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DOSAGE FORM

HARISHANKAR SAHU
B.pharmacy 4th year
Shri Rawatpura Sarkar institute of pharmacy,Durg

Terms:Drug:-(active pharmaceutical ingredient API)


chemical compound intended for
used in
diagnosis, treatment or
prevention of
diseases.
Excipients:(inactive pharmaceutical ingredients)
Technological, biopharmaceutical
and/or
stability reasons.
Diluents/fillers, binders,
lubricants,
desintegrants,
coatings, preservants and
stabilizers, colorants and flavourings
dosage form:Drug+excipients

CLASSIFICA
TION

SOLID SEMI-SOLID LIQUID


1.Monophasic liquid:_syrup
_solution

1.Unit solid:_tablets
_capsules

2.Biphasic liquid:_emulsion
_suspension

2.Bulk dosage form:_powder


_Dusting powder
Cream
Paste

Gel
suppositories

GAS
_Inhaler
_aerosols

SOLID

Tablets: They are unit solid dosage


forms consisting of active
ingredient and suitable
pharmaceutical excipients.
They may vary in size, shape,
weight, hardness, thickness,
disintegration and dissolution
characteristics, and in other
aspects.

Capsules: They are unit solid dosage forms


consisting gelatin shell that
breaks open after the capsule has
been swallowed and releasing the
drug.
Types hard-shell gelatin capsule
soft-shell gelatin capsule

1. soft gelatin shell manufactured in one


piece with drug usually in liquid form
inside the shell, e.g. fat-soluble vitamins A
and E, Procardia (nifidepine), etc.
2. hard shell manufactured in two pieces
that fit together and hold the drug, either
in powdered or granular form.

lozenges :tablets formed from hardened base or sugar and water containing drug
and other flavors.
They are designed to dissolve slowly in the mouth and release the drug
topically to the tissues of mouth and throat; they are not to be
swallowed.

Powder: They are bulk solid dosage forms


consisting two or more
medicament meant for internal
use.
The size of particle range from
10,000 microns to 0.1microns.
Size of the powder determine the
effectiveness of physiological
properties.

SEMI-SOLID

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SEMI-SOLID
Semisolids contain both liquids and solids semi-solid.
dosage forms that are too soft in structure to qualify for
solids but too thick to be considered liquid.
They are meant for topical application.

Creams: Creams are semi-solid emulsions, that is mixtures of oil


and water.
They are divided into two types1.O/W TYPE
2.W/O TYPE

A.O/W creams: which are composed of small droplets


of oil dispersed in a continuous
aqueous phase.
cosmetically acceptable as they are
less greasy and more easily washed
off using water.
B.W/O creams:
which are composed of small droplets
of water dispersed in a continuous oily
phase.
Water-in-oil creams are more difficult
to handle.
Water-in-oil creams are also more
moisturising as they provide an oily
barrier which reduces water loss from
the stratum corneum,the outermost
layer of the skin.

Ointment/Pastes

Pastes are semisolid dosage forms


that contain one or more drug
substances intended for topical
application.
Generally, pastes contain a higher
proportion of solid materials than
ointments.
They are more stiff, less greasy, and
more absorptive of serous secretions
when used on the skin.
Medicated dental pastes are also
prepared for adhesion to the mucous
membranes for local effect.

LIQUID

Elixirs:solutions that contain an alcohol and water base, added sugar and
flavorings, e.g. Tylenol; commonly used for pediatric and elderly
patients who have difficulty swallowing tablets or capsules.
Syrups:do not contain alcohol and are concentrated solutions of sugar,
water, and flavorings. They are sweeter and more viscous than elixirs.
Most OTC cough medications are syrup based and dont only carry
the drug but also act to soothe the inflamed mucous membranes of
the throat.
Solutions:one homogenous phase, prepared by dissolving one or more
solutes in a solvent.
Emulsions:-a dispersion system consisting of two immiscible liquids
-o/w or w/o
o
w
-cloudy appearance.
Suspensions:A dispersion system where solid particles are dispersed in liquid
phase
Solid particles called dispersed phaes and liquid called
continuous phaes.

Liniments
Liniments are alcoholic or
oleaginous solutions,
suspensions, or emulsions
of medicinal agents
intended for external
application to the skin,
generally by rubbing.

GAS

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Inhalations
Inhalations are finely
powdered drug
substances, solutions, or
suspensions of drug sub
stances administered by
the nasal or oral
respiratory route for local
or systemic effects.
Special devices are used
to facilitate
administration.
Thanks to a new insulin inhaler, researchers say, the daily injections many
diabetics take may become relics of the past.

aerosol sprays
- Several different types
of pharmaceutical
product may be
packaged in
pressurized
dispensers, known as
aerosols.
- used as surface
disinfectants, wound or
burn dressing, relieve
irritation of bites.

L
B
A
T
T
E

Tablets
Tablets are oral solid unit dosage form of medicaments
with or without suitable diluents and prepared either by
molding or compression. They are solid, flat or biconvex
disc in shape.
They vary greatly in shape, size and weight which
depend upon amount of medicament used and mode of
administration.
They also vary in hardness, thickness, disintegration
and dissolution characteristics and in other aspects
depending upon their intended use and method of
manufacture
They are used for local & systemic effect.
Usually used for oral administration
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Advantages
Large scale production at
lowest cost
Easiest and cheapest to
package and ship
High stability
Easy to handling
Easy to administration
Lightest and most compact
Tablets are formulated as a
special release of products
such as enteric or delayed
release products.

Disadvantages
Its not suitable for poorly
water-soluble or poorly
absorbable drugs, less
bioavailability.
Drugs that are sensitive to
oxygen or may also require
special coating.
Enhances local irritant effect
of some drugs or cause harm
to the gastrointestinal mucosa

Types of tablets

1)compressed tablets
2)sugar coated tablets
3)film coated tablets
4)enteric coated
tablets
5)effervescent tablets
6)chewable tablets
7)dispersible tablets
8)sustained release
tablets
9)multilayer tablets
10)sublingual tablets
11)buccal tablets
12)vaginal tablets

Tablet Ingredients
(excipients)

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Filler or diluent
They use to make required bulk of the tablet .
to provide better tablet properties such as to improve cohesion,
to permit use of direct compression manufacturing
to improve flow
Ex:1. Lactose, sucrose, mannitol; frequently used, water soluble,
improves tablet disintegration.
2.Dicalcium phosphate dihydrate, insoluble in water,
disintegrating agent is a must.
3. Mannitol, dextrose, sucrose,
4. Lactose-anhydrous and spray dried lactose
5.Directly compressed starch-Sta Rx 1500
6. Hydrolyzed starch-Emdex and Celutab
7. Microcrystalline cellulose-Avicel (PH 101, 102)
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Disintegrant
Role: to ensure that the tablet, when in contact with a liquid, breaks up
into small fragments, which promotes rapid drug dissolution.
Mode of action:
1. Facilitate water uptake into the pores of tablet,
e.g. surface active agents
2.facilitate rupture of tablet by swelling during water sorption,
e.g. Sodium starch glycolate, Crosscarmelose- cross linked cellulose;
modified cellulose, Ac-Di-Sol
3. Release of gases to disrupt the tablet structure, normally carbon
dioxide, in contact with water. e.g. effervescent tablets.

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Binder and adhesive


Role: Ensure that granules and tablets can be
formed with the required mechanical strength.
( glue that holds powders together to form
granules )
Examples:
starch paste 5-25%
gelatin solution 10-20%,
gum acacia, tragacanth, 10-25%
Liquid glucose 50%,
Cellulose derivative
Polyvinylpyrrolidone 2% (PVP), PEG
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Lubricant
Role: Lubricants
prevent adherence of granule/powder to die wall and promote
smooth ejection from the die after compaction, reduce inter particle
friction and improve the rate of flow of the tablet granulation.

Glidant
Role: Improve flowability of the powder
They are added during direct compaction and to granulation
before tabletting ( they reduce interparticulate friction).
Ex.1. Talc (at concentration 1-2 %).
2. Colloidal silica (0.2 %).
3. Corn Starch 5-10%
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a
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Stages of pharmaceutical
manufacturing
Finished
Product

API

Primary
Packaging

API
Excipients

Starting Materials
(Chemicals)

Secondary
Packaging

Processing routes
Direct Compression
Drug
Diluent
Glidant
Disintegrant

Mixing

Dry Granulation
Drug
Diluent
Lubricant

Mixing
Compression
Comminution

Wet Granulation
Drug
Diluent

Mixing
Wetting

Binder
Solvent

Granulation
Drying

Lubricant

Mixing

Tablet
Compressio
n

Disintegrant
Glidant
Lubricant

Screening
Mixing

Fill die

Compress Tablet
Coating, Packaging etc..

Disintegrant
Glidant
Lubricant

Screening
Mixing

Other Routes
Fluidized bed granulation
Extrusion / rotary granulation

Tablet compression
machines
Hopper for holding and feeding
granulation to be compressed
Dies that define the size and shape of the
tablet
Punches for compressing the granulation
within the dies
Cam tracks for guiding the movement of
the punches
Feeding mechanisms for moving
granulation from the hopper into the dies

Single punch machine


Multiple punch machine

Single Punch
Machine (Tablets)

Upper and
Lower Collar
Collar locker

Multi-station rotary presses


The head of the tablet machine that
holds the upper punches, dies and
lower punches in place rotates
As the head rotates, the punches are
guided up and down by fixed cam
tracks, which control the sequence of
filling, compression and ejection.
The portions of the head that hold the
upper and lower punches are called
the upper an lower turrets

The way to get started is to


quit talking & being doing..
Walt Disney.

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