Powders and Granules

Question 1

A ________ is defined as a dosage form composed of a solid or mixture of solids reduced to a finely divided state and intended for internal or external use.

Answer 1

powder

Question 2

True or False

As synthetic drugs were introduced, powders were used to administer insoluble drugs such as calomel, bismuth salts, mercury, and chalk

Answer 2

True

Question 3

For internal use, powders can be taken orally, administered through the nose as _____,
or blown into a body cavity as an ________

Answer 3

snuffs

insufflation

Question 4

True or false

Unlike a standardized capsule or tablet, powders enable a primary care provider to easily alter the quantity of medication for
each dose.

Answer 4

True

Question 5

Powders provide a ________ because they are readily dispersed,
have a large surface area, and usually require
only dissolution, not disintegration, before
absorption.

Answer 5

rapid onset of action

Question 6

True or False

Although the use of medicated powders per
se in therapeutics is limited, the use of powdered substances in the preparation of other
dosage forms is extensive

Answer 6

True

Question 7

are prepared agglomerates of powdered materials

Answer 7

Granules

Question 8

powders have a uniform,
small particle size that has an elegant appearance. In general, powders are more stable
than are _________ and are rapidly soluble, enabling the drug to be absorbed
quickly.

Answer 8

liquid dosage forms

Question 9

True or False

powder dosage forms have a large surface area that is exposed to atmospheric conditions

Answer 9

True

Question 10

Powders should be dispensed in ______

Answer 10

tight containers

Question 11

An increase in surface free energy can increase the absolute solubility of the drug and have a positive effect
on its bioequivalence.

Answer 11

True

Question 12

True or False

Topical powders should have a uniform, small particle size that will not irritate the skin when applied. They should be impalpable and free flowing, should easily adhere to the skin, and should be passed through at least a No. 100-mesh sieve to minimize skin irritation.

Answer 12

True

Question 13

Highly sorptive powders should not be used for topical powders that are to be applied to oozing wounds, as a _______ may form

Answer 13

hard crust

Question 14

_______, or any other naturally derived product that is to be used on open wounds,
should first be sterilized to avoid an infection
in the area.

Answer 14

Talc

Question 15

Topical powders usually consist of a base or vehicle, such as________; an adherent, such as______________; and possibly an active ingredient, along with an aromatic material.

Answer 15

cornstarch or talc

magnesium stearate, calcium stearate, or zinc stearate

Question 16

are finely divided powders that are intended to be applied in a body cavity, such as the ears, nose, vagina, tooth socket, or throat

Answer 16

Insufflated powders

Question 17

a moisture-activated adherent, such as _____, can be incorporated into the insufflated powder

Answer 17

Polyox

Question 18

is an ethylene oxide polymer with a high molecular weight that forms a viscous, mucoadhesive gel when in contact with moisture

Answer 18

Polyox

Question 19

The particles of pharmaceutical powders and granules may range from being extremely coarse, about ________, to extremely fine, approaching colloidal dimensions of _____

Answer 19

10 mm (1 cm) in diameter

1 μm or less

Question 20

In order to characterize
the particle size of a given powder, the _________ uses these descriptive terms: very coarse, coarse, moderately
coarse, fine, and very fine, which are related to the proportion of powder that is capable

Answer 20

United States Pharmacopeia (USP)

Question 21

Made of wire cloth woven from brass, bronze, or other suitable wire

Answer 21

Sieves

Question 22

________: All particles pass
through a No. 8 sieve, and not more than 20% pass through a No. 60 sieve.

Answer 22

Very coarse (No. 8)

Question 23

_________: All particles pass through a No. 20 sieve, and not more than 40% pass through a No. 60 sieve.

Answer 23

Coarse (No. 20)

Question 24

__________: All particles pass through a No. 40 sieve, and not more than 40% pass through a No. 80 sieve.

Answer 24

Moderately coarse (No. 40)

Question 25

_______ : All particles pass through a No. 60 sieve, and not more than 40% pass through a No. 100 sieve.

Answer 25

Fine (No. 60)

Question 26

_________ : All particles pass through a No. 80 sieve. There is no limit to greater fineness

Answer 26

Very fine (No. 80)

Question 27

Granules typically fall within the range of ____ to _____ sieve size, although granulations of powders prepared in the 12- to 20-sieve range are sometimes used in ____________

Answer 27

tablet making

Question 28

Dissolution rate of particles intended to dissolve; __________ can increase the rate of drug dissolution and its
bioavailability.

Answer 28

drug micronization

Question 29

Suspendability of particles intended to remain undissolved but uniform dispersed in a _______ (e.g., fine dispersions have particles ~0.5 to 10 μm)

Answer 29

liquid vehicle

Question 30

Uniform distribution of a drug substance in a powder mixture or solid dosage form to ensure _______ uniformity (3)

Answer 30

dose-to-dose content

Question 31

Penetrability of particles intended to be inhaled for deposition deep in the _______ (e.g., 1 to 5 μm) (4)

Answer 31

respiratory tract

Question 32

_______ of solid particles in dermal ointments, creams, and ophthalmic
preparations (e.g., fine powders may be 50
to 100 μm in size)

Answer 32

Lack of grittiness

Question 33

is the study of a number of characteristics, including particle size and size
distribution, shape, angle of repose, porosity, true volume, bulk volume, apparent density, and bulkiness.

Answer 33

Micromeritics

Question 34

a _______ is any unit of matter having defined
physical dimensions.

Answer 34

particle

Question 35

True or False

It is important to study particles because most drug dosage forms are
solids, solids are not static systems, the physical state of particles can be altered by physical
manipulation, and particle characteristics can alter therapeutic effectiveness

Answer 35

True

Question 36

The _______ method can include not fewer than 200 particles in a single plane using
a calibrated ocular on a microscope.

Answer 36

microscopic

Question 37

______, 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 (range about 40 to 9,500 μm,
depending upon sieve sizes)

Answer 37

Sieving

Question 38

_________, in which sample particles are
sized through the use of a calibrated grid
background or other measuring device
(range 0.2 to 100 μm)

Answer 38

Microscopy

Question 39

_________, in which particle size
is determined by measuring the terminal
settling velocity of particles through a liq-
uid medium in a gravitational or centrifu-
gal environment (range 0.8 to 300 μm).
Sedimentation rate may be calculated
from Stokes law.

Answer 39

Sedimentation rate

Question 40

____________,
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 (range
0.2 to 500 μm) (4). Laser scattering utilizes
a ___________, silicon photo diode detec-
tors, and an ultrasonic probe for particle
dispersion (range 0.02 to 2,000 μm)

Answer 40

Light energy diffraction or light scattering

He–Ne laser

Question 41

__________, 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 (range 1.4 to 100 μm)

Answer 41

Laser holography

Question 42

____________, which is based on the
principle that a particle driven by an air-
stream will hit a surface in its path, pro-
vided its inertia is sufficient to overcome
the drag force that tends to keep it in the
airstream (7). Particles are separated into
various size ranges by successively in-
creasing the velocity of the airstream in
which they are carried

Answer 42

Cascade impaction

Question 43

True or False

A reduction in particle size increases the number of particles and the total surface area.

Answer 43

True

Question 44

reduction of the particle size of a solid substance to a finer state

Answer 44

Comminution

Question 45

used to facilitate crude drug extraction, increase the dissolution rates of a drug, aid in the formulation of pharmaceutically acceptable dosage forms, and enhance the absorption of drugs.

Answer 45

Comminution

Question 46

True or False

The reduction in the particle size of a solid is accompanied by a great increase in the specific surface area of that substance.

Answer 46

True

Question 47

On a small scale, the pharmacist reduces the size of chemical substances by grinding with ________ and ______

Answer 47

a mortar and pestle

Question 48

Grinding a drug in a mortar to reduce its particle size is termed _______

Answer 48

trituration or comminution

Question 49

On a large scale, various types of ______ and _______ may be used to reduce particle size.

Answer 49

Mills and pulverizers

Question 50

_________ is commonly used in small-scale preparation of ointments and suspensions to reduce the particle size and grittiness of the added powders.

Answer 50

Levigation

Question 51

A _________ is
formed by combining the powder and a
small amount of liquid (the levigating agent)
in which the powder is insoluble.

Answer 51

paste

Question 52

are commonly used levigating agents

Answer 52

Mineral Oil and glycerin

Question 53

True or False

When two or more powdered substances
are to be combined to form a uniform mix-
ture, it is best to reduce the particle size of
each powder individually before weighing
and blending

Answer 53

True

Question 54

____________ is blending small amounts of powders by movement of a spatula through
them on a sheet of paper or an ointment tile

Answer 54

Spatulation

Question 55

Very little compression or compacting of the powder results from spatulation, which is especially suited to mixing solid substances that form _______ (or liquefy) when in close and prolonged contact with one another

Answer 55

eutectic mixtures

Question 56

When a small amount of a potent substance is to be mixed with a large amount
of diluent, the ____________ is
used to ensure the uniform distribution of the
potent drug.

Answer 56

geometric dilution method

Question 57

This method is especially indi-
cated when the potent substance and other
ingredients are the same color and a visible
sign of mixing is lacking.

Answer 57

Geometric Dilution

Question 58

By this method, the
potent drug is placed with an approximately
equal volume of the diluent in a mortar and
is mixed thoroughly by trituration. Then, a
second portion of diluent equal in volume
to the mixture is added and the trituration
repeated

Answer 58

Geometric dilution

Question 59

results in a light,
fluffy product. This process is not acceptable
for the incorporation of potent drugs into a
diluent powder.

Answer 59

Sifting

Question 60

Special small-scale and large-scale motorized
powder blenders mix powders by tumbling
them. Mixing by this process
is thorough but time consuming. Such blend-
ers are widely employed in industry, as are
mixers that use motorized blades to blend
powders in a large vessel.

Answer 60

Tumbling they powder in a rotating chamber

Question 61

• is an undesirable separation
  of the different components of the blend.
• may occur by sifting or percolation, air entrapment (fluidization), and particle
  entrapment (dusting).

Answer 61

Segregation

Question 62

Fine particles tend to sift or percolate through coarse particles and
end up at the bottom of the container and
actually “lift” the larger particles to the surface.

Answer 62

Segregation

Question 63

General guidelines to minimize or prevent segregation include (a) minimum number of transfer steps and drop heights;
(b) control of dust generation;
(c) control of fluidization of the powder;
(d) slow fill/transfer rate;
(e) appropriate venting;
f ) use of a deflector, vane, or distributor; and
(g) proper hopper
design and operating valves (if present).

Answer 63

True

Question 64

To keep the powders dry, one can mix them with a bulky
powder adsorbent such as light magnesium oxide or magnesium carbonate.

Answer 64

Eutectics

Question 65

Also, these
powders should be triturated very lightly
on a pill tile by using a spatula for mixing
rather than a mortar and pestle.

Answer 65

Eutectics

Question 66

Another approach is to first make the ________ and then adsorb the paste or liquid that results onto a bulky powder. One also has the option of dispensing the ingredients separately. After preparation, the charts can be
dispensed in a plastic bag.

Answer 66

eutectic

Question 67

____________ powders will absorb moisture from the air.

_________ powders will
absorb moisture from the air to the extent that they will partially or wholly liquefy

Answer 67

Hygroscopic

Deliquescent

Question 68

The best approach is to dispense the ingre-
dients in tight containers and incorporate a
desiccant packet or capsule when necessary.

Answer 68

Hygroscopic and Deliquescent powders

Question 69

An _______ powder is a crystalline powder that contains water of hydration
or crystallization

Answer 69

efflorescent

Question 70

This water can be liberated
either during manipulations or on exposure to a low-humidity environment. What kind of powder?

Answer 70

Efflorescent

Question 71

One approach is to use an anhydrous salt form of the drug, keeping in mind the potency differential between its anhydrous form and its hydrated form.

Another method is to include a drying bulky powder and to use a light, noncompacting method of mixing the powders.

Answer 71

Efflorescent powders

Question 72

Some combinations of powders may react violently when mixed together. Special precautions must be taken if it is necessary to prepare a formulation containing these mixtures.

Answer 72

Explosive Mixtures

Question 73

This method may
be especially suitable for high-potency drugs
or flavoring agents because it minimizes the
possibility that clumps of active drug will
develop in the powder blend.

Answer 73

Incorporation of Liquids

Question 74

A liquid that is to be incorporated into a dry
powder can be adsorbed onto an inert mate-
rial (carrier) such as lactose or starch and
then geometrically introduced into the bulk of the powder

Answer 74

Incorporation of Liquid

Question 75

A primary disadvantage of the use of oral powders is the _____________ of the drug.

Answer 75

Undesirable taste

Question 76

• 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.
• 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.

Answer 76

Medicated powders

Question 77

A ______ is a device used to administer an inhalation powder in a finely divided state suitable for oral inhalation by the patient.

Answer 77

DPI

Question 78

is one used with a device that aerosolizes and delivers an accurately metered amount

Answer 78

Inhalation powder

Question 79

Inhalation powders, commonly known as dry DPIs, consist of a mixture of _______ and typically
the carrier; and all formulation components exist in a finely divided solid state packaged in
a suitable container closure system

Answer 79

active pharmaceutical ingredients (APIs)

Question 80

• have an internal reservoir that contains a sufficient quantity of formulation for multiple doses that are metered by the device during actuation by
  the patient.

Answer 80

Device-metered DPIs

Question 81

• contain a previously measured amount of formulation in individual units (e.g., capsules, blisters) that are inserted into the device before use.
• may also contain premetered
  dose units as ordered multidose assemblies in the delivery system
• include a mechanism designed to pierce the capsule or open the unit-dose container and allow mobilization and aerosolization of the powder by the patient inhaling through the integral
  mouthpiece.

Answer 81

Premetered DPIs

Question 82

Medicated powders may be provided to the patient in bulk or may be divided into unit-of-use packages. Some powders are packaged by manufacturers, whereas others are
prepared and packaged by the pharmacist.

Answer 82

Bulk and Divided Powders

Question 83

Bulk powders available in pre-packaged amounts
(e.g., Massengill powder), dissolved in warm water by the patient for vaginal use

Answer 83

douche powders

Question 84

bulk powders available in pre-
packaged amounts:

____________ (e.g.,
sodium bicarbonate) and __________ (e.g.,
psyllium [Metamucil]), which the patient
takes by mixing with water or another beverages before swallowing;

Answer 84

Antacids

Laxatives

Question 85

Bulk powders available in pre-packaged amounts
________ containing B-complex vita-
mins and other nutritional supplements

Answer 85

brewer’s yeast powder

Question 86

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.

Answer 86

True

Question 87

Latin word for Powder paper

Answer 87

Chartula

Question 88

a
transparent waterproof paper

Answer 88

Waxed paper

Question 89

a thin, semiopaque paper
with limited moisture resistance

Answer 89

Vegetable parchment

Question 90

a glazed, transparent paper, also with limited
moisture resistance

Answer 90

Glassine

Question 91

a dosage form com-
posed of dry aggregates of powder particles
that may contain one or more APIs, with or without other ingredients

Answer 91

Granules

Question 92

frequently
compacted into tablets or filled into capsules,
with or without additional ingredients

Answer 92

Granules

Question 93

pre-
pared agglomerates of smaller particles of
powder

Answer 93

Granules

Question 94

Granules are prepared by _____ method and _____ methods

Answer 94

Wet methods and dry methods

Question 95

Another type of wet method is
_________, 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

Answer 95

fluid bed processing

Question 96

A __________, 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

Answer 96

Roll compactor

Question 97

An alternative dry method, termed ________, is the compression of a powder or powder mixture into large tablets or slugs on a compressing machine under 8,000 to 12,000 lb of pressure, depending on the physical characteristics of the powder

Answer 97

slugging

Question 98

An ____________, frequently tablets or granules, contains ingredients that, when in contact with water, rapidly release carbon dioxide

Answer 98

effervescent dosage form

Question 99

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.

Answer 99

Effervescent salts

Question 100

Effervescent Granulated Salts

When 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.

Answer 100

True

Question 101

Effervescent granules are prepared by
two general methods: (a) the _____ or. _______ method and (b) the _____ method.

Answer 101

a) dry of fusion method
b) the wet method

Question 102

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

Answer 102

True

Question 103

Dry and Fusion Method

A No. 4 sieve produces large granules

A No. 8 sieveprepares medium size granules,

A No. 10 sieve prepares small granules. The granules are dried at a temperature not exceeding 54°C and are immediately placed in containers and tightly sealed.

Answer 103

True

Question 104

Difference between dry and fusion method, and wet method?

Answer 104

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.

Question 105

Quality Control:

The pharmacist should compare the final
weight of the preparation with the theoretical
weight. The powder should be examined for
uniformity of color, particle size, flowability,
and freedom from caking.

Answer 105

Bulk Powders

Question 106

Quality Control:

For divided powders, the pharmacist should
individually weigh the divided papers and
then compare that weight with the theoreti-
cal weight. The packets should be checked to
confirm uniformity.

Answer 106

Divided powers

Question 107

Quality Control:

Reconstituted suspensions should be thor-
oughly mixed or shaken before use to resus-
pend the dispersed particulates. This is
especially true of suspension preparations
dosed from multiple-dose containers. For
particularly viscous suspensions prone to
air entrapment, instructions may advise the
user how to shake the preparation to resus-
pend settled particles while minimizing air
entrapment.

Answer 107

Patient Counseling

Question 108

Quality Control:

• The powder mixture is packaged according
  to its use.

-Specific instructions for reconstitution pro-
vided by the manufacturer should be carefully followed.

Answer 108

Packaging/Dispensing