March 07, 2013

How are pills, tablets and caplets made?

 

How are pills, tablets and caplets made?

These days, the majority of medications are in the form of pills, tablets, caplets, capsules or soft gels. In the case of tablets, manufacturers have standard size molds for the precise size of their pill. During the manufacturing process, in addition to the active ingredients, the manufacturer will usually add a variety of other ingredients to take up space, hold the ingredients together, and assist in disintegration. It may even be necessary to coat the tablet so that the taste and odor are masked (coatings).

Fillers are necessary for the manufacturing process, but do nothing more for the pill itself than take up volume. The pill must be large enough for human fingers to handle easily. Even some small pills are quite a bit larger than the active ingredients they contain. Some common fillers are lactose (milk sugar), microcrystalline cellulose, corn starch, sugars (including sucrose, mannitol, sorbitol, fructose, and dextrose), whey and yeast. Binders are used to make the components stick together when the ingredients are compressed to make the pill. Some common binders are povidone, xanthan gum and Carbopol (an acrylic resin). Some fillers may also serve as binding agents and are referred to as filler/binders.

Disintegrants facilitate the breakdown of the tablet in the stomach. Crospovidone, croscarmellose sodium, and gellan gum are commonly used to help break up the pill in your digestive system.

Coatings help to prevent the tablet from dissolving too soon, thus breaking up in your mouth. They may also prevent you from tasting or smelling the active ingredients. A typical coating is shellac - the same as used on wood floors and boats! Time-release capsules contain a variety of micro-pills designed to dissolve in the stomach at different times. Each micro-pill has a little bit of active ingredient and fillers coated with a mixture of shellac and other compounds. The precise nature of the chemicals used in the coating controls the time the micro-pill takes to dissolve in the stomach.

The elliptical radiopaque densities scattered throughout the abdomen represent undissolved tablets. (Courtesy of Paul Van Wyk, DC, Denver, Colorado) From the medical text: Essentials of Skeletal Radiology, Terry R. Yochum, and Lindsay J. Rowe. Other ingredients, such as lubricants, colorants, flavors (in chewable tablets) and plasticizers, may also be used. Lubricants include magnesium stearate, stearic acid, sodium stearyl fumarate and hydrogenated vegetable oil. Lubricants help the tablet mass to compress without sticking to the wall of the mold. The molds may also be sprayed with a releasing agent such as polyethylene glycol, which is another form of wax or grease to allow the pill to drop out of the mold. A variety of colorants may be used depending on the color of the tablet. Colorants or pigments include titanium dioxide (white) and iron oxides (red or yellow). Plasticizers increase the flexibility of coatings so that they don't crack or chip. (You've probably noticed how small amounts of material will rub or chip off uncoated tablets, simply through handling of the pill bottle.) In order to be acceptable for use in nutraceutical products, all the excipients used must be listed in either the USP (US Pharmacopeia) or NF (National Formulary) for products sold in the USA, or the EP (European Pharmacoepia) for products sold in Europe. The acceptable added ingredients are usually either food products like lactose, sugar or starch, or chemically inert ingredients that pass through the body without any effect like povidone, cellulose or titanium dioxide.

Normal tablets must meet U. S. Pharmaceutical standards here or European standards in Europe. This means the tablets must dissolve within 15 to 30 minutes once in your stomach. To check your tablets, place white vinegar (to simulate the stomach acid) in a bowl or glass, and drop in your pill. Check periodically. To meet standards, the pill should dissolve within 15 to 30 minutes. If it doesn't, then you are paying a high price for fillers! You can keep this test up for 45 to 60 minutes, but if the pill is not dissolved by then, it is highly unlikely to be of any value to your body.

What are by-products?

By-products are second-hand substances derived from an original product. Brewer's Yeast is a leftover from the making of beer (where yeast is used to ferment the sugar). Many companies take these secondary products, put them in a white plastic bottle with a few other ingredients and label them with sensational sounding names - but usually they are just waste products with little nutritional value. They may list the percentage of each component, but dirt is high in mineral contents too! Would you pay money for dirt?