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PHA 069 > SAS 6 Commercial Manufacturing (Suppositories) > Flashcards

SAS 6 Commercial Manufacturing (Suppositories) Flashcards

1
Q

a medicated solid dosage form generally intended for use in the rectum, vagina, and
to a lesser extent, the urethra

A

suppository

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2
Q

usually employ vehicles that melt or soften
at body temperature

A

Rectal and urethral
suppositories

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3
Q

also made as compressed
tablets that disintegrate in the body fluids

A

vaginal suppositories/pessaries

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4
Q

Bruno Solomon published a critical study of
suppository bases, in which he classified them into three
broad types:

A

(1) cocoa butter

(2) fat and wax combinations with cocoa butter

(3) glycerinated gelatin bases

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5
Q

In children, this route is especially useful. An ill child may refuse oral medication and may fear injections.

A

rectal

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6
Q

Avoids first-pass effect

A

rectal administration

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7
Q

Provides better drug stability for drugs susceptible to gastric degradation

A

rectal administration

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8
Q

Can administer large doses of drugs compared to oral dosage forms

A

rectal administration

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9
Q

Can administer large doses of drugs compared to oral dosage forms

A

rectal administration

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10
Q

Can administer large doses of drugs compared to oral dosage forms

A

rectal administration

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11
Q

suppository after insertion can leave the anorectal site and ascend to the
rectosigmoid and descending colon. Hence, one may consider that suppositories with this
shape possibly should not be used at bedtime

A

The ―bullet-shaped‖ suppository

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12
Q

may interrupt the absorption process of the rectal administrated drug; this may especially occur if the
drug is irritating

A

Defecation

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13
Q

intended for local action are most frequently used to relieve constipation or
the pain, irritation, itching, and inflammation associated with hemorrhoids or other anorectal
conditions.

A

Rectal suppositories

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14
Q

commonly used to promote laxation by local irritation of
the mucous membranes, probably by the dehydrating effect of the glycerin on
those membranes.

A

Glycerin suppository

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15
Q

commonly used as contraceptives, antiseptics in feminine hygiene and
agents to combat specific invading pathogen

A

Vaginal suppositories

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16
Q

commonly used as antibacterial or local anesthetic preparative for
local examination.

A

commonly used as antibacterial or local anesthetic preparative for
local examination.

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17
Q

For systemic effects, the ________________ of the rectum and vagina permit the absorption of
many soluble drugs

A

mucous membranes

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18
Q

m is used frequently as the site for the systemic absorption of drugs, the vagina is not as frequently used for this purpose

A

rectum

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19
Q

for the relief of nausea and vomiting and as a
tranquilizer

A

Prochlorperazine and chlorpromazine

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20
Q

for opioid analgesia

A

Morphine and oxymorphone

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21
Q

for the relief of migraine syndrome

A

Indomethacin

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22
Q

a nonsteroidal anti-inflammatory analgesic and antipyretic

A

Indomethacin

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23
Q

for the relief of nausea and vomiting

A

Ondansetron

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24
Q

is usually determined by the USP method,
manufacturers of bases occasionally use different methods for determining melting
characteristics, such as ―Wiley melting point,‖ ―capillary melting point,‖ ―softening
point,‖ ―incipient melting (or thaw) point,‖ and others

A

melting range‖

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25
Q

either entirely natural or synthetic, or modified natural products

A

source of origin

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26
Q

compound, or a well-defined or poorly elucidated mixture

A

chemical
makeup

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27
Q

is a measure of the percentage of fat in crystalline (solid) phase
to total fat (the remainder being in liquid phase) across a temperature gradient.

A

Solid fat index (SFI)

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28
Q

This method is based on measuring the heat of fusion successively at different
temperatures.

A

Solid-fat index (SFI)

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29
Q

By reference to the total melting heat, the fraction of fat melted is
determined

A

Solid-fat index (SFI)

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30
Q

This technique is faster than dilatometry, and gives results comparable
with NMR.

A

Solid-fat index (SFI)

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31
Q

This is a measure of unesterified positions on glyceride molecules and reflects the
monoglyceride and diglyceride content of a fatty base.

A

Hydroxyl Value

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32
Q

This value allows prediction of the time required for solidifying the base when it
is chilled in the mold.

A

Solidification point

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33
Q

The number represents the
milligrams of KOH that would neutralize the acetic acid used to acetylate 1 g of fat.

A

Hydroxyl Value

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34
Q

If the interval between the melting range and solidification point
is 10°C or more, the time required for solidification may have to be shortened
by augmenting refrigeration to produce a more efficient manufacturing procedure.

A

Solidification point

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35
Q

The number of milligrams of potassium hydroxide required to neutralize the free
acids and saponify the esters contained in 1 g of a fat is an indication of the type (mono-, di-, or tri-) glyceride, as well as the amount of glyceride present.

A

Saponification Value

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36
Q

This value expresses the number of grams of iodine that reacts with 100 g of fat or
other unsaturated material.

A

Iodine Value

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37
Q

The possibility of decomposition by moisture, acids, and
oxygen (which leads to rancidity in fats) increases with high iodine values.

A

Iodine Value

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38
Q

The amount of water, in grams, that can be incorporated in 100 g of fat is expressed
by this value.

A

Water Number

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39
Q

can be increased by the addition of surface
active agents, monoglycerides, and other emulsifiers

A

Water number

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40
Q

The number of milligrams of potassium hydroxide required to neutralize the free
acid in 1 g of substance is expressed by this value.

A

Acid value

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41
Q

complete absence of acid is important for good suppository bases.

A

Low ―acid values

42
Q

complicate formulation work, because they react with other ingredients and can also cause irritation when in contact with mucous membranes.

A

Free acids

43
Q

The ―acid value‖ is

A

below 0.2

44
Q

The ―saponification value‖

A

ranges from 200 to 245

45
Q

The ―iodine value‖ is

A

less than 7

46
Q

The ―iodine value‖ is

A

small or the SFI
curve is sharp

47
Q

Most frequently employed suppository base

A

Fatty or Oleaginous Bases

48
Q

Most common base used for rectal suppositories

A

Cocoa butter, NF

49
Q

Most common base used for rectal suppositories, spreading action.

A

Cocoa butter, NF

50
Q

Fat obtained from the roasted seed of Theobroma cacao

A

Cocoa butter, NF

51
Q

At room temperature, it is a yellowish-white solid having a faint, agreeable chocolate-like odor.

A

Cocoa butter, NF

52
Q

It melts at 30°C to 36°C (86°F to 97°F), making it an ideal suppository base,
melting just below body temperature and yet maintaining its solidity at
usual room temperatures.

A

Cocoa butter, NF

53
Q

least stable cocoa butter

A

Alpha (α)

54
Q

most stable cocoa butter , solid until 32°C and melts at around 34-35°C

A

Beta (β)

55
Q

can decrease Beta cocoa butter melting point when incorporated w/ it

A

Phenol & Chloral Hydrate

56
Q

Made from triglycerides from palm, palm kernel, and coconut oils with self-emulsifying glyceryl monostearate and polyoxyl stearate

A

Fattibase

57
Q

From triglycerides derived from coconut oil

A

From triglycerides derived from coconut oil

58
Q

From triglycerides of saturated fatty acids C12–C18 with varied portions of the
corresponding partial glycerides

A

Witepsol

59
Q

Witepsol, Major:

A

Lauric acid

60
Q

The main members of this group are glycerinated gelatin and polyethylene glycols

A

Water-soluble and Water-miscible Bases

61
Q

During administration, moisten the tip of the suppository to prevent mucosal irritation and to
facilitate the smooth passage of suppository in the body-orifices.

A

Water-soluble and Water-miscible Bases

61
Q

Most frequently used in preparation of vaginal suppositories

A

Glycerinated gelatin

62
Q

Slower to soften and mix w/ the physiologic fluids

A

Glycerinated gelatin

63
Q

Polymers of ethylene oxide and water

A

Polyethylene glycols

64
Q

Do not melt at body temperature but rather dissolve slowly in the body’s fluid

A

Polyethylene glycols

65
Q

Commonly employed for vaginal administration

A

Polyethylene glycols

66
Q

These are mixtures of oleaginous and water-soluble or water-miscible materials

A

Miscellaneous Bases

67
Q

a surface-active agent that is employed in a
number of commercial suppository base

A

Polyoxyl 40 stearate

68
Q

Generally combination of lipophilic and hydrophilic substances

A

Miscellaneous Bases

69
Q

The simplest and oldest method of preparing a suppository is by hand, i.e., by rolling the well-blended suppository base containing the active ingredients into the desired shape.

A

Hand Molding

70
Q

This method is practical and economical for the manufacture of small numbers of
suppositories.

A

Hand Molding

71
Q

is simple and results in a more elegant appearance than
does hand molding. It avoids the possibilities of sedimentation of the insoluble solids
in the suppository base, but is too slow for large-scale production.

A

cold compression method

72
Q

A more uniform and pharmaceutically elegant suppository can be made by compressing
the cold-grated mass into a desired shape.

A

Compression Molding

73
Q

One of the major disadvantages of the use of the cold compression technique for molding fat-type base suppositories is

A

air entrapment

74
Q

This unavoidable inclusion of air makes
close weight control impossible and also favors the possible oxidation of both the base and active ingredients

A

air entrapment

75
Q

The most commonly used method for producing suppositories on both a small and a large scale is the molding process.

A

Pour Molding

76
Q

A significant advance in suppository manufacturing was the development of automated
methods for molding suppositories directly in their wrapping material. This is currently accomplished with either plastic or aluminum foil.

A

In-package Molding

77
Q

Machines utilizing plastic either thermoform the mold and fill the mold in sequence, or
simply fill the mass into previously thermoformed molds. Machines using
aluminum foil/ polypropylene/lacquer laminates emboss two parallel strips of foil so
that when they are sealed together, molds are formed.

A

In-package Molding

78
Q

accelerates the oxidation of fats

A

Water

79
Q

Glycerinated gelatin suppositories lose moisture by evaporation in dry climates and absorb moisture under conditions of high humidity.

A

Hygroscopicity

80
Q

The rate of moisture change in polyethylene glycol bases depends not only on humidity and temperature, but also on the chain length of the molecule.

A

Hygroscopicity

81
Q

is important in the manufacture of the suppository and to its behavior in the rectum after melting.

A

Viscosity

82
Q

Suppositories made from cocoa butter are quite elastic and do not fracture readily. Synthetic
fat bases with a high degree of hydrogenation and high stearate contents, and therefore a
higher solids content at room temperature, are usually more brittle.

A

Brittleness

83
Q

To calculate the amount of drug per suppository, the ___________ of the base must be known.

A

denisty

84
Q

This phenomenon occurs in many melted suppository bases after cooling in the mold.

A

Volume Contraction

85
Q

This is caused by the mass pulling away from the sides of the mold. This contraction facilitates the removal of the suppositories from the mold,
eliminating the need for mold release agents.

A

Good mold release

86
Q

This undesirable feature
results in lowered suppository weight and imperfect appearance of the suppository.

A

Contraction hole formation at the open end of the mold

87
Q

Mineral oil, an aqueous solution of sodium lauryl sulfate, various silicones, alcohol, and
tincture of green soap are examples of agents employed for this purpose. They are applied
by wiping, brushing, or spraying.

A

Lubricants or Mold Release Agents

88
Q

Cocoa butter adheres to suppository molds because of its low volume contraction. These
suppositories are difficult to remove from the molds, and various mold lubricants or release agents must be used to overcome this difficulty.

A

Lubricants or Mold Release Agents

89
Q

results from the autoxidation and subsequent decomposition of unsaturated fats
into low- and medium-molecular-weight saturated and unsaturated aldehydes, ketones, and acids, which have strong, unpleasant odors.

A

Rancidity

90
Q

This test is also called the macromelting range test and is a measure of the time it takes for
the entire suppository to melt when immersed in a constant-temperature (37°C) water bath.
In contrast, the micromelting range test is the melting range measured in capillary’ tubes for
the fat base only.

A

Melting Range Test

91
Q

A modification of a method developed by Krowczynski is another useful test of finished
suppositories.

A

Liquefaction or Softening Time Tests

92
Q
A

Liquefaction or Softening Time Tests

93
Q

It consists of a U-tube partially submersed in a constant-temperature water bath. A
constriction on one side holds the suppository in place in the tube.

A

Liquefaction or Softening Time Tests

94
Q

measures the liquefaction time of rectal suppositories in an apparatus that simulates in vivo condition.

A

softening time

95
Q

A glass rod is placed on
top of the suppository, and the time for the rod to pass through to the constriction is
recorded as the

A

softening time

96
Q

designed as a method for measuring the fragility or brittleness of suppositories. The apparatus used for the test consists of a double-wall chamber in which
the test suppository is placed.

A

breaking test

97
Q

The test is conducted by placing 600 g on the platform. At 1 -min intervals, 200-g weights are
added, and the weight at which the suppository collapses is the breaking point, or the force
that determines the fragility or brittleness characteristics of the suppository.

A

Breaking Test

98
Q

Testing for the rate of in vitro release of drug substances from suppositories has always
posed a difficult problem, owing to melting, deformation, and dispersion in the dissolution
medium.

A

Dissolution Testing

99
Q

Early testing was carried out by simple placement in a beaker containing a medium

A

Dissolution Testing

PHA 069 (2 decks)

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