HOW ARE VITAMIN TABLETS COATED IN THE INDUSTRY?

HOW ARE VITAMIN TABLETS COATED IN THE INDUSTRY?

The industrial scale production of vitamins has been evolving over the century and it is extremely complex and difficult process. We shall touch upon the different tablet coating processes in this blog and the advantage we feel Frunutta Micro Quick Soft Molded tablets offer over the more traditional vitamin coatings. There are two principal methods of coating tablet: sugar coating and film coating. Both have advantages and disadvantages, and both coatings consist of a sugar or cellulose based binder, plasticizer, film forming agent and colorant.

In addition to enhancing the appearance and aiding identification of the product, tablet coatings perform several functions:

  • To protect the tablet from moisture and other adverse conditions.
  • To lubricate the tablet to ease swallowing.
  • To disguise unpleasant tastes.
  • To create a barrier between the active ingredient and the gastrointestinal tract.
  • To control the release of the drug into the body.

SUGAR COATING

Compressed tablets are often coated with layer of sugar that may be colored or uncolored depending on the purpose of the tablet. The sugar coating is water-soluble making it easier to dissolve quickly when it meets any liquid medium such as gastrointestinal fluids.

Four processes are commonly involved in sugar coating, in the following order:

  • Sealing (Water Proofing)
  • Grossing (Smoothing)
  • Coloring
  • Polishing

Sealing involves hardening the external surface of the tablet by providing a moisture barrier. Sealants that are commonly used include Shellac, Zinc oxide, Cellulose acetate phthalate, Polyvinyl acetate phthalate, Hyroxylpropylcellulose, Hyroxypropylmethylcellulose

Binders that are commonly used: Gelatin, Acacia Gum, Sucrose

Sub-coatings that are commonly used: Calcium carbonate, Titanium dioxide, Talc (asbestos free) Sucrose, Acacia gum.

Grossing or smoothing step involves filling out and smoothing irregular features or areas of the tablet. An application of approximately 60-70% of sugar solids is enough to smooth the tablet. The solution usually contains a mixture of starch, pigments, acacia, and gelatin.

In certain instances, color may be added in during the grossing stage to give the appearance of a homogenous coating layer.

Coloring is the most crucial stage. In the coating process as multiple sugar solutions are added to ensure that the predetermined color is achieved. Soluble dyes have been used to give the desired color as these stick to the surface of the tablet during the drying process.

Recently, companies prefer the use of insoluble certified aluminum lake pigments. These are materials that tint the tablet by dispersion. Lakes are produced from dyes but are oil dispersible, but not oil soluble, and thus can be mixed with oils and fats. They can also be dispersed or suspended in other carriers such as propylene glycol, glycerin, and sucrose (water and sugar).

Polishing the final step in the sugar-coating process finishes the tablet to give it a glossy and professional appearance. This is carried out to impart a shiny distinctive appearance to the tablet. Polishers that commonly used are wax such as carnauba wax, candelilla wax, beeswax and hard paraffin.

FILM COATING

Film coating starts by enveloping the tablet’s core with a thin film of protective polymer. Think of trying to protect the ingredients of the tablet with protective layers. The polymer that is to serve as the coating film is dissolved in a suitable solvent, together with additives such as pigments and plasticizers.

Ingredients used in film coating process are the following:

Film Formers commonly used in the industry include Hydroxy Propyl Methyl Cellulose (HPMC), Methyl Hydroxy Ethyl Cellulose (MHEC), Ethyl Cellulose (EC), Hydroxy Propyl Cellulose (HPC), Povidone (PVP), Sodium Carboxy Methyl Cellulose, Polyethylene glycol (PEG), Acrylate Polymers.

Enteric Coating is a term used to describe the coating that gives complete protection to the core of the tablet. Enteric coating protects the active ingredients against attack by acids in the stomach.  Providing the tablet with sort of resistance to attack by the gastric fluids.

Solvents are used to dissolve the polymers and other additives. Film coating requires lots of Solvents. Examples include ethanol, chloroform, water, methanol, isopropanol, acetone, and methylene chloride.

Plasticizers that are commonly used are Castor oil, PG, glycerin, and PEG.

Colorants most used lakes and dyes are the certified FD & C and D &C type.

Opaquant-Extenders are fine inorganic powders used to increase the fill coverage and provide more pastel color shade to the tablet. Common inorganic powders include:

OTHER TECHNIQUES IN COATING

In addition to the two commonly used coating methods described above, there are other specialized coating methods that can be applied for specific circumstances such as the following:

  • Compressed coating
  • Electrostatic coating,
  • Dip coating
  • Vacuum film coating

HEALTH CONCERNS

All above named added ingredients or ‘other ingredients’ as is commonly seen on vitamin labels are what the industry calls excipients. Excipients for tablet industry are not limited to the above-named products which are mostly impossible to pronounce. At this time, it should be quite clear that there is a plethora of other excipients in any named group mentioned in this article.

It should be noted that many of the products mentioned above are used in the wood, iron, steel and cream industries.

While FDA considered all categories and excipients as Generally Recognized As Safe (GRAS), and considered nontoxic with no pharmacological actions, but, there are no data on the prevalence of long term side effects.

Delayed hypersensitivity reactions (DHR) can be one such reaction with clinical signs of allergy to excipients which can range from skin disorders to life-threatening systemic reactions.

Always remember, everyone who prescribes a modern formulated drug or supplement is aware of the risks of adverse reactions due to the properties inherent in the active ingredients, but not all are aware of the risks due to the properties of the added excipients.

The risks of adverse reaction to excipients are intensified when inappropriate and inferior quality excipients are used.

SUMMARY

It should be obvious that the industry has many reasons for its use of excipients, or other ingredients in tablet manufacturing which we tried to touch on briefly in this article. We at Frunutta have used a radical approach to tablet production and absorption with bypassing the need for coating. Our soft molded tablets are free of any coating and unnecessary and unnatural excipients. By using the under the tongue ‘sublingual’ route for absorption of our tablets we have done away with the need to produce coatings on our tablets and hence we have been able to avoid all the above what we consider unnecessary ingredients.

Read our labels and compare us to your current products and you can see for yourself the Frunutta difference.

This information is only for educational purposes and is not medical advice or intended as a recommendation of any specific products. Consult your health care provider for more information. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

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