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Tablet Making Definitions

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3 June 2016 No comments

Here is a list of commonly used terms and there definitions.

If there is something that you feel needs adding to the list then please feel free to get in contact and we will add it.

Active / API / Active Pharmaceutical Ingredient

An active pharmaceutical ingredient is defined by the FDA as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.

People often use the term API to refer to the active component in there tablets. This could be the pharmaceutical, vitamin, mineral, herbal extract or other supplement.

Capsule

In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:

  • Hard-shelled capsules, which are typically made using gelatin and contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronisation. These are made in two halves: a lower-diameter "body" that is filled and then sealed using a higher-diameter "cap".
  • Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.

Also see Softgel and Capsule Filler.

Capsule Filler

Capsules are prepared by filling the powder or formulation containing active ingredients and the mixtures of active ingredients with combinations of different excipients by the usage of different capsule filling machines. To form a capsule, the powder or formulation containing active ingredients and the mixtures of active ingredients with combinations of different excipient materials are filled with the help of filling rings into the body of the capsule from the powder hopper and then close the body of the capsule with the cap by the help of second filling ring.

They come in 3 main forms:

  • Manual (Hand held) Capsule Filling Machine
  • Semi Automatic Capsule Filling Machine
  • Automatic Capsule Filling Machine

Die

See: Tooling

Dry Granulation

The dry granulation process is used to form granules without using a liquid solution because the product granulated may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders. In this process the primary powder particles are aggregated under high pressure. Sweying granulator or a high-shear mixer-granulator can be used for the dry granulation.

Drying Oven

Designed to remove moisture. Typical applications are pre-treating and painting. Such ovens are also sometimes known as kilns, though they do not reach the same high temperatures as are used in ceramic kilns.

Ejection Height

The ejection hight is the hight that the lower punch on a tablet press is lifted to for the tablet to be ejected. This hight can often be changed to account for different forms of tablet.

Fill Depth

The Fill Depth is the amount of space in the die that the powder can flow in to on a tablet press. This can be controlled by adjusting how high or low the lower punch sits in the die during this sep of the process.

Gelcap / Gel-Cap

See Capsule

Granulation

Is the process of making Granules – Also see: Wet Granulation, Dry Granulation and Granules.

Granules

Granules are types of medicinal powders that have unpleasant and bitter taste, often making patients feel nauseous but these are not compressed into a tablet or capsule form as large quantities of the powder is often required even for a single dosage.

Kilonewton / Kn

1 kiloNewton = 1000 Newtons. A Newton is a unit of force. It is defined as the force required to accelerate a mass of 1 kg at a constant 1 meter per second per second.

Pills

Pills are defined as small or oval shaped matter that contain drug substances and meant to be swallowed. These medicinal products often contain filters and lactose that allows the pill to be formed in the desired shape by machine operated equipment or through manual means.

Punch

See: Tooling

Punch Pressure

The Punch Pressure of a tablet press is the amount of force that is used to from the tablets. This is ajustable on most tablet presses. If the tablets are to soft you would have to increase the Punch Pressure. If the machine keeps jamming you may have to reduce the Punch Pressure.

Rotary Tablet Press

Most high speed tablet presses take the form of a rotating turret that holds any number of punches. As they rotate around the turret, the punches come into contact with cams which control the punch's vertical position. Punches and dies are usually custom made for each application, and can be made in a wide variety of sizes, shapes, and can be customized with manufacturer codes and scoring lines to make tablets easier to break. Depending on tablet size, shape, material, and press configuration, a typical modern press can produce from 250,000 to over 1,000,000 tablets an hour.

Single Station Tablet Press

The single station/single punch/eccentric press is a mechanical device which compresses the powder into tablets of uniform size with different shape and uniform weight. This compressing machine can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, illicit drugs, cleaning products, and cosmetics.

It is the simplest machine for manufacturing of tablets. Single station press employs a single tooling station that is a die and a pair of lower and upper punch.

In this single press the compression force is exerted by only the upper punch while the lower punch is immovable.

Soft Gel

A softgel is an oral dosage form for medicine similar to capsules. They consist of a gelatin based shell surrounding a liquid fill. Softgel shells are a combination of gelatin, water, opacifier and a plasticiser such as glycerin or sorbitol.

Tablets

Definition: Tablets are a type of solid dosage form administered orally in order to deliver the drug substances inside the body with or without the need of any diluents. Tablets may come in different sizes, shapes and weights depending on the method of manufacture, an example of which are the compressed tablets.

Tooling

Tooling is normally changeable on a tablet press or capsule filler to allow different tablets to be pressed or capsules filled.

Tooling is what enables a tablet press to from tablets. It consists of a punch and dies set:

Punch: These punches are a part of tablet press. Unlike most punches, tablet press punches have a concave ending in the shape of the desired tablet. There are the lower and the upper punches to compress the powder in between.

Die: A die is a specialized tool used in manufacturing industries to cut or shape material mostly using a press. Like molds, dies are generally customized to the item they are used to create. Products made with dies range from simple paper clips to complex pieces used in advanced technology.

On a Rotary Tablet Press there are multiple punch and die sets while on a single station there is only one.

Wet Granulation

In wet granulation, granules are formed by the addition of a granulation liquid onto a powder bed which is under the influence of an impeller (in a high-shear granulator), screws (in a twin screw granulator) [2] or air (in a fluidized bed granulator). The agitation resulting in the system along with the wetting of the components within the formulation results in the aggregation of the primary powder particles to produce wet granules.[2] The granulation liquid (fluid) contains a solvent which must be volatile so that it can be removed by drying, and be non-toxic. Typical liquids include water, ethanol and isopropanol either alone or in combination. The liquid solution can be either aqueous based or solvent-based. Aqueous solutions have the advantage of being safer to deal with than solvents.