US 20120321727A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0321727 A1 Windschauer et al. (43) Pub. Date: Dec. 20, 2012

(54) TASTE MASKING COMPOSITIONS AND A636/54 (2006.01) EDIBLE FORMS THEREOF A6II 3/40 (2006.01) A6II 3L/225 (2006.01) (75) Inventors: Robert J. Windschauer, Largo, FL A6IP 5/00 (2006.01) (US); Teresa T. Virgallito, A2.3L. I./22 (2006.01) Beavercreek, OH (US) A2.3L I/0562 (2006.01) A2.3L I/053 (2006.01) (73) Assignee: ACME SPECIALTY A2.3L I/054 (2006.01) PRODUCTS, LLC, Tampa, FL A2.3L I/0524 (2006.01) (US) A2.3L I/0522 (2006.01) A2.3L I/0532 (2006.01) (21) Appl. No.: 13/455,520 A2.3L I/0534 (2006.01) A2.3L I/0526 (2006.01) (22) Filed: Apr. 25, 2012 A23G 3/42 (2006.01) O O A63L/453 (2006.01) Related U.S. Application Data (52) U.S. Cl...... 424/737; 514/326; 424/769; 424/760; (60) Provisional application No. 61/480,102, filed on Apr. 424/754; 424/755; 424/756; 514/718; 514/627; 28, 2011. 424/739; 514/425; 514/548; 426/650: 426/573; 426/576; 426/577; 426/578; 426/575 Publication Classification (57) ABSTRACT (51) Int. Cl. A23G 3/36 (2006.01) Disclosed are edible formulations, for example, edible films A6 IK 36/28 (2006.01) and gummi confectioneries, that mask the taste of semen. The A6 IK 36/758 (2006.01) films and confectioneries include a composition that upon A6 IK 36/8 (2006.01) activation in the oral cavity provides a lasting taste masking A6 IK 36/8962 (2006.01) effect that endures for up to 20 minutes. The composition A6 IK 36/3 (2006.01) includes a film former or gelling agent, an effective amount of A6 IK 36/9068 (2006.01) a protein masker, and an effective amount of a bitter masker. A6 IK3I/085 (2006.01) The composition may also include a flavoring agent, Sweet A6 IK3I/I65 (2006.01) ening agents, and sensates. US 2012/0321727 A1 Dec. 20, 2012

TASTE MASKING COMPOSITIONS AND 0008 Both the edible film and the edible gummi confec EDIBLE FORMS THEREOF tionery, upon activation in Saliva in the oral cavity, provide a lasting taste masking effect that endures for about 5 to 20 RELATED APPLICATIONS minutes. The enduring taste masking effect is possible because of the presence of at least one protein masking agent 0001. This application claims the benefit of U.S. Provi and at least one bitter masking agent. The protein masking sional Application No. 61/480,102, filed Apr. 28, 2011. agent constitutes about 0.01% to about 16% dry weight of either the edible film or the edible gummi confectionery, and FIELD OF THE INVENTION the bitter masking agent may constitute about 0.1% to 7% dry 0002 The present invention relates to taste masking com weight thereof. positions, in particular, edible forms of the taste masking 0009. Both the edible film and the edible gummi confec composition Such as films and gummi confectioneries. tionery may include a flavoring agent, a sensate, and/or a Sweetening agent. The flavoring agent may constitute about BACKGROUND OF THE INVENTION 0.1% to about 30% dry weight, the sensate may constitute about 0.1% to about 25% dry weight, and the Sweetening 0003 Because of the unpleasant taste of many pharmaceu agent may constitute about 1% to about 20% dry weight of ticals or nutritional Supplements, flavorings alone or in com either the edible film or the edible gummi confectionery. bination with Sweetening agents have been employed to 0010. In another embodiment, edible compositions improve taste and palatability. Flavorings and Sweetening capable of providing up to twenty minutes of taste masking agents, however, are not satisfactorily effective against bitter effectiveness are disclosed that include a delivery vehicle, a tasting Substances and/or actives. physiological effective amount of a protein masking agent, a 0004 Various delivery vehicles for taste masking or taste physiological effective amount of a bitter masking agent, and modifying the delivery of pharmaceuticals or nutritional a physiological effective amount of a sensate. The edible Supplements have been employed, such as flavored liquid composition may also include a flavoring agent and a Sweet Suspensions, coatings on pharmaceutical tablets and/or cap ening agent. Sules, and even dissolvable films. However, in each of these 0011. In another aspect, methods of making an edible film situations, the Substance to be masked is present at the time of for masking the taste of semen are disclosed. delivery of the taste masking or modifying Substance. For 0012. In another aspect, methods of making an edible example, dissolvable films have been used to deliver pharma gummi confectionery for masking the taste of semen are ceutical actives to children and to deliver breath-freshening disclosed. agents such as menthol. In both instances, the Substance to be taste-masked was either present in the formulation itself or DETAILED DESCRIPTION OF INVENTION was already present, which makes developing taste masking formulations easier. 0013 To address the complex composition of semen and 0005 Semen is a semi-variable, yet specific chemical the time sensitive nature of the delivery thereof, edible com composition that includes at least one bitter tasting Substance. positions were developed that are capable of providing up to Semen typically includes approximately 150 mg of protein, twenty minutes of taste masking effectiveness for masking 11 mg of carbohydrate, 6 mg offat, 3 mg of cholesterol, and the taste of semen. The taste masking effectiveness may be trace amounts of ascorbic acid, calcium, chlorine, choline, formulated to last for about five to about twenty minutes. In citric acid, creatine, deoxyribonucleic acid, fructose, glu another embodiment, the taste masking effectiveness may tathione, hyaluronidase, inositol, lactic acid, magnesium, last for about seven to about fifteen minutes. nitrogen, phosphorus, potassium, purine, pyrimidine, pyruvic 0014. The edible compositions disclosed herein are acid, selenium, Sodium, Sorbitol, Vitamin B12, and zinc. One designed to be placed in a user's mouth (or oral cavity) for factor that makes semen variable is the diet of the individual. chewing and/or dissolving, depending upon the delivery 0006 Semen is a complex composition for which to for vehicle. Once chewed and/or dissolved, the formulation's mulate a taste masking composition, especially to make it ingredients such as one or more taste masking agents, a sen universally effective on a semi-variable composition. Fur sate, a flavoring agent, or a Sweetening agent act upon the thermore, the formulation must account for the unpredictable taste receptors in the oral cavity, including those around the timing of the delivery of the semen, which depends upon tongue, on the Soft palate at back roof of the mouth, and even sexual stimulation. These factors complicate the formulation the epiglottis, to provide a physiological effect of lasting taste of an effective composition and a delivery vehicle that can masking effectiveness. In one embodiment, the delivery provide the needed taste masking effect at the appropriate vehicle of the edible taste masking composition is as an edible film. In another embodiment, the delivery vehicle of the time. edible composition is as an edible gummi confectionery. The delivery vehicle may also be, but is not limited to a chewable SUMMARY OF INVENTION tablet, a liquid carrier, a hard confectionery, a gel confection 0007. In one aspect, edible compositions are disclosed ary, a foam confectionary, a chewing gum, a dissolvable tab herein that are capable of providing up to twenty minutes of let, and a powder confectionary. taste masking effectiveness to mask the taste of semen. The 00.15 Methods for making such delivery vehicles are composition may be in the form of any suitable delivery known and can be adapted for by one of skill in the art to vehicle. In one embodiment, the delivery vehicle is a film. In provide a delivery vehicle for the taste masking compositions another embodiment, the delivery vehicle is a gummi confec disclosed herein. Various methods for forming orally disinte tionery. While the discussion herein focuses on the film and grating tablets, whether by applying heat or a non-heat pro gummi confectionery delivery vehicles, the formulations are cess, orally disintegrating films, chewing gums, particles and/ not so limited. or microencapsulated compositions are described in the US 2012/0321727 A1 Dec. 20, 2012 article “Orally Disintegrating Systems: Innovations in For agent, two bitter masking agents, three sensates, one flavoring mulation and Technology” by Goel et al. in Recent Patents on agent, and one Sweetening agent as shown in Example 1 Drug Delivery & Formulation, 2008, Vol. 2, No. 3, pages below. 258-274. The article and the patents referenced therein teach 0021 Any suitable water-soluble, film-former can be used how to make such delivery vehicles. to produce an edible thin film product. Suitable film-formers 0016. The delivery vehicles described in the Goel et al. include but are not limited to water-soluble non-starch article are directed to the delivery of an active pharmaceutical polysaccharides such as carboxymethylcellulose (CMC), ingredient. The edible compositions herein, regardless of the methylcellulose, hydroxypropylmethylcellulose (HPMC), delivery vehicle, are free of an active pharmaceutical ingre guar gum, locust bean gum, Xanthum gum, carrageenan, dient. As used herein, the phrase “active pharmaceutical algins, propylene glycol, levan, elsinan, pullulan, pectins, ingredient’ or API means any substance or mixture of sub chitosan, and gum arabic; native starches such as corn starch, stances intended to be used in the manufacture of a drug waxy maize starch, high-amylose corn starch, potato, tapioca, (medicinal) product and that, when used in the production of rice and wheat Starch; modified Starches such as those that a drug, becomes an active ingredient of the drug product. have been acid modified, bleached, oxidized, esterified, Such substances are intended to furnish pharmacological etherified, crosslinked, and treated enzymatically; starch activity or other direct effect in the diagnosis, cure, mitiga hydrolyzed products such as maltodextrin; protein Such as tion, treatment, or prevention of diseases or other ailments. albumen, gelatin, casein, salts of casein, whey, wheat gluten, The taste masking agents, sensates, flavoring agents, and Zein, and protein derived from Soybeans; polymers such as sweeteners that individually may contribute to the taste mask polyvinyl pyrrolidone, methycrylate copolymer, and carbox ing effectare not active pharmaceutical ingredients as defined yvinyl copolymers alone or in any combination. In one herein. embodiment, the concentration of the film-forming agent 0017. The edible compositions are a taste masking deliv constitutes between 5% to about 60% by dry weight, or 20% ery system that has a synergistically effective amount of taste to about 40% by dry weight of the final film composition. maskers and sensates that dissolve in the oral cavity and upon 0022. If it is desired to use lower levels of film forming dissolution are deposited on the tongue. The masking agents agents, softeners can also be employed to ensure the flexibil and sensates (and optionally one or more Sweeteners) interact ity of the film, thereby reducing brittleness. The softeners, with taste receptors on the tongue to provide taste masking which are also known as plasticizers, may include tallow, effectiveness that masks the taste of semen (which is inde hydrogenated tallow, hydrogenated and partially hydroge pendently delivered to the oral cavity). The taste masking nated vegetable oils, cocoa butter, sorbitol and other polyols, molecules interacts with taste receptors on the tongue and including polyoxyethylene Sorbitan monooleate, glycerin, provide a sensation, which is the result of signal transduction polyethylene glycol, propylene glycol, invert Sugars, corn from the receptor organs for taste, commonly known as taste syrup, lecithin, hydrogenatedlecithin, mono-, di- and triglyc buds. These taste buds contain very sensitive nerve endings, erides, acetylated monoglycerides, fatty acids (e.g. Stearic, which produce and transmit electrical impulses via the sev palmitic, oleic and linoleic acids), Polyoxyethylene (80) sor enth, ninth and tenth cranial nerves to those areas of the brain, bitan monooleate, and combinations thereof. In one embodi which are devoted to the perception of taste. The masking ment, the softener may constitute 0% to about 20% by dry agents in the disclosed compositions effectively turn “off the weight of the film, or about 2% to about 10% by dry weight of taste buds for a period of about 20 minutes, i.e., long enough the film. for fellatio. The edible compositions disclosed herein are 0023 The film composition includes one or more protein formulated with taste masking agents and sensates that are masking agents that are not irritating to the skin (in particular, not irritating to the skin (in particular, that of the penis) as will that of the penis). Protein masking agents are generally oil be explained in more detail herein. and water Soluble compositions that coat the taste receptors 00.18 Edible Films and makes them non-responsive to the unpleasant taste of 0019. The edible film may be referred to as an “edible thin proteins and/or flavors selected to deceive the senses into film. As used herein, "edible thin films’ refers to composi associating the bitterness with an acceptable Substance Such tions that include a film-former Substrate and are designed to as chocolate or a fruit flavor. In the compositions disclosed adhere to at least a portion of the oral cavity of a consumerand herein, the protein masking agentis present in a physiological rapidly dissolve therein. “Rapidly dissolve” means that the effective amount to mask the protein-based components of substrate dissolves in less than 20 seconds, preferably less semen. In one embodiment, the protein masking agent con than 15 seconds and most preferably less than 10 seconds. To stitutes about 0.01 to about 16% dry weight of the film. In “dissolve” means to substantially lose the shape and form of another embodiment, the protein masking agent constitutes the substrate. An example of an edible thin film product is the about 0.05 to about 10% dry weight of the film. Listerine(R) PocketPaksTM oral care strip sold by Pfizer. 0024. One suitable protein masking agent is GSB Natural 0020. In addition to the film-former, the edible thin films Masking Agent for Animal Protein O.S. #5187, which is an for masking the taste of semen include a physiological effec oil soluble liquid flavoring that masks the unpleasant taste of tive amount of a protein masking agent and a physiological protein notes in a composition. Other flavors may mask the effective amount of a bitter masking agent. The term “mask unpleasant taste of proteins and other bitter-tasting ingredi ing agent” as used herein, with respect to all the compositions ents. For examples, Vanilla, chocolate, coffee and caramel disclosed herein, also encompasses Substances that may be flavors may be used to mask protein, in particular the bitter classified as taste-receptor blockers. The edible thin films ness often associated with protein. Certain flavors are not may include a sensate, a flavoring agent, and/or a Sweetening Suitable as protein or bitter masking agent, including chamo agent. It is understood that one or more of any of these mile, mint, dandelion, angelica, horehound, milk thistle, pep individual ingredients may be used in a formulation. For permint, licorice, citrus peel, green apple, vinegar, yarrow, example, the composition may include one protein masking ginger, apricot seed, cherry seed, grapefruit, cinnamon bark US 2012/0321727 A1 Dec. 20, 2012

or for inclusion in the formulations because they can irritate ological tingling agent, each of which are effective on the and/or burn the skin, including cherry flavoring (artificial mucous membranes of the oral cavity. The formulations dis and/or natural), amyl acetate, amyl alcohol, annatto bixine, closed herein may include one or more of each type of sensate benzaldehyde, benzyl acetate, cinnamyl formate, acetoni and/or combinations thereof. The total sensate content of an trile, benzyl chloride, cinnamaldehyde, limonene, thymol. edible thin film may constitute about 0.1 to about 25% dry menthol, and eucalyptus. weight of the film, or about 1% to about 15% by dry weight of 0025 Acids found naturally in fruit such as malic acid the film. (apple's primary acidulant) and citric acid (prevalent in Straw 0030. As used herein, “physiological cooling agent” does berries) deceive the senses into associating the bitterness with not include traditional flavor-derivatives such as menthol or the fruit used, rather than the protein. These acids do not mask menthone. Suitable physiological cooling agents are those the protein. They merely make the brain think the bitterness is that do not have a perceptible flavor of their own, but simply from an acceptable source and should not be considered to be provide a cooling effect. The physiological cooling agent may a protein masker as used herein. constitute about 0.1 to about 25% dry weight of the film, or 0026. In another embodiment, a combination of soy pro about 1% to about 15% by dry weight of the film. The physi tein isolate and pectin can be added to the composition to taste ological cooling agents include, but are not limited to, isop masker a casein hydrolysate. Solae's Supro soy protein iso ulegol, N-substituted-p-menthane-3-carboxamides, acyclic late (SPI) and CP Kelco's Genu low-methoxy pectin are tertiary and secondary carboxamides, 3-1-menthoxy propan examples of a Suitable combination. 1.2-diol, p-menthane-3,8-diol, monomenthyl glutarate, and 0027. One or more bitter masking agents may be present in monomenthyl saccidate, alone or in any combination. The the film in an amount to mask the bitter taste of semen, N-substituted-p-menthane-3-carboxamides, such as N-ethyl especially when combined with the protein masking agent. In p-menthane-3-carboxamide, and trimethyl isopropylbutana one embodiment, the bitter masking agent constitutes about mide are both commercially available under the trademark 0.1 to 7% dry weight of the film. In another embodiment, the Winsense(R) from LyondellBasell Flavors & Fragrances, bitter masking agent constitutes about 0.5 to 5% dry weight of LLC, for example as WS-3 and WS-23, respectively. Mono the film. The bitter masking agents should be one that is not menthylglutarate is commercially available under the trade irritating to the skin (in particular, that of the penis). mark Ultracool 2 from IFF (Netherlands). 0028. A particularly effective class of compounds which 0031. Other physiological cooling agents include, but are can function as a bitter masking agent are hydrogenated, not limited to, 3-(1-menthoxy)-2-methylpropane-1,2-diol. ethoxylated glycerol esters. These types of compounds are p-menthane-2,3-diol, 6-isopropyl-9-methyl-1,4-dioxaspiro commercially available and may be formed in a well-known 4.5 decane-2-methanol, menthyl Succinate and its alkaline manner, namely by the ethoxylation of glycerol. One com earth metal salts, trimethylcyclohexanol, N-ethyl-2-isopro mercially available compound which works as a bitter mask pyl-5-methylcyclohexanecarboxamide, menthone glycerol ing agent is sold by the BASF Company under the trade name ketal, menthyl lactate, 3-(1-menthoxy)ethan-1-ol. 3-(1-men CREMOPHORR), including CREMOPHORR 40 and CRE thoxy)propan-1-ol. 3-(1-menthoxy)butan-1-ol. 1-menthy MOPHOR.R. 60 hydrogenated ethoxylated castor oils. Other lacetic acid N-ethylamide, 1-menthyl-4-hydroxypentanoate, Suitable bitter masking agent or blocker include, but are not 1-menthyl-3-hydroxybutyrate, N.2,3-trimethyl-2-(1-methyl limited to adenosine 5'-monophosphate, thymidine 5' mono ethyl)-butanamide, n-ethyl-t-2-c-6 nonadienamide, N.N- phosphate, adenosine 5' diphosphate, adenosine 3' mono dimethyl menthyl Succinamide, and menthylpyrrolidone car phosphate, adenosine 5'-Succinate, adenosine 5' triphosphate, boxylate. adenosine 2 monophosphate, 5'-cytidylic acid, inosinic acid. 0032. The compositions of the present invention may Some commercially available bitter masking agents, include include a warming agent alone or in addition to other sensates Ottens BITTERNESS BLOCKERS(R) NI-1915-A and Fir Such as cooling agents and/or tingling agents. The warming menich SWEETNESS ENHANCER(R) 598960 TP 1054, agent is preferably present in a physiologically effective Quest NATURAL BITTER BLOCKERS(R, Fontarome amount. The warming agent may constitute about 0.001 to MAG-NIFIQUER), Givaudan MASKING FLAVORR), about 10%, or from about 0.005 to about 5%, or from about WILDFAE(R), GSB Natural Soy Masking Flavor (Milk Type) 0.01 to about 1% by dry weight of the film. P.F. #8236, GSB Natural Sweetness Masking Flavor W.S. 0033 Suitable physiological warming agents include, but #7895, GSB Natural Masking Agent Flavor W.S. #5206, GSB are not limited to, Vanillyl alcohol n-butyl ether, vanillyl Natural Masking Flavor W.S. #6500, GSB Natural Sugar alcohol n-propyl ether, Vanillyl alcohol isopropyl ether, Vanil Extender Type Flavor W.S. #8490, Mother Murphy NAT. lyl alcohol isobutyl ether, vanillyl alcohol n-amino ether, MASKING TYPE FLAVOR 188505, Mother Murphy NAT. vanillyl alcohol isoamyl ether, vanillyl alcohol n-hexyl ether, MASKING FLAVOR 155122, Mother Murphy NAT BIT vanillyl alcohol methyl ether, vanillyl alcohol ethyl ether, TER MASKING FLAVOR 2111197, Mother Murphy N&A gingerol, shogaol, paradol, Zingerone, capsaicin, dihydrocap MASKING FLAVOR, W.S. 2110085, Taste Advantage Natu saicin, nordihydrocapsaicin, homocapsaicin, homodihydro ral Flavor-Mouthfeel Enhancer Type 1 in EtOH, Bioga capsaicin, ethanol, iso-propyl alcohol, iso-amylalcohol, ben pressTM Vegetal BM 297 ATO Glyceryl dipalmitostearate, Zyl alcohol, chloroform, eugenol, cinnamon oil, cinnamic Glycerol monostearate (type I) EP, Mono and diglycerides aldehyde, phosphate derivatives thereof, and mixtures NF, Precirol RATO 5 Glycerol distearate (type I) EP. Glyceryl thereof. The phosphate derivatives mentioned are those distearate NF, other commercially available bitter masking described in WO 97/02273. A commercial example of a suit agents, and combinations thereof. able warming agent for use herein is Optaheat (Symrise, 0029. The compositions disclosed herein may also include Germany). a variety of sensates that are not irritating to the skin (in 0034. The compositions herein may also include a physi particular, that of the penis). The sensate may be a physiologi ological tingling agent alone or in addition to the cooling cal cooling agent, a physiological warming agent, or a physi agent and/or the warming agent. As used herein, "physiologi US 2012/0321727 A1 Dec. 20, 2012

cal tingling agent” refers to agents which trigger a tingling, sucralose, aspartame, N-substituted APM derivatives such as stinging, or numbing sensation in the oral cavity. These tin neotame, salts of acesulfame, alitame, Saccharin and its salts, gling agents may be selected from a plethora of compounds cyclamic acid and its salts, glycyrrhizin, dihydrochalones, (plant extracts or synthetic compounds) that are known in the thaumatin, monellin, and the like, alone or in any combina art to provide a tingling sensation and are used accordingly in tion. Combinations of Sugar and/or Sugarless Sweeteners may a number of food products. Such plant extracts include be used in the film product in any suitable amount. In one extracts from pepper, onion, garlic, radish, horseradish, mus embodiment, the Sweetening agent constitutes about 1% to tard, chili, ginger etc. These may also include, but are not about 20%, or about 2% to about 15% dry weight of the film. limited to Jambu Oleoresin or para cress (Spilanthes sp.) in 0040. If desired, the edible thin film formulations of the which the active ingredient is Spilanthol; Japanese pepper present invention can also include colorants or coloring extract (Zanthoxylum peperitum), including the ingredients agents which can be used in any suitable amount to produce a known as Saanshool-I, Saanshool-II and Sanshoamide; black desired color. Further, the edible thin films of the present pepper extract (piper nigrum), including the active ingredi invention may have multi-colored patterns and/or other ents chavicine and piperine; Echinacea extract; Northern related designs or shapes to produce color contrasts. Coloring Prickly Ash extract; and red pepper oleoresin. agents can include, for example, natural food colors and dyes 0035) A variety offlavoring agents can also be added to the Suitable for food, drug, and cosmetic applications. The colo edible thin films. Any suitable amount and type of artificial rants are typically known as FD&C dyes and lakes Such as and/or natural flavoring agents can be used in any sensorially FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, acceptable fashion. However, the word “suitable' as used FD&C Yellow No. 5, FD&CYellow No. 6, FD&C Red No. 3, herein means that the flavoring agent does not cause irritation FD&C Red No. 33, FD&C Red No. 40, and combinations and/or burning to the skin. The flavoring agent may constitute thereof. The coloring agents may constitute about 0.01% to about 0.1% to about 30%, or about 1 to about 20%, or about about 1% dry weight of the edible thin film. 5% to about 15% dry weight of the film. The flavoring agent 0041) Depending on the ingredients being used to make can include, for example, essential oils, synthetic flavors or the edible thin film product, preservatives may also be mixtures including but not limited to oils derived from plants employed to ensure the safety and quality of the film. Suitable and fruits such as citrus oil, fruit essences, peppermint oil, preservatives include, but are not limited to, Sorbic acid, spearmint oil, other mint oils, clove oils, oil of wintergreen, Sodium benzoate, potassium Sorbate, methyl p-hydroxyben anise and the like, or combinations thereof. Other suitable Zoate, sodium propionate, and propyl p-hydroxybenzoate flavoring agents include chocolate flavors, cocoa powder, alone or in any combination. In addition, suitable antioxi vanilla, Vanillin and ethyl vanillin. dants can also be utilized. Preservatives or the antioxidants 0.036 Certain flavors are not suitable for inclusion in a may be present in the composition as 0.01% to about 1% dry tasking masking agent used during fellatio because they can weight of the edible thin film. irritate and/or burn the skin. These flavors include cherry 0042 Edible thin films can be formed by a variety of flavoring (artificial and/or natural), amyl acetate, amyl alco different processes. One such process is as follows: (1) an hol, annatto bixine, benzaldehyde, benzyl acetate, cinnamyl aqueous solution is formed by blending film-forming mate formate, acetonitrile, benzyl chloride, cinnamaldehyde, rials together with water and are agitated until the powdered limonene, thymol, menthol, and eucalyptus. materials are mostly hydrated and a few lumps are present; (2) 0037. The flavor can be enhanced and distributed evenly to this mixture, protein masking agents, bitter masking throughout the product by emulsification. Any Suitable agents, plasticizers, softening agents, colors, Sweeteners, amount and type of natural and/or synthetic food-grade emul cooling agents, flavoring agents, and other ingredients are sifier can be used. For example, the emulsifier can include blended together to form a homogeneous solution; and (3) lecithin, food-grade non-ionic emulsifiers, such as a starch or this solution is then cast onto a Suitable carrier, and dried to modified starch, fatty acids (Co-Cs), mono and diacylglyc form a film. erides, OX bile extract, polyglycerol esters, polyethylene Sor 0043. The carrier material should be impermeable to the bitan esters, propylene glycol, Sorbitan monopalmitate, Sor film coating, allowing the film coating to disperse evenly onto bitan tristerate, other like emulsifiers or combinations the carrier. This also allows for ease of removal of the plastic thereof. film from the carriers. Examples of suitable carriers include 0038. The flavors are emulsified using any suitable emul plastic or polyester films, polypropylene, polycarbonate, sification process. Such as mechanical processing, vigorous non-siliconized polyethylene terephthalate film, non-sili stirring, intense pressure fluctuations that occur in turbulent conized Kraft paper, polyethylene impregnated Kraft paper, flow Such as homogenization, Sonification, colloid milling metal belts, Voltage or corona treated belts, drum dryers, and and the like. polytetrafluorethylene-impregnated glass fabric. Multiple 0039 Sweetening agents may also be used in the edible carriers may be employed to create a multi-layered film prod thin films. The Sweetening agents may include Sugar Sweet uct. The carriers may be coated with a release coating. eners and/or Sugarless Sweeteners, including high intensity 0044. It has been found that a particularly preferred artificial Sweeteners. The Sugar Sweeteners generally include method of casting the film on the carrier may be through use saccharide-containing components including, but not limited of a slot die extrusion. By use of multiple extruders and to. Sucrose, dextrose, maltose, dextrin, invert Sugar, fructose, appropriately constructed dies, it is possible to add multiple levulose, galactose, corn syrup Solids, Vanilla syrup, and the color Stripes or designs to the product. It is also possible to like, alone or in any combination. Sugarless Sweeteners oscillate the die head to produce wavy lines on the product. include, but are not limited to Sugar alcohols, such as Sorbitol, The resulting films can be laminated to produce various visual mannitol. Xylitol, isomalt, hydrogenated Starch hydrolysates, effects. maltitol, and the like, alone or in any combination. The high 0045. The casting of the solution onto a suitable carrier intensity artificial sweeteners include, but are not limited to, material can be performed using any conventional coating US 2012/0321727 A1 Dec. 20, 2012 technique. Examples of coating techniques include spraying, 0052 The gelling agent is typically present in an aqueous dipping, comma coaters, knife over plate, roll over roll, Solution. Accordingly, the gummi confectionery contains reverse roll, slot die extrusion, and various extrusion tech water as the balance of the composition. In one embodiment, niques. Film thickness can be controlled by adjusting the gap the water may constitute about 40% to about 90%, or about on the coating head, or by applying the desired amount of the 50% to 80% by weight of the gummi confectionery. solution onto the substrate? carrier. 0053. The edible gummi confectionery includes at least one protein masking agent. The protein masking agent may 0046. It should be noted that no particular limitation is be any of the substances discussed above for the edible thin placed on the thickness of the film layer except that the films. The protein masking agent may constitute about 0.01% resultant film must rapidly dissolve in the mouth of the con to about 20%, or about 1% to about 15%, or about 5% to about Sumer. Therefore the thickness of the film can be varied based 10% dry weight of the gummi confectionery. on, for example, the desired speed of dissolution of the edible film while in the oral cavity. Not only can the thickness be 0054 The edible gummi confectionery includes at least varied but a multi-layered film product may be provided. one bitter masking agent. The bitter masking agent may be any of the substances discussed above for the edible thin 0047. After the coating step, the film may pass through a films. The bitter masking agent is present in the film in an dryer for moisture reduction. In the dryer, drying is carried amount to mask the bitter taste of semen, especially when out through a variety of different means, such as high Velocity combined with the protein masking agent. In one embodi turbulent hot air, conduction from steam heated slide bed, ment, the bitter masking agent constitutes about 0.1% to direct heating or casting offilm onto a heated drum or belt, hot about 7%, or about 0.5% to about 5% dry weight of the or cold air impingement, infrared heating, or any other Suit gummi confectionery. able drying equipment that does not adversely affect the com 0055. The edible gummi confectionery may also include ponents of the film. one or more sensates. The sensate may be a physiological 0048. The edible thin films may then be processed to a cooling agent, a physiological warming agent, or a physi desirable size to deliver a taste masking effective amount of ological tingling agent as discussed above for the edible thin the taste masking composition. In one embodiment, the films. The sensate(s) may constitute content about 0.1 to edible thin films may be formed or cut as strips that are about 25%, or about 1% to about 15% dry weight of the dimensioned to a desired size. For instance, the films may be gummi confectionery. 0.75 inch by 1.25 inch. While these dimensions illustrate that 0056. The edible gummi confectionery may also include the film is cut as a rectangle, it is not limited thereto and any one or more flavoring agents. The flavoring agents may be any shape including, but not limited to, square, diamond, circular, of the substances discussed above for the edible thin films. elliptical, and a die cut of any predetermined shape. Proce Any Suitable amount can be used in any sensorially accept dures for forming or cutting the edible thin films are well able fashion. In one embodiment, the flavoring agent can known in the art. constitute about 0.1% to about 30%, or about 1% to about 0049 Gummi Confectioneries 20%, or about 5 to about 15% dry weight of the gummi 0050. The edible gummi confectioneries, similarly to the confectionery. edible thin films, are an edible composition designed to dis 0057 Sweetening agents may also be used in the edible solve in the oral cavity in about 20 seconds or less (typically gummi confectionery. The Sweetening agents may include upon chewing) to provide the taste masking effect. The edible any of the Sweeteners and combinations thereof, discussed gummi confectioneries include a gelling agent to provide the above for the edible thin films. In one embodiment, the sweet confectionery composition with moldable and/or settable ening agent constitutes about 1% to about 20%, or about 2% characteristics Such that the confectionery can conform to the to about 15%, or about 10% dry weight of the gummi con shape of a mold and thereafter retain that shape. In addition to fectionery. the gelling agent, the confectionery composition for masking 0.058 Additionally, the gummi confectionery may include the taste of semen includes a physiological effective amount other ingredients to provide desired characteristics to the of a protein masking agent and a physiological effective composition. For example, coloring agents, preservatives, amount of a bitter masking agent. The confectionery compo other thickening agents, emulsifiers, plasticizers, antioxi sition may also include a sensate, a flavoring agent, and/or a dants, and combinations thereof may be added to the compo Sweetening agent. It is understood that one or more of any of sition according to the same dry weights disclosed for the these individual ingredients may be used in a confectionery edible thin film. composition. For example, the composition may include one 0059 Edible gummi confectionery may be manufactured protein masking agent, two bitter masking agents, two sen by preparing molds, preparing a gummi confectionery com sates, one flavoring agent, and one Sweetening agent as shown position, pouring the gummi confectionery composition in in Example 2 below. the mold, allowing the composition to set, and removing the 0051. Any suitable gelling agent can be used to produce a set gummi confectionery from the mold. The gummi confec gummi confectionery product. Suitable film-formers include tionery composition may be prepared by dissolving a gelling but are not limited to gelatin, gum arabic, pullulan, pectin, agent in water and heating to dissolve the gelling agent. To the agar, carrageenan, clear gum, Xanthan gum, alginic acid, algi gelling agent Solution the taste masking agents, sensates, nates such as Sodium alginate, potassium alginate, ammo Sweeteners, flavoring agents and any otheringredients may be nium alginate, calcium alginate, locust bean gum, tapioca added with mixing. The resulting gummi confectionery com starch, konjac, ficus pumila, gellan gum, dextrin, maltodex position may be molded into desired shapes that will deliver trin, modified food starches, corn starch. In one embodiment, the correct amount of the taste masking composition. the concentration of the gelling agent constitutes between 0060. In another embodiment, the gummi confectionary about 0.5% to about 30% dry weight, or about 1% to about may include a hydrocolloid ingredient in addition to the gel 15% dry weight of the gummi confectionery. ling agent. Suitable hydrocolloids include natural and modi US 2012/0321727 A1 Dec. 20, 2012

fied gums, cellulosics, modified cellulosics, pectins, mucil film will be removable therefrom. The slurry includes 10 lages, modified Starches, noncellulosic polysaccharides, algal grams of water and the amount of the remaining ingredients polysaccharides and mixtures thereof. More specifically the as indicated below in Table 2 in dry weight percent based on hydrocolloids include Starch, agar-agar, microcrystalline cel the final film produced. lulose, methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), xanthan gum, car TABLE 2 rageenangum, locust bean gum, alginates, acacia, carboxym ethylcellulose (CMC), karayagum, acacia gum, Sodium algi Ingredient Dry Wt 9% nate, sodium CMC, guar gum, tragacanth, mixtures of the corn starch 27.8 hydrocolloids and the like. modified tapioca starch 9.3 pullulan solution, 6.5% 1.2 0061. When including a hydrocolloid, various ratios of polysorbate 80 4.6 gelatin/hydrocolloids have been discovered which have been sorbitol solution, 70% 3.3 found to possess beneficial mouthfeel, texture and chewing gelatin solution, 30% 14 characteristics. For example, when using starch, the weight the emulsion of flavors from Part B 11.5 cooling agent 13.9 ratio of from about 1:1.3 to about 1:1.8 possesses desirable protein masker O.S characteristics. More preferably the gelatin/starch weight bitter masker* 4.6 ratio is from 1:1.4 to about 1:1.55 and most preferably the vanilla syrup 9.3 weight ratio is about 1:1.50. When agar-agar is used, the The bitter masker included a first bitter masker and a second bitter masker at 1.8 dry weight weight ratio is about 1:0.35 to about 1:1.5, preferably from percent and 2.8 dry weight percent, respectively, 1:0.6 to about 1:1.2, and most preferably about 1:0.75. When employing hydroxypropylcellulose, the ratio is from about 0067 Part D: The slurry from Part Ciscast onto the release 1:0.2 to about 1:0.8, preferably the HPC/starch weight ratio is paper by a knife over roll coater set at a coating gap of 13 mil from about 1:0.3 to about 1:0.6 and most preferably the at a line speed of 1-3 fpm while the slurry is warm (about 104° weight ratio is about 1:0.45. Those with skill in the art will F. (40°C.)). The release paper coated with the slurry passed recognize that other hydrocolloids can be used in combina through an oven at a temperature of about 180 to 200° F. tion with the specified hydrocolloids in the ratios specified, (356-392 C.) to evaporate the water and form a film. i.e., a mixture of two or more hydrocolloids, without depart 0068. The resulting film may be cut to any desired dimen ing from the present invention. sions for packaging and/or consumption that provides the 0062. The edible taste masking compositions disclosed correct amount of the formulation for the desired extended herein are useful for masking the taste of semen. Other appli taste masking effect. cations for the taste masking compositions disclosed herein may include use as masking other Substances that include a Example 2 bitter component and/or a protein component. 0063. The present invention is further illustrated by the Edible Film for Masking the Taste of Semen following non-limiting examples. 0069. An aqueous solution of 40% gum arabic was pre Example 1 pared according to Part A of Example 1 using standard tech niques to dissolve the gum arabic in the water while heating Edible Film for Masking the Taste of Semen and stirring. 0064 Part A: An aqueous solution of 40% gum arabic was 0070 Part B: Then an emulsion of a selected flavor, here prepared using standard techniques to dissolve the gum ara watermelon, was prepared by placing 80 ml of the 40% gum bic in the water while heating and stirring. arabic solution into a blending vessel, weighting out selected 0065 Part B: An emulsion of a selected flavor, here mango flavor and an emulsifying agent, and slowly adding the flavors citrus, was prepared by placing 80 ml of the 40% gum arabic and emulsifying agent to the blending vessel with mixing. Solution into a blending vessel, weighting out selected flavors Once added, the mixing was maintained for about 20 addi and an emulsifying agent, and slowly adding the flavors and tional minutes to form the emulsion. The dry weight percent emulsifying agent to the blending vessel with mixing. Once for the ingredients added to the 40% gum arabic are presented added, the mixing was maintained for about 20 additional below in Table 3. minutes to form the emulsion. The dry weight percent for the ingredients added to the 40% gum arabic are presented below TABLE 3 in Table 1. Ingredient Dry Wt 9% TABLE 1. emulsifying agent 43 Watermelon flavoring 43 Ingredient Dry Wt 9% emulsifying agent 43 (0071 Part C: The emulsion of the selected flavor was mango flavoring 28S added to a film formulation. The film formulation was pre citrus flavoring 28S pared as a slurry by mixing the following ingredients together using known techniques and then casting the film formulation 0066 Part C: The emulsion of the selected flavor was onto a paper coated with or having a release Surface so that the added to a film formulation. The film formulation was pre film will be removable therefrom. The slurry includes 10 pared as a slurry by mixing the following ingredients together grams of water and the amount of the remaining ingredients using known techniques and then casting the film formulation as indicated below in Table 4 in dry weight percent based on onto a paper coated with or having a release Surface so that the the final film produced. US 2012/0321727 A1 Dec. 20, 2012

TABLE 4 TABLE 6 ngredient Dry Wt 9% Ingredient Dry Wt 9% modified food starch 18 modified food starch 18 dextrin 10.7 maltodextrin 18 pullulan agar-agar 2 polysorbate 80 polysorbate 80 3 glycerin glycerin 3 gelatin gelatin 4 he emulsion of flavors from Part B 2 the emulsion of flavors from Part B 22 cooling agent cooling agent 1 1 protein masker 1 protein masker 1 3 bitter masker bitter masker 6 vanilla syrup vanilla syrup 4.4 protein masker 2 1 protein masker 2 6 ingler tingler O.S FD&C Blue 1 FD&C Blue 1 O.1 FD&C Yellow 5 : cooling agent 2 5 Sweetener Sweetener 4

Total: 100 Total: 100

0072 Part D: The slurry from Part Ciscast onto the release (0077 Part D: The slurry from Part Ciscast onto the release paper by a knife over roll coater set at a coating gap of 13 mil paper by a knife over roll coater set at a coating gap of 13 mil at a line speed of 1-3 fpm while the slurry is warm (about 104° at a line speed of 1-3 fpm while the slurry is warm (about 104° F. (40°C.)). The release paper coated with the slurry passed F. (40°C.)). The release paper coated with the slurry passed through an oven at a temperature of about 180 to 200° F. through an oven at a temperature of about 180 to 200° F. (356-392 C.) to evaporate the water and form a film. (356-392 C.) to evaporate the water and form a film. 0073. The resulting film may be cut to any desired dimen 0078. The resulting film may be cut to any desired dimen sions for packaging and/or consumption that provides the sions for packaging and/or consumption that provides the correct amount of the formulation for the desired extended correct amount of the formulation for the desired extended taste masking effect. taste masking effect. Example 4 Example 3 Edible Gummi Confectionery for Masking the Taste Edible Film for Masking the Taste of Semen of Semen (0079 Part A: Confectionery molds were prepared by 0074 Part A: An aqueous solution of 40% gum arabic was spraying the selected molds with a non-stick cooking spray. prepared using standard techniques to dissolve the gum ara The molds are of a size that provides the correct amount of the bic in the water while heating and stirring. formulation for the desired extended taste masking effect. 0075 Part B: An emulsion of a selected flavor, here 0080 Part B: A mango citrus flavor emulsion was pre vanilla, was prepared by placing 80 ml of the 40% gum arabic pared as disclosed in Example 1, Part B. Solution into a blending vessel, weighting out selected flavor I0081 Part C: A gummi confectionery mixture was pre and an emulsifying agent, and slowly adding the flavors and pared by boiling 45 grams of water in a saucepan over emulsifying agent to the blending vessel with mixing. Once medium-high heat and immediately upon boiling adding 30 added, the mixing was maintained for about 20 additional grams of gelatin with mixing until all dissolved. Once the minutes to form the emulsion. The dry weight percent for the gelatin was dissolved, 0.5 grams of polysorbate 80, 3.3 grams ingredients added to the 40% gum arabic are presented below of the mango citrus flavor emulsion, 1.5 grams of coolants, in Table 5. 0.05 grams of a protein masker, 0.5 grams of a bitter masker, and 2 grams of Vanilla syrup were added to the dissolved TABLE 5 gelatin with stirring until a homogenous mixture was formed. I0082 Part D: The mixture from Part C was poured into the Ingredient Dry Wt 9% molds prepared in Part A. The molds were refrigerated until emulsifying agent 43 the gummi confectioneries were set. Once removed from the vanilla flavoring 43 molds, the confectioneries were ready for consumption. 0076 Part C: The emulsion of the selected flavor was Example 5 added to a film formulation. The film formulation was pre Alpha Survey Evaluation of the Lasting Taste Mask pared as a slurry by mixing the following ingredients together ing Effect using known techniques and then casting the film formulation onto a paper coated with or having a release Surface so that the I0083. An alpha survey was run on 21 test subjects. The film will be removable there from. The slurry includes 10 purpose of the alpha Survey was to evaluate the taste masking grams of water and the amount of the remaining ingredients film strip for taste masking effectiveness in masking the taste as indicated below in Table 6 in dry weight percent based on of semen. The test group was composed of both male and the final film produced. female Subjects. The test Subject placed the taste masking film US 2012/0321727 A1 Dec. 20, 2012

strip in their mouth on the middle of their tongue, and after the 6. The edible film of claim 3 wherein the film former is film strip dissolved in their mouth performed oral sex on their selected from the group consisting of carboxymethylcellu partner. The test Subjects evaluated how many minutes of lose, methylcellulose, hydroxypropylmethylcellulose, guar taste masking effectiveness was delivered by the film strip. gum, locust bean gum, Xanthum gum, carrageenan, algins, Table 7 shows the taste masking effectiveness of the film strip propylene glycol, levan, elsinan, pullulan, pectin, chitosan, in masking the taste of semen for the 21 test Subjects. and gum arabic, waxy maize starch, high-amylose corn starch, potato starch, tapioca Starch, rice starch, wheat starch, TABLE 7 a modified Starch, dextrin, maltodextrin, albumen, gelatin, casein, salts of casein, whey, wheat gluten, Zein, and soybean Taste Masking Effectiveness in Minutes derived protein, polyvinyl pyrrolidone, methycrylate copoly Test Subject Time mers, carboxyvinyl copolymers, and combinations thereof. 7. The edible film of claim 3 wherein the composition 1 1 min. 2 6 min. includes a flavoring agent, the flavoring agent constituting 3 8 min. about 0.1% to about 30% dry weight of the edible film. 4 9 min. 8. The edible film of claim 3 further comprising a sensate, 5 4 min. 6 7 min. the sensate constituting about 0.1 to about 25% dry weight of 7 2 min. the edible film. 8 8 min. 9. The edible film of claim 8 wherein the sensate is selected 9 O min. from the group consisting of a physiological cooling agent, a 10 9 min. physiological warming agent, and a physiological tingling 11 6 min. 12 6 min. agent each of which are effective on the mucous membranes 13 1 min. of the mouth. 14 8 min. 15 7 min. 10. The edible film of claim 3 wherein the composition 16 7 min. further comprises a Sweetening agent, the Sweetening agent 17 9 min. constituting about 1 to about 20% dry weight of the edible 18 7 min. film. 19 4 min. 2O 3 min. 11. An edible gummi confectionery comprising a compo 21 9 min. sition effective to taste mask semen. 12. The edible gummi confectionery of claim 11 wherein the compositions upon activation in saliva in a user's mouth 0084. The taste masking effectiveness of the film strip to provides a lasting taste masking effect that endures for about mask the taste of semen was found to last for about five to 5 to about 20 minutes. about twenty minutes. The data above reflects how long the taste masking effect lasted relative to the release of semen. 13. The edible gummi confectionery of claim 12 wherein The Subjects stopped the clock once the semen was intro the composition comprises: duced, even though the taste masking effect may actually a gelling agent; have lasted longer. The importance of the data is that for those a physiological effective amount of a non-skin irritating men who took longer to be stimulated, 14 to 19 minutes (Test protein masking agent; and Subjects 4, 5, 11, 16, and 19), the taste masking was still in a physiological effective amount of a non-skin irritating effect for the partner. bitter masking agent. 0085 Having described the invention in detail and with 14. The edible gummi confectionery of claim 13 wherein reference to specific advantages thereof it will be apparent the protein masking agent constitutes about 0.01% to about that numerous modifications are possible without departing 20% dry weight of the edible gummi confectionery. from the spirit and scope of the following claims. 15. The edible gummi confectionery of claim 14 wherein What is claimed is: the bitter masking agent constitutes about 0.1% to about 7% 1. An edible film comprising a composition effective to dry weight of the edible gummi confectionery. mask the taste of semen. 16. The edible gummi confectionery of claim 13 wherein 2. The edible film of claim 1 wherein the composition upon the gelling agent is selected from the group consisting of activation in saliva in a user's oral cavity provides a lasting gelatin, gum arabic, pullulan, pectin, mucillages, modified taste masking effect that endures for about 5 to about 20 starches, corn starch, noncellulosic polysaccharides, algal minutes. polysaccharides, agar-agar, methylcellulose, hydroxypropyl 3. The edible film of claim 2, wherein the composition cellulose, ethyl cellulose, hydroxypropyl methylcellulose, comprising: Xanthan gum, carrageenan gum, locust bean gum, alginates, a film former; carboxymethylcellulose, karaya gum, acacia gum, Sodium a physiological effective amount of a non-skin irritating CMC, guar gum, tragacanth, kappa carrageenan, gellangum, protein masking agent; and clear gum, alginic acid, tapioca starch, konjac, ficus pumila, a physiological effective amount of a non-skin irritating dextrin, maltodextrin, and combinations thereof. bitter masking agent. 17. The edible gummi confectionery of claim 13 wherein 4. The edible film of claim 3 wherein the protein masking the composition includes a flavoring agent, the flavoring agent constitutes about 0.01% to about 16% dry weight of the agent constituting about 0.1% to about 30% dry weight of the edible film. edible gummi confectionery. 5. The edible film of claim 4 wherein the bitter masking 18. The edible gummi confectionery of claim 17 further agent constitutes about 0.1% to about 7% dry weight of the comprising a sensate, the sensate constituting about 0.1% to edible film. about 25% dry weight of the edible gummi confectionary. US 2012/0321727 A1 Dec. 20, 2012

19. The edible gummi confectionery of claim 18 wherein a delivery vehicle: the sensate is selected from the group consisting of a physi ological cooling agent, a physiological warming agent, and a a physiological effective amount of a non-skin irritating physiological tingling agent each of which are effective on the protein masking agent; and mucous membranes of the mouth. a physiological effective amount of a non-skin irritating 20. The edible film of claim 13 wherein the composition further comprises a Sweetening agent, the Sweetening agent bitter masking agent. constituting about 1% to about 20% dry weight of the edible 22. The edible composition of claim 21 further comprising gummi confectionery. a physiological effective amount of a sensate, a flavoring 21. An edible composition capable of providing up to agent, and a Sweetening agent. twenty minutes of taste masking effectiveness, the composi tion comprising: c c c c c