Topic 1: Sterile Dosage Forms

Question 1

are pharmaceutical dosage forms that are injected through one or more layers of skin

Answer 1

parenteral preparations

Question 2

provide the most rapid onset of action of any parenteral route

Answer 2

intravenous

Question 3

pass out of vessel into the tissue, blood, lymph

Answer 3

extravasation

Question 4

Clotting within a blood vessel

Answer 4

thrombosis

Question 4

into a substance or a cell

Answer 4

infiltration

Question 5

inflammation of the vein

Answer 5

phlebitis

Question 6

air is introduced into the vein

Answer 6

air emboli

Question 7

A complication wherein a circulating clot carried by the blood stream lodges into a blood vessel

Answer 7

embolism

Question 8

Drugs intended for prolonged or delayed absorption

Answer 8

intramuscular

Question 9

needles used for intramuscular injections

Answer 9

2 inch to 3 inches long
20 to 22 gauge in size.

Question 10

vol of admin for intramuscular

Answer 10

NMT 5 ml - gluteal region
NMT 2 ml - deltoid arm

Question 11

Women tend to have more fat in this region than men, so the possibility of an ___ is significant.

Answer 11

intralipomatous injection

Question 12

complications of intramuscular

Answer 12

Abscesses
Cysts
Embolism
Hematoma
Skin sloughing
Scar formation

Question 13

The usual site for intradermal injections

Answer 13

anterior surface of the forearm

Question 14

needles for intradermal injections

Answer 14

3/8 inches long
23 to 26 gauge

Question 15

Drugs that are injected for diagnostic determinations, desensitization, or immunization.

Answer 15

intradermal

Question 16

vol of admin for intradermal injections

Answer 16

0.1 mL

Question 17

it can be used for both short term and very long term therapies

Answer 17

subcutaneous

Question 18

vol of admin for subcutaneous injections

Answer 18

2 mL

Question 19

needles for subcutaneous injections

Answer 19

3/8 to 1 inch
24 to 26 gauge

Question 20

drugs that are intradermally injected are agents for

Answer 20

diagnostic determinations, desensitization, or immunization

Question 21

syringe used for intradermal injection

Answer 21

tuberculin syringe

Question 22

administration is injection of a drug directly into the heart.

Answer 22

intracardiac

Question 23

refers to injection of large volumes of a solution into subcutaneous tissue to provide a continuous, abundant drug supply. This route occasionally is used for antibiotic administration in children

Answer 23

hypodermoclysis

Question 24

administration refers to injection into the spinal column

Answer 24

intraspinal

Question 25

administration means injection into a joint space

Answer 25

intra-articular

Question 26

administration refers to injection into the joint fluid

Answer 26

intrasynovial

Question 27

administration is injection into the spinal fluid; it sometimes is used for antibiotics

Answer 27

intrathecal

Question 28

Liquid preparation that are drug substances or solutions thereof

Answer 28

injection

Question 29

Dry solids added with suitable vehicles

Answer 29

for injection

Question 30

Liquid preparation dissolved or dispersed in an emulsion medium

Answer 30

injectable emulsion

Question 31

Liquid preparation of solid suspended in a suitable liquid medium

Answer 31

injectable suspension

Question 32

Dry solids added with vehicles to make them injectable suspension

Answer 32

for injectable suspension

Question 33

is the vehicle of the greatest importance for sterile products and especially, for parenterals since it is the vehicle for all natural fluids

Answer 33

water

Question 34

It must meet the requirements for water for injection, USP

Answer 34

water

Question 35

Meets requirements for Purified Water USP plus the USP "Pyrogen Test"

Answer 35

water for injection

Question 36

It must not contain more than 1mg/100mL of total solids

Answer 36

water for injection

Question 37

Meets requirements for Water for Injection USP plus passes the USP "Sterility Test"

Answer 37

Sterile Water for Injection

Question 38

Packaged in single dose containers not larger than 1 L

Answer 38

sterile water for injection

Question 39

Sterile water with antimicrobial agents

Answer 39

Bacteriostatic Water for Injection

Question 40

Packaged in container not more 30 mL

Answer 40

Bacteriostatic Water for Injection Bacteriostatic Sodium chloride

Question 41

benzyl alcohol poisoning

Answer 41

gasping syndrome

Question 42

sterile, isotonic

Answer 42

Sodium chloride for Injection

Question 43

NaCl for injection vol

Answer 43

154 mEq of Na and Cl per L solution

Question 44

Contains 1 or more antimicrobials

Answer 44

Bacteriostatic Sodium chloride

Question 45

“NOT FOR USE IN NEONATES”

Answer 45

Bacteriostatic Water for Injection Bacteriostatic Sodium chloride

Question 46

Ringer's injection contains

Answer 46

NaCl, KCl, CaCl2

Question 47

Electrolyte replenisher and plasma volume expander

Answer 47

ringer's injection

Question 48

Fluid and electrolyte replenisher and systemic alkalizer.

Answer 48

Lactated Ringer’s

Question 49

vehicle component for single dose

Answer 49

sterile water for injection

Question 50

vehicle components for multiple doses

Answer 50

bacteriostatic for injection, bacteriostatic sodium chloride

Question 51

must not be toxic, irritating or sensitizing and must not exert any adverse effect on the ingredients of the formulation

Answer 51

non-aqueous vehicle

Question 52

most frequently used non-aqueous solvents

Answer 52

polyethylene glycol propylene glycol alcohol glycerin fixed oils

Question 53

used as solvent for IM injection

Answer 53

Corn oil cottonseed oil peanut oil sesame oil

Question 55

The most commonly used agents include the two mercurials

Answer 55

phenylmercuric nitrate thimerosal

Question 56

the four homologous esters of

Answer 56

p-hydroxybenzoic acid phenol benzyl alcohol chlorobutanol

Question 57

is one of the pathways of degradation of which can be accelerated during thermal sterilization.

Answer 57

oxidation

Question 58

Antioxidants used in sterile products are classified into

Answer 58

Reducing agents Blocking agents Synergist Chelating agents Inert gases

Question 59

antioxidants which function by being preferentially oxidized;

Answer 59

Reducing agents

Question 60

antioxidants which block an oxidative chain reaction in which they are not usually consumed;

Answer 60

Blocking agents

Question 61

ompounds increase the effectiveness of antioxidants, particularly those blocking oxidative reactions

Answer 61

Synergist

Question 62

Reducing agents examples

Answer 62

ascorbic acid, sodium bisulfite, and metabisulfite, sodium formaldehyde sulfoxylate, thiourea.

Question 63

Blocking agents examples

Answer 63

ascorbic acid esters, butyl hydroxytoluene(BHT) and tocopherols.

Question 64

Synergist examples

Answer 64

ascorbic acid, citric acid, citraconic acid, phosphoric acid and tartaric acid.

Question 65

those that complex with catalysts which otherwise would accelerate the oxidative reactions;

Answer 65

chelating agents

Question 66

chelating agent example

Answer 66

ethylenediaminetetraacetic acid salts

Question 67

like nitrogen and carbon dioxide have been used to displace oxygen from solution and reduced the possibility of the oxidative changes in the formulation

Answer 67

inert gases

Question 68

added to maintain the required pH for many products

Answer 68

buffers

Question 69

The principal buffer systems used to stabilize pH are the

Answer 69

acetates, citrates and phosphates

Question 70

Compounds contributing to the isotonicity of a product

Answer 70

tonicity contributors

Question 71

Reduced the pain of injection in the areas with nerve endings

Answer 71

tonicity contributors

Question 72

LEORA

Answer 72

Loss of Electron Oxidation Reducing Agents

Question 73

GEROA

Answer 73

Gain of Electron Reduction Oxidizing Agents