Tablet

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For other uses, see Tablet (disambiguation).
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Common disk-shaped tablets

A tablet is a pharmaceutical dosage form. It comprises a mixture of active substances

and excipients, usually in powder form, pressed or compacted into a solid. The excipients
can include binders, glidants (flow aids) and lubricants to ensure efficient tabletting;
disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours to
enhance taste; and pigments to make the tablets visually attractive. A polymer coating is
often applied to make the tablet smoother and easier to swallow, to control the release
rate of the active ingredient, to make it more resistant to the environment (extending its
shelf life), or to enhance the tablet's appearance.

The compressed tablet is the most popular dosage form in use today. About two-thirds of
all prescriptions are dispensed as solid dosage forms, and half of these are compressed
tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is
usually taken orally, but can be administered sublingually, rectally or intravaginally. The
tablet is just one of the many forms that an oral drug can take such as syrups, elixirs,
suspensions, and emulsions. Medicinal tablets were originally made in the shape of a disk
of whatever color their components determined, but are now made in many shapes and
colors to help distinguish different medicines. Tablets are often stamped with symbols,
letters, and numbers, which enable them to be identified. Sizes of tablets to be swallowed
range from a few millimeters to about a centimeter. Some tablets are in the shape of
capsules, and are called "caplets". Medicinal tablets and capsules are often called pills.
This is technically incorrect, since tablets are made by compression, whereas pills are

1
ancient solid dose forms prepared by rolling a soft mass into a round shape. Other
products are manufactured in the form of tablets which are designed to dissolve or
disintegrate; e.g. cleaning and deodorizing products.

Contents
[hide]

• 1 Tabletting formulations
• 2 Advantages and disadvantages
• 3 Tablet properties
• 4 Manufacturing
o 4.1 Manufacture of the tableting blend
o 4.2 Direct compression
o 4.3 Wet granulation
o 4.4 Dry granulation
o 4.5 Granule lubrication
o 4.6 Manufacture of the tablets
• 5 Tablet compaction simulator
• 6 Tablet presses
• 7 Tablet coating
• 8 Pill-splitters
• 9 See also

• 10 References

[edit] Tabletting formulations

Capping (top) and lamination (right) tablet failure modes

In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered
or granular, somewhat uniform in particle size, and freely flowing. Mixed particle sized
powders can segregate during manufacturing operations, which can result in tablets with
poor drug or active pharmaceutical ingredient (API) content uniformity. Content
uniformity ensures that the same API dose is delivered with each tablet.

Some APIs may be tableted as pure substances, but this is rarely the case; most
formulations include excipients. Normally, an pharmacologically inactive ingredient

2
(excipient) termed a binder is added to help hold the tablet together and give it strength.
A wide variety of binders may be used, some common ones including lactose, dibasic
calcium phosphate, sucrose, corn (maize) starch, microcrystalline cellulose and modified
cellulose (for example hydroxypropyl methylcellulose).

Often, an ingredient is also needed to act as a disintegrant to aid tablet dispersion once
swallowed, releasing the API for absorption. Some binders, such as starch and cellulose,
are also excellent disintegrants.

Small amounts of lubricants are usually added, as well. The most common of these is
magnesium stearate; however, other commonly used tablet lubricants include stearic acid
(stearin), hydrogenated oil, and sodium stearyl fumarate. These help the tablets, once
pressed, to be more easily ejected from the die.

[edit] Advantages and disadvantages

Variations on a common tablet design, which can be distinguished by both color and
shape

Tablets are simple and convenient to use. They provide an accurately measured dosage of
the active ingredient in a convenient portable package, and can be designed to protect
unstable medications or disguise unpalatable ingredients. Colored coatings, embossed
markings and printing can be used to aid tablet recognition. Manufacturing processes and
techniques can provide tablets special properties, for example, sustained release or fast
dissolving formulations.

Some drugs may be unsuitable for administration by the oral route. For example, protein
drugs such as insulin may be denatured by stomach acids. Such drugs cannot be made
into tablets. Some drugs may be deactivated by the liver when they are carried there from
the gastrointestinal tract by the hepatic portal vein (the "first pass effect"), making them
unsuitable for oral use. Drugs which can be taken sublingually are absorbed through the
oral mucosae, so that they bypass the liver and are less susceptible to the first pass effect.
The oral bioavailability of some drugs may be low due to poor absorption from the
gastrointestinal tract. Such drugs may need to be given in very high doses or by injection.
For drugs that need to have rapid onset, or that have severe side effects, the oral route
may not be suitable. For example salbutamol, used to treat problems in the pulmonary
system, can have effects on the heart and circulation if taken orally; these effects are
greatly reduced by inhaling smaller doses direct to the required site of action.

3
[edit] Tablet properties
Tablets can be made in virtually any shape, although requirements of patients and
tableting machines mean that most are round, oval or capsule shaped. More unsusual
shapes have been manufactured but patients find these harder to swallow, and they are
more vulnerable to chipping or manufacturing problems.

Tablet diameter and shape are determined by the machine tooling used to produce them -
a die plus an upper and a lower punch are required. This is called a station of tooling. The
thickness is determined by the amount of tablet material and the position of the punches
in relation to each other during compression. Once this is done, we can measure the
corresponding pressure applied during compression. The shorter the distance between the
punches, thickness, the greater the pressure applied during compression, and sometimes
the harder the tablet. Tablets need to be hard enough that they don't break up in the bottle,
yet friable enough that they disintegrate in the gastric tract.

Tablets need to be strong enough to resist the stresses of packaging, shipping and
handling by the pharmacist and patient. The mechanical strength of tablets is assessed
using a combination of (i) simple failure and erosion tests, and (ii) more sophisticated
engineering tests. The simpler tests are often used for quality control purposes, whereas
the more complex tests are used during the design of the formulation and manufacturing
process in the research and development phase. Standards for tablet properties are
published in the various international pharmacopeias (USP/NF, EP, JP, etc).

[edit] Manufacturing
[edit] Manufacture of the tableting blend

In the tablet pressing process, the main guideline is to ensure that the appropriate amount
of active ingredient is in each tablet. Hence, all the ingredients should be well-mixed. If a
sufficiently homogenous mix of the components cannot be obtained with simple blending
processes, the ingredients must be granulated prior to compression to assure an even
distribution of the active compound in the final tablet. Two basic techniques are used to
granulate powders for compression into a tablet: wet granulation and dry granulation.
Powders that can be mixed well do not require granulation and can be compressed into
tablets through direct compression.

[edit] Direct compression

Please refer to Direct Compression (DC)

[edit] Wet granulation

Wet granulation is a process of using a liquid binder to lightly agglomerate the powder
mixture. The amount of liquid has to be properly controlled, as over-wetting will cause

4
the granules to be too hard and under-wetting will cause them to be too soft and friable.
Aqueous solutions have the advantage of being safer to deal with than solvent-based
systems.

• Procedure
o Step 1: The active ingredient and excipients are weighed and mixed.
o Step 2: The wet granulate is prepared by adding the liquid binder–
adhesive to the powder blend and mixing thoroughly. Examples of
binders/adhesives include aqueous preparations of cornstarch, natural
gums such as acacia, cellulose derivatives such as methyl cellulose,
gelatin, and povidone.
o Step 3: Screening the damp mass through a mesh to form pellets or
granules.
o Step 4: Drying the granulation. A conventional tray-dryer or fluid-bed
dryer are most commonly used.
o Step 5: After the granules are dried, they are passed through a screen of
smaller size than the one used for the wet mass to create granules of
uniform size.

Low shear wet granulation processes use very simple mixing equipment, and can take a
considerable time to achieve a uniformly mixed state. High shear wet granulation
processes use equipment that mixes the powder and liquid at a very fast rate, and thus
speeds up the manufacturing process. Fluid bed granulation is a multiple-step wet
granulation process performed in the same vessel to pre-heat, granulate, and dry the
powders. It is used because it allows close control of the granulation process.

[edit] Dry granulation

Dry granulation processes create granules by light compaction of the powder blend under
low pressures. The compacts so-formed are broken up gently to produce granules
(agglomerates). This process is often used when the product to be granulated is sensitive
to moisture and heat. Dry granulation can be conducted on a tablet press using slugging
tooling or on a roll press called a roller compactor. Dry granulation equipment offers a
wide range of pressures to attain proper densification and granule formation. Dry
granulation is simpler than wet granulation, therefore the cost is reduced. However, dry
granulation often produces a higher percentage of fine granules, which can compromise
the quality or create yield problems for the tablet. Dry granulation requires drugs or
excipients with cohesive properties, and a 'dry binder' may need to be added to the
formulation to facilitate the formation of granules.

[edit] Granule lubrication

After granulation, a final lubrication step is used to ensure that the tableting blend does
not stick to the equipment during the tableting process. This usually involves low shear
blending of the granules with a powdered lubricant, such as magnesium stearate or stearic
acid.

5
[edit] Manufacture of the tablets

Whatever process is used to make the tableting blend, the process of making a tablet by
powder compaction is very similar. First, the powder is filled into the die from above.
The mass of powder is determined by the position of the lower punch in the die, the
cross-sectional area of the die, and the powder density. At this stage, adjustments to the
tablet weight are normally made by repositioning the lower punch. After die filling, the
upper punch is lowered into the die and the powder is uniaxially compressed to a porosity
of between 5 and 20%. The compression can take place in one or two stages (main
compression, and, sometimes, pre-compression or tamping) and for commercial
production occurs very fast (500–50 msec per tablet). Finally, the upper punch is pulled
up and out of the die (decompression), and the tablet is ejected from the die by lifting the
lower punch until its upper surface is flush with the top face of the die. This process is
simply repeated many times to manufacture multiple tablets.

Common problems encountered during tablet manufacturing operations include:

• poor (low) weight uniformity, usually caused by uneven powder flow into the die
• poor (low) content uniformity, caused by uneven distribution of the API in the
tableting blend
• sticking of the powder blend to the tablet tooling, due to inadequate lubrication,
worn or dirty tooling, and sub-optimal material properties
• capping, lamination or chipping. Such mechanical failure is due to improper
formulation design or faulty equipment operation.

[edit] Tablet compaction simulator

Tablet formulations are designed and tested using a laboratory machine called a Tablet
Compaction Simulator or Powder Compaction Simulator. This is a computer controlled
device that can measure the punch positions, punch pressures, friction forces, die wall
pressures, and sometimes the tablet internal temperature during the compaction event.
Numerous experiments with small quantities of different mixtures can be performed to
optimise a formulation. Mathematically corrected punch motions can be programmed to
simulate any type and model of production tablet press. Initial quantities of active
pharmaceutical ingredients are very expensive to produce, and using a Compaction
Simulator reduces the amount of powder required for product development.

[edit] Tablet presses

6
The tablet pressing operation

An old Cadmach rotary tablet press

Tablet presses, also called tableting machines, range from small, inexpensive bench-top
models that make one tablet at a time (single-station presses), with only around a half-ton
pressure, to large, computerized, industrial models (multi-station rotary presses) that can
make hundreds of thousands to millions of tablets an hour with much greater pressure.
The tablet press is an essential piece of machinery for any pharmaceutical and
nutraceutical manufacturer. Common manufacturers of tablet presses include Fette,
Korsch, Kikusui, Manesty and Courtoy. Tablet presses must allow the operator to adjust
the position of the lower and upper punches accurately, so that the tablet weight,
thickness and density can each be controlled. This is achieved using a series of cams,
rollers, and/or tracks that act on the tablet tooling (punches). Mechanical systems are also
incorporated for die filling, and for ejecting and removing the tablets from the press after
compression. Pharmaceutical tablet presses are required to be easy to clean and quick to
reconfigure with different tooling, because they are usually used to manufacture many
different products.

7
[edit] Tablet coating
Many tablets today are coated after being pressed. Although sugar-coating was popular in
the past, the process has many drawbacks. Modern tablet coatings are polymer and
polysaccharide based, with plasticizers and pigments included. Tablet coatings must be
stable and strong enough to survive the handling of the tablet, must not make tablets stick
together during the coating process, and must follow the fine contours of embossed
characters or logos on tablets. Coatings are necessary for tablets that have an unpleasant
taste, and a smoother finish makes large tablets easier to swallow. Tablet coatings are
also useful to extend the shelf-life of components that are sensitive to moisture or
oxidation. Opaque materials like titanium dioxide can protect light-sensitive actives from
photodegradation[citation needed]. Special coatings (for example with pearlescent effects) can
enhance brand recognition.

If the active ingredient of a tablet is sensitive to acid, or is irritant to the stomach lining,
an enteric coating can be used, which is resistant to stomach acid, and dissolves in the
high pH of the intestines. Enteric coatings are also used for medicines that can be
negatively affected by taking a long time to reach the small intestine, where they are
absorbed. Coatings are often chosen to control the rate of dissolution of the drug in the
gastrointestinal tract. Some drugs will be absorbed better at different points in the
digestive system. If the highest percentage of absorption of a drug takes place in the
stomach, a coating that dissolves quickly and easily in acid will be selected. If the rate of
absorption is best in the large intestine or colon, then a coating that is acid resistant and
dissolves slowly would be used to ensure it reached that point before dispersing. The area
of the gastrointestinal tract with the best absorption for any particular drug is usually
determined by clinical trials.

[edit] Pill-splitters
It is sometimes necessary to split tablets into halves or quarters. Tablets are easier to
break accurately if scored, but there are devices called pill-splitters which cut unscored
and scored tablets. Tablets with special coatings (for example enteric coatings or
controlled-release coatings) should not be broken before use, as this will expose the tablet
core to the digestive juices, short-circuiting the intended delayed-release effect.

[edit] See also

• Pharmaceutical formulation

[edit] References
• Kibbe, A.H., ed. Handbook of Pharmaceutical Excipients. 3rd Edition ed. 2000,
American Pharmaceutical Association & Pharmaceutical Press: Washington, DC
& London, UK.

8
 • Hiestand, E.N., 2003. Mechanics and physical principles for powders and
compacts, SSCI Inc., West Lafayette, In, USA.
• United States Pharmacopeia, United States Pharmacopeia / National Formulary
(USP25/NF20). 2002, Rockville, MD: United States Pharmacopeia Convention
Inc.

[hide]
v•d•e
Route of administrations / Dosage forms

Capsule · Pill ·
Tablet · Orally
disintegrating
Solidstablet · Film ·
OROS (osmotic
controlled
Enteral/ digestive
release capsule)
tract
Elixir ·
Oral Emulsion ·
LiquidsSyrup ·
Suspension ·
Tincture

Inhaler (Metered-dose,
Respiratory tract
Dry powder) · Nebulizer

Sublingual
Circulatory system
administration

Eye/ENT Eye drop · Ear drop · Intranasal

Emulsion (Ointment · Cream · Lotion ·

Liniment · Gel · Paste · Film) · Medicated
Transdermal
shampoo · Transdermal implant · Transdermal
patch

Subcutaneous (SC) · Intravenous (IV) ·

Injection/parenteral Intramuscular (IM) · Intraosseous ·
Intraperitoneal (IP) · Intrathecal · Intracavernosal

Pessary (vaginal suppository) · Vaginal ring ·

Vaginal
Douche · Intrauterine device

9
 Rectal Suppository · Enema
Retrieved from "http://en.wikipedia.org/wiki/Tablet"
Categories: Chemical engineering | Pharmaceutical industry | Pharmacology | Dosage
forms
Hidden categories: Articles lacking reliable references from July 2006 | Articles needing
cleanup from October 2009 | All pages needing cleanup | All articles with unsourced
statements | Articles with unsourced statements from September 2009

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Capsule (pharmacy)
From Wikipedia, the free encyclopedia

Jump to: navigation, search

In the manufacture of pharmaceuticals, encapsulation refers to a range of 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 normally used for dry, powdered
ingredients, and soft-shelled capsules, primarily used for oils and for active ingredients
that are dissolved or suspended in oil. Both of these classes of capsule are made both
from gelatine and from plant-based gelling substances like carrageenans and modified
forms of starch and cellulose.

Since their inception, capsules have been viewed by consumers as the most efficient
method of taking medication. For this reason, producers of drugs such as OTC analgesics
wanting to emphasize the strength of their product developed the "caplet" or "capsule-
shaped tablet" in order to tie this positive association to more efficiently-produced tablet
pills. After the 1982 Tylenol tampering murders, capsules experienced a minor fall in
popularity as tablets were seen as more resistant to tampering.[1]

Contents
[hide]

• 1 Soft gel encapsulation

• 2 Two-part gel capsules
• 3 Sizing
• 4 References
o 4.1 Footnotes
o 4.2 General references

• 5 See also

[edit] Soft gel encapsulation

12
Cod liver oil soft gel capsules.

In 1834, Mothes and Dublanc were granted a patent for a method to produce a single-
piece gelatin capsule that was sealed with a drop of gelatin solution. They used individual
iron moulds for their process, filling the capsules individually with a medicine dropper.
Later on, methods were developed that used sets of plates with pockets to form the
capsules. Although some companies still use this method, the equipment is not produced
commercially any more. All modern soft-gel encapsulation uses variations of a process
developed by R.P. Scherer in 1933. His innovation was to use a rotary die to produce the
capsules, with the filling taking place by blow molding. This method reduced wastage,
and was the first process to yield capsules with highly repeatable dosage.

The current owner of the RPScherer technology is Catalent Pharma Solutions, the worlds
largest manufacturer of prescription pharmaceutical softgels.

Softgels can be an effective delivery system for oral drugs, especially poorly soluble
drugs. This is because the fill can contain liquid ingredients that help increase solubility
or permeability of the drug across the membranes in the body. Liquid ingredients are
difficult to include in any other solid dosage form such as a tablet. Softgels are also
highly suited to potent drugs (for example, where the dose is <100ug), where the highly
reproducible filling process helps ensure each softgel has the same drug content, and
because the operators are not exposed to any drug dust during the manufacturing process.

In 1949, the Lederle Laboratories division of the American Cyanamid Company

developed the "Accogel" process, allowing powders to be accurately filled into soft
gelatin capsules.

[edit] Two-part gel capsules

Two-part hard starch capsules

James Murdock patented the two-part telescoping gelatin capsule in London in 1847.[2]
The capsules are made in two parts by dipping metal rods in molten starch or cellulose
solution. The capsules are supplied as closed units to the pharmaceutical manufacturer.
Before use, the two halves are separated, the capsule is filled with powder (either by

13
placing a compressed slug of powder into one half of the capsule, or by filling one half of
the capsule with loose powder) and the other half of the capsule is pressed on. The
advantage of inserting a slug of compressed powder is that control of weight variation is
better, but the machinery involved is more complex.[3]

[edit] Sizing
In Canada, starch or cellulose are available in a range of sizes with designations 000, 00,
0E, 0, 1, 2, 3, and 4. The respective volumetric capacities are 1.37ml, 950µl, 770µl,
680µl, 480µl, 360µl, 270µl, and 200µl.[4]

[edit] References
[edit] Footnotes

1. ^ Sims, Calvin (1986-02-15). "Despite "mystique" of capsules, many drugs work in other
forms". New York Times. http://query.nytimes.com/gst/fullpage.html?
sec=health&res=9A0DE1D71F3BF936A25751C0A960948260.
2. ^ "History of dosage forms and basic preparations". Encyclopedia of Pharmaceutical
Technology. 7. Informa Health Care. 1998. pp. 304–306. ISBN 0824728068.
3. ^ Bill Bennett and Graham Cole (2003). Pharmaceutical Production, an Engineering
Guide. IChemE. pp. 126–129. ISBN 0852954409.
4. ^ "CapsCanada: Technical Specifications for Gelatin Capsules".
http://www.capscanada.com/assets/technical%20specifications%20gelatin.pdf.

Liquid Filled Hard Gelatin Capsules [1]

[edit] General references

• L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and Practice of
Industrial Pharmacy (3rd Ed.). Lea & Febiger, Philadelphia. ISBN 0-8121-0977-
5.

[edit] See also

• Pharmaceutical formulation
• Pill splitting
• OROS

[hide]
v•d•e
Route of administrations / Dosage forms

14
 Capsule · Pill · Tablet ·
Orally disintegrating
Solidstablet · Film · OROS
(osmotic controlled
Enteral/ digestive tract release capsule)

Elixir · Emulsion ·
Oral
LiquidsSyrup · Suspension ·
Tincture

Inhaler (Metered-dose, Dry

Respiratory tract
powder) · Nebulizer

Circulatory systemSublingual administration

Eye/ENT Eye drop · Ear drop · Intranasal

Syrup
From Wikipedia, the free encyclopedia

Jump to: navigation, search

For other uses, see Syrup (disambiguation).

A pot of syrup used to make stroopwafels

In cooking, a syrup (from Arabic ‫ شراب‬sharab, beverage, via Latin siropus) is a thick,
viscous liquid, containing a large amount of dissolved sugars, but showing little tendency
to deposit crystals. The viscosity arises from the multiple hydrogen bonds between the
dissolved sugar, which has many hydroxyl (OH) groups, and the water. Technically and
scientifically, the term syrup is also employed to denote viscous, generally residual,
liquids, containing substances other than sugars in solution. Artificial maple syrup is
made with water and an extremely large amount of dissolved sugar. The solution is
heated so more sugar can be put in than normally possible. The solution becomes super-
saturated.

15
Contents
[hide]

• 1 Pharmaceutical syrup
• 2 Culinary syrup
• 3 Syrups for beverages
o 3.1 Simple syrup
o 3.2 Gomme syrup
• 4 See also
• 5 References

• 6 External links

[edit] Pharmaceutical syrup

The syrup employed as a base for medicinal purposes consists of a concentrated or
saturated solution of refined sugar in distilled water. The "simple syrup" of the British
Pharmacopoeia is prepared by adding 1 kg of refined sugar to 500 mL of boiling distilled
water, heating until it is dissolved and subsequently adding boiling distilled water until
the weight of the whole is 1.5 kg. The specific gravity of the syrup should be 1.33. This is
a 66° Brix solution.

Flavoured syrups are made by adding flavouring matter to a simple syrup. For instance,
syrupus aromaticus is prepared by adding certain quantities of orange flavouring and
cinnamon water to simple syrup. Similarly, medicated syrups are prepared by adding
medicaments to, or dissolving them in, the simple syrup.

[edit] Culinary syrup

Golden syrup is a by-product of the process of obtaining refined crystallized sugar.
Molasses is a syrup obtained at a different stage of refining.

[edit] Syrups for beverages

A variety of beverages call for sweetening to offset the tartness of some juices used in the
drink recipes. Granulated sugar does not dissolve easily in cold drinks or ethyl alcohol.
Since the following syrups are liquids, they are easily mixed with other liquids in mixed
drinks, making them superior alternatives to granulated sugar.

16
Bottles of syrup used for flavouring drinks in a coffee house.

[edit] Simple syrup

A basic sugar-and-water syrup used to make drinks at bars is referred to by several

names, including simple syrup, sugar syrup, simple sugar syrup, and bar syrup.

Simple syrup is made by stirring granulated sugar into hot water in a sauce pan until the
sugar is dissolved and then cooling the solution. Generally, the ratio of sugar to water can
range anywhere from 1:1 to 2:1.

This type of syrup (often with additional flavourings) is also commonly used at coffee
bars, especially in the United States, to make flavoured drinks.

[edit] Gomme syrup

Gomme syrup is an ingredient commonly used in mixed drinks. It is also commonly

used as a sweetener for iced coffee in Japan. Like bar syrups, it is a sugar and water
mixture, but has an added ingredient of gum arabic which acts as an emulsifier. Gomme
syrup is made with the highest percentage of sugar to water possible, while the gum
arabic prevents the sugar from crystallizing and adds a smooth texture.

[edit] See also

• Agave nectar • Fruit syrup • Maple syrup • Sugar beet
• Barley malt • Golden Syrup • Molasses syrup
syrup • Hickory syrup • Palm syrup • Torani
• Birch syrup • Honey • Peanut butter • Treacle
• Brown rice • Inverted sugar • Sorghum • Yacon syrup
syrup syrup syrup
• Chocolate • Syrup Of
syrup • Kithul treacle • Squash Maidenhair
(drink)
• Corn syrup

[edit] References

17