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WO 2017/021983 Al 9 February 2017 (09.02.2017) P O P C T

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WO 2017/021983 Al 9 February 2017 (09.02.2017) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/021983 Al 9 February 2017 (09.02.2017) P O P C T (51) International Patent Classification: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61K 31/00 (2006.01) A61K 31/736 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (21) International Application Number: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PCT/IN20 16/050261 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (22) International Filing Date: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 5 August 2016 (05.08.2016) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 2969/MUM/2015 6 August 2015 (06.08.2015) IN TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: RUBICON RESEARCH PRIVATE LIM¬ LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, ITED [IN/IN]; Rubicon Research Private Limited, 221, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Annexe Building, Goregaon Mulund Link Road, Off. GW, KM, ML, MR, NE, SN, TD, TG). L.B.S Marg, Bhandup West, Mumbai 400078 (IN). Declarations under Rule 4.17 : (72) Inventors: PILGAONKAR, Pratibha; Rubicon Research — as to applicant's entitlement to apply for and be granted a Private Limited, 221, Annexe Building, Goregaon Mulund patent (Rule 4.1 7(H)) Link Road, Off. L.B.S Marg, Bhandup West, Mumbai 400078 (IN). GANDHI, Anilkumar; Rubicon Research — as to the applicant's entitlement to claim the priority of the Private Limited, 221, Annexe Building, Goregaon Mulund earlier application (Rule 4.1 7(in)) Link Road, Off. L.B.S Marg, Bhandup West, Mumbai — of inventorship (Rule 4.17(iv)) 400078 (IN). JAIN, Paras; Rubicon Research Private Limited, 221, Annexe Building, Goregaon Mulund Link Published: Road, Off. L.B.S Marg, Bhandup West, Mumbai 400078 — with international search report (Art. 21(3)) (IN). — before the expiration of the time limit for amending the (81) Designated States (unless otherwise indicated, for every claims and to be republished in the event of receipt of kind of national protection available): AE, AG, AL, AM, amendments (Rule 48.2(h)) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, o o (54) Title: PARTICULATE DELIVERY SYSTEMS (57) Abstract: The present invention provides particulate delivery systems comprising plurality of particles comprising fenugreek gum and at least one pharmaceutically acceptable excipient. The particulate delivery systems of the present invention are used for the delivery of therapeutic, immunologic or diagnostic agents, and the like. PARTICULATE DELIVERY SYSTEMS Field of the Invention The present invention relates to particulate delivery systems comprising fenugreek gum. Particularly, the present invention provides particulate delivery systems comprising plurality of particles comprising fenugreek gum and at least one pharmaceutically acceptable excipient. The particulate delivery systems of the present invention are used for the delivery of therapeutic, immunologic or diagnostic agents, and the like. Background of the Invention There has been a considerable research interest in the area of particulate delivery systems as carriers for small and large molecules. The concept of using particles to deliver therapeutic agents has gained tremendous interest over years. Particulate delivery systems can change the fate of a drug without modifying the chemical structure, and increase efficacy and decrease toxicity of a drug. Some particulate drug delivery systems having better capability to overcome physiological barriers, precisely control the release rates, or target drugs to a specific body site, have a marked impact on the health care system. Particulate systems especially nano- and micro scale based systems offer versatility by virtue of their small size and efficient carrier characteristics, enabling the tailoring of delivery systems with consideration of the biological target, desired pharmacokinetic profile, and route of administration. Both nano scale (1-100nm) and micro scale (0.1-1000 µ ) systems have been extremely important in developing various clinically useful particulate delivery systems. Nanotechnology has been strategically used for developing such particulate delivery systems. Nanocarriers and microcarriers such as nanoparticies, nanospheres, nanoemulsions, nanocapsules, liposomes, micelles, microparticles, microspheres, and the like demonstrate a broad variety of useful properties, such as controlled or modified drug release; uptake through biological membranes, longevity in the blood allowing for their accumulation in pathological areas with compromised vasculature; specific targeting to certain disease sites due to various targeting iigands attached to the surface of the carriers; enhanced intracellular penetration with the help of surface-attached cell-penetrating molecules; contrast properties due to the carrier loading with various contrast materials allowing for direct carrier visualization in vivo; stimuli-sensitivity allowing for drug release from the carriers under certain physiological conditions, and others. Such nano- and micro scale based particulate delivery systems comprising multitude of particulate units also provide many advantages over single-unit systems or systems having larger particle size, like reduced risk of local irritation and toxicity, predictable bioavailability, reduced likelihood of dose dumping, minimized fluctuations in the plasma concentration of the biological agent, high dose-strength administration, reduced risk of systemic toxicity and site specific or targeted therapeutic effect, controllable particle size, flexibility of delivering by various routes of administration, more reproducible pharmacokinetic behavior, lower intra- and inter- subject variability than conventional single unit formulations. Many attempts have been made towards the preparation of particulate delivery systems employing different nanofechnology processes and different particulate carrier materials. US Patent 5,768,635 discloses preparation of nanoparticies by dissolving a poly (ethylene oxide) and/or poly (propylene oxide) polyiactic copolymer in an organic solvent followed by mixing the solution containing the polymer with an aqueous solution and by precipitation or by microfluidization and solvent evaporation. US Patent 8,293,278 discloses methods of making nanoparticies having about 0.2 to about 35 weight percent of a therapeutic agent; and about 10 to about 99 weight percent of a polymer such as a dibiock poly (lactic) acid-poly (ethylene) glycol. Schubert et a . describe in Journal of Polymer Science, Part A , Polymer Chemistry, Vol. 48, 3924-3931, 2010, the preparation of nanoparticies from solutions of poly (methyl mefhacrylafe) and its copolymers by nanoprecipitation method. US Patent Application 20100297237 discloses a pharmaceutical composition comprising nanoparticies comprising: a poorly water soluble drug; a poorly aqueous soluble non-ionizabie polymer selected from the group consisting of ethyiceliuiose, cellulose acetate, cellulose propionate, cellulose butyrate, cellulose acetate butyrate, and mixtures thereof; and an amine-functionalized methacry!ate copolymer, poly [ethyiacryiate-co-methyl methacrylate- co-trimethylamonioethyl methacrylate chloride]. Though various attempts have been made to develop particulate delivery systems using synthetic polymers, these polymers may be toxic, non-biodegradable, allergic, incompatible with some drugs, or not economical. Natural excipients are therefore employed in particulate delivery systems as they are inert, safe, non-toxic, biocompatible, biodegradable, economical, eco-friendly and abundantly available in nature compared to the synthetic polymers. Natural polysaccharides have been widely investigated for their benefits in particulate delivery systems. Polysaccharides consist of long carbohydrate molecules containing repeated monosaccharide units which are joined together by means of glycosidic bonds. They represent the most abundant biomolecu!es in nature. Polysaccharides are highly biocompatible and biodegradable. They can be classified by their origin: vegetal origin (e.g. pectin), algal origin (e.g. alginate), microbial origin (e.g. dextran, xanthan gum), and animal origin (chitosan, heparin). Polysaccharides may also be classified by their charge: cationic (chitosan), anionic (hyaluronic acid, heparin) and nonionic (dextran). Polysaccharides can be homopolysaccharides or heteropolysaccharides depending on their monosaccharide components. A variety of particulate delivery systems have been attempted using different polysaccharides. US Patent 6,677,388 discloses a process for producing starch nanoparticles in which the starch is plasticized using shear forces and a crosslinking agent is added during the processing. After the processing, starch was dissolved or dispersed in an aqueous medium to a concentration between 4 and 40 wt. % which results in starch nanoparticles that are characterized
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