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Dosage Forms Lecture > Module 1 > Flashcards

Module 1 Flashcards

1
Q

what are drugs intended to be used for in humans or in animals?

A

diagnosis, mitigation, treatment, cure, prevention

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2
Q

drugs used to diagnose or determine a disease by…

A

assaying the percentage of antibodies present

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3
Q

given for diagnosis of diseases or thyroid related problems

A

radiopharmaceuticals

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4
Q

deals with a disease, injury, etc. in order to make someone feel better or become healthy again

A

treatment

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5
Q

what is better than a cure?

A

prevention

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6
Q

GAMOT

A

G - inhawa (mitigation)
A - lisin ang sanhi (cure)
M - aibalik sa normal (treatment)
U - miwas sa sakit (prevention)
T - ukuyin ang dahilan (diagnosis)

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7
Q

preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration

A

dosage form

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8
Q

another name for dosage forms?

A

pharmaceuticals

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9
Q

ACTIVE INGREDIENTS

A

active pharmaceutical agents (API), pharmacologically active therapeutic ingredients

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10
Q

NON ACTIVE INGREDIENTS

A

inert, inactive ingredients, additives, excipients

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11
Q

what do non active ingredients do to the pharmaceutical?

A

Give the formulation its unique composition and characteristic physical appearance

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12
Q

According to USP, it holds the article and is or maybe in direct contact with the article immediate container (the one that is in direct contact with the article at all times) closure

A

Container

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13
Q

protects the content from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution

A

well-closed container

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14
Q

protects the contents from contamination by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is capable of tight re-closure

A

tightly-closed container

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15
Q

an uptake of salt that causes a decrease in water

A

efflorescence

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16
Q

absorption of moisture

A

deliquescence

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17
Q

is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution

A

hermetic container

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18
Q

how are substances in hermetic containers delivered?

A

injection or parenteral preparation

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19
Q

provides protection from the degradative effects of light by reducing light transmission

A

light-resistant containers

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20
Q

light-resistant containers are also called…

A

amber bottles

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21
Q

added to decrease the transmission of short ultraviolet rays

A

ultraviolet absorbers

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22
Q

USP standard on limit if light transmission is between…

A

290-450 nm

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23
Q

container that is significantly difficult for
children to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly

A

child-resistant container

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24
Q

child-resistant containers are specially made for children aged…

A

5 years old and below

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25
Q

four basic designs of child resistant containers

A

align the arrows
press down and turn
squeeze and turn
latch top

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26
Q

packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred.

A

tamper-evident container

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27
Q

one that holds a quantity of drug intended as a single dose and when opened cannot be resealed with assurance that sterility has been maintained

A

single dose

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28
Q

examples of single dose containers

A

ampules, prefilled syringes or cartridges

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29
Q

contains more than a single dose of the
medication and permits the withdrawal of
successive portions without changing the
strength or endangering the quality or purity of the remaining portion

A

multiple dose

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30
Q

examples of multiple dose containers

A

vials

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31
Q

type I of glass is composed of

A

highly-resistant borosilicate glass

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32
Q

what is type I, II, and III glass used for?

A

parenteral products

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33
Q

type II of glass is composed of

A

treated soda-lime glass

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34
Q

type III of glass is composed of

A

soda lime glass

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35
Q

type NP of glass is composed of

A

general purpose soda-lime glass

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36
Q

what is type NP glass used for?

A

other preparations

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37
Q

what type of glass is most resistant?

A

type I

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38
Q

plastic material that is rigid and has good
clarity;

A

polyvinyl chloride (PVC)

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39
Q

PVC is useful in

A

blister packaging of tablets and capsules

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40
Q

PVC is not suitable when

A

gamma sterilization is required

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41
Q

PET plastic used in water bottles and the likes

A

polyethylene terephthalate

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42
Q

APET

A

amorphous polyethylene terephthalate glycol

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43
Q

PETG

A

polyethylene terephthalate glycol

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44
Q

have excellent transparency and luster and can be sterilized with gamma radiation

A

APET and PETG

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45
Q

advantage of plastic containers

A

-Lightness in weight
-Resistance to impact
-Versatility in container design and consumer acceptance
-Consumer preference for plastic squeeze bottles
-Popularity of blister packaging and unit dose dispensing

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46
Q

disadvantages of plastic containers

A

-Permeability of the container to atmospheric oxygen and to moisture vapor
-Leaching of the constituent of the container to the internal contents
-Absorption of drugs from the contents to the container
-Transmission of light through the container
-Alteration of the container upon storage (deformity)

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47
Q

Statement of pharmacologic category; No Rx symbol

A

OTC label

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48
Q

prescription drug label contains…

A

Nonproprietary and Proprietary name of the drug
Name and address of manufacturer
Dosage strength or potency
Type of dosage form
Net content
Prescription logo and Legend statement
Label reference to see the accompanying package insert
Special storage instructions
Bar code and Registration number
Lot or control number
Expiration date

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49
Q

for controlled substances…

A

the symbol “C” and the statement “Warning: Maybe habit-forming”

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50
Q

OTC drug label contains…

A

Product name (generic and brand)
Name and address of manufacturer
Net content
Formulation
Name of any habit-forming substances
Pharmacologic category (principal intended action)
Cautions and warnings
Na+ content for oral preparations
Storage conditions
Description of tamper-evident feature
Lot number and expiration date

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51
Q

dietary supplement labels should contain

A

This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease

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52
Q

herbal products should state…

A

specific parts of the plant used

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53
Q

product standardization includes

A

USP verified program
NSF certification program
Consumer Laboratories

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54
Q

assurance of product safety but not guarantee effectiveness

A

SEAL

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55
Q

any temperature not exceeding 8 degrees celcius

A

cold temperature

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56
Q

refrigerator

A

2 to 8 c

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57
Q

freezer

A

-25 to -10 c

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58
Q

any temperature between 8 to 15 c

A

cool temperature

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59
Q

temperatures between 20 to 25 c, sometimes 15 - 30 c

A

controlled room temperature

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60
Q

temperature between 30 to 40 c

A

warm temperature

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61
Q

temperature above 40 c

A

excessive heat

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62
Q

risks of freezing; breakage of container; loss of potency/strength; destructive alteration of the dosage form

A

protection from freezing

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63
Q

to protect drug substances from the destructive influence of gastric acid after oral administration

A

enteric coated tablets

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64
Q

to provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle

A

suspension or clear preparation solution

65
Q

to conceal bitter, offensive, or salty taste or odor of a drug substance

A

capsule, Coated tablets, syrups

66
Q

to provide rate controlled drug action

A

controlled release tablet, capsule, suspension

67
Q

to provide optimal drug action from topical administration sites

A

ointment, creams, transdermal patches, ophthalmic prep. ear prep, nasal prep

68
Q

to provide for insertion of drug into one of the body’s orfices

A

rectal, vaginal suppositories

69
Q

to provide placement of drug directly in the bloodstream or body tissues

A

injection

70
Q

to provide optimal drug action through inhalation therapy

A

inhalants, inhalation aerosols

71
Q

the formulation that best meets the goals for the product is selected to be its

A

master formula

72
Q

pre formulation considerations

A

-physical descriptions
-microscopic examination
-heat vaporization
-melting point depression
-phase rule
-particle size
-polymorphism
-solubility
-dissolution
-membrane permeability
-partition coefficient
-dissociation constant

73
Q

general considerations in dosage forms designs

A
  1. physical and chemical properties of the drug substance
  2. therapeutic considerations
74
Q

therapeutic considerations

A

i. nature of illness
ii. manner in which it is treated
iii. age and the anticipated condition of the patient

75
Q

the purity of the chemical substance substance is essential for its identification and for evaluation of its chemical, physical and biological properties

A

physical description

76
Q

structure, form, and reactivity

A

chemical property

77
Q

physical description, particle size, crystalline structure, melting point and solubility

A

physical property

78
Q

ability to get to a site of action and elicit responses

A

biological property

79
Q

Gives an indication of particle size and size range of the raw materials along with the crystal structure

A

microscopic examination

80
Q

which flow more freely: spherical and ovals powders of needle shaped powders?

A

spherical and oval powders

81
Q

heat vaporization

A

-The amount of heat absorbed when 1 g of liquid vaporizes
-Operation of implantable pumps delivering medicine
-Aerosol dosage forms
-Nasal inhalants for treating nasal decongestion
-Particle size affects vapor pressure; the smaller the particle size the greater the vapor pressure

82
Q

melting point depression is used to determine

A

the purity of the substance

83
Q

change in melting point of product means it is

A

not pure

84
Q

a useful device for relating the effect of the least number of independent
variables (e.g., temperature, pressure, and concentration) upon the various phases (solid, liquid, and gaseous) that can exist in an equilibrium system containing a number of components.

A

phase rule

85
Q

Certain physical and chemical properties of drug substances, including dissolution rate, bioavailability, content uniformity, taste, texture, color and stability are affected by the particle size distribution Flow characteristics and sedimentation rates Particle size influences oral absorption

A

particle size

86
Q

polymorphism

A

crystal or amorphous, and affects melting point and solubility

87
Q

should possess aqueous solubility for therapeutic effect

A

solubility

88
Q

frequently added to increase solubility

A

salt and water

89
Q

can increase solubility

A

adjustment in particle size and pH

90
Q

rate limiting step in the absorption process

A

dissolution

91
Q

the time it takes for the drug to be dissolved in the fluids at the absorption site

A

dissolution rate

92
Q

To produce biological response, the drug
molecules must first cross the biologic membrane (acts as lipid barrier) permits absorption of lipid soluble substance by passive diffusion

A

membrane permeability

93
Q

measure of drug’s lipophilic character

A

partition coefficient

94
Q

the extend of dissociation and ionization of the drug

A

pKa/dissociation constant

95
Q

has strong effect on drug absorption, distribution, and elimination

A

extent of ionization

96
Q

absorbs moisture from air

A

hygroscopic powder

97
Q

absorb moisture from air before liquefying

A

deliquescent powder

98
Q

give up water for crystallization and may even become damp and pasty

A

efflorescent powder

99
Q

drugs are either weak acids or weak bases and have limited water solubility, often used the salts of the product to increase the aqueous solubility

A

organic salt consideration

100
Q

Prepared for increase solubility, stability,
resistance to degradation after administration, use of prodrug

A

organic ester consideration

101
Q

preformulation stability studies

A
  • Solid state stability of the drug alone
  • Solution phase stability
  • Stability in the presence of expected excipients
102
Q

A solvolysis process in which drug interact with water to yield breakdown products of different chemical constitution

A

hydrolysis

103
Q

examples of hydrolysis

A

acetylsalicylic acid + water
salicylic acid + acetic acid

104
Q

also prone to hydrolytic decomposition

A

amides, lactones, and lactams

105
Q

Involves the loss of electrons from an atom or a molecule

A

oxidation

106
Q

oxidation is common to

A

aldehydes, alcohols, phenols, sugars, alkaloids, and unsaturated fats and oils

107
Q

defined as the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its
manufacture

A

stability

108
Q

each active ingredient retain its chemical
integrity and labeled potency, within specified limits.

A

chemical stability

109
Q

chemical stability is important for

A

-selecting storage conditions (temperature, light, humidity)
-selecting the proper container (glass vs. plastic, clear vs. amber)
-anticipating interactions when mixing drugs

110
Q

the original physical properties, including
appearance, palatability, uniformity, dissolution and suspendability are retained

A

physical stability

111
Q

sterility or resistance to microbial growth is retained
Antimicrobial agents that are present retain effective within specified limits

A

microbiologic stability

112
Q

the therapeutic effect remains unchanged

A

therapeutic stability

113
Q

approaches in the stabilization of drug products against hydrolytic decomposition

A

-reduction of water from the pharmaceutical system
-applying waterproof protective coating
-replacing water with different substitute liquids
-usage of anhydrous vegetable oils in injectable products
-suspending drug in a nonaqueous vehicle
-supply drug in a dry form for reconstitution
-refrigeration
-use for buffering agents
-use of antioxidant

114
Q

in liquid preparations, water can be frequently replaced or reduced through the use of substitute liquids such as

A

glycerin, propylene glycol, and alcohol

115
Q

for most hydrolyzable drugs, optimum stability is on the…

A

acid side (pH 5 and 6)

116
Q

high pH
sodium sulfite

A

aqueous prep

117
Q

alpha-tocopherol

A

oleaginous prep

118
Q

intermediate pH

A

aqueous prep

119
Q

hutyl hydroxy anisole

A

oleaginous prep

120
Q

low pH
hypophosphorous acid
ascorbic acid

A

aqueous prep

121
Q

ascorbyl palmitate

A

oleaginous prep

122
Q

factors that affects oxidation

A

-oxygen present as airspace within the container
-nitrogen trace elements in drugs, solvent, container and
stopper -chelating agent eg. EDTA
ethylenediaminetetraacetic acid)and calcium disodium edetate
light-light resistance or opaque plastic
temperature -cool place
ph of the preparation- maintain solution in pH most favorable to its stability

123
Q

low MW salts

A

salty

124
Q

high MW salts

A

bitter

125
Q

increase hydroxyl group

A

increase sweetness

126
Q

pleasant to taste

A

aldehyde, organic esters, alcohols

127
Q

nitrogen compound

A

(plant alkaloids) bitter

128
Q

aspartame

A

sweet

129
Q

mask salty taste of drugs (Chlorides of Na, K, and Ammonium)

A

cinnamon, raspberry, and orange flavors

130
Q

mask the bitter taste of drugs (alkaloids, epsom salt)

A

cocoa

131
Q

combat acid or sour taste

A

fruit or citrus flavors

132
Q

commonly used sweetener from sugar canes/beets

A

sucrose

133
Q

less sweet than sucrose but more viscous

A

glycerin

134
Q

300 times as sweet as sucrose; has a bitter after taste; carcinogenic in animal

A

saccharin

135
Q

180 to 200 times sweeter than sucrose; contraindicated to phenylketonuria

A

aspartame

136
Q

has carcinogenic potential; artificial sweetener

A

cyclamate

137
Q

130 times as sweet as sucrose

A

acesulfame potassium

138
Q

natural, non-toxic, safe and 30 times sweeter than sucrose

A

stevia powder

139
Q

plant dyes

A

achuete

140
Q

minerals

A

Ferric Oxide (red); it is mixed in small
portion with Zinc oxide imparting a characteristic pink color in Calamine powder

141
Q

synthetic

A

coal tar dyes, anthracene dyes, aniline dyes

142
Q

used in food, drugs, and cosmetics

A

FD & C (brilliant blue)

143
Q

approved for use in drugs, some in cosmetics, and some in medical devices

A

D & C

144
Q

use of which is restricted to external parts of the body, not including the lipids or any body surface covered by mucous membrane

A

external D & C

145
Q

changes of colorant according to toxicological findings

A

a) withdrawal of certification
b) the transfer of colorant from one certification category to another
c) the addition of new color to the list

146
Q

can cause allergic reactions to patient who has sensitivity reaction to aspirin; FDA requires the listing of this dye on the labels of food and ingested drugs containing the substance

A

FD & C Yellow No. 5 (tartrazine)

147
Q

drug products requiring colorants

A

capsules
compressed tablets
sugar-coated tablets
suspension

148
Q

drug products that do not contain color additives

A

ophthalmic products
parenteral products
ointments
suppositories

149
Q

amount of liquid dyes added to liquid preparations ranges from

A

0.0005 to 0.001% depending ypon the colorant and the depth of color desired

150
Q

a pigment consisting of a substratum of alumina hydrate on which the dye is adsorbed or precipitated.

A

FD and C

151
Q

lake pigments are suitable for coloring products in which the moisture levels are…

A

low

152
Q

products requiring preservatives

A

syrups
emulsions
semisolid preparations
ophthalmic products
parenteral (multiple-dose packages)

153
Q

products not requiring preservitives

A

alcoholic and hydroalcoholic solutions
large volume parenterals

154
Q

what percentage of alcohol in solutions will prevent microbial contamination

A

15-20%

155
Q

parenterals and ophthalmic preparations are sterilized by

A

autoclaving, bacterial filtration, and dry heat, however may still require additional preservatives

156
Q

frequently used in preservatives in ophthalmic preparations because of their low degree of irritant qualities

A

chlorobutanol, benzalkonium chloride, and phenyl mercuric nitrate

157
Q

_____ are more effective in ______

A

acidic preservatives, acid media

158
Q

_______ are less effective in acid or neutral media but more effective in _______

A

alkaline preservatives, alkaline media

Dosage Forms Lecture (2 decks)

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