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.