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(12) Patent Application Publication (10) Pub. No.: US 2003/0152629 A1 Shefer Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2003/0152629 A1 Shefer Et Al US 2003O152629A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0152629 A1 Shefer et al. (43) Pub. Date: Aug. 14, 2003 (54) MULTICOMPONENT CONTROLLED (57) ABSTRACT RELEASE SYSTEM FOR ORAL CARE, FOOD PRODUCTS, NUTRACETICAL AND The present invention relates to an improved controlled BEVERAGES release System that can encapsulate different flavors, Sensory markers, and active ingredients, or combinations of flavors, (76) Inventors: Adi Shefer, East Brunswick, NJ (US); Sensory markers and various active ingredients and release Samuel David Shefer, East Brunswick, multiple active ingredients in a consecutive manner, one NJ (US) after the other. The controlled delivery system of the present invention is substantially free-flowing powder formed of Correspondence Address: Solid hydrophobic nanospheres that are encapsulated in a Diane Dunn McKay moisture Sensitive microSpheres. The flavors, and active Mathews, Collins, Shepherd & McKay, P.A. ingredients encapsulated in the hydrophobic nanospheres, in Suite 306 the water Sensitive microSphere, or in both the nano and the 100 Thanet Circle microSphere. The flavors and active ingredients encapsu Princeton, NJ 08540 (US) lated in the nanospheres can be the same or different from those encapsulated in the microSpheres. The encapsulation (21) Appl. No.: 10/387,907 of different flavors or active agents in the various compo nents of the System, Such as nanospheres and microSpheres, (22) Filed: Mar. 13, 2003 provides flavor transition (change in flavor character) during Related U.S. Application Data the use of the products. The controlled release system of the present invention enhances the Stability and bioavailability (63) Continuation-in-part of application No. 09/696,148, of wide range of flavors, Sensory markers, and other active filed on Oct. 25, 2000. ingredients, prolong their residence time in the oral cavity, control their release characteristics, and prolong the Sensa Publication Classification tion of flavors and other Sensory markers in the mouth to provide long lasting organoleptic perception or long lasting (51) Int. Cl. .................................................... A61K 9/14 mouthfeel. The invention further relates oral care, food (52) U.S. Cl. ......................... 424/484; 424/486; 424/487; products, and beverages comprising the controlled release 424/488 System of the present invention. Patent Application Publication Aug. 14, 2003 Sheet 1 of 3 US 2003/0152629 A1 Water sensitive micro-sphere composed of hydrophobic nano-spheres encapsulated in a Water sensitive matrix Hydrophobic nano-spheres F.G. 1 Patent Application Publication Aug. 14, 2003 Sheet 2 of 3 US 2003/0152629 A1 Patent Application Publication Aug. 14, 2003 Sheet 3 of 3 US 2003/0152629 A1 8 O -C)- Neat Citral 2 O -- Encap. O 2O 4O 6O 8O 1OO 12O Time (hrs) FIG. 4 US 2003/0152629 A1 Aug. 14, 2003 MULTICOMPONENT CONTROLLED RELEASE trins (25-50%), and a high molecular weight carbohydrate SYSTEM FOR ORAL CARE, FOOD PRODUCTS, Such as gum arabic, gum acacia or chemically modified NUTRACETICAL AND BEVERAGES starch (10-35%) to which flavoring agents are added and the 0001. This patent application is a continuation in part of Subsequent Solution spray dried to yield a free flowing U.S. application Ser. No. 09/696,148, filed Oct. 25, 2000, powder with a bulk density of 0.50 g/cc. entitled “Multicomponent Biodegradable Bioadhesive Con 0010 U.S. Pat. No. 4,859,377 describes the use of amy trolled Release System for Oral Care Products,” the contents lose-containing pregelatinized Starch to encapsulate ento of which are incorporated by reference into this application. mopathogens, thereby protecting Such biocontrol agents from environmental degradation and also promoting infec BACKGROUND OF THE INVENTION tion of target pests. The encapsulation is effected in an aqueous dispersion of the pregelatinized Starch: for dry, 0002) 1. Field of the Invention granular products, the Starch Solids content of the dispersion 0003. The present invention relates to multi component is 25-40%; for sprayable liquid products, chemically controlled release System that can be incorporated in oral degraded Starch is used at a Solids content of 1-10%. care products, nutraceutical, food products and beverages to effectively encapsulate one or multiple active ingredients 0011 U.S. Pat. No. 4,911,952 discloses chemical biologi and Sensory markers (i.e., flavors, cooling agents, Sweeten cal agents to be encapsulated are blended into an aqueous ers, etc.) and release multiple active ingredients in a con dispersion of an unmodified Starch comprising about 5% to secutive manner, one after the other. The controlled release about 25% by weight amylose. The dispersion, having an System of the present invention enhances the Stability and initial starch Solids content of about 20% by weight, is bioavailability of wide range of flavors, Sensory markers, characterized by completely disrupted Starch granules and and other active ingredients, prolongs their residence time in completely disassociated amylose molecules that are not the oral cavity, controls their release characteristics, and Significantly depolymerized. Subsequent drying is accom prolongs the Sensation of flavors and Sensory markers in the plished by reasSociation of the amylose molecules which mouth to provide long lasting organoleptic perception or converts the dispersion into a protective matrix and binds the long lasting mouthfeel. The invention further relates to oral agents within the interstices of the reasSociating Starch care, food products, and beverages comprising the con chains. Rate of release of agents to the environment can be altered by varying the proportion of amylose in the Starch. trolled release System of the present invention. Encapsulation of biologically active compositions provides 0004 2. Description of the Related Art protection against degradative environmental conditions, 0005 Extensive effort has been directed in recent years improves Safety in handling, and Slows the release of Such towards controlling the release characteristics of various compounds to the Surrounding medium. active ingredients flavors and Sensory markers to prolong 0012 U.S. Pat. No. 5,183,690 discloses biologically product shelf life and to prolong the Sensation in the mouth active agents to be encapsulated are continuously blended during consumption of food products and beverages. Vari with a Starchy material and water, Subjected to high-Shear ous methods and compositions have been described for mechanical action at a temperature above the gelatinization providing enhanced Stability and better control of the release temperature of Starch, and continuously recovered as an of active ingredients and flavors in food products. insolubilized matrix of Starch that entraps discontinuous 0006 Spray drying, accounts for the majority of com domains of the agent. Alternatively, the core material to be mercial encapsulated materials in food products. The Spray encapsulated is added and blended with the aqueous disper drying encapsulation process is relatively simple, economi Sion of Starch after the Starch and water have been Subjected cal, and easily Scaled to large production volumes. A major to an elevated temperature Sufficient to gelatinize the Starch. benefit of Spray drying encapsulation is the broad range of Rate of release of agents to the environment can be con actives and Sensory markers which can be encapsulated. trolled by pre-Selecting a set of conditions related to various These actives include oil-soluble flavors, water-soluble processing parameters. Encapsulation of biologically active compounds, natural extracts, Single component flavor com compositions provides protection against degradative envi pounds, as well as complex compounded flavors having both ronmental conditions, improves Safety in handling, and water- and oil-Soluble components. Slows the release of Such compounds to the Surrounding medium. 0007 U.S. Pat. No. 3,971,852 discloses the use of modi fied Starch, gums and other natural hydro-colloids with 0013 U.S. Pat. No. 5,506,353 discloses particulate flavor lower molecular weight polyhydroxy compounds to yield a composition comprising a flavor oil fixed in a particulate glassy cellular matrix with encapsulated oil at a maximum of low cariogenic matrix of hydrogenated Starch hydrolysate 80 volume 76. This system forms a shell Surrounding the oil and a maltodextrin having a dextrose equivalent value of flavoring but is limited to lipophilic flavoring agents. less than 20. A process for the encapsulation of a flavor oil comprising forming a homogeneous mixture of the flavor oil 0008 U.S. Pat. No. 4,532,145 describe a process and with (a) from about 40 to about 85 percent by weight of a composition in which a volatile flavorant is fixed by Spray particulate polyol consisting of hydrogenated Starch drying from a carrier solution made up of 10-30% of a low hydrolysate, (b) from about 10 to about 30 percent by weight molecular weight component Such as a Sugar or an edible of a maltodextrin having a dextrose equivalent of less than food acid with the balance of solids being a maltodextrin 20, (c) an emulsifier and water, and spray-drying the result carbohydrate in the amount of 70-90%. ant mixture to form a particulate product of from about 0.15 0009 U.S. Pat. No. 5,124,162 discloses a carrier mixture to about 0.85 g/cc bulk free flow density. Methods to confer, composed of mono- and disaccharides (22-45%), maltodex enhance or modify the flavor
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