Rudra Narayan Sahoo

PHARMACEUTICAL POWDERS
 Historically, powders represent one of the' oldest
dosage forms.
 A pharmaceutical powder is solid dosage form which
contains mixture of finely divided drugs or chemicals in a
dry form meant for internal or external use.
 It is a preparation in which drug is blended with other
powdered substances and used for internal or external
purpose.
 Powder as a dosage form permits drugs to be reduced to a
very fine state of division, which often enhances their
therapeutic activity or efficacy by an increase of dissolution
rate and/or absorption.
 Divided powders are also found to be convenient for
administering drugs that are excessively bitter, nauseous,
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or otherwise offensive to the taste.

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POWDERS
 Although powders are not used now-a-day’s extensively as a
dosage form, they are widely used in preparation of various
dosage forms
 Powdered drugs can be blended with . other powdered
materials (additives) prior to fabrication into other solid
dosage forms such as tablet and capsule
 Powdered drugs are frequently added to other ingredient to
make ointments, pastes, suppositories, and others
 Powder properties relevant to pharmaceutical formulations
are single particle (fundamental) properties and bulk (derived)
properties
 Collectively these includes particle-particle interactions,
powder morphology (particle size, specific surface area,
porosity, and particle shape), and mixing and blending
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properties (types of mechanism of mixing. types‘ mixing

equipment, and minimizing segregation tendencies)
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POWDERS
 It is also important for preparing powder formulation to understand
hoppers and powder transfer method, mechanisms of particle size
reduction, and various types of mills used.
 Powders are subdivided solids which are classified in the BP
according to the size of their constituent particles ranged from
1.25 mm to 1.7 mm in diameter.
 A good powder formulation has a uniform particle size distribution. If
the particle size distribution is not uniform, the powder can segregate
as per to particle size which may result in inaccurate dosing or
inconsistent performance.
 A uniform particle size distribution ensures a uniform dissolution
rate if the powder is to dissolve, a uniform sedimentation rate if
the powder is used to remain in a suspension, and minimizes
stratification when powders are stored or transported.
 Reduction in particle size of a powder results in-a uniform
distribution of particle size‘
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 The process of reducing the particle size is called comminution.

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PHARMACEUTICAL POWDERS
In extemporaneous compounding, there are three methods of
comminution:
Trituration:- Trituration is the continuous rubbing or grinding of
the powder in a mortar with a pestle.
This method is used when working with hard, fracturable
powders.
Pulverization by intervention:- Pulverization by intervention
method is used with hard crystalline powders that do not crush or
triturate easily, or gummy-type substances.
The first step is to use an "intervening" solvent (such as
alcohol or acetone) that will dissolve the compound.
The dissolved powder is then mixed in a mortar or spread on
an ointment slab to enhance the evaporation of the solvent.
As the solvent evaporates, the powder will recrystallize out of
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solution as fine particles.

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PHARMACEUTICAL POWDERS
Levigation:- Levigation reduces the particle size by
triturating it in a mortar or spatulating it on an ointment
slab or pad with a small amount of a liquid in which the
solid is not soluble.
The solvent should be somewhat viscous such as
mineral oil or glycerin.
This method is also used to reduce the particle size of
insoluble materials when compounding ointments and
suspensions.
Advantages:-
(i) Drugs that have to be given in bulk can be best
administered in powder form by mixing them with
food or drinks.
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(ii) Useful for bulky drugs with large dose.

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POWDERS
(iii) Powders are more stable than liquid dosage form; hence
many antibiotics and injections are manufactured as powder
for reconstitution in respective vehicle.
(iv) More convenient to swallow than tablet or capsules.
(v) Powder possesses good chemical stability.
(vi) Since powders are in the form of small particles; they
offer a large surface area and are rapidly dissolved in the
gastrointestinal tract minimizing the problems of local
irritation.
(vii) Rapid dissolution powder facilitates rapid
absorption.
(viii) Highly compatible compared to liquid dosage tom.
(ix) Manufacturing of powder is economic hence product
coat is quite low as compared to other dosage forms.
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PHARMACEUTICAL POWDERS
Disadvantages:-
(i) Bulk powders are not suitable for administering potent drug
with low dose.
(ii) Not suitable for drugs which are unstable in normal
atmospheric condition
(iii) Powder form is not suitable for drugs that are inactivated
in. or cause damage to stomach: these should he presented as
enteric-coated tablets.
(iv) Not suitable for bitter. nauseating and corrosive drugs,
if are meant tor oral administration.
(V) The masking unpleasant tastes may be a problem with this
type of preparation a method of attempting this is by
formulating the powder‘ into a pleasantly tasting or taste-
masked effervescent product. whereas tablets and capsules are a
more common alternative for low-dose products
(vi) inaccuracy of dose in case of bulk powder.
(vii) inconvenient to carry.
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(viii) They are susceptible to physical instability

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PHARMACEUTICAL POWDERS
CLASSIFICATION OF POWDERS
1.Powders for internal use
(a) Divided powders
(i) Simple powders
(ii) Compound powders
(iii) Powders enclosed in cachet
(iv) Tablet triturates
(b) Bulk powders
(i) Antacid
(ii) Laxative
2. Powders for external use
(a) Dusting powders
(i) Medicated dusting powders
(ii) Surgical dusting powders
(b) insufflations
(c) Douche powder
(d) Dentifrices
3. Special powders
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(a) Eutectic mixtures

(b) Effervescent powders
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POWDERS
1.Powders for Internal use/Oral powders
According to Indian Pharmacopoeia 2007, oral powders
are finely divided powders that contain one or more
medicaments with or without auxiliary substances
including, where specified,flavouring and coloring
agents. However, addition of saccharin or its salts it not
permitted in the preparations meant for pediatric use.
They are intended to be take‘ internally with or without
the aid of water or any other suitable liquid.
(a) Divided powders:
Divided powders (or charta) are single doses of
powdered drugs individually wrapped in cellophane,
metallic foil, or paper.
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POWDERS
The divided powder is a more accurate dosage form than bulk
powder because the patient is not involved in measurement of
the dose.
Cellophane and foil-enclosed powders are better protected
from the external environment until the time of administration
than paper-enclosed powders.
Divided powders are commercially available in foil,
cellophane or paper packs.
(i) Simple powder:
it consists of only one active ingredient and suitable inen
substances. If powder is in crystalline form, then it is reduced
to fine.
Example;-
Aspirin Powder, Calcium Gluconate Powder etc.
Aspirin powder -300 mg
Procedure: Triturate aspirin so as to get fine powder.
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Weigh the calculated amount of aspirin powder. Wrap each

dose in individual powder paper and pack it.
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POWDERS
(ii) Compound powder:
It consists of mixture of more than one active
ingredient and other constituents.
Example:
1. Aspirin, Paracetamol and Caffeine Powder
Aspirin-300 mg
Paracetamol-150 mg
Caffeine-50 mg
Procedure:
Triturate all the ingredients separately so as to get fine
powder.
Weigh the calculated amount of aspirin powder;
paracetamol powder and caffeine powder and mix
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them in ascending order of their weight.

Wrap each dose in individual powder paper.
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POWDERS
2. Macrogol Compound Oral Powder
Each sachet contains the following
quantitative composition of active
ingredients:
Sodium chloride -0.3507g
Sodium hydrogen carbonate-0.1785g
Potassium chloride-0.0466g
Macrogol 3350-13.125g
Macrogol compound Oral Powder is a laxative
prescribed for the treatment of long-term
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constipation.
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POWDERS
(iii) Powders enclosed in cachet:
Cachets consist of a dry powder enclosed in a shell, usually
prepared from a mixture of rice flour and water by molding
into a suitable shape and drying.
They are quite useful for administering the drugs with
nauseating and unpleasant taste and a large dose can be
enclosed in a cachet than in a tablet or capsule.
A cachet offers little protection against light -and
moisture.
Now-a-days cachets are replaced by capsule. There are two
types of catches:
Wet cachets:
Lower half of the cachet is filled with powdered drug,then
the flange of the empty upper half of the cachet is
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moistened with water and pressed over the lower half.

The cachet is dried for 15 minutes.
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POWDERS
Dry cachets:
Drug powder is filled in the lower half and the
upper half is pressed over it just like a capsule.
They are used for administering the drug with
unpleasant taste and a large dose.
Before administration, a cachet should be immersed
in water for few seconds and then placed on the
tongue and swallowed with water.
Example:-
Sodium Amino salicylate Cachets,
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Sodium Amino salicylate with lsoniazid

Cachets.
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POWDERS
(iv) Tablet triturates:
Tablet triturates are powders molded into
tablets.
Tablet triturates are generally prepared by mixing
the active drug with lactose, dextrose, sucrose,
mannitol, or some other appropriate diluents that
can serve as the base.
This base must be readily water soluble and
should not degrade during the tablet's
preparation.
Lactose is the preferred base but mannitol
adds a pleasant, cooling sensation and
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additional sweetness in the mouth

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POWDERS
The base ordinarily used for molded tablet
triturates is lactose containing 10% 20%
sucrose, the latter being added to make a
firmer tablet.
Drugs that react chemically with sugars
require special bases such as precipitated
calcium carbonate, precipitated calcium
phosphate, kaolin, or bentonite.
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POWDERS
A liquid is added to moisten the powder mixture
so it will adhere while being pressed into the mold
cavities.
Mixtures of alcohol and water in varying proportions
(typically about 50 80% alcohol) are employed; the
alcohol will speed-up the drying of the liquid and the
water will cause the sugars to dissolve and bind the
tablet.
If the tablet contains ingredients that are very
soluble in water, water can be omitted altogether
and alcohol alone can be used.
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POWDERS
Tablet triturates are used for oral administration or
sublingual use
(For example, nitroglycerin tablets)
They may also be used in compounding procedures
by pharmacists in the preparation of other solid or
liquid dosage forms.
They can be inserted into capsules, and this eliminates
the problems of measuring the accurate amount of
potent drugs in the powder form.
Example:
Propranolol Scopolamine Tablet Triturate
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Propranolol hydrochloride 40 mg Scopolamine

hydrobromide 0.5 mg
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POWDERS
(b) Bulk powder
Bulk powders are non-potent and can be closed with
acceptable accuracy and safety using measuring
devices such as the teaspoon, cup, or insufflators.
The mixed ingredients are packed into a suatable
bulk container, such as a wide- mouthed glass jar.
Because of the disadvantages of this type of
Preparation the constituents are usually relatively
non-toxic medicaments with a large dose.
This practically limits the use Of orally
administered bulk Powders to antacids, dietary
supplements, laxatives, and a few analgesics,
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POWDERS
(I) Antacid
Example:
Magnesium Trisilicate Compound Oral Powder BP
Magnesium trisilicate-250 mg
Chalk-250 mg
Heavy magnesium carbonate-250 mg
Sodium bicarbonate-250 mg
All powders are sieved using 250 um sieve and mixed
well by triturating them in mortar. The final product
is packed in amber colored glass jar or plastic
container with screw cap.
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Use:- For relief of the symptoms of indigestion,

heartburn and dyspepsia.
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POWDERS
(ii) Laxative Example:
Polyethylene Glycol 3350 NF Powder for Oral
Solution
Polyethylene glycol 3350-13.125 9
Sodium chloride-350.7 mg
Sodium hydrogen carbonate-178.5 mg
Potassium chloride-46.6 mg
Polyethylene glycol 3350 NF powder for oral
solution is an osmotic agent which causes water to
be retained with the stool and used for the treatment
of constipation. it is supplied in powdered form, for
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oral administration after dissolution in water, juice,

soda, coffee, or tea.
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POWDERS
2. Powders for external use
(a) Dusting powders
Dusting Powders are externally used bulk powders.
They are free flowing very fine powders containing
antiseptics, antipruritics, astringents, antiperspirants,
absorbents, lubricants etc.
(i) Medicated dusting powders:
Medicated dusting powders are sterile ones and
meant for application on superficial skin.
Body dusting powders have a wide appeal because of
smooth feel and cooling effect, which they impart while
they temporarily absorb moisture.
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The cooling effect is due to extra heat loss due to large

surface area of talc particles.
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POWDERS
Talc-51 g
Kaolin-15g
Precipitated chalk-21g
Zinc stearate-3g
Boric acid-5g
Salicylic acid-5g
Perfume Quantity sufficient
Talc in a major ingredient in medicated dusting powder
formulation, which should have good slip characteristics,
covering power and body adhesion.
The slip and adhesion properties of medicated dusting
powder essentially depend on talc. it is essential to use grid
and alkali free high quality cosmetic talc in preparation of
medicated dusting powder.
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Talc should be free from bacteria and therefore

sterilized grades should only be used.
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POWDERS
In order to improve adhesion properties, metallic
stearates such as zinc stearate or magnesium stearate
and kaolin are incorporated.
To improve absorbency, magnesium carbonate,
starch, kaolin and precipitated chalk are used in
combination.
Zinc oxide and titanium dioxide, at low levels along with
earth colors can be incorporated and should be
sufficiently powerful to cover the base odour.
Other ingredients sometimes included are boric acid to
act as skin buffering agent and fused silica to give
powder a lower density; salicylic acid for antibacterial
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action. Aluminum chloride is also incorporated as an

antiperspirant
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POWDERS
(ii) Surgical dusting powders:
Surgical dusting powders are intended to be used into
deep layer of skin and also on major wounds as a
result on burns and umbilical cords of infants.
Surgical dusting powders must be free from
pathogenic microorganism and hence it must be
sterilized before their use.
The dusting powders are mainly used for their
antiseptic, astringent, absorbent, antiperspirant, and
antipruritl'c action.
It mainly contains antimicrobial agents like
chlorhexidine and hexachlorophene.
They are generally prepared by mixing two or
more ingredients one of which must be starch, talc
or kaolin as one of the ingredients of the
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formulation.
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POWDERS
Talc is more commonly used because of its
chemical inertness.
However, since such ingredients are readily
contaminated with pathogenic bacteria, these must
be sterilized by dry heat method before use.
Dusting powders are dispensed in Sifter-top
container or aerosol containers.
It may also be applied with powder puff or
sterilized gauze pad.
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POWDERS
Example:
Neosporin Dusting Powder
Neosporin dusting powder is composed of the
following active ingredients (salts)
Bacitracin (5000 IU)
Neomycin (3400 IU)
Polymyxin B (400 IU)
Bacitracin topical is used alone or in combination
with neomycin and polymyxim treat and prevent
superficial and minor skin infections due to wounds,
cuts burns.
Bacitracin belongs to the class of medications called
polypeptide antibiotics It acts by inhibiting the
growth of bacteria in the wounds thereby relieving
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associated symptoms
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POWDERS
Neomycin belongs to the class of medications called it antibiotics. it prevents
the bacterial growth by stopping the production of essential protein in the
bacterial cells, thereby relieving the associated symptoms.
Polymyxin B belongs to a group of medications called as polypeptide
antibiotic. It works by killing the bacteria that causes the infection.
(b) lnsufflations
lnsufflations are medicated dusting powders meant for introduction into
the body cavities such as nose. throat, ears, etc. with the help of an
apparatus known as insufflators (powder blower).
lt sprays the powder into a stream of finely divided particles all over the
site of application.
The insufflations are used to produce a local effect, as in the treatment
of ear, nose and throat infection with antibiotics or to produce a
systemic effect from a drug that is destroyed in the gastrointestinal
tract.
As like aerosols, uniform dose may not be obtained by insufflations.
Examples:
Cromolyn Sodium Powder,
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Compound Clioquin Powder USP

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POWDERS
(c) Douche powder
Douche powders are intended to be used as antiseptics or
cleansing agents for a body cavity; most commonly for vaginal
use, although they may be formulated for nasal, otic or
ophthalmic use also.
As douche powder formulation often include aromatic oils. it
becomes necessary to pass them through a sieve 40 or 60 to
eliminate agglomeration and to ensure complete mixing.
They can be dispensed either in wide mouth glass bottles or in
powder boxes but the former are preferred because of
protection afforded against air and moisture.
Example:
Douche powder
Zinc sulphate Magnesium sulphate
Boric acid
Lemon oil
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Purified water
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POWDERS
(d) Dentifrices
Dentifrices are preparations meant to clean the
teeth and other parts of oral cavity (gums) using a
finger or a toothbrush.
They are available as tooth powder, toothpastes,
gels, dental creams and even as dental foams.
They are meant to enhance the personal
appearance of the teeth (daily removal of
pellicles) by maintaining cleaner teeth.
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POWDERS
Reduction of bad odour (removal of putrifying food
particles from spaces between teeth) and also make
the gum healthy.
They contain a suitable detergent or soap, some
abrasive substance and a suitable flavour.
The abrasive agents such as calcium sulphate,
magnesium carbonate, sodium carbonate and
sodium chloride are used in fine powder form.
A strong abrasive substance should not be used as it
may damage the tooth structure.
The main components of toothpowders are solid
particles of very fine size and the end product is also a
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very dry powder.

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POWDERS
Since the main components like abrasives, surface active
agent are solid powders, it is required that they all are in
very fine particle size, comminuted, if desired, passed
through a sieve and mixed in a mortar in the lab scale
and in blenders on an industrial scale.
The flavoring oils are added at the end either by
spraying on the powder mixture orfnrst blending with
one of the components and then mixing this blend to
the rest of the mixture by the method of dilution or
geometric proportion.
Hard soap (in fine powder) -50g
Precipitated calcium carbonate -935g
Saccharine sodium -2g
Peppermint oil -4ml
Cinnamon oil -2ml
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Methyl salicylate- 8ml

To make-about -1000g
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POWDERS
3. Special powders
(a) Eutectic mixtures:
Eutectic mixtures are defined as mixtures of low melting point
ingredients which on mixing together turn to liquid form due to
depression in melting point of the mixture below room temperature.
They are mixtures of substances, that liquefy when mixed,
rubbed or triturated together.
The melting points of many eutectic mixtures are below room
temperature.
Examples of the substances which tend to liquefy on mixing are
camphor, thymol, menthol, salol.
Any two of these drugs turn to liquid when mixed.
This problem during formulation of powders of such material can
be solved by using inert adsorbent such as starch, talc, lactose to
prevent dampness of the powder and dispensing the components of
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the eutectic mixture separately.

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POWDERS
(b) Effervescent powders:
Effervescent powders contain materials which react
in presence of water evolving carbon dioxide.
This class of preparations can be supplied
either by compounding the ingredients as
granules or dispensed in the form of salts.
For evolution of the gas two constituents are
essential, a soluble carbonate such as sodium
bicarbonate and an organic acid such as citric or
tartaric acid.
The preparation can be supplied either as a
bulk powder or distributed in individual
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powders.
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POWDERS
There are three alternative methods of dispensing
effervescent powders based upon th‘ nature of
prescription.
1f the effervescent salts are prescribed to be dispensed
in bulk form, no granulation is necessary.
The ingredients are mixed uniformly and directions
stated on the labgl to add the prescribed quantity to
water, before use.
(ii) If the effervescent salt is prescribed in divided doses, the
ingredients which cause effervescence on mixing with water
are enclosed separately in papers of different color.
The patient is advised to take one powder of each color and
add to water before use.
Quantities of the sodium bicarbonate and the organic
acid, citric q; tartaric, are equimolecular in proportion.
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(iii) In the third case, the product contains all the ingredients
mixed together in t granular form.
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POWDERS
PREPARATION OF POWDERS
Particle size reduction: For preparation of powder, each ingredient
should be needed in finely ground form; hence manufacturer must
use a number of procedures and equipment to reduce the particle
size of powder ingredients, this process is called as comminution.
The most common method used for particle size reduction in
powder formulation is trituration which involves placing the solid
in a mortar and continually grinding the chemical between the
mortar and the pestle using a firm, downward pressure.
The powder must be frequently scraped from the sides of the
mortar to ensure that all particles are evenly reduced and mixed.
A levigatingl agent, such as glycerin, may be added to the solid and
processed by either continued trituration or by placing the mixture
on an ointment slab and using spatulation to wet the solid and
further reduce the particle size.
A small mesh sieve can be used to determine the prevalent
particle size of a powder after it has been tritu rated.
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POWDERS
Preparing a homogenous mixture:
Particle size reduction is followed by homogeneous mixing of all powder
ingredients. Many times processes similar to those used for particle size
reduction are used for obtaining homogenous mixture.
Powders that have been blended with a protectant to prevent the formation
of a eutectic mixture must be mixed carefully with little or no pressure.
Spatulation, or the mixing of particles with a spatula on an ointment slab,
results in a light, wellmixed powder without interfering with the protectant.
Trituration serves the dual purpose of reducing particle size and
mixing powders.
It is especially effective for mixing small quantities of potent drugs with
larger amounts of diluents. Hazardous substances can be effectively mixed
by a process called tumbling.
The powders are sealed in zipper-sealed bags or clear bottles with a
lid and tumbled until they are well mixed.
The addition of a coloring agent can assist in determining homogeneity in
the mixture. If powders being combined are unequal in quantity, then
geometric dilution method is
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POWDERS
Geometric dilution:
Geometric dilution is the process by which a homogenous
mixture or even distribution of two or more substances is
achieved. This method is used when potent substances must be
mixed with a large amount of diluent.
The potent drug and an approximately equal volume of
diluent are placed in a mortar and thoroughly mixed by
trituration.
A second portion of diluent, equal in volume to the powder
mixture in the mortar is added, and trituration is repeated.
The process is continued; equal volumes of diluent are added
to the powder mixture in the mortar until all of the diluent is
incorporated.
For example, if dose of potent drug is 120 mg, while mixing
entire quantity (120 mg) of potent drug is taken and to it 120
mg of the diluents are added and mix thoroughly.
The resulting 240 mg mixture of potent drug and diluents is
again mixed with further 240 mg of diluents and the process is
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repeated until all the diluents are incorporated

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POWDERS
(iv) Packaging of powders:
Bulk powders for external use (sometimes called dusting
powders) are often dispensed in a shaker-top container to
facilitate topical application. T
hey may also be dispensed in a wide-mouth jar or a plastic
container with a flip-top lid.
The jar or plastic container can be closed tightly to provide
increased stability and protection from light and moisture,
especially for compounds that contain volatile ingredients.
Package should contain label as "For external use only”.
Bulk powders intended for internal use should be dispensed in an
amber colored, wide-mouth powder jar with a tight-fitting lid.
They should be accompanied by an appropriately sized dosing
spoon or cup and adequate directions for removing and
administering a correct dose.
Bulk powders for internal use should be labeled with the
strength of the active ingredient per dose (e.g., Potassium
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chloride 600 mg per tablespoonful). sis” mamas ’. for

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POWDERS
PROBLEMS ENCOUNTERED IN POWDER
FORMULATION
Efflorescent powders
Hygroscopic powders and deliquescent powder
Incorporation of liquids
Incorporation of extracts
Incompatible salts
Expensive mixtures
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POWDERS
Evaluation of powder
Content uniformity
Particle size and size distribution
Flow property
Angle of repose
Flow rate
Density
Bulk density
Tapped density
True density
Hausner’s ratio
Moisture content
Tensile and cohesive strength measurements
Safety and efficacy
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stability