PART 1 Flashcards by Karrizze Basto

Q

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

A

Drug

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

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

A

Dosage Forms

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

2 general components of dosage forms

A

Active Pharmaceutical Ingredients (API) / Drug

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Solid, liquid, or gaseous

A

Physical Description

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Measure of a drug’s lipophilic property

A

Partition Coefficient

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Affects melting point and solubility

A

Polymorphism

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

PHYSICAL AND CHEMICAL PROPERTIES OF DRUG SUBSTANCES

Affected by particle size and pH

A

Solubility

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

Rate limiting step in the absorption process

A

Dissolution

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FIVE TYPES OF STABILITY

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

A

Chemical

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FIVE TYPES OF STABILITY

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

A

Physical

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FIVE TYPES OF STABILITY

The therapeutic effect remain unchanged.

A

Therapeutic

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FIVE TYPES OF STABILITY

No significant increase in toxicity occurs.

A

Toxicological

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

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

A

Hydrolysis

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

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

A

Oxidation

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

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

A

Decarboxylation

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

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

A

Deamination

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

ASA + water = salicylic acid + acetic acid

A

Hydrolysis

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

MECHANISM OF DEGRADATION

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

A

Oxidation

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

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

A

0.5%

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

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

5%

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

10%

Products requiring preservatives

SemPOSE ``` SEMisolid preparations Parenterals Ophthalmic products Syrups Emulsions ```

Products NOT requiring preservatives

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

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

Autoclaving Bacterial filtration Dry heat

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

Chlorobutanol Benzalkonium Chloride Phenyl Mercuric Nitrate

True or False: Acidic preservatives are more effective in acid media, while alkaline preservatives are more effective in alkaline media.

True

Mask the salty taste of drugs

Cinnamon Raspberry Orange flavors

Mask the bitter taste of drugs

Cocoa

Combat acid or sour taste of drugs

Fruit or citrus flavors

True or False: Organic esters, alcohols, and aldehydes are pleasant to taste.

True

Alkaloids and Epsom salt are ___ to taste.

Bitter

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

Salty

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

Sucrose

True or False: Glycerin is sweeter than sucrose.

False. Glycerin is less sweet than sucrose.

Which sweetening agent is 300 times as sweet as sucrose?

Saccharin

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

Saccharin

Which sweetening agent is contraindicated to phenylketonurics?

Aspartame

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

Aspartame

Which artificial sweetener has carcinogenic potential?

Cyclamate

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

Stevia powder

Acesulfame potassium is ___ times as sweet as sucrose.

130

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

0.0005 to 0.001%

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

Lake pigments

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

Alumina hydrate

CLASSIFICATION OF CERTIFIED COLOR ADDITIVES It is used in food, drugs, and cosmetics

FD & C

CLASSIFICATION OF CERTIFIED COLOR ADDITIVES It is approved for use in drugs, some in cosmetics, and some in medical devices.

D & C

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.

External D & C

Drug products requiring colorants

CCSS Capsules Compressed tablets Sugar-coated tablets Suspensions

Drug products that DO NOT contain color additives

OPOSup Ophthalmic products Parenteral products Ointments SUPpositories

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

Yellow 5 tartrAZine (AZpirin)

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

Red | 4

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

Red 2 amaRAnTh (RAT)

Two parts of pharmaceutical containers

1. Immediate container | 2. Closure

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

Well-closed container

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

Tight-closed container

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.

Hermetic container

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.

Light-resistant container

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.

Child-resistant containers

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.

Tamper-resistant container

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.

Tamper-resistant container

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT It holds the product which is intended for single use. This is also known as unit-dose package.

Single-dose container

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.

Multiple-dose container

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT Examples are vials and plastic tablet bottles.

Multiple-dose container

PHARMACEUTICAL CONTAINERS ACCORDING TO CONTENT Glass ampules, prefilled syringes, and cartridges are examples of ___.

Single-dose container

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

PLAST ``` Permeability Leaching Alteration Sorption Transmission ```

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

1. amorphous polyethylene terephthalate glycol (APET) | 2. polyethylene terephthalate glycol (PETG)

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

polyvinyl chloride (PVC)

Which types of glass containers may be used for parenterals?

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

GLASS CONTAINERS Material for TYPE I

Highly resistant borosilicate glass

GLASS CONTAINERS Material for TYPE II

Treated soda-lime glass

GLASS CONTAINERS Material for TYPE III

Soda-lime glass

GLASS CONTAINERS Material for TYPE IV (NP)

General purposes soda-lime glass

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

Controlled substances

It contains the Rx symbol or the legend: Act prohibits | dispensing without prescription.

Prescription Drug

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

Over-the-counter (OTC) drugs

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

Cold

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

Cool

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

Refrigerator

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

Freezer

STORAGE CONDITIONS The temperature prevailing in the working area.

Room Temperature

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

Warm

STORAGE CONDITIONS Any temperature above 40°C (104°F).

Excessive Heat

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).

Controlled Room Temperature

What are the risks of freezing?

CAP Container breakage Alteration of the dosage form Potency/Strength loss