Powders and

Granules
Definition

• Powders and granules not only are dosage forms

themselves but are also used as a beginning point for other
dosage forms.
• Powders are fine particles that can result from the
comminution of any dry substance. They consist of
particles ranging from 0.1um to 10mm
 • It may be used to describe the physical form
of a material – a dry substance composed of
Powders finely divided particles
• Or it may be used to describe a
pharmaceutical dosage form – a medicated
powder intended for internal or external
use. Powders are intimate mixtures of dry,
finely subdivided drugs and/or chemicals.
Granules
• They are prepared agglomerates of powdered
materials, they may used for their medicinal
content or they may be used for
pharmaceutical purposes.
• Granules typically fall within the range of 4 to
12 sieve size although 12 to 20 sieve range are
sometimes used in tablet making,
 Particle Size
(USP)
The USP uses descriptive terms when describing the sizes
of powders
OFFICIAL DEFINITION OF
POWDERS OF ANIMAL AND
VEGETABLE DRUGS
• VERY COARSE #8 – all particles pass through no .8
sieve and not more than 20% through sieve no. 60
• COARSE #20 – all particles pass through no. 20 sieve
and not more than 40% through sieve no. 60
• MODERATELY COARSE #40 – all particles pass
through no. 40 sieve and not more than 40%
through sieve no 80.
• FINE #60 – all particles pass through no. 60 sieve
and not more than 40% through sieve no 100.
• VERY FINE #80 – all particles pass through a no. 80
sieve. There is no limit as to greater fineness
OFFICIAL DEFINITION OF
POWDERS OF CHEMICAL
DRUGS
• COARSE #20 – all particles pass through no. 20 sieve
and not more than 40% through sieve no. 60
• MODERATELY COARSE #40 – all particles pass
through no. 40 sieve and not more than 60% pass
through sieve no. 60
• FINE #80 – all particles pass through no 80. sieve
and there is no greater limit as to greater fineness
Comminution of
drugs
 • Comminution or trituration – Grinding
a drug in a mortar to reduce the
particle size

Types of • Use of millers and pulverizers

• Levigation – commonly used in small-
comminution scale preparation of ointments and
suspensions to reduce the particle size
and grittiness of the added powders.
• Trituration with intervention
 Blending of powders

• When two or more powdered substances

are to be combined to form a uniform
mixture, it is best to reduce the particle size
individually before blending
Types of blending
• Spatulation – blending of small amounts of powder to form a uniform
mixture by use of a spatula through a sheet of paper or ointment tile.
It is not suitable for large quantities of powders or for powders
containing potent substances.
• Trituration – may be employed to both comminute and mix powders.
• Sifting - results in light, fluffy products
• Tumbling – mixing of powders in a rotating chamber.
Spatulation
Trituration
Sifting
Tumbling
Things to consider

• Potency – When mixing potent drugs, it is best to use

geometric dilution
• Eutexia – Eutexia is the reduction of melting point of
substances when combined with other eutectic
substances. This leads to liquefaction and a wet powder.
Particle Size Analysis /
Micromeritics
• The purpose of particle size analysis in pharmacy is to
obtain quantitative data on the size, distribution and
shapes of the drug and other components to be used in
pharmaceutical formulations
• There may be substantial differences in particle size, crystal
morphology and amorphous character within the
substances.
Particle Size affects the following:

• Dissolution rate of particles intended to be dissolved. Drug

micronization can increase the rate of drug dissolution and
its bioavailability
• Suspendability of particles intended to be undissolved but
uniformly dispersed in a liquid vehicle
• Uniform distribution of a drug substance in a powder
mixture to ensure dose-to-dose uniformity
Particle Size affects the following:

• Penetrability of particles intended to be inhaled for

deposition in the respiratory tract
• Lack of grittiness of solid particles in dermal preparations
and ophthalmic preparations
Methods of determining
Particle Size
Sieving

• in which particles are passed

by mechanical shaking
through a series of sieves of
known and successively
smaller size and the
proportion of powder passing
through or being withheld on
each sieve is determined.
Microscopy
• in which sample particles are sized
through the use of a calibrated grid
background or other measuring device
Sedimentation rate

• in which particle size is determined by

measuring the terminal settling velocity
of particles through a liquid medium in a
gravitational or centrifugal environment.
• Sedimentation rate may be calculated
from Stokes’ law.
Light Energy Diffraction

• Light energy diffraction or light

scattering, in which particle
size is determined by the
reduction in light reaching the
sensor as the particle,
dispersed in a liquid or gas,
passes through the sensing
zone
• Laser scattering utilizes a He-
Ne laser, silicon photo diode
detectors, and an ultrasonic
probe for particle dispersion
Laser Holography

• in which a pulsed laser is fired

through an aerosolized
particle spray and is
photographed in three
dimensions with a holographic
camera, allowing the particles
to be individually imaged and
sized
Cascade impaction

• which is based on the principle

that a particle driven by an
airstream will hit a surface in
its path, provided its inertia is
sufficient to overcome the
drag force that tends to keep it
in the airstream
• Particles are separated into
various size ranges by
successively increasing the
velocity of the airstream in
which they are carried.
Medicated Powders

• Some medicated powders are intended to be used

internally and others, externally. Most powders for
internal use are taken orally after mixing with water
or in the case of infants in their infant formulas.
• Other dry powders are commercially packaged for
constitution with a liquid solvent or vehicle, some for
administration orally, others for use as an injection,
and still others for use as a vaginal douche.
• Medicated powders for external use are dusted on
the affected area from a sifter-type container or
applied from a powder aerosol.
External Use Powder

• Medicated powders for external use are

dusted on the affected area from a
sifter-type container or applied from a
powder aerosol. Powders intended for
external use should bear a label marked
external use only or a similar label.
Medicated powders for Oral Use

• Medicated powders for oral use may be intended for local

effects (e.g., laxatives) or systemic effects (e.g.,
analgesics). and may be preferred to counterpart tablets
and capsules by patients who have difficulty swallowing
solid dosage forms.
• For administration, they can be mixed with a liquid or soft
food. Powders taken orally for systemic use may be
expected to result in faster rates of dissolution and
absorption than solid dosage forms, because there is
immediate contact with the gastric fluids.
Caveats

• A primary disadvantage of the use of oral powders is the

undesirable taste of the drug.
• Some medications, notably antibiotics for children, are intended
for oral administration as liquids but are relatively unstable in
liquid form.
• They are provided to the pharmacist by the manufacturer as a
dry powder or granule for constitution with a specified quantity
of purified water at the time of dispensing.
• Under labeled conditions of storage, the resultant product
remains stable for the prescribed period of use, generally up to
2 weeks
Aerosol Powders
• Some medicated powders are administered by inhalation
with the aid of dry-powder inhalers, which deliver
micronized particles of medication in metered quantities
Insufflators

• Powder blowers or
insufflators may be used to
deliver dry powders to various
parts of the body, e.g., nose,
throat, lung, vagina.
Depression of the device’s
rubber bulb causes turbulence
of the powder in the vessel,
forcing it out through the
orifice in the tip.
 • Bulk Powders
• Among the bulk powders available in
prepackaged amounts are (a) antacids
(e.g., sodium bicarbonate) and laxatives
(e.g., psyllium [Metamucil]), which the
patient takes by mixing with water or
Bulk and another beverages before swallowing; (b)
douche powders (e.g., Massengill
Divided powder), dissolved in water for vaginal
use.
Powders • Dispensing powder medication in bulk
quantities is limited to non potent
substances. Powders containing
substances that should be administered in
controlled dosage are supplied to the
patient in divided amounts in folded
papers or packets.
Divided powders

• After a powder has been properly

blended (using the geometric dilution
method for potent substances), it may
be divided into individual dosing units
based on the amount to be taken or
used at a single time. Each divided
portion of powder may be placed on a
small piece of paper (Latin : Chartula).
Granules
Granules

• As indicated previously, granules are prepared

agglomerates of smaller particles of powder.
• They are irregularly shaped but may be prepared to be
spherical. They are usually in the 4- to 12-mesh sieve size
range.
Preparation of Granules

One basic wet method is to moisten the powder or

powder mixture and then pass the resulting paste
through a screen of the mesh size to produce the
desired size of granules.

Then the granules are dried, with usual movement to

prevent clumping into a large mass.
• Another type of wet method is
fluid bed processing, in which
particles are placed in a conical
piece of equipment and are
vigorously dispersed and
suspended while a liquid excipient
is sprayed on the particles and
the product dried, forming
granules or pellets of defined
particle size
Dry granulation

• By one method, the dry powder is passed through a roll

compactor and then through a granulating machine. A roll
compactor, also called a roll press or roller compactor,
processes a fine powder into dense sheets or forms by
forcing it through two mechanically rotating metal rolls
running counter to each other.
• The compacted powder is granulated to uniform particle
size in a mechanical granulator. Powder compactors are
generally combined in sequence in integrated compactor–
granulation systems.
An alternative dry method, termed slugging, is the compression of
a powder or powder mixture into large tablets or slugs on a
compressing machine under 8,000 to 12,000 lbs of pressure,
depending on the physical characteristics of the powder

The slugs are granulated into the desired particle size, generally for
use in the production of tablets.
Benefits of granules

• Granules flow well compared to powders. For

comparison, consider the pouring and flowing
characteristics of granulated sugar and powdered sugar.
Because of their flow properties, granulations are
commonly used in tablet making to facilitate free flow of
material from the feeding container (or hopper) into the
tablet press
• Because their surface area is less than that of a
comparable volume of powder, granules are usually more
stable to the effects of atmospheric humidity and are less
likely to cake or harden upon standing.
• Granules also are more easily wetted by liquids than are
certain light and fluffy powders (which tend to float on the
surface) and are often preferred for dry products intended
to be constituted into solutions or suspensions.
• A number of commercial products containing antibiotic
drugs that are unstable in aqueous solution are prepared
as small granules for constitution by the pharmacist with
purified water just prior to dispensing.
Effervescent Granulated Salts

• Effervescent salts are granules or coarse to very coarse powders

containing a medicinal agent in a dry mixture usually composed of
sodium bicarbonate, citric acid, and tartaric acid
• When added to water, the acids and the base react to liberate carbon
dioxide, resulting in effervescence. The resulting carbonated solution
masks undesirable taste of any medicinal agents
• Using granules or coarse particles of the mixed powders rather than
small powder particles decreases the rate of solution and prevents
violent and uncontrollable effervescence.
Dry or Fusion Method

• In the fusion method, the one molecule of water present in each

molecule of citric acid acts as the binding agent for the powder mixture
Wet Method

• The wet method differs from the fusion method in that the
source of binding agent is not the water of crystallization
from the citric acid but the water added to alcohol as the
moistening agent, forming the pliable mass for granulation