Module 1 Flashcards
(158 cards)
1
Q
what are drugs intended to be used for in humans or in animals?
A
diagnosis, mitigation, treatment, cure, prevention
2
Q
drugs used to diagnose or determine a disease by…
A
assaying the percentage of antibodies present
3
Q
given for diagnosis of diseases or thyroid related problems
A
radiopharmaceuticals
4
Q
deals with a disease, injury, etc. in order to make someone feel better or become healthy again
A
treatment
5
Q
what is better than a cure?
A
prevention
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)
7
Q
preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration
A
dosage form
8
Q
another name for dosage forms?
A
pharmaceuticals
9
Q
ACTIVE INGREDIENTS
A
active pharmaceutical agents (API), pharmacologically active therapeutic ingredients
10
Q
NON ACTIVE INGREDIENTS
A
inert, inactive ingredients, additives, excipients
11
Q
what do non active ingredients do to the pharmaceutical?
A
Give the formulation its unique composition and characteristic physical appearance
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
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
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
15
Q
an uptake of salt that causes a decrease in water
A
efflorescence
16
Q
absorption of moisture
A
deliquescence
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
18
Q
how are substances in hermetic containers delivered?
A
injection or parenteral preparation
19
Q
provides protection from the degradative effects of light by reducing light transmission
A
light-resistant containers
20
Q
light-resistant containers are also called…
A
amber bottles
21
Q
added to decrease the transmission of short ultraviolet rays
A
ultraviolet absorbers
22
Q
USP standard on limit if light transmission is between…
A
290-450 nm
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
24
Q
child-resistant containers are specially made for children aged…
A
5 years old and below
25
four basic designs of child resistant containers
align the arrows
press down and turn
squeeze and turn
latch top
26
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.
tamper-evident container
27
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
single dose
28
examples of single dose containers
ampules, prefilled syringes or cartridges
29
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
multiple dose
30
examples of multiple dose containers
vials
31
type I of glass is composed of
highly-resistant borosilicate glass
32
what is type I, II, and III glass used for?
parenteral products
33
type II of glass is composed of
treated soda-lime glass
34
type III of glass is composed of
soda lime glass
35
type NP of glass is composed of
general purpose soda-lime glass
36
what is type NP glass used for?
other preparations
37
what type of glass is most resistant?
type I
38
plastic material that is rigid and has good
clarity;
polyvinyl chloride (PVC)
39
PVC is useful in
blister packaging of tablets and capsules
40
PVC is not suitable when
gamma sterilization is required
41
PET plastic used in water bottles and the likes
polyethylene terephthalate
42
APET
amorphous polyethylene terephthalate glycol
43
PETG
polyethylene terephthalate glycol
44
have excellent transparency and luster and can be sterilized with gamma radiation
APET and PETG
45
advantage of plastic containers
-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
46
disadvantages of plastic containers
-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)
47
Statement of pharmacologic category; No Rx symbol
OTC label
48
prescription drug label contains...
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
49
for controlled substances...
the symbol “C” and the statement “Warning: Maybe habit-forming”
50
OTC drug label contains...
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
51
dietary supplement labels should contain
This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease
52
herbal products should state...
specific parts of the plant used
53
product standardization includes
USP verified program
NSF certification program
Consumer Laboratories
54
assurance of product safety but not guarantee effectiveness
SEAL
55
any temperature not exceeding 8 degrees celcius
cold temperature
56
refrigerator
2 to 8 c
57
freezer
-25 to -10 c
58
any temperature between 8 to 15 c
cool temperature
59
temperatures between 20 to 25 c, sometimes 15 - 30 c
controlled room temperature
60
temperature between 30 to 40 c
warm temperature
61
temperature above 40 c
excessive heat
62
risks of freezing; breakage of container; loss of potency/strength; destructive alteration of the dosage form
protection from freezing
63
to protect drug substances from the destructive influence of gastric acid after oral administration
enteric coated tablets
64
to provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle
suspension or clear preparation solution
65
to conceal bitter, offensive, or salty taste or odor of a drug substance
capsule, Coated tablets, syrups
66
to provide rate controlled drug action
controlled release tablet, capsule, suspension
67
to provide optimal drug action from topical administration sites
ointment, creams, transdermal patches, ophthalmic prep. ear prep, nasal prep
68
to provide for insertion of drug into one of the body's orfices
rectal, vaginal suppositories
69
to provide placement of drug directly in the bloodstream or body tissues
injection
70
to provide optimal drug action through inhalation therapy
inhalants, inhalation aerosols
71
the formulation that best meets the goals for the product is selected to be its
master formula
72
pre formulation considerations
-physical descriptions
-microscopic examination
-heat vaporization
-melting point depression
-phase rule
-particle size
-polymorphism
-solubility
-dissolution
-membrane permeability
-partition coefficient
-dissociation constant
73
general considerations in dosage forms designs
1. physical and chemical properties of the drug substance
2. therapeutic considerations
74
therapeutic considerations
i. nature of illness
ii. manner in which it is treated
iii. age and the anticipated condition of the patient
75
the purity of the chemical substance substance is essential for its identification and for evaluation of its chemical, physical and biological properties
physical description
76
structure, form, and reactivity
chemical property
77
physical description, particle size, crystalline structure, melting point and solubility
physical property
78
ability to get to a site of action and elicit responses
biological property
79
Gives an indication of particle size and size range of the raw materials along with the crystal structure
microscopic examination
80
which flow more freely: spherical and ovals powders of needle shaped powders?
spherical and oval powders
81
heat vaporization
-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
melting point depression is used to determine
the purity of the substance
83
change in melting point of product means it is
not pure
84
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.
phase rule
85
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
particle size
86
polymorphism
crystal or amorphous, and affects melting point and solubility
87
should possess aqueous solubility for therapeutic effect
solubility
88
frequently added to increase solubility
salt and water
89
can increase solubility
adjustment in particle size and pH
90
rate limiting step in the absorption process
dissolution
91
the time it takes for the drug to be dissolved in the fluids at the absorption site
dissolution rate
92
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
membrane permeability
93
measure of drug's lipophilic character
partition coefficient
94
the extend of dissociation and ionization of the drug
pKa/dissociation constant
95
has strong effect on drug absorption, distribution, and elimination
extent of ionization
96
absorbs moisture from air
hygroscopic powder
97
absorb moisture from air before liquefying
deliquescent powder
98
give up water for crystallization and may even become damp and pasty
efflorescent powder
99
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
organic salt consideration
100
Prepared for increase solubility, stability,
resistance to degradation after administration, use of prodrug
organic ester consideration
101
preformulation stability studies
* Solid state stability of the drug alone
* Solution phase stability
* Stability in the presence of expected excipients
102
A solvolysis process in which drug interact with water to yield breakdown products of different chemical constitution
hydrolysis
103
examples of hydrolysis
acetylsalicylic acid + water
salicylic acid + acetic acid
104
also prone to hydrolytic decomposition
amides, lactones, and lactams
105
Involves the loss of electrons from an atom or a molecule
oxidation
106
oxidation is common to
aldehydes, alcohols, phenols, sugars, alkaloids, and unsaturated fats and oils
107
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
stability
108
each active ingredient retain its chemical
integrity and labeled potency, within specified limits.
chemical stability
109
chemical stability is important for
-selecting storage conditions (temperature, light, humidity)
-selecting the proper container (glass vs. plastic, clear vs. amber)
-anticipating interactions when mixing drugs
110
the original physical properties, including
appearance, palatability, uniformity, dissolution and suspendability are retained
physical stability
111
sterility or resistance to microbial growth is retained
Antimicrobial agents that are present retain effective within specified limits
microbiologic stability
112
the therapeutic effect remains unchanged
therapeutic stability
113
approaches in the stabilization of drug products against hydrolytic decomposition
-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
in liquid preparations, water can be frequently replaced or reduced through the use of substitute liquids such as
glycerin, propylene glycol, and alcohol
115
for most hydrolyzable drugs, optimum stability is on the...
acid side (pH 5 and 6)
116
high pH
sodium sulfite
aqueous prep
117
alpha-tocopherol
oleaginous prep
118
intermediate pH
aqueous prep
119
hutyl hydroxy anisole
oleaginous prep
120
low pH
hypophosphorous acid
ascorbic acid
aqueous prep
121
ascorbyl palmitate
oleaginous prep
122
factors that affects oxidation
-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
low MW salts
salty
124
high MW salts
bitter
125
increase hydroxyl group
increase sweetness
126
pleasant to taste
aldehyde, organic esters, alcohols
127
nitrogen compound
(plant alkaloids) bitter
128
aspartame
sweet
129
mask salty taste of drugs (Chlorides of Na, K, and Ammonium)
cinnamon, raspberry, and orange flavors
130
mask the bitter taste of drugs (alkaloids, epsom salt)
cocoa
131
combat acid or sour taste
fruit or citrus flavors
132
commonly used sweetener from sugar canes/beets
sucrose
133
less sweet than sucrose but more viscous
glycerin
134
300 times as sweet as sucrose; has a bitter after taste; carcinogenic in animal
saccharin
135
180 to 200 times sweeter than sucrose; contraindicated to phenylketonuria
aspartame
136
has carcinogenic potential; artificial sweetener
cyclamate
137
130 times as sweet as sucrose
acesulfame potassium
138
natural, non-toxic, safe and 30 times sweeter than sucrose
stevia powder
139
plant dyes
achuete
140
minerals
Ferric Oxide (red); it is mixed in small
portion with Zinc oxide imparting a characteristic pink color in Calamine powder
141
synthetic
coal tar dyes, anthracene dyes, aniline dyes
142
used in food, drugs, and cosmetics
FD & C (brilliant blue)
143
approved for use in drugs, some in cosmetics, and some in medical devices
D & C
144
use of which is restricted to external parts of the body, not including the lipids or any body surface covered by mucous membrane
external D & C
145
changes of colorant according to toxicological findings
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
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
FD & C Yellow No. 5 (tartrazine)
147
drug products requiring colorants
capsules
compressed tablets
sugar-coated tablets
suspension
148
drug products that do not contain color additives
ophthalmic products
parenteral products
ointments
suppositories
149
amount of liquid dyes added to liquid preparations ranges from
0.0005 to 0.001% depending ypon the colorant and the depth of color desired
150
a pigment consisting of a substratum of alumina hydrate on which the dye is adsorbed or precipitated.
FD and C
151
lake pigments are suitable for coloring products in which the moisture levels are...
low
152
products requiring preservatives
syrups
emulsions
semisolid preparations
ophthalmic products
parenteral (multiple-dose packages)
153
products not requiring preservitives
alcoholic and hydroalcoholic solutions
large volume parenterals
154
what percentage of alcohol in solutions will prevent microbial contamination
15-20%
155
parenterals and ophthalmic preparations are sterilized by
autoclaving, bacterial filtration, and dry heat, however may still require additional preservatives
156
frequently used in preservatives in ophthalmic preparations because of their low degree of irritant qualities
chlorobutanol, benzalkonium chloride, and phenyl mercuric nitrate
157
_____ are more effective in ______
acidic preservatives, acid media
158
_______ are less effective in acid or neutral media but more effective in _______
alkaline preservatives, alkaline media
