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DOSAGE > M1 > Flashcards

M1 Flashcards

1
Q

One that HOLDS THE ARTICLE and is or may be in DIRECT CONTACT with the article

A

CONTAINER

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2
Q

Is the one that has a DIRECT CONTACT with the articles AT ALL TIMES

A

IMMEDIATE CONTAINER

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3
Q

It protects the contents from EXTRANEOUS SOLIDS and from LOSS OF ARTICLE under ordinary conditions of handling, shipping, storage and distribution.

A

WELL-CLOSED CONTAINER

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4
Q

It 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

TIGHT CONTAINER

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5
Q

It 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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6
Q

Examples of products where hermetic containers are used

A

AMPULE

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7
Q

It provides protection from the DEGRADATIVE EFFECTS of LIGHT by reducing light transmission

A

LIGHT RESISTANT CONTAINER

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8
Q

Another term for light resistant containers

A

AMBER BOTTLE

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9
Q

PLASTIC that REDUCE LIGHT TRANSMISSION sufficiently to protect a light sensitive pharmaceutical.

A

LIGHT-RESISTANT OPAQUE PLASTIC

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10
Q

Agents that is added to DECREASE THE TRANSMISSION of SHORT ULTRAVIOLET RAYS

A

ULTRAVIOLET ABSORBERS

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11
Q

What is the USP standard on limit for LIGHT TRANSMISSION

A

290 - 450 nm

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12
Q

A package with ONE OR MORE “INDICATORS OR BARRIERS” to entry, which if breached or missing is known as _________.

A

TAMPER-EVIDENT PACKAGING

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13
Q

A kind of tamper evident packaging where SEALED AROUND product and/or product container; film must be CUT OR TORN to remove the product

A

FILM WRAPPER

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14
Q

A kind of tamper evident packaging where INDIVIDUALLY SEALED DOSE UNITS; removal requires tearing or breaking individual compartment.

A

BLISTER / STRIP PACK

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15
Q

A kind of tamper evident packaging where product and container SEALED IN PLASTIC, usually MOUNTED ON DISPLAY CARD; plastic must be cut or broken open to remove the product.

A

BUBBLE PACK

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16
Q

A kind of tamper evident packaging where band or wrapper SHRUNK BY HEAT or DRYING TO CONFORM TO CAP; must be torn to open the package.

A

SHRINK SEAL

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17
Q

A kind of tamper evident packaging where sealed INDIVIDUAL PACKET; must be torn to reach the product

A

POUCH

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18
Q

A kind of tamper evident packaging where PAPER OR FOIL sealed to the MOUTH OF THE CONTAINER, under the cap; must be torn or broken to reach the product.

A

BOTTLE SEAL

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19
Q

A kind of tamper evident packaging where paper or foil SEALED OVER CARTON FLAP OR BOTTLE CAP; must be torn or broken to reach the product.

A

TAPE SEAL

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20
Q

A kind of tamper evident packaging where plastic or metal TEAR-AWAY CAP over container; must be broken to remove.

A

BREAKABLE CAP

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21
Q

A kind of tamper evident packaging where SEAL OVER MOUTH OF TUBE; must be PUNCTURED to reach the product.

A

SEALED TUBE

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22
Q

A kind of tamper evident packaging where CARTON FLAP SEALED; carton cannot be opened without damage.

A

SEALED CARTON

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23
Q

One that is significantly difficult for children, under 5 years of age, to open or obtain a harmful amount of its contents within a reasonable time.

A

CHILDREN-RESISTANT CONTAINER

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24
Q

One that holds a quantity of drug intended as a single dose

A

SINGLE-UNIT CONTAINER

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25
Q

Example of single dose containers (2)

A

Fusion-sealed ampules
Prefilled syringes & cartridges

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26
Q

Permits the withdrawal of SUCCESSIVE PORTIONS, without changing the strength or endangering the quality or purity of the remaining portion

A

MULTIPLE-DOSE CONTAINER

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27
Q

Example of multiple dose containers

A

VIALS

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28
Q

Rigid and has good clarity; useful in blister packaging of tablets and capsules and NOT SUITABLE WHEN GAMMA STERILIZATION IS REQUIRED

A

POLYVINYL CHLORIDE

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29
Q

Have excellent transparency and luster can be sterilized with gamma radiation (2)

A

Amorphous polyethylene terephthalate glycol (APET)

Polyethylene terephthalate glycol (PETG)

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30
Q

Highly resistant borosilicate glass

A

TYPE 1

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31
Q

Treated soda lime glass

A

TYPE II

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32
Q

Soda lime glass

A

TYPE III

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33
Q

General purpose soda lime glass

A

TYPE NP

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34
Q

ADVANTAGES OF PLASTIC

A
  1. lightness of weight
  2. versatility in design & consumer acceptance
  3. consumer preference
  4. popularity
  5. resistance to impact
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35
Q

TEMPERATURE:
cold

A

any temp not exceeding 8C

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36
Q

TEMPERATURE:
refrigerated

A

between 2C & 8C

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37
Q

TEMPERATURE:
freezer

A

between -25C & -10C

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38
Q

TEMPERATURE:
cool

A

any temp between 8C & 15C

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39
Q

TEMPERATURE:
room temp (official)

A

20C - 25C

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40
Q

TEMPERATURE:
controlled room temp

A

15C - 30C

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41
Q

TEMPERATURE:
warm

A

30C - 40C

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42
Q

TEMPERATURE:
excessive heat

A

above 40C

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43
Q

It refers to the formulation that BEST MEETS THE GOALS for a finished product.

A

MASTER FORMULATION

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44
Q

The ____ of the product is ESSENTIAL for the IDENTIFICATION & EVALUATION of the physical, chemical and biologic properties of a drug substance

A

PURITY

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45
Q

Properties that includes structure, form and reactivity

A

CHEMICAL PROPERTIES

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46
Q

Properties that includes physical description, particle size, crystalline structure, melting point and solubility

A

PHYSICAL PROPERTIES

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47
Q

Properties relate to its ability to get a site of action and elicit a biological response

A

BIOLOGIC PROPERTIES

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48
Q

Gives indication of particle size and size range of raw material, along with the crystalline structure

A

MICROSCOPIC EXAMINATION

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49
Q

INDICATES THE PURITY of the drugs substance. If impurities are present the drug substance will exhibit a change in _______________

A

MELTING POINT

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50
Q

is 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

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51
Q

It affect dissolution rate, bioavailability, content uniformity, taste, texture, color and stability properties, as well as sedimentation rates and flow characteristics.

A

PARTICLE SIZE

52
Q

It exhibits different PHYSICOCHEMICAL PROPERTIES, such as melting point and solubility

A

POLYMORPHIC FORMS

53
Q

A drug must possess __________ solubility for therapeutic efficacy, it must enter the systemic circulation and exert a therapeutic effect.

A

AQUEOUS SOLUBILITY

54
Q

The rate limiting steps in absorption

A

DISSOLUTION

55
Q

It refers to the time it takes for the drug to dissolve in the fluids at the absorption site.

A

DISSOLUTION RATE

56
Q

To PRODUCE A BIOLOGIC RESPONSE, the drug molecule MUST FIRST CROSS THE BIOLOGICAL MEMBRANE

A

MEMBRANE PERMEABILITY

57
Q

The biologic membrane acts as a lipid barrier to most drugs and PERMITS THE ABSORPTION OF LIPID-SOLUBLE SUBSTANCES by _____________

A

PASSIVE DIFFUSION

58
Q

Measure of drug’s LIPOPHILIC character

A

PARTITION COEFFICIENT

59
Q

Give the 3 stability studies conducted in the pre-formulation phase

A

SOLID-STATE STABILITY
SOLUTION-PHASE STABILITY
STABILITY IN PRESENCE OF EXCIPIENTS

60
Q

A SOLVOLYSIS PROCESS in which the drug molecules interact with water molecules to produce breakdown products.

A

HYDROLYSIS

61
Q

The LOSS OF ELECTRONS (hydrogen atom) from an atom or molecule

A

DEHYDROGENATION

62
Q

The extent of which a product RETAINS, within specified limits and throughout its period of storage and use the same properties and characteristics that is possessed at the time of its manufacture

A

STABILITY

63
Q

Types of stability that the active/s retain its CHEMICAL INTEGRITY and labeled potency

A

CHEMICAL STABILITY

64
Q

Types of stability that the appearance, palatability, uniformity, dissolution and suspendability are retained.

A

PHYSICAL STABILITY

65
Q

Types of stability that ANTI-MICROBIAL AGENTS retain effectiveness

A

MICROBIOLOGIC

66
Q

Types of stability that the therapeutic effect remains unchanged.

A

THERAPEUTIC STABILITY

67
Q

Types of stability that no significant increase in TOXICITY.

A

TOXICOLOGICAL STABILITY

68
Q

Give the 3 importance of determining chemical stability

A

selecting storage conditions
selecting proper container
anticipating interactions

69
Q

Addition of ____ can ENHANCE STABILITY of the products AGAINST OXIDATION

A

ANTIOXIDANTS

70
Q

It is effective for masking the BITTER taste of the drugs

A

COCOA FLAVORED VEHICLES

71
Q

It combats SOUR/ACID taste of the drugs

A

FRUIT / CITRUS FLAVORS

72
Q

Makes SALTY tasting drugs more palatable

A

CINNAMON, ORANGE, RASPBERRY

73
Q

They prefer sweet, candy like flavours

A

CHILDREN

74
Q

Prefer less sweet flavors, with a tart, rather than a fruit flavor

A

ADULTS

75
Q

Introduced into beverage and foods in the 50’s and dominated the artificial sweetener market in the 60’s. BANNED by the US-FDA in 1969 due to possible CARCIGONECITY, genetic damage and testicular atrophy

A

CYCLAMATE

76
Q

It is a NON-NUTRITIVE SWEETENER approved in 1992 by BFAD. Structurally similar to saccharin, it is 130 times as sweet as sucrose. Mostly used in chewing gum, confectionery, instant coffees / teas.

A

ACESULFAME POTASSIUM

77
Q

It can cause CANCER IN ANIMALS and contraindicated to persons with pku or phenylketonuria, which can lead to mental retardation and affect the fetus of pregnant women who has pku.

A

ASPARTAME

78
Q

Extracted from the leaves of the plant, stevia rebaudiana bertoni. And it is non-toxic, safe and about 30 times as sweet as cane sugar

A

STEVIOL GLYCOSIDES

79
Q

Restricted to external parts of the body, not including the lips or any body surface covered with mucous membrane

A

EXTERNAL D&C

80
Q

Also known as TARTRAZINE causes allergic-type reactions in people allergic also to asa / ASPIRIN. Commonly used in junk foods

A

FD&C YELLOW #5

81
Q

Generally added to pharmaceuticals in the form of DILUTED SOLUTIONS, rather than as concentrated dry powders

A

DYES

82
Q

A pigment consisting of a substratum of alumina hydrate, on which a dye is adsorbed or precipitated

A

FD&C LAKE

83
Q

Are suitable for coloring products in which the MOISTURE LEVELS ARE VERY LOW

A

OIL-SOLUBLE DYES

84
Q

Vehicle that are SELF-STERILIZING dosage forms and do not require additional preservatives

A

ALCOHOL-CONTAINING PHARMACEUTICALS

85
Q

Dosage forms that provides excellent growth media for microorganisms (4)

A

SYRUPS
EMULSIONS
SUSPENSIONS
CREAMS

86
Q

Preservatives commonly used in OPHTHALMIC preparations wherein they
Have LOW IRRITANT QUALITIES (3)

A

CHLOROBUTANOL
BENZALKONIUM CHLORIDE
PHENYLMERCURIC NITRATE

87
Q

Added to AQUEOUS to enhance stability of production against oxidation

A

SODIUM SULFITE
SODIUM BISULFITE
SODIUM METABISULFITE
ASCORBIC ACID
HYPOPHOSPHOROUS ACID

88
Q

Added to OLEAGNINOUS preparations to enhance stability of production against oxidation

A

ALPHA-TOCOPHEROL
BYTL HYDROXY ANISOLE
ASCORBYL PALMITATE

89
Q

tamper evident packaging that is the most hard to destroy / damage

A

AEROSOL CONTAINER

90
Q

a SINGLE UNIT PACKAGE is termed as

A

UNIT-DOSE PACKAGE

91
Q

most commonly used type of glass

A

TYPE 1

92
Q

DISADVANTAGES OF PLASTIC

A

permeability
leaching
absorption/adsorption
transmission of light

93
Q

a process of SOLUTION & DIFFUSION, with the penetrant dissolving in the plastic on one side and diffusing through the other side

A

PERMEABILITY

94
Q

permeability should not be confused with

A

POROSITY

95
Q

minute holes or cracks in the plastic ALLOW GAS or MOISTURE VAPOR to move through directly

A

POROSITY

96
Q

the MOVEMENT of COMPONENTS of a CONTAINER into the CONTENTS

A

LEACHING

97
Q

a term used to indicate the BINDING OF MOLECULES to POLYMER MATERIALS, includes both adsorption and absorption

A

SORPTION

98
Q

plastic materials with ____ are particularly PRONE to SORPTION

A

POLAR GROUPS

99
Q

the republic act that says all generic name should be in the label

A

RA1675

100
Q

products intended to supplement the diet

A

DIETARY SUPPLEMENT

101
Q

dietary supplements labels should have

A

SUPPLEMENT FACTS

102
Q

for herbal products, the label should also contain

A

the part of the plant used

103
Q

the general area of study concerned with the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms is referred to as

A

PHARMACEUTICS

104
Q

to protect the drug substance from the destructive influences of atmospheric OXYGEN or HUMIDITY

A

coated tablets, sealed ampuls

105
Q

to protect the drug substance from the destructive influence of GASTRIC ACID after oral administration

A

enteric coated tablets

106
Q

used in SYSTEMIC USE and ORAL ADMINISTRATION. the MOST CONVINIENT in self-administration

A

TABLETS / CAPSULES

107
Q

used in EMERGENCIES in which a patient may be in a COMATOSE or unable to take the medication orally

A

INJECTABLE FORM

108
Q

used for people who has difficulty in SWALLOWING (kids or adults)

A

CHEWABLE TABLETS

109
Q

a device used to help SWALLOW solid dosage forms

A

PILL GLIDE

110
Q

STRONGEST bonding interaction

A

ION-ION

111
Q

the process of OPTIMIZING a drug through the determination and/or definition of those physical and chemical properties

A

PREFORMULATION

112
Q

the SIMPLEST METHOD in determining the PARTICLE SIZES but does not provide much information on particle shape

A

SIEVE ANALYSIS

113
Q

weak acid + weak base =

A

NOT SOLUBLE

114
Q

are those that will tend to ABSORB MOISTURE from the air

A

HYGROSCOPIC POWDERS

115
Q

are those that will absorb moisture from the air and will LIQUEFY

A

DELIQUESCENT POWDERS

116
Q

are those that may GIVE UP their WATER OF CRYSTALLIZATION and may even become DAMP & PASTY (powderized)

A

EFFLORESCENT POWDERS

117
Q

weak acids and weak bases are often used as ____ to INCREASE THEIR AQUEOUS SOLUBILITY

A

SALTS

118
Q

ENHANCE solubility

A

SALT form

119
Q

destroys ESTERS, AMIDES, LACTONES, LACTAMS

A

HYDROLYSIS

120
Q

destroys ALDEHYDES, ALCOHOLS, PHENOLS, SUGARS, ALKALOIDS, AND UNSTAURATED FATS & OILS

A

OXIDATION

121
Q

LOW MW

A

salty

122
Q

HIGH MW

A

BITTER

123
Q

color additives which may be used in food, drugs, and cosmetics

A

FD&C

124
Q

color additives used in drugs, some cosmetics, and medical devices

A

D&C

125
Q

color additives which is restricted to EXTERNAL PARTS OF THE BODY, not including the LIPS or any other parts that are covered by the mucous membrane

A

EXTERNAL D&C

126
Q

prone to microbial growth

A

WATER

127
Q

concentration of alcohol as preservatives

A

15% - 20%

DOSAGE (19 decks)

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