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PHARMACEUTICAL DOSAGE FORM

 Pharmaceutical dosage form

Definition: Dosage forms are the means by which drug molecules are delivered to sites of action within the body.
The need for dosage forms:
1- Accurate dose.
2- Protection e.g. coated tablets, sealed ampules.
3- Protection from gastric juice.
4- Masking taste and odour.
5- Placement of drugs within body tissues.
6- Sustained release medication.
7- Controlled release medication.
8- Optimal drug action.
9- Insertion of drugs into body cavities (rectal, vaginal)
10- Use of desired vehicle for insoluble drugs.
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TABLETS
 Introduction
• Solid medicaments may be administered orally as powders, pills, cachets, capsules or tablets. These dosage
forms contain a quantity of drug which is given as a single unit and they are known collectively as solid unit
dosage forms.
• A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit
dosage form.
• Tablet is defined as a compressed solid dosage form containing medicaments with or without excipients.
• According to the Indian Pharmacopoeia, Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage
form, prepared by compressing a drugs or a mixture of drugs, with or without diluents. They vary in shape
and differ greatly in size and weight, depending on amount of medicinal substances and the intended mode
of administration.
• It is the most popular dosage form and 70% of the total medicines are dispensed in the form of Tablet. All
medicaments are available in the Tablet form except where it is difficult to formulate or administer
• Tablets are prepared either by molding or by compression.
• The excipients can include diluents, binders or granulating agents, 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 or aid in visual identification
of an unknown tablet.
• 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.
• Medicinal tablets were originally made in the shape of a disk, but are now made in many shapes and colours
to help distinguish different medicines.
• Tablets are often imprinted with symbols, letters, and numbers, which allow them to be identified, or a
groove to allow splitting by hand.
• Sizes of tablets to be swallowed range from a few millimetres to about a centimetre.

 The advantages of the Tablet dosage form are:

i) They are unit dosage form and offer the greatest capabilities of all oral dosage form for the greatest dose
precision and the least content variability.
ii) Cost is lowest of all oral dosage form. iii) Lighter and compact.
iv) Easiest and cheapest to package and strip. v) Easy to swallow vi)
Sustained release product is possible by enteric coating. vii) Objectionable
odor and bitter taste can be masked by coating technique.
viii) Suitable for large scale production.
ix) Greatest chemical and microbial stability over all oral dosage form.
x) Product identification is easy and rapid requiring no additional steps when employing an embossed and/or
monogrammed punch face.
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 Disadvantages of Tablet dosage form are:

i) Difficult to swallow in case of children and unconscious patients.
ii) Some drugs resist compression into dense compacts, owing to amorphous nature, low density character.
iii) Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may require
encapsulation or coating which may increase production cost.
iv) High dose drugs are difficult to formulate as tablets.
v) Some drugs which preferably get absorbed from the upper part of GIT may cause bioavailability problems in
tablet dosage form.
vi) Drugs having poor wetting properties, slow dissolution profile and high optimal gastrointestinal absorption
are difficult or impossible to formulate as tablet.

 Types of tablets

(A) Tablet ingested orally - they are designed to be swallowed

a) Compressed Tablets ex: Paracetamol

b) Multiple compressed tablets- Multiple compressed tablets are compressed tablets made by more than one
compression cycle. They are usually prepared to separate physically or chemically incompatible ingredients or to
produce repeat or prolong action of drug.
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c) Sustained action tablets- A tablet that releases its active ingredient in specified doses at timed intervals.
d) Enteric coated tablets- Prevent the drug from early dissolution or disintegration by gastric acid, help the drug to
pass the gastric.
e) Sugar coated tablets-A sugar-coated tablet is coated with sugar to disguise the taste.
f) Film coated tablets is a tablet covered by a
thin layer of film to protect it or make it
easier to swallow.
g) Chewable tablets- Chewable tablets are an
oral dosage form intended to be chewed
and then swallowed by the patient rather
than swallowed whole. They should be
designed to be palatable and be easily
chewed and swallowed.

(B) Tablet used in oral cavity -

a) Buccal tablets- buccal tablet one which dissolves when it is held between the cheek and gum, permitting direct
absorption of the active ingredient through the oral mucosa
b) Sublingual tablets- Sublingual administration involves placing a drug under your tongue to dissolve and absorb into
your blood.
c) Lozenge tablet and troches- A throat lozenge (also known as a cough drop, troche, cachou, pastille or cough sweet)
is a small, typically medicated tablet intended to be dissolved slowly in the mouth to temporarily stop coughs

d) Dental cones- These are relatively minor compressed tablets meant for placing them in the empty sockets after
tooth extraction. They prevent the multiplication of bacteria in the socket by using slow-releasing antibacterial
compounds or to reduce bleeding by containing the astringent.
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(C) Tablets administered by other routes

a) Implantation tablets-These tablets are placed under the skin or inserted subcutaneously by means of minor
surgical operation and are slowly absorbed.

b) Vaginal tablets- Tablet contains clotrimazole, an antifungal medicine. It is used in the treatment of fungal infection
of the vagina and helps in relieving symptoms of fungal infection of the vagina.

(D) Tablets used to prepare solutions

a. Effervescent tablets- tablets are also a common intervention for gastric
problems like heartburn, upset stomach, and acid indigestion.
b. Dispersing tablets(DT)-These dispersible tablets disintegrate quickly in
water or disperse immediately in the mouth. Aspirin is available as a
dispersible tablet that you can dissolve in water before taking.
c. Hypodermic tablets-Hypodermic tablets are soft, readily soluble tablets.
These tablets are dissolved in a suitable vehicle (water for injections) and
administered by parenteral route.
d. Triturates-A tablet made by moistening the medication then molding it into
shape and allowing the liquid to evaporate. It usually disintegrates readily

1. Coated tablets
• The coating is defined as a procedure in which the desired dosage form may be a granule or tablet coated
with an outer dry film to obtain specific objectives such as masking taste or protecting against environmental
conditions.
• The coating material may be composed of coloring materials, flavorants, gums, resins, waxes, plasticizers,
and a polyhydric alcohol.
• In the modern era, polymers and polysaccharides were principally used as coating materials along with other
excipients like plasticizers(a substance that is added to a material to make it softer and more flexible, to
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increase its plasticity, to decrease its viscosity, and/or to decrease friction during its handling in
manufacture.) and pigments.

 Objective of coating
• The coating helps maintain the physical and chemical integrity of the active ingredient
• It also controls the drug release
• The coating used to enhance the elegance of the pharmaceuticals,
• The sophistication of appearance was enhanced by printing or making them with attractive colors
 Types of tablet coating
i) Sugar coated tablet- The sugar syrup is coated on the tablet and water is left to evaporate from the syrup
leaving a sugar coating. The coating result in a highly flavored and shiny tablet. These tablets especially
used for kids.
ii) Film coated tablet- This coating is especially used for beautifying the tablets using different colours.
Spraying is used to create an even film around a tablet. This coating creates stable and strong tablet. iii)
Gelatin coated tablet- Gelatin is used to create the gelcap, a capsule-shaped tablet as the outer covering iv)
Enteric coated tablet- Enteric coated tablets are tablets that are coated with an enteric coating. Enteric
coatings are polymers that are put on certain tablets to prevent them from dissolving in acid. Your stomach
is very acidic, and some drugs need to be protected from the acid in your stomach in order to work properly
in your body.
v) Compression coating tablet- A compression-coated tablet is a system in which the entire surface of an
inner core is completely surrounded by the coat and these coats prevent drug release from the core until
the polymeric coat is entirely eroded, dissolved or removed. It delays the release of tablets especially
those for intestine.

 Advantage of coating
i) Coating provides stability to the tablets in handling and prevents them from sticking together.
ii) The coating also improves the mechanical strength of the dosage form, causes the dosage form smoother
and more suitable for swallowing purposes. iii) Pharmaceutical companies could print their marks,
symbols, or abbreviations on the tablets and mask a disagreeable color or odor of the tablets.
iv) The release of the active ingredient can even be controlled with the help of coatings. Coated dosage forms
could be site-specific.
v) The coating prevents acid-sensitive drugs from having a negative impact on the intestine.
vi) The drug release rate in the gastrointestinal tract (GIT) could be controlled by controlling the dissolution rate
of the tablet
 Disadvantages of tablet coating:
• The major disadvantage of tablet coating is that the coating process is tedious and time-consuming, which
makes it expensive.
• The pharmacodynamic properties of the formulation can interfere with the tablet coating.
• The technique may often lead to several defects in the coating, such as chipping, cracks, etc.
• The coating process is complex compared to other processes and therefore a trained person is required to
handle this process
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2. Uncoated tablet
A single layer or more than one layer of formulation that consists of active ingredients and excipients
compressed together without any additional coat or cover
 Difference between coated and uncoated tablet
Uncoated tablet Coated tablet
These tablets do not have any coating. These tablets have coating on them
They have rough surface these have smooth and shiny surfaces
Tablet= Drugs + Excipient Tablet = Drug +excipient + coating
Cannot be classified, as they have no coating Can be classified as film coated, sugar coated etc
Prepared by compression of granules Prepared by compression of granules and then coating
Only tablet punching machine is required Tablet punching machine + coating machine required
As there is no coating therefore, sealing, subcoating, All these steps are present
syruping steps are absent
No need of tablet soaking in any medium before Soaking is required to dissolve the coating disintegrating test
Disintegrating time: within 15 min Disintegrating time
Film coated: within 15 min
Sugar coated: 60 min
Enteric coated: 2 hr
Disintegrate in stomach Disintegrating location depends on coating
No film/coating defect are seen Film/coating defect are present such as blistering etc

 Tablet manufacturing
Regardless of whether a tablet is manufactured by direct compression or granulation, processing aids will be
required: These materials are called excipients and are either:
i) Diluents-A diluent is simply an ingredient that is used as a bulking agent to make tablets large enough to handle
and swallow. Examples include: Micro-crystalline cellulose, Lactose, Di-calcium phosphate
ii) Lubricants- Lubricants are materials that lubricate powder mixes and aid tablet ejection. Without lubrication
powder may stick to the punches especially if is too moist. Examples include: Magnesium Stearate, Stearic Acid,
Talc iii) Disintegrants-A material to promote disintegration of the tablet when swallowed. Enhances water
penetration by wicking effect, Increases porosity, Swells in contact with water and breaks cohesive bonds. Examples
include:
Starch Croscarmellose, Sodium Starch Glycollate, Crospovidone iv) Glidants-Glidants are materials that
improve the flow of powder mixes. An example is Colloidal Silicon Dioxide. Most powders, without the aid of flow
agents, simply cannot flow at speeds required for high speed tabletting.
v) Binders-A material that imparts cohesiveness to the formulation. Helps bind powder particles into granules
during granulation. Helps bind granules together during the compression process Examples include: Hydroxy
propyl methyl cellulose (HPMC in water), Starch paste in warm water, Gelatin, Polyvinyl pyrrolidone (PVP)
 Granulation
• Granulation is the process of particle enlargement by agglomeration technique, is one of the most significant
unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules. Granulation
process transforms fine powders into free-flowing, dust-free granules that are easy to compress.
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• Granulation process can be divided into two types: wet granulation that utilize a liquid in the process and dry
granulation that requires no liquid. The type of process selection requires thorough knowledge of
physicochemical properties of the drug and excipients
• Among currently available technologies, spray drying, roller compaction, high shear mixing, and fluid bed
granulation are famous
• Three principle methods of preparing powder formulations for compression
i) Direct Compression
ii) Wet Granulation iii)
Dry Granulation

1. DIRECT COMPRESSION
• This is the ideal option but is rarely achievable due to:
i) Active particle size/density mismatch with excipients causing poor homogeneity ii)
Large quantity per tablet of poorly compressible active resulting in weak friable tablets
• Problems Associated With Direct Compression-If the material is a powder rather than a granule:
i) it will have poor flow characteristics, which can lead to uneven tablet weights.
ii) The pressure transmission through a powder mass is poor, due to low packing density. Consequently
particles do not ‘knit’ together very readily.
iii) Powders, especially fine ones tend to blow out of the die at the top and seep out at the bottom
iv) Dusty powders tend to mix with oil/grease and eventually cause sticking of the punches in the dies or turret
bores. Powders containing two or more components may segregate.
• Advantages of Direct Compression
i) Few stages involved ii) Low
handling costs iii) Losses
near zero iv) No water or
heat involved
v) Reduces the risk of degradation of the active

 Why granulate?
i) To improve powder flow ii) To improve compressibility iii) To
reduce fines iv) To control tendency of powders to segregate. v)
To control density vi) To capture and fuse small quantities of
active material.

2. Wet granulation
• Wet granulation involves the massing of a mix of dry primary
powder particles using a granulating fluid (the process of adding a
liquid solution to powders). The 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.
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• The granulation liquid may be used alone or, more usually, as a solvent containing a dissolved adhesive (also
referred to as a binder or binding agent) which is used to ensure particle adhesion once the granule is dry.
• Water is commonly used for economic and ecological reasons (safer to nature and operator). Its disadvantages as
a solvent are that it may adversely affect drug stability, causing hydrolysis of susceptible products, and it needs a
longer drying time than do organic solvents.
• Organic solvents are used when water-sensitive drugs are processed, as an alternative to dry granulation, or
when a rapid drying time is required.
• Water mixed into the powders can form bonds between powder particles that are strong enough to lock them
together. However, once the water dries, the powders may fall apart. Therefore, water may not be strong enough
to create and hold a bond. In such instances, a liquid solution that includes a binder (pharmaceutical glue) is
required. Povidone, which is a polyvinyl pyrrolidone (PVP), is one of the most commonly used pharmaceutical
binders. When PVP and a solvent/water are mixed with powders, PVP forms a bond with the powders during the
process, and the solvent/water evaporates (dries).
• Once the solvent/water has been dried and the powders have formed a more densely held mass, then the
granulation is milled. This process results in the formation of granules.
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3. Dry granulation
• The formation of granules by compacting powder mixtures into large pieces or compacts which are
subsequently broken down or sized into granules (often referred to as dry granulation, double
compression or pre- compression) is a possible granulation method which, however, is not widely used
in the manufacture of tablets.
• Steps-

Advantage
• Dry granulation serves as a lower-cost method of processing powder and powder blends.
• It does not require the use of a liquid binding agent, which eliminates the need for separate moisture
addition and material drying stages. Compared to wet granulation, this distinction saves on material,
labor, and energy costs.