solubility and/ and easy to implement. The active principle(s) may belong to or the protection of the active principle in order to make easier the pharmaceutical, parapharmaceutical and cosmetic field, the administration of liposoluble and/or hydrosoluble mol to the field of personal care, food complements or food pro ecules (generally with a low bioavailability) and wherein the cessing industry, being liposoluble and/or hydroSoluble. Such integrity of the active principles is maintained. a powder is impregnated with a liquid based on one or more Still another object of the present invention is the use of an active principle(s). Such a liquid may optionally have the impregnated powder for increasing the bioavailability and/or form of a solution and a dispersed system. 25 the Solubility Such as previously defined, and more particu larly allowing to increase the absorption, the solubility and/or BACKGROUND OF THE INVENTION the protection of the active principle in order to make easier the administration of liposoluble and/or hydrosoluble mol The bioavailability corresponds to the active principle ecules (generally with a low bioavailability), for formulating amount being administered reaching the systemic circulation. 30 various preparations. The efficiency of an active principle depends on the bioavail The above-mentioned objects are reached according to the ability thereof. invention by an impregnated powder for increasing the bio Many active principles suffer, through the oral route, from availability and/or the solubility of at least one active prin a low bioavailability. ciple comprising a solid inert Support, in a particle form Before reaching the Vena cava, an active principle is con 35 impregnated by a liquid medium comprising a hydrophobic veyed through the gastrointestinal tract and passes through phase and optionally a hydrophilic phase, at least one Surfac the intestine wall and the liver. At the liver level, the active tant and at least one active principle dissolved in at least one principles may be metabolised in an inactive form and are of said phases, wherein said active principle(s) is(are) also subjected to the effect of the first hepatic passage before present in at least one of said phases in the form of a Suspen reaching the systemic circulation.
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