Pharmaceutical glaze

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Pharmaceutical glaze is an alcohol-based solution of various types of food-grade shellac. [1] The shellac is derived from the raw material sticklac, which is a resin scraped from the branches of trees left from when the small insect, Kerria lacca (also known as Laccifer lacca), creates a hard, waterproof cocoon. [2] When used in food and confections, it is also known as confectioner's glaze, resinous glaze, pure food glaze, natural glaze, [3] [4] or confectioner's resin. [5]

Pharmaceutical glaze may contain 20–51% shellac in solution in ethyl alcohol (grain alcohol) that has not been denatured (denatured alcohol is poisonous), [1] waxes, and titanium dioxide as an opacifying agent. Confectioner’s glaze used for candy contains roughly 35% shellac, while the remaining components are volatile organic compounds that evaporate after the glaze is applied. [6]

Pharmaceutical glaze is used by the drug and nutritional supplement industry as a coating material for tablets and capsules. It serves to improve the product's appearance, extend shelf life and protect it from moisture, as well as provide a solid finishing film for pre-print coatings. It also serves to mask unpleasant odors and aid in the swallowing of the tablet.

The shellac coating is insoluble in stomach acid and may make the tablet difficult for the body to break down or assimilate. For this reason, it can also be used as an ingredient in time-released, sustained or delayed-action pills. The product is listed on the U.S. Food and Drug Administration's (FDA) inactive ingredient list. [7]

Shellac is labeled as GRAS (generally recognized as safe) by the US FDA and is used as glaze for several types of foods, including some fruit, coffee beans, chewing gum, and candy. Examples of candies containing shellac include candy corn, Hershey's Whoppers and Milk Duds, Nestlé's Raisinets and Goobers, Tootsie Roll Industries's Junior Mints and Sugar Babies, Jelly Belly's jelly beans and Mint Cremes, Russell Stover's jelly beans, and several candies by Godiva Chocolatier and Gertrude Hawk. M&M's do not contain shellac. [6]

A competing non-animal-based product is zein, a corn protein. [8] It is preferred by some vegans [9] because shellac production can kill many insects. [6]

Related Research Articles

Lac resinous secretion of lac insects

Lac is the resinous secretion of a number of species of lac insects, of which the most commonly cultivated is Kerria lacca.

Shellac

Shellac (/ʃəˈlæk/) is a resin secreted by the female lac bug on trees in the forests of India and Thailand. It is processed and sold as dry flakes and dissolved in alcohol to make liquid shellac, which is used as a brush-on colorant, food glaze and wood finish. Shellac functions as a tough natural primer, sanding sealant, tannin-blocker, odour-blocker, stain, and high-gloss varnish. Shellac was once used in electrical applications as it possesses good insulation qualities and it seals out moisture. Phonograph and 78 rpm gramophone records were made of it until they were replaced by vinyl long-playing records from the 1950s onwards.

Wax

Waxes are a diverse class of organic compounds that are lipophilic, malleable solids near ambient temperatures. They include higher alkanes and lipids, typically with melting points above about 40 °C (104 °F), melting to give low viscosity liquids. Waxes are insoluble in water but soluble in organic, nonpolar solvents. Natural waxes of different types are produced by plants and animals and occur in petroleum.

Resin Solid or highly viscous substance

In polymer chemistry and materials science, resin is a solid or highly viscous substance of plant or synthetic origin that is typically convertible into polymers. Resins are usually mixtures of organic compounds. This article focuses on naturally occurring resins.

Candy Sweet confection

Candy, also called sweets or lollies, is a confection that features sugar as a principal ingredient. The category, called sugar confectionery, encompasses any sweet confection, including chocolate, chewing gum, and sugar candy. Vegetables, fruit, or nuts which have been glazed and coated with sugar are said to be candied.

Acetophenone is the organic compound with the formula C6H5C(O)CH3 (also represented by the pseudoelement symbols PhAc or BzMe). It is the simplest aromatic ketone. This colorless, viscous liquid is a precursor to useful resins and fragrances.

Tablet (pharmacy)

A tablet is a pharmaceutical oral dosage form or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose.

Jelly bean Small bean-shaped confectionery

Jelly beans are small bean-shaped sugar candies with soft candy shells and thick gel interiors. The confection is primarily made of sugar and sold in a wide variety of colors and flavors.

Varnish Transparent hard protective finish or film

Varnish is a clear transparent hard protective finish or film. It is neither a paint nor stain. In its native state it has little or no color, but may be pigmented as desired, and is sold commercially in various shades.

Lacquer

The term lacquer is used for a number of hard and potentially shiny finishes applied to materials such as wood or metal. These fall into a number of very different groups.

Carmine Pigment, aluminum salt of caminic acid

Carmine, also called cochineal, cochineal extract, crimson lake or carmine lake, natural red 4, C.I. 75470, or E120, is a pigment of a bright-red color obtained from the aluminium complex derived from carminic acid. It is also a general term for a particularly deep-red color.

An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts, or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility. Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerns such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors. A comprehensive classification system based on structure-property-application relationships has been proposed for excipients used in parenteral medications.

Sugar candy

Sugar candy is any candy whose primary ingredient is sugar. The main types of sugar candies are hard candies, fondants, caramels, jellies, and nougats. In British English, this broad category of sugar candies is called sweets, and the name candy or sugar-candy is used only for hard candies that are nearly solid sugar.

Zein is a class of prolamine protein found in maize (corn). It is usually manufactured as a powder from corn gluten meal. Zein is one of the best understood plant proteins. Pure zein is clear, odorless, tasteless, hard, water-insoluble, and edible, and it has a variety of industrial and food uses.

An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment. This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach. Some drugs are unstable at the pH of gastric acid and need to be protected from degradation. Enteric coating is also an effective method to obtain drug targeting. Other drugs such as some anthelmintics may need to reach a high concentration in a specific part of the intestine. Enteric coating may also be used during studies as a research tool to determine drug absorption. Enteric-coated medications pertain to the "delayed action" dosage form category. Tablets, mini-tablets, pellets and granules are the most common enteric-coated dosage forms.

Magnesium stearate

Magnesium stearate is the chemical compound with the formula Mg(C
18
H
35
O
2
)
2
. It is a soap, consisting of salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate is a white, water-insoluble powder. Its applications exploit its softness, insolubility in many solvents, and low toxicity. It is used as a release agent and as a component or lubricant in the production of pharmaceuticals and cosmetics.

Types of chocolate A range of foods derived from cocoa

Chocolate is a range of foods derived from cocoa (cacao), mixed with fat and finely powdered sugar to produce a solid confectionery. There are several types of chocolate, classified according to the proportion of cocoa used in a particular formulation.

Orally disintegrating tablet

An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole. The ODT serves as an alternative dosage form for patients who experience dysphagia or for where compliance is a known issue and therefore an easier dosage form to take ensures that medication is taken. Common among all age groups, dysphagia is observed in about 35% of the general population, as well as up to 60% of the elderly institutionalized population and 18-22% of all patients in long-term care facilities ODTs may have a faster onset of effect than tablets or capsules, and have the convenience of a tablet that can be taken without water. During the last decade, ODTs have become available in a variety of therapeutic markets, both OTC and by prescription.

Plastic bottle Bottle constructed of plastic

A plastic bottle is a bottle constructed from high-density or low density plastic. Plastic bottles are typically used to store liquids such as water, soft drinks, motor oil, cooking oil, medicine, shampoo, milk, and ink. The size ranges from very small bottles to large carboys. Consumer blow molded containers often have integral handles or are shaped to facilitate grasping.

Animal products in pharmaceuticals play a role as both active and inactive ingredients, the latter including binders, carriers, stabilizers, fillers, and colorants. The religious, cultural, and ethical concerns of patients and the disclosure of animal ingredients in pharmaceuticals are a growing area of concern for some people. These would include people who abide by veganism ("vegans"), the practice of abstaining from the use of animal products. Vegan medicines are medications and dietary supplements that do not have any ingredients of animal origin. The vegan status can be determined either through self-proclamation of the company or certification from a third-party organization, such as Vegan Society or PETA.

References

  1. 1 2 Smolinske, Susan C. (1992). Handbook of Food, Drug, and Cosmetic Excipients. CRC Press. p. 347. ISBN   0-8493-3585-X.
  2. Flinn, Angel. "Shellac and Food Glaze" . Retrieved 2013-11-13.
  3. Blech, Zushe Yosef (2004). Kosher Food Production. Blackwell Publishing. p. 275. ISBN   0-8138-2570-9. Many candies are polished with "confectioner's glaze." otherwise known as "resinous glaze." The base of this material is shellac, which is derived from the lac insect. Although most Kashrus organizations accept this material, some do not.
  4. Adams, Cecil (1992). "The Straight Dope: Is some candy coated with beetle juice?". Creative Loafing Media, Inc. Retrieved 2009-02-02.
  5. Dresdner, Michael (13 Jan 2003). "Shellac Bugs?". Woodworker's Journal. Retrieved 3 July 2014.
  6. 1 2 3 Yacoubou, Jeanne (30 Nov 2010). "Q & A on Shellac". Vegetarian Resource Group. Retrieved 3 July 2014.
  7. "FDA Inactive Ingredients Database". US Food and Drug Administration. Retrieved 23 August 2013.
  8. Klahorst, Suanne J. (September 1999). "Credible Edible Films". Food Product Design. Retrieved 2009-02-02.
  9. Flinn, Angel (15 Aug 2011). "Shellac & Food Glaze". Gentle World. Retrieved 3 July 2014.