WO2011022318A1 - Système d'administration en chocolat pour composés pharmaceutiques et composés nutraceutiques - Google Patents

Système d'administration en chocolat pour composés pharmaceutiques et composés nutraceutiques Download PDF

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Publication number
WO2011022318A1
WO2011022318A1 PCT/US2010/045579 US2010045579W WO2011022318A1 WO 2011022318 A1 WO2011022318 A1 WO 2011022318A1 US 2010045579 W US2010045579 W US 2010045579W WO 2011022318 A1 WO2011022318 A1 WO 2011022318A1
Authority
WO
WIPO (PCT)
Prior art keywords
chocolate
api
candy
chewable composition
delivery system
Prior art date
Application number
PCT/US2010/045579
Other languages
English (en)
Inventor
Judy Davis
Original Assignee
Hero Nutritionals, LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hero Nutritionals, LLC filed Critical Hero Nutritionals, LLC
Priority to CA2772231A priority Critical patent/CA2772231A1/fr
Publication of WO2011022318A1 publication Critical patent/WO2011022318A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Definitions

  • the invention relates generally to an edible, chewable chocolate pharmaceutical composition, and more particularly, to an edible, chewable chocolate candy for the oral delivery of pharmaceutical and nutraceutical compounds and a method for manufacturing the same.
  • OTC Over-the-counter
  • prescription drugs play a vital role in America's health care system. While both are regulated by the U.S. Food and Drug Administration (FDA), OTC drug products are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control products, and over 100,000 OTC drug products are currently being sold in this country. Thus, OTCs are critical to our country's health care system because they provide easy access to certain drugs that can be used safely without the help of a health care practitioner.
  • FDA U.S. Food and Drug Administration
  • chocolate is created from the cocoa bean, which is harvested, fermented, and dried, and then shipped to a chocolate manufacturing facility.
  • the beans are cleaned, roasted, and graded.
  • the shell is then removed, resulting in cacao nibs, which are then ground into a thick creamy paste, known as chocolate liquor or cocoa paste.
  • the next step in the process is blending, where the chocolate liquor may be mixed with more cocoa butter, sugar, milk or milk powder, and vanilla. It is in this step where the various types of chocolate are made: dark chocolate, milk chocolate (by adding milk or milk powder), and white chocolate (having no cocoa solids, only cocoa butter).
  • the blended chocolate is then conched, tempered, molded, and wrapped for eventual distribution to consumers.
  • a delivery system is provided for the oral delivery of pharmaceuticals and other nutritional supplements.
  • the delivery system includes chocolate in the form of a molded or formed solid candy.
  • the edible, chewable composition includes a drug delivery system for delivering pharmaceutical and nutraceutical compounds to a user's body.
  • the drug delivery system includes a drug delivery vehicle in the form of a molded or formed solid chocolate candy, and a pharmaceutical and/or nutraceutical compound as an active pharmaceutical ingredient (API) contained within the chocolate candy.
  • the delivery vehicle may include chocolate that has been blended, conched, and tempered.
  • the chocolate may also include natural and/or artificial flavors, colors, and preservatives.
  • the API may include an OTC or a prescription drug to provide a desired effect on the user.
  • the drug delivery system may also include a secondary API such as a nutraceutical (i.e., an extract of food purported to have a medicinal effect on human health) such as botanical and herbal extracts and antioxidants, or any combination of food supplements such as vitamins, minerals, soluble and insoluble fiber, herbs, plants, amino acids, and digestive enzymes.
  • a nutraceutical i.e., an extract of food purported to have a medicinal effect on human health
  • botanical and herbal extracts and antioxidants or any combination of food supplements such as vitamins, minerals, soluble and insoluble fiber, herbs, plants, amino acids, and digestive enzymes.
  • a method of preparing a chewable solid chocolate candy containing an API includes preparing a chocolate liquor by blending the necessary ingredients for the desired type of chocolate, adding the API to the chocolate liquor, conching the chocolate liquor with the API to achieve the desired taste and texture, and then tempering the chocolate. After tempering, the chocolate may be stored in large blocks for later processing, or molded or formed into smaller pieces and individually wrapped.
  • FIG. 1 shows a flow diagram that illustrates one example method of manufacturing a chocolate delivery system for delivering an active pharmaceutical ingredient in accordance with the present invention.
  • the present invention relates to a method of manufacturing a chocolate delivery system, in particular, a delivery system that is an edible, solid chocolate candy designed to enhance delivery of the pharmaceuticals and/or other active ingredients contained therein.
  • the delivery system includes an active pharmaceutical ingredient, which may be an OTC or prescription drug, to provide the desired effect, and chocolate as the delivery vehicle that contains the active pharmaceutical ingredient for delivery.
  • Figure 1 illustrates a method 100 of manufacturing a chocolate delivery system of the present invention.
  • the method of manufacturing the chocolate delivery system involves three main phases: (a) blending; (b) conching; and (c) tempering.
  • the chocolate liquor made from the cacao nibs which is a combination of cocoa butter (usually 50-60%) and cocoa solids, is blended with additional ingredients to obtain the desired individual chocolate recipe for the delivery vehicle.
  • dark chocolate consists of sugar, cocoa butter, cocoa liquor, and vanilla (optional).
  • Milk chocolate essentially is the dark chocolate with added milk or milk powder, while white chocolate is the dark chocolate without any cocoa solids.
  • An emulsifying agent such as soy lecithin may be added to improve the texture of the chocolate.
  • the appropriate dosage of the desired pharmaceuticals may undergo additional processing before being mixed with the blended chocolate and going to the conching phase 106.
  • the blended chocolate may be placed in a container filled with metal beads, which act as grinders, or in more modern conches, a rotary container with mixing blades, hi general, in the conching phase, the blended chocolate mass is kept warm and in a liquid state by frictional heat while it is "kneaded" at controlled temperatures (generally around 110-140 0 F), which process may continue for four to six hours for lower- quality chocolate and seventy-two hours or longer for high-quality chocolate.
  • the purpose of the conching is to reduce the size of the particles in the chocolate mass so as to produce a chocolate that is perfectly smooth and thus more desirable to the consumer. Generally, this requires reducing the size of the particles in the chocolate to approximately 18-20 microns in size. Additionally, the conching process is believed to improve the taste of the chocolate by removing harsh-tasting components and developing the more desirable flavor components of the chocolate. Thus, the duration of the conching process is dependent on many factors and varies with the type of chocolate desired to be produced and the quality of the original ingredients.
  • the active pharmaceutical ingredient may be necessary to process the active pharmaceutical ingredient if its particle size is too large for the conching process.
  • the active pharmaceutical ingredient is in a solid powder form, it may be advantageous to pulverize it into a finer powder with a uniform particle size, while at the same removing any moisture in the ingredient. If the active pharmaceutical ingredient is ground extremely fine, this may reduce the conching time.
  • the active pharmaceutical ingredient is in the form of an oil extract, such as, for example, flaxseed oil as a source of omega-3 fatty acid, it would not be necessary for this ingredient to go through step 104, but such an ingredient may go directly to the conching process 106. Additionally, in the case of probiotics, encapsulation may be required before the conching process.
  • an oil extract such as, for example, flaxseed oil as a source of omega-3 fatty acid
  • step 106 the appropriate dosage of the desired active pharmaceutical ingredient is added to the refined and blended chocolate from step 102, and conching of this mixture continues for the desired duration.
  • conching or as a supplement
  • an emulsification process may be utilized, in which case there may be less of a need to pre-process the active pharmaceutical ingredient.
  • the conched chocolate is heated, cooled, and then reheated to obtain the proper crystalline form and a uniform texture and appearance.
  • the tempered chocolate may be poured into molds of various sizes and shapes for candy bars or individually-wrapped pieces, which may then be wrapped and packaged for distribution to wholesale and retail outlets.
  • the tempered chocolate may also be formed into large blocks, which may then be stored and/or transported to confectionary makers or other manufacturers who reheat and reprocess the chocolate to make their own products for their customers. These confectionary makers and other manufacturers may also purchase tempered chocolate that does not contain any active pharmaceutical ingredients and produce their own chocolate delivery systems by repeating steps 104 through 110 of method 100.
  • a chocolate delivery system comprising a chewable, solid chocolate candy and at least one active pharmaceutical ingredient that is uniformly dispersed throughout the chocolate candy.
  • the chocolate delivery system may be used to deliver OTCs or the active ingredients thereof to treat symptoms of common illnesses.
  • OTC drugs may include Benadryl®, Sudafed®, Claritin®, Maalox®, Mylanta®, Turns®, Pepcid® AC, Monistat®, Ex-Lax®, Imodium® A.D., Robitussin®, Chloraseptic®, Thera-flu®, Alka-Seltzer, Motrin®, Dramamine®, and the like, in liquid or powder form.
  • a single piece of chocolate candy of a weight of, as an example, 7-10 grams may contain 10 mg of famotide, 800 mg of calcium carbonate, and 165 mg of magnesium hydroxide, which is the equivalent of one gelcap of Pepcid® Supreme®.
  • the API would constitute approximately 10.0% by weight.
  • the amount of the API added to the candy formulation must be balanced to insure that the eventual candy product will taste good as well as retain the desired texture. So, depending on the API being delivered, larger pieces of candy may be required or other flavorings and sweeteners may need to be added to the chocolate to mask the API in the more bitter formulations.
  • the serving size could be that of a standard size candy bar, e.g., 1.45-1.55 oz. (or 41-43 g) that contains the same amounts of the API.
  • the active pharmaceutical ingredient may include a prescription drug.
  • prescription drugs such may include Lipitor®, Singulair®, Lexapro, Plavix®, Morphine, Hydrocodone (Vicodin®), Demerol®, Codeine, Diazepam (Valium®), Penicillin, Prevacid®, Allegra-D®, Celebrex®, Crestor®, Cialis®, Valtrex®, Ambien CR®, Viagra®, Flomax®, Prozac®, and the like, in liquid or powder form.
  • pharmaceutical compounds are generally expressed in terms of grams or milligrams, but may also be expressed in active units, or international unit (IU).
  • a "pharmaceutical compound” or “drug” shall include, but is not limited to, any drug, hormone, peptide, nucleotide, antibody, or other chemical or biological substances used in the treatment or prevention of disease or illness, or substances which affect the structure or function of the body.
  • the active pharmaceutical ingredient in the chocolate delivery system may also include nutraceuticals, i.e., extracts of food purported to have a medicinal effect on human health, such as botanical and herbal extracts and antioxidants. Also included are food supplements such as probiotics, vitamins and co-vitamins, minerals, amino acids, and enzymes.
  • nutraceuticals i.e., extracts of food purported to have a medicinal effect on human health, such as botanical and herbal extracts and antioxidants.
  • food supplements such as probiotics, vitamins and co-vitamins, minerals, amino acids, and enzymes.
  • the chocolate delivery system may include one or more active pharmaceutical ingredients, which may be any combination of the aforementioned OTC and prescription drugs, nutraceuticals, probiotics, and other food supplements, with the only limitation being that the chocolate candy retain its flavor, appearance, texture, and smoothness, and that the active pharmaceutical ingredient and any other supplemental ingredients be uniformly distributed throughout the delivery system.
  • the delivery vehicle may further include natural colors, natural and artificial flavors, and preservatives.
  • the chocolate delivery system may take the form of a chocolate coating that is applied over another type of candy, such as caramel or nougat, i.e., a typical candy bar.

Abstract

L'invention porte sur un bonbon en chocolat comestible et masticable, pour l'administration par voie orale de composés pharmaceutiques et nutraceutiques. Le bonbon plein formé ou moulé en chocolat contient au moins un ingrédient pharmaceutique actif (API) qui est mélangé avec le bonbon en chocolat durant le conchage du bonbon en chocolat. L'invention porte également sur un procédé de fabrication du bonbon en chocolat masticable. Durant la phase de mélange, un cacao liquide est mélangé avec des ingrédients supplémentaires pour obtenir la recette de chocolat individuelle désirée pour le véhicule d'administration en chocolat. Les composés pharmaceutiques et/ou les composés nutraceutiques choisis sont ensuite ajoutés au cacao liquide, qui est ensuite conché pendant la période de temps désirée. Lorsque la phase de conchage est achevée, le chocolat conché est tempéré, après quoi le chocolat tempéré peut être formé en différentes tailles et formes pour des morceaux à emballage individuel, ou formé en grands blocs pour stockage et expédition.
PCT/US2010/045579 2009-08-17 2010-08-16 Système d'administration en chocolat pour composés pharmaceutiques et composés nutraceutiques WO2011022318A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2772231A CA2772231A1 (fr) 2009-08-17 2010-08-16 Systeme d'administration en chocolat pour composes pharmaceutiques et composes nutraceutiques

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US23462109P 2009-08-17 2009-08-17
US61/234,621 2009-08-17
US60883109A 2009-10-29 2009-10-29
US12/608,831 2009-10-29

Publications (1)

Publication Number Publication Date
WO2011022318A1 true WO2011022318A1 (fr) 2011-02-24

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PCT/US2010/045579 WO2011022318A1 (fr) 2009-08-17 2010-08-16 Système d'administration en chocolat pour composés pharmaceutiques et composés nutraceutiques

Country Status (2)

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CA (1) CA2772231A1 (fr)
WO (1) WO2011022318A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011107259A1 (fr) * 2010-03-05 2011-09-09 Ophthalmopharma Ag Chocolat nutraceutique ou produit composé à base de chocolat

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5753296A (en) * 1993-08-03 1998-05-19 Immunopath Profile, Inc. Product and process of making hypoallergenic chocolate compositions
US6241997B1 (en) * 1998-03-16 2001-06-05 Smtm Group. Llc Chewable calcium supplement and method
US20060134294A1 (en) * 2004-12-09 2006-06-22 Pro-Health, Inc. Product and method for oral administration of nutraceuticals
US20060141008A1 (en) * 1999-04-06 2006-06-29 Ream Ronald L Over-coated product including consumable center and medicament
US20070269558A1 (en) * 2006-05-19 2007-11-22 Lang Kevin W Delivery of active agents using a chocolate vehicle
US20090130281A1 (en) * 2005-02-01 2009-05-21 Atsushi Ogino Chocolate and Method of Producing the Same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5753296A (en) * 1993-08-03 1998-05-19 Immunopath Profile, Inc. Product and process of making hypoallergenic chocolate compositions
US6241997B1 (en) * 1998-03-16 2001-06-05 Smtm Group. Llc Chewable calcium supplement and method
US20060141008A1 (en) * 1999-04-06 2006-06-29 Ream Ronald L Over-coated product including consumable center and medicament
US20060134294A1 (en) * 2004-12-09 2006-06-22 Pro-Health, Inc. Product and method for oral administration of nutraceuticals
US20090130281A1 (en) * 2005-02-01 2009-05-21 Atsushi Ogino Chocolate and Method of Producing the Same
US20070269558A1 (en) * 2006-05-19 2007-11-22 Lang Kevin W Delivery of active agents using a chocolate vehicle

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011107259A1 (fr) * 2010-03-05 2011-09-09 Ophthalmopharma Ag Chocolat nutraceutique ou produit composé à base de chocolat

Also Published As

Publication number Publication date
CA2772231A1 (fr) 2011-02-24

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