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Dosage Forms > PART 1 > Flashcards

PART 1 Flashcards

1
Q

Any article or agent that is used for diagnosis, mitigation, treatment, prevention, and cure of diseases in man and in animals

A

Drug

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2
Q

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

A

Dosage Forms

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3
Q

2 general components of dosage forms

A
  1. Active Pharmaceutical Ingredients (API) / Drug

2. Non-Active Ingredients/Excipients/ Additives/Adjuncts

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4
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Solid, liquid, or gaseous

A

Physical Description

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5
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Dissolution rate, bioavailability, content uniformity, taste, texture, color, and stability; flow properties and sedimentation rates

A

Particle Size

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6
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Measure of a drug’s lipophilic property

A

Partition Coefficient

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7
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Extent of ionization of a drug has a strong effect on its extent of absorption, distribution and elimination

A

Dissociation Constant

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8
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Affects melting point and solubility

A

Polymorphism

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9
Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Affected by particle size and pH

A

Solubility

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10
Q

Rate limiting step in the absorption process

A

Dissolution

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11
Q

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

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12
Q

FIVE TYPES OF STABILITY

Each active ingredient retains its chemical integrity and labeled potency, within specified limits.

A

Chemical

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13
Q

FIVE TYPES OF STABILITY

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

A

Physical

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14
Q

FIVE TYPES OF STABILITY

Sterility or resistance to microbial growth is retained. Antimicrobial agents that are present retain effectiveness within specified limits.

A

Microbiological

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15
Q

FIVE TYPES OF STABILITY

The therapeutic effect remain unchanged.

A

Therapeutic

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16
Q

FIVE TYPES OF STABILITY

No significant increase in toxicity occurs.

A

Toxicological

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17
Q

MECHANISM OF DEGRADATION

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

A

Hydrolysis

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18
Q

MECHANISM OF DEGRADATION

It involves the loss of electrons from an atom or a molecule.

A

Oxidation

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19
Q

MECHANISM OF DEGRADATION

It involves a reaction between two or more identical molecules with a resultant formation of a new and generally larger molecule.

A

Polymerization

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20
Q

MECHANISM OF DEGRADATION

Decomposition of an organic acid and the consequent release of carbon dioxide

A

Decarboxylation

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21
Q

MECHANISM OF DEGRADATION

It involves the removal of the nitrogen-containing group from an organic amine.

A

Deamination

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22
Q

MECHANISM OF DEGRADATION

ASA + water = salicylic acid + acetic acid

A

Hydrolysis

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23
Q

MECHANISM OF DEGRADATION

Common to aldehydes, alcohols, phenols, sugars, alkaloids, unsaturated fats, and oils.

A

Oxidation

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24
Q

Alcohol limit for oral preparations for children below 6 years old.

A

0.5%

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25
Q

Alcohol limit for oral preparations for children 6-12 years old.

A

5%

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26
Q

Alcohol limit for oral preparations for patients over 12 years old.

A

10%

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27
Q

Products requiring preservatives

A

SemPOSE

SEMisolid preparations
Parenterals
Ophthalmic products
Syrups
Emulsions
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28
Q

Products NOT requiring preservatives

A

TEALS

Tinctures
Elixirs
Alcoholic and hydroalcoholic solutions (15-20% alcohol)
Large volume parenterals
Spirits
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29
Q

Parenterals and ophthalmic preparations are sterilized by ___, ___, and ___. However, it may still require additional preservatives.

A

Autoclaving
Bacterial filtration
Dry heat

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30
Q

___, ___, and ___ are frequently used preservatives in ophthalmic preparations because of their low degree of irritant qualities.

A

Chlorobutanol
Benzalkonium Chloride
Phenyl Mercuric Nitrate

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31
Q

True or False:

Acidic preservatives are more effective in acid media, while alkaline preservatives are more effective in alkaline media.

A

True

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32
Q

Mask the salty taste of drugs

A

Cinnamon
Raspberry
Orange flavors

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33
Q

Mask the bitter taste of drugs

A

Cocoa

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34
Q

Combat acid or sour taste of drugs

A

Fruit or citrus flavors

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35
Q

True or False:

Organic esters, alcohols, and aldehydes are pleasant to taste.

A

True

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36
Q

Alkaloids and Epsom salt are ___ to taste.

A

Bitter

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37
Q

Chlorides of Na, K, and Ammonium are ___ to taste.

A

Salty

38
Q

___ is the commonly used sweetener from sugar cane/sugar beet.

A

Sucrose

39
Q

True or False:

Glycerin is sweeter than sucrose.

A

False. Glycerin is less sweet than sucrose.

40
Q

Which sweetening agent is 300 times as sweet as sucrose?

A

Saccharin

41
Q

____ has a bitter after taste and is carcinogenic in animals.

A

Saccharin

42
Q

Which sweetening agent is contraindicated to phenylketonurics?

A

Aspartame

43
Q

This sweetening agent is common in the market and is 180 to 200 times sweeter than sucrose.

A

Aspartame

44
Q

Which artificial sweetener has carcinogenic potential?

A

Cyclamate

45
Q

___ is natural, non-toxic, safe, and about 30 times sweeter than sucrose.

A

Stevia powder

46
Q

Acesulfame potassium is ___ times as sweet as sucrose.

A

130

47
Q

The amount of liquid dyes added to liquid preparations ranges from ___ to ___ depending upon the colorant and the depth of color desired.

A

0.0005 to 0.001%

48
Q

______ are suitable for coloring products in which the moisture levels are low

A

Lake pigments

49
Q

FD & C lake is a pigment consisting of a substratum of ___ on which the dye is absorbed or precipitated.

A

Alumina hydrate

50
Q

CLASSIFICATION OF CERTIFIED COLOR ADDITIVES

It is used in food, drugs, and cosmetics

A

FD & C

51
Q

CLASSIFICATION OF CERTIFIED COLOR ADDITIVES

It is approved for use in drugs, some in cosmetics, and some in medical devices.

A

D & C

52
Q

CLASSIFICATION OF CERTIFIED COLOR ADDITIVES

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

A

External D & C

53
Q

Drug products requiring colorants

A

CCSS

Capsules
Compressed tablets
Sugar-coated tablets
Suspensions

54
Q

Drug products that DO NOT contain color additives

A

OPOSup

Ophthalmic products
Parenteral products
Ointments
SUPpositories

55
Q

FD & C ___ No. ___ (___) can cause allergic reactions in patients allergic to aspirin.

A

Yellow
5
tartrAZine (AZpirin)

56
Q

FD & C ___ No. ___ is now permitted only in externally applied drugs and cosmetics because of unresolved safety questions.

A

Red

4

57
Q

Certification for FD & C ___ No. ___ (___) has been withdrawn since it can cause cancer in rats.

A

Red
2
amaRAnTh (RAT)

58
Q

Two parts of pharmaceutical containers

A
  1. Immediate container

2. Closure

59
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

Protection from extraneous solids and from loss of the drug
under ordinary conditions of handling, shipment, storage, and distribution

A

Well-closed container

60
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

Protection from contamination by extraneous solids,
liquids, or vapors, from the loss of the drug and from efflorescence, deliquescence, or evaporation under the usual conditions of handling, shipment, storage, and distribution

A

Tight-closed container

61
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

Impervious to air or any other gas under the ordinary condition of handling, shipment, storage, and distribution. It is used for parenterals.

A

Hermetic container

62
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

It protects the contents against photochemical degradation. It uses light-resistant opaque plastic as a UV absorber.

A

Light-resistant container

63
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

___ are designed to prevent the child from accessing the potentially hazardous product.

A

Child-resistant containers

64
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

Closed container fitted with a device that irreversibly indicates if the container has been opened.

A

Tamper-resistant container

65
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO THEIR ABILITY TO PROTECT THE CONTENT FROM EXTERNAL CONDITIONS

Examples are strip packs, blister packs, tape seals, and bubble packs. Others are film wrappers, foils, shrink seals, bottle seals, breakable caps, tube seals, and aerosols.

A

Tamper-resistant container

66
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT

It holds the product which is intended for single use. This is also known as unit-dose package.

A

Single-dose container

67
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT

It permits the withdrawal of successive portions of the contents without changing the strength or endangering the quality of the remaining portions.

A

Multiple-dose container

68
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT

Examples are vials and plastic tablet bottles.

A

Multiple-dose container

69
Q

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT

Glass ampules, prefilled syringes, and cartridges are examples of ___.

A

Single-dose container

70
Q

Enumerate the problems encountered in the use of plastics in packaging.

A

PLAST

Permeability
Leaching
Alteration
Sorption
Transmission
71
Q

Which plastic materials have excellent transparency and luster and can be used in gamma sterilization?

A
  1. amorphous polyethylene terephthalate glycol (APET)

2. polyethylene terephthalate glycol (PETG)

72
Q

Which plastic material is rigid and has good clarity, but is not for gamma sterilization?

A

polyvinyl chloride (PVC)

73
Q

Which types of glass containers may be used for parenterals?

A

TYPE I – highly resistant borosilicate glass
TYPE II – treated soda-lime glass
TYPE III – soda-lime glass

74
Q

GLASS CONTAINERS

Material for TYPE I

A

Highly resistant borosilicate glass

75
Q

GLASS CONTAINERS

Material for TYPE II

A

Treated soda-lime glass

76
Q

GLASS CONTAINERS

Material for TYPE III

A

Soda-lime glass

77
Q

GLASS CONTAINERS

Material for TYPE IV (NP)

A

General purposes soda-lime glass

78
Q

It must indicate “Warning – May be habit forming”.

A

Controlled substances

79
Q

It contains the Rx symbol or the legend: Act prohibits

dispensing without prescription.

A

Prescription Drug

80
Q

It indicates the pharmacologic category and has no Rx symbol on the labeling.

A

Over-the-counter (OTC) drugs

81
Q

STORAGE CONDITIONS

Any temperature not exceeding 8°C (46°F)

A

Cold

82
Q

STORAGE CONDITIONS

Any temperature between 8°C and 15°C (46° and 59°F)

A

Cool

83
Q

STORAGE CONDITIONS

Temperature is maintained thermostatically between 2° and 8°C (36° and 46°F)

A

Refrigerator

84
Q

STORAGE CONDITIONS

Temperature is maintained thermostatically between -20° and -10°C (-4° and 14°F)

A

Freezer

85
Q

STORAGE CONDITIONS

The temperature prevailing in the working area.

A

Room Temperature

86
Q

STORAGE CONDITIONS

Any temperature between 30° and 40°C (86° and 104°F).

A

Warm

87
Q

STORAGE CONDITIONS

Any temperature above 40°C (104°F).

A

Excessive Heat

88
Q

STORAGE CONDITIONS

The usual working environment of 20°C and 25°C(68°F
to 77°F) but also allows temperature variations between 15°C and 30°C (59°F and 86°F).

A

Controlled Room Temperature

89
Q

What are the risks of freezing?

A

CAP

Container breakage
Alteration of the dosage form
Potency/Strength loss

90
Q
A

Dosage Forms (6 decks)

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