DEFINITION !?

Powders are mixtures of dry, finely divided drugs and/or

chemicals that may be intended for internal or external
use.
The term ‘Powder’ may be used to describe:
The physical form of a material, that is, a dry substance
composed of finely divided particles.
Or, it may be used to describe a type of pharmaceutical
preparation, that is, a medicated powder intended for:
internal (i.e., oral powder)
external (i.e., topical powder) use.
 COMMINUTION OF DRUGS

The process of reducing the particle size of a

solid substance
Objectives of Comminution
• Facilitate crude drug extraction
• Increase the dissolution rates of drugs
• Aid in the formulation process
• Enhance absorption
 COMMINUTION OF DRUGS

On a small scale, a pharmacist can reduce the particle

size of powders by
1. Trituration
2. Pulverization
3. Levigation
1. Trituration is the grinding of powders with a mortar and
pestle.
A finer grinding action is accomplished by using a mortar
with a rough surface (as a porcelain mortar) than one
with a smooth surface (as a glass mortar).
 PULVERIZATION
Pulverization is the process in which a volatile
solvent is added during trituration of solids to
reduce its particle size. Pulverization
For example Camphor, which cannot be
pulverized easily by trituration because of its
sticky properties; however, on the addition of a
small amount of alcohol or other volatile
solvent, this compound can be reduced readily
to a fine powder because when the solvent is
permitted to evaporate a fine powdered
material is formed.
 LEVIGATION
Levigation is the process in which a non-solvent (the levigating agent) is
added to solid material to form a paste, and particle-size reduction
then is accomplished by rubbing the paste in a mortar with a pestle
or on an ointment slab using a spatula.
Levigation is commonly used in small-scale preparation of ointments
and suspensions to reduce the particle size and grittiness of the
added powders.
1. A paste is formed by combining the powder and a small amount of
liquid (the levigating agent) in which the powder is insoluble.
2. The paste is then triturated, reducing the particle size.
3. The levigated paste may then be added to the ointment base and the
mixture made uniform and smooth by rubbing them together with a
spatula on the ointment tile.
Mineral oil and glycerin are commonly used levigating agents.
On a large scale, various types of mills and pulverizers may be
used to reduce particle size.
The following figure shows one such piece of equipment, a
FitzMill comminuting machine with a product containment
system.
Principle:
Through the grinding action of rapidly moving blades in the
comminuting chamber, particles are reduced in size
and passed through a screen of desired dimension to the
collection container.
 BLENDING POWDERS
When two or more powdered substances are to be combined to
form a uniform mixture, it is best to reduce the particle size of
each powder individually before weighing and blending.

Depending on the nature of the ingredients, the amount of

powder, and the equipment, powders may be blended by
spatulation, trituration, sifting, and tumbling.
 • SPATULATION
Spatulation is blending small amounts of
powders by movement of a spatula
through them on a sheet of paper or an
ointment tile.
It is not suitable for large quantities of
powders or for powders containing potent
substances, because homogeneous
blending is not as certain as other
methods.
 EUTECTIC MIXTURES
Very little compression or compacting of the powder results from
spatulation, so it is suited to mixing solid substances that form eutectic
mixtures.
Eutectic mixtures are solids when in close and prolonged contact with one
another liquefy. Substances that form eutectic mixtures when combined
include phenol, camphor, menthol, thymol, aspirin, phenyl salicylate,
and other similar chemicals.
To diminish contact, a powder prepared from such substances is commonly
mixed in the presence of an inert diluent, such as light magnesium oxide
or magnesium carbonate, to separate physically the troublesome agents.
 TRITURATION
Trituration may be employed both to comminute and
to mix powders. If simple admixture is desired
without the special need for comminution, the
glass mortar is usually preferred.
When a small amount of a potent substance is to be
mixed with a large amount of diluent, the
geometric dilution method is used to ensure the
uniform distribution of the potent drug.
Geometric method is especially indicated when the
potent and other ingredients are the same color
and a visible sign of mixing is lacking.
 STEPS OF GEOMETRIC BLENDING

In the geometric method,

1. the potent drug is placed on an approximately equal volume of
the diluent in a mortar and mixed by trituration.
2. Then, a second portion of diluent equal in volume to the
mixture is added, and the trituration repeated
3. This process is continued by adding equal volumes of diluent to
the powder mixture and repeating until all of the diluent is
incorporated.
4. Some pharmacists add an inert colored powder to the diluent
before mixing to permit visual inspection of the mixing
process.
 SIFTING

Special small-scale and large-scale motorized

powder blenders are available to mix powders
(sifting and tumbling).
Powders may also be mixed by passing them
through sifters like those used in the kitchen to
sift flour.
Sifting results in a light, fluffy product.
This process is not acceptable for the
incorporation of potent drugs into a diluent
powder.
 TUMBLING
Another method of mixing powders is
tumbling the powder in a rotating chamber.
Special small-scale and large-scale motorized
powder blenders mix powders by tumbling
them.
Mixing by this process is thorough but time
consuming.
Such blenders are widely employed in
industry, as are mixers that use motorized
blades to blend powders in a large vessel.
Double Cone Tumbling Mixer V Type Pharmaceutical Mixer
Planetary Mixers
 POWDERS
Powders are intimate mixtures of dry, finely divided drugs and/or
chemicals that may be intended for internal or external use.
 ADVANTAGES OF MEDICATED POWDERS
1. Medicated powders for oral use may be intended for local
effects (e.g., laxatives) or systemic effects (e.g., analgesics)
2. They may be preferred to counterpart tablets and capsules by
patients who have difficulty swallowing solid dosage forms.
3. The doses of some drugs are too bulky to be formed into
tablets or capsules of convenient size, so they may be
administered as powders.
4. 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.
 TYPES OF MEDICATED POWDERS
Medicated powders are of three types:
1) Bulk Powders
2) Divided Powders
3) Dusting Powders
4) Douche Powders
5) Insufflations
6) Dry Powder Inhalers
7) Powders requiring Reconstitution
 MEDICATED POWDERS
1. 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.
2. Some powders are intended to be inhaled for local and systemic
effects.
3. Other dry powders are commercially packaged for reconstitution 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.
4. 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.
CONTINUED..
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.
 1) BULK POWDERS
The mixed ingredients are packed into a suitable bulk container, such
as a wide-mouthed glass jar. Patients take this powder with a 5 ml
spoon and dissolve it in water before use.
The constituents of bulk powders are usually relatively non-potent and
non-toxic medicaments with a large dose.
 EXAMPLES OF 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
another beverages before swallowing
b. Douche powders: dissolved in warm water by the patient for vaginal
use
c. Medicated powders for external application to the skin, usually
topical anti-infectives (e.g., bacitracin zinc and polymyxin B sulfate)
or antifungals (e.g., tolnaftate)
In some cases, a small measuring scoop, spoon, or other device is
dispensed with the powder for measuring the dose of the drug.
 IMPORTANT NOTES ABOUT BULK POWDERS
Dispensing powder medication in bulk quantities is limited to non-potent
substances.
Patients should be educated about appropriate handling, storage,
measurement, and preparation of bulk powder prescription and
nonprescription products in addition to the customary counseling at the
time of dispensing or purchase.
Generally, these products are stored at room temperature in a clean, dry
place.
These products should be kept out of the reach of children and animals.
Patients should be instructed how to measure the appropriate amount of
the powder and be told the type of liquid or vehicle to use to deliver the
medication consistent with package and/or physician instructions.
 2) DIVIDED POWDERS
Divided powders are dispensed in the form of individual doses. They are
dispensed in papers (properly folded), metal foil, small heat-sealed plastic
bags, sachet or other containers.
Hygroscopic and volatile drugs can be protected best by using a waxed paper,
double-wrapped with a bond paper to improve the appearance of the
completed powder.
Effervescent powders can now be packed in units because of the protective
qualities of laminates. Effervescent powders contain sodium bicarbonate
with a mixture of citric and tartaric acids, which react and effervesce when
the patient adds the powder to water to produce a draught. Effervescent
powders should be protected from moisture during manufacture and on
subsequent storage to prevent the reaction occurring prematurely.
 PACKAGING MATERIALS
The selection of the type of paper is based primarily on the nature
of the powder.
 If the powder contains hygroscopic materials, waterproof or
waxed paper should be used.
 Powders containing volatile components should be wrapped in
waxed or glassine papers.
 Powders containing neither volatile components nor ingredients
adversely affected by air or moisture are usually wrapped in a
white bond paper
 3) DUSTING POWDERS
Dusting powders are normally dispensed in glass or metal containers
with a perforated lid. The powder must flow well from such a
container, so that they can be dusted over the affected area. The
active ingredients must therefore be diluted with materials having
reasonably good flow properties, e.g. talc or maize starch.
Dusting powders contain ingredients used for therapeutic, prophylactic
or lubricant purposes and are intended for external use.
A. Dusting powders for lubricant purposes or superficial skin conditions
They do not need to be sterile but they should be free from pathogenic
organisms. Talc Dusting Powder is used as a lubricant to prevent
chafing
 EXAMPLES OF DUSTING POWDER
B. Dusting powders for wounds
Only sterile dusting powders should be applied to open wounds.
They should be prepared using materials and methods designed to
ensure sterility and to avoid the introduction of contaminants and the
growth of microorganisms.
Dusting Powder contains an anti-microbial agents are used for the
treatment of bacterial or fungal infections,
e.g. Canesten Powder (clotrimazole) is used as an antifungal agent and
chlorhexidine acetate is used as a general skin disinfectant
 4) DOUCHE POWDERS
Douche powders are completely soluble and are dissolved in
water prior to use as antiseptics or cleansing agents for a body
cavity.
They most commonly are intended for vaginal use, although they
may be formulated for nasal, otic, or ophthalmic use.
Douche powders may be packaged as bulk or divided powders.
 5) INSUFFLATIONS
Insufflations are medicated powders which are blown
into regions such as the ear, nose and throat using
an insufflator.
Some potent drugs are now presented in this way
because they are rapidly absorbed when
administered as a fine powder via the nose.
Sufficient drug for one dose may be presented in a
hard gelatin capsule diluted with an inert, soluble
diluent such as lactose. The capsule is placed in the
body of the insufflator and is broken when the
device is assembled. The drug is inhaled by the
patient as a fine powder.
 DRY-POWDER INHALERS
The use of dry-powder systems for pulmonary drug
delivery is now extensive.
A dry-powder inhaler is a device that delivers
medication to the lungs in the form of a dry powder.
DPIs are commonly used to treat respiratory
diseases such as asthma, bronchitis, emphysema
and COPD although DPIs have also been used in the
treatment of diabetes mellitus.
This dosage form has developed into one of the most
Three types of dry
effective methods of delivering active ingredients to powder inhalers:
the lung for the treatment of asthma and chronic Turbuhaler, Accuhaler and
obstructive pulmonary disease Ellipta devices.
 7) POWDERS REQUIRING RECONSTITUTION
For patients who have difficulty taking capsules and tablets, for example,
young children, a liquid preparation of a drug offers a suitable
alternative, but many antibiotics are physically or chemically unstable
when formulated as a suspension or solution.
The method used to overcome this problem is to present the dry
ingredients in a suitable container in the form of a powder or granules.
When the pharmacist dispenses the product, a given quantity of water is
added to constitute the solution or suspension. Once it is reconstituted,
the patient is warned of the short shelf-life.
A shelf-life of 1-2 weeks for the reconstituted syrup should not be a serious
problem for the patient.
POWDER FOR SUSPENSION
 7) POWDERS REQUIRING RECONSTITUTION

B. Powders for injection

Injections of medicaments that are unstable in
solution must be made immediately prior to use
and are presented as sterile powders in ampoules.
Sufficient diluent, e.g. sterile Water for Injections, is
added from a second ampoule to produce the
required drug concentration and the injection is
used immediately.
The powder may contain suitable excipients in
addition to the drug, e.g. sufficient additive to
produce an isotonic solution when the injection is
reconstituted.
 PROBLEMS ENCOUNTERED IN POWDER FORMULATION
1- Hygroscopic and Deliquescent Powder
Problem: Absorption of moisture from air leading to partial or
complete liquefaction.
Solution:
a. Reduce the amount of surface area exposed to the moisture
b. Packed in aluminum foil or in plastic film packets
c. Addition of light magnesium oxide to reduce the tendency to damp
d. Addition of adsorbent materials such as starch
Examples: Ammonium Bromide/Chloride/Iodide, Calcium
Bromide/Chloride, Ephedrine Sulfate
Hyoscyamine HBr/Sulfate, Lithium Bromide, Phenobarbital Sodium,
Potassium Acetate/Citrate
 PROBLEMS ENCOUNTERED IN POWDER FORMULATION
2- Efflorescent powders
The loss of water (or a solvent) of crystallization from a hydrated
or solvated salt to the atmosphere on exposure to air.
Problem: Crystalline substances which during storage loose their
water of crystallization and change to powder (to be
efflorescent). The liberated water convert the powder to a paste
or to a liquid.
Examples: Alum, atropine sulfate, citric acid, codeine phosphate.
Solution: Using the anhydrous form and/or treating it in a manner
similar to hygroscopic powders ( include drying bulky powder)
 PROBLEMS ENCOUNTERED IN POWDER FORMULATION
3- Eutectic Mixtures
A proportion of components that will give the lowest melting point
Problem: mixture of substances that liquefy when mixed, rubbed or
triturated together. The melting points of many eutectic mixtures are
below room temperature.
Examples: Menthol, thymol, phenol, camphor…….
Solution:
A- using inert adsorbent such as starch, talc, lactose to prevent dampness of
the powder
B- dispensing the components of the eutectic mixture separately.
C- To diminish contact, a powder prepared from such substances is
commonly mixed in the presence of an inert diluent, such as light
magnesium oxide or magnesium carbonate, to separate physically the
troublesome agents.
 PROBLEMS ENCOUNTERED IN POWDER FORMULATION

4- Explosive mixtures
Oxidising agents give oxygen to another substance.
Reducing agents remove oxygen from another substance.
Problem: Oxidizing agents (ex. Pot. Salts of chlorate, dichromate,
permanganate and nitrate- Sod. Peroxide- silver nitrate and
silver oxide) explore violently when triturated in a mortar with
a reducing agent ( ex. sulfides- sulfur- tannic acid- charcoal).
Solution:
A- Comminute each salt separately.
B- Subject to a minimum pressure.