PHARMACEUTUICAL DOSAGE FORM & DDS
POWDERS
- solid or mixture of solids reduced to a finely divided
state and intended for internal or external use;
- used to administer insoluble drugs such as calomel,
bismuth salts, mercury, and chalk;
- rapid onset because they are readily dispersed and
requires only dissolution
- should be placed in tight containers because the
greater surface area they become more reactive in
nature
- mostly for paracheutic preparations
TOPICAL POWDERS
- should be free flowing, easy to adhere to the skin,
passed through at least 100-mesh sieve to
minimize skin rotation
 Mesh- number of holes in an inch; the
greater the mesh, the smaller the number of
holes
- products for open wound should be first sterilized to
avoid infection e.g. TALC
- consists of a base or vehicle ( corn starch, talc), an
adherent (magnesium stearate, calcium stearate,
zinc stearate), API and aromatic material
INSUFFLATED POWDERS
- intended to be applied on body cavities; anti-
infective
 Polyox- ethylene oxide polymer that forms a
viscous, adhesive gel when in contact with
moisture; being incorporated with the
powder for long term drug delivery span
PARTICLE SIZE AND ANALYSIS
- to determine the particle size, the methods use are
sieving and microscopy (not fewer than 200
particles in a single plane)
 Micrometrics- science of small particles; a
particle is any unit of matter having defined
physical dimensions
 Angle of Repose- estimating the flow
properties of a powder; powders with a low
angle of repose flow freely, and powders
with a high angle of repose flow poorly
PARTICLE SIZE REDUCTION
- reducing the size of the particle is important for a
uniform distribution of powder
 Comminution- reduction of the particle size
of a solid substance to a finer state
PARTICLE SIZE REDUCTION (Small Scales)
 Levigation- for ointments and suspensions;
addition of non-solvent (levitating agent) that
would form a paste then triturate; commonly
used agents are MINERAL OIL and
GLYCERIN
 Trituration- grinding a drug in a mortar;
comminute and to mix powders
 Pulverization with Intervention- the material
to be added must be easily removed to help in
reduction;
 Camphor- add 95% Alcohol to be soft
PARTICLE SIZE REDUCTION (Large Scales)
 Use Mills and Pulverisers
BLENDING POWDERS
- Light powders should always go first before heavy
powders
 Spatulation- useful for solid substances that
are easy to liquefy; not suitable for large
quantities or for powders that contain potent
substances; adds inert diluent (light magnesium
oxide or magnesium carbonate) to separate
troublesome agents
 Trituration- the use of glass motor is highly
preferred particularly for stain-causing powders
 Geometric Dilution- ensure the uniform
distribution of the potent drug; wedge wood
mortar
 Sifting- produces light fluffy products; not
suitable for the incorporation of potent drugs
into a diluent powder
 Tumbling- thorough but time consuming; use
of motorized blades to blend powders in a large
vessel
POWDERED DOSAGE FORMS
ADVANTAGES DISADVANTAGES
Rapid dispersion of Unpleasant taste
ingredients
Good chemical stability Hygroscopic
characteristic
It can be for internal or Time consuming
external use preparation
 Hygroscopic- absorb moisture from the air;
should be placed in a tight and closed amber
bottle
 Deliquescent- absorb moisture from the air to
the extent that they will partially or wholly
liquefy
E.g. Pepsin, Zinc Chloride, Calcium Bromide
 Efflorescent- crystalline powder that contains
water; use anhydrous salt
 Inhaled Powders- for asthma or bronchial
diseases
 PHARMACEUTUICAL DOSAGE FORM & DDS
 Oral Powders- mixed with water; intended for
local effects (laxatives) or systemic effects
(analgesics) and may be preferred to
counterpart tablets and capsules
AEROSOL POWDERS
- administered by inhalation with the aid of DPI (dry
powder inhalers)
- particle size range from 1-6 micrometre
- contain propellants (crystalline alpha-lactose
monohydrate) to aid in formulation’s flow properties
and to protect the powder from humidity
e.g.
 Advair Diskus- contain Fluticasone Propionate
(bronchodilator)
 Foradile Aerolizer- capsule; contain lactose
(carrier) and Formoterol Fumarate, a receptor
agonist that act as bronchodilator
 Relenza- for influenza; usual dose is two
inhalations
BULK POWDERS
- mostly antacids (sodium bicarbonate), laxatives
(psyllium), douche powders that are being
dissolved in warm water for vaginal use, topical
anti-infective or antifungals and Brewer’s yeast
powder that contains Vit. B-complex
- dispensing these powders are limited to non-potent
substances
DIVIDED POWDERS
- taken or used at a single time
- should be placed on a powdered paper (chartula)
 Simple Bond paper- not moisture resistant;
use only after wrapping the powder with a
moisture-resistant paper
 Vegetable Parchment- semi-opaque paper
with moisture resistance; baking
 Glassine- glazed, transparent paper and
limited moisture resistance
 Waxed Paper- transparent, waterproof paper;
used for volatile, hygroscopic and deliquescent
materials
QUALITY CONTROL
 Bulk Powders- pharmacist should compare
the final weight of the preparation with the
theoretical weight. The powder should be
examined for uniformity of colour, particle
size, flow ability, and freedom from caking.
 Divided Powders – same with bulk and the
packets should be checked to confirm
uniformity.
GRANULES
- prepared agglomerates of smaller particles
- irregularly shaped but maybe prepared to be
spherical
- 4-12 mesh-sieve size
- intermediates in capsules and tablets
WET METHOD
- usually used in granule preparation
 Fluid bed processing- particles are placed
in a conical piece of equipment and are
dispersed and suspended while a liquid
excipient is sprayed on the particles and the
product dried, forming granules or pellets of
defined particle size
 Povidone- most common binder
DRY METHOD
- forms granules without liquid (LOL)
- can be heat sensitive or moist
 Roller Compactor- fine powder into
dense sheets or forms
 Slugging- 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; slugs are about 2.5
cm in diameter
CHARACTERISTICS OF GRANULES
- flow well compared to powders; commonly used in
tablet
- more stable in atmospheric humidity; less likely to
cake
- preferred for dry products intended to be
constituted into solutions or suspensions
 Biaxin Granules- oral suspension
 Lactinex Granules- treatment of
uncomplicated diarrhea and diarrhea due to
antibiotic therapy
EFFERVESCENT GRANULATED SALTS
- contains a medicinal agent in a dry mixture usually
composed of sodium bicarbonate, citric acid, and
tartaric acid
- liberates CO2 when added with water
- Tartaric acid is used as the sole acid, the resulting
granules readily lose their firmness and crumble.
Citric acid alone results in a sticky mixture difficult
to granulate.
- not be swallowed directly
PREPARATION
 Dry/Fusion Method- citric acid acts as the
binding agent; mix powders in low humidity to
avoid moisture absorption and premature chem
rxn; put in an oven, 34-40C then dried at 54C
 PHARMACEUTUICAL DOSAGE FORM & DDS
 Wet Method- the water added to alcohol acts
as the binding agent