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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
Example of single dose containers (2)
Fusion-sealed ampules Prefilled syringes & cartridges
26
Permits the withdrawal of SUCCESSIVE PORTIONS, without changing the strength or endangering the quality or purity of the remaining portion
MULTIPLE-DOSE CONTAINER
27
Example of multiple dose containers
VIALS
28
Rigid and has good clarity; useful in blister packaging of tablets and capsules and NOT SUITABLE WHEN GAMMA STERILIZATION IS REQUIRED
POLYVINYL CHLORIDE
29
Have excellent transparency and luster can be sterilized with gamma radiation (2)
Amorphous polyethylene terephthalate glycol (APET) Polyethylene terephthalate glycol (PETG)
30
Highly resistant borosilicate glass
TYPE 1
31
Treated soda lime glass
TYPE II
32
Soda lime glass
TYPE III
33
General purpose soda lime glass
TYPE NP
34
ADVANTAGES OF PLASTIC
1. lightness of weight 2. versatility in design & consumer acceptance 3. consumer preference 4. popularity 5. resistance to impact
35
TEMPERATURE: cold
any temp not exceeding 8C
36
TEMPERATURE: refrigerated
between 2C & 8C
37
TEMPERATURE: freezer
between -25C & -10C
38
TEMPERATURE: cool
any temp between 8C & 15C
39
TEMPERATURE: room temp (official)
20C - 25C
40
TEMPERATURE: controlled room temp
15C - 30C
41
TEMPERATURE: warm
30C - 40C
42
TEMPERATURE: excessive heat
above 40C
43
It refers to the formulation that BEST MEETS THE GOALS for a finished product.
MASTER FORMULATION
44
The ____ of the product is ESSENTIAL for the IDENTIFICATION & EVALUATION of the physical, chemical and biologic properties of a drug substance
PURITY
45
Properties that includes structure, form and reactivity
CHEMICAL PROPERTIES
46
Properties that includes physical description, particle size, crystalline structure, melting point and solubility
PHYSICAL PROPERTIES
47
Properties relate to its ability to get a site of action and elicit a biological response
BIOLOGIC PROPERTIES
48
Gives indication of particle size and size range of raw material, along with the crystalline structure
MICROSCOPIC EXAMINATION
49
INDICATES THE PURITY of the drugs substance. If impurities are present the drug substance will exhibit a change in _______________
MELTING POINT
50
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.
PHASE RULE
51
It affect dissolution rate, bioavailability, content uniformity, taste, texture, color and stability properties, as well as sedimentation rates and flow characteristics.
PARTICLE SIZE
52
It exhibits different PHYSICOCHEMICAL PROPERTIES, such as melting point and solubility
POLYMORPHIC FORMS
53
A drug must possess __________ solubility for therapeutic efficacy, it must enter the systemic circulation and exert a therapeutic effect.
AQUEOUS SOLUBILITY
54
The rate limiting steps in absorption
DISSOLUTION
55
It refers to the time it takes for the drug to dissolve in the fluids at the absorption site.
DISSOLUTION RATE
56
To PRODUCE A BIOLOGIC RESPONSE, the drug molecule MUST FIRST CROSS THE BIOLOGICAL MEMBRANE
MEMBRANE PERMEABILITY
57
The biologic membrane acts as a lipid barrier to most drugs and PERMITS THE ABSORPTION OF LIPID-SOLUBLE SUBSTANCES by _____________
PASSIVE DIFFUSION
58
Measure of drug’s LIPOPHILIC character
PARTITION COEFFICIENT
59
Give the 3 stability studies conducted in the pre-formulation phase
SOLID-STATE STABILITY SOLUTION-PHASE STABILITY STABILITY IN PRESENCE OF EXCIPIENTS
60
A SOLVOLYSIS PROCESS in which the drug molecules interact with water molecules to produce breakdown products.
HYDROLYSIS
61
The LOSS OF ELECTRONS (hydrogen atom) from an atom or molecule
DEHYDROGENATION
62
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
STABILITY
63
Types of stability that the active/s retain its CHEMICAL INTEGRITY and labeled potency
CHEMICAL STABILITY
64
Types of stability that the appearance, palatability, uniformity, dissolution and suspendability are retained.
PHYSICAL STABILITY
65
Types of stability that ANTI-MICROBIAL AGENTS retain effectiveness
MICROBIOLOGIC
66
Types of stability that the therapeutic effect remains unchanged.
THERAPEUTIC STABILITY
67
Types of stability that no significant increase in TOXICITY.
TOXICOLOGICAL STABILITY
68
Give the 3 importance of determining chemical stability
selecting storage conditions selecting proper container anticipating interactions
69
Addition of ____ can ENHANCE STABILITY of the products AGAINST OXIDATION
ANTIOXIDANTS
70
It is effective for masking the BITTER taste of the drugs
COCOA FLAVORED VEHICLES
71
It combats SOUR/ACID taste of the drugs
FRUIT / CITRUS FLAVORS
72
Makes SALTY tasting drugs more palatable
CINNAMON, ORANGE, RASPBERRY
73
They prefer sweet, candy like flavours
CHILDREN
74
Prefer less sweet flavors, with a tart, rather than a fruit flavor
ADULTS
75
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
CYCLAMATE
76
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.
ACESULFAME POTASSIUM
77
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.
ASPARTAME
78
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
STEVIOL GLYCOSIDES
79
Restricted to external parts of the body, not including the lips or any body surface covered with mucous membrane
EXTERNAL D&C
80
Also known as TARTRAZINE causes allergic-type reactions in people allergic also to asa / ASPIRIN. Commonly used in junk foods
FD&C YELLOW #5
81
Generally added to pharmaceuticals in the form of DILUTED SOLUTIONS, rather than as concentrated dry powders
DYES
82
A pigment consisting of a substratum of alumina hydrate, on which a dye is adsorbed or precipitated
FD&C LAKE
83
Are suitable for coloring products in which the MOISTURE LEVELS ARE VERY LOW
OIL-SOLUBLE DYES
84
Vehicle that are SELF-STERILIZING dosage forms and do not require additional preservatives
ALCOHOL-CONTAINING PHARMACEUTICALS
85
Dosage forms that provides excellent growth media for microorganisms (4)
SYRUPS EMULSIONS SUSPENSIONS CREAMS
86
Preservatives commonly used in OPHTHALMIC preparations wherein they Have LOW IRRITANT QUALITIES (3)
CHLOROBUTANOL BENZALKONIUM CHLORIDE PHENYLMERCURIC NITRATE
87
Added to AQUEOUS to enhance stability of production against oxidation
SODIUM SULFITE SODIUM BISULFITE SODIUM METABISULFITE ASCORBIC ACID HYPOPHOSPHOROUS ACID
88
Added to OLEAGNINOUS preparations to enhance stability of production against oxidation
ALPHA-TOCOPHEROL BYTL HYDROXY ANISOLE ASCORBYL PALMITATE
89
tamper evident packaging that is the most hard to destroy / damage
AEROSOL CONTAINER
90
a SINGLE UNIT PACKAGE is termed as
UNIT-DOSE PACKAGE
91
most commonly used type of glass
TYPE 1
92
DISADVANTAGES OF PLASTIC
permeability leaching absorption/adsorption transmission of light
93
a process of SOLUTION & DIFFUSION, with the penetrant dissolving in the plastic on one side and diffusing through the other side
PERMEABILITY
94
permeability should not be confused with
POROSITY
95
minute holes or cracks in the plastic ALLOW GAS or MOISTURE VAPOR to move through directly
POROSITY
96
the MOVEMENT of COMPONENTS of a CONTAINER into the CONTENTS
LEACHING
97
a term used to indicate the BINDING OF MOLECULES to POLYMER MATERIALS, includes both adsorption and absorption
SORPTION
98
plastic materials with ____ are particularly PRONE to SORPTION
POLAR GROUPS
99
the republic act that says all generic name should be in the label
RA1675
100
products intended to supplement the diet
DIETARY SUPPLEMENT
101
dietary supplements labels should have
SUPPLEMENT FACTS
102
for herbal products, the label should also contain
the part of the plant used
103
the general area of study concerned with the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms is referred to as
PHARMACEUTICS
104
to protect the drug substance from the destructive influences of atmospheric OXYGEN or HUMIDITY
coated tablets, sealed ampuls
105
to protect the drug substance from the destructive influence of GASTRIC ACID after oral administration
enteric coated tablets
106
used in SYSTEMIC USE and ORAL ADMINISTRATION. the MOST CONVINIENT in self-administration
TABLETS / CAPSULES
107
used in EMERGENCIES in which a patient may be in a COMATOSE or unable to take the medication orally
INJECTABLE FORM
108
used for people who has difficulty in SWALLOWING (kids or adults)
CHEWABLE TABLETS
109
a device used to help SWALLOW solid dosage forms
PILL GLIDE
110
STRONGEST bonding interaction
ION-ION
111
the process of OPTIMIZING a drug through the determination and/or definition of those physical and chemical properties
PREFORMULATION
112
the SIMPLEST METHOD in determining the PARTICLE SIZES but does not provide much information on particle shape
SIEVE ANALYSIS
113
weak acid + weak base =
NOT SOLUBLE
114
are those that will tend to ABSORB MOISTURE from the air
HYGROSCOPIC POWDERS
115
are those that will absorb moisture from the air and will LIQUEFY
DELIQUESCENT POWDERS
116
are those that may GIVE UP their WATER OF CRYSTALLIZATION and may even become DAMP & PASTY (powderized)
EFFLORESCENT POWDERS
117
weak acids and weak bases are often used as ____ to INCREASE THEIR AQUEOUS SOLUBILITY
SALTS
118
ENHANCE solubility
SALT form
119
destroys ESTERS, AMIDES, LACTONES, LACTAMS
HYDROLYSIS
120
destroys ALDEHYDES, ALCOHOLS, PHENOLS, SUGARS, ALKALOIDS, AND UNSTAURATED FATS & OILS
OXIDATION
121
LOW MW
salty
122
HIGH MW
BITTER
123
color additives which may be used in food, drugs, and cosmetics
FD&C
124
color additives used in drugs, some cosmetics, and medical devices
D&C
125
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
EXTERNAL D&C
126
prone to microbial growth
WATER
127
concentration of alcohol as preservatives
15% - 20%

DOSAGE (19 decks)

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