FINAL

Question 1

refers to the injectable routes of administration. It derives from the Greek words para (outside) and enteron (intestine) and denotes routes of administration other than the oral routes.

Answer 1

parenterals

Question 2

Are sterile preparations intended to be administered by injection under or through one or more layers of the skin or mucous membranes. They are usually packed in ampules or vials.

Answer 2

parenteral

Question 3

parenteral solutions which are administered by intravenous route.

Answer 3

transfusion fluid

Question 4

commonly used as injections and available in single dose containers or multiple dose containers

Answer 4

solutions/emulsions of medicaments for injection

Question 5

these drugs are supplied as dry sterile solids which are dissolved in a suitable solvent for administration into the body.

Answer 5

sterile solids

Question 6

Available in dry solids because drugs are not stable in solution form.

Answer 6

sterile solids

Question 7

sterile suspensions of drugs in a suitable solvent and are administered by intramuscular route.

Answer 7

sterile suspensions

Question 8

Liquid preparations that are drug substances or solutions thereof

Answer 8

[drug] injection

Question 9

Dry solids that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for Injections.

Answer 9

[drug] for injection

Question 10

Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium.

Answer 10

[drug] injectable emulsion

Question 11

Liquid preparations of solid suspended in a suitable liquid medium.

Answer 11

[drug] injectable suspension

Question 12

Dry solids that, upon the addition of suitable vehicles, yield preparations conforming in all respects to the requirements for Injectable
Suspensions.

Answer 12

[drug] for injectable suspension

Question 13

sterile preparations should be free from all types of microorganisms.

Answer 13

sterility

Question 14

Ophthalmic formulations must be especially free from Pseudomonas aeruginosa, gram-negative bacteria which is commonly found in ophthalmic formulations and can cause serious infections to cornea.

Answer 14

sterility

Question 15

Parenteral preparations should be isotonic with blood plasma and body fluids.

Answer 15

isotonocity

Question 16

Ophthalmic formulations must be isotonic with lachrymal secretions.

Answer 16

isotonocity

Question 17

sterile formulations must be free from pyrogens and toxins.

• These products must pass pyrogen test as pyrogens are responsible for rise in body temperature.

Answer 17

free from pyrogens

Question 18

these products must be free from foreign particles, dust, fibers and must pass clarity test.

Answer 18

free from foreign particles

Question 19

pH of tears is about 7.4. pH plays crucial role in therapeutic activity, solubility, stability, and comfort to the patient.

Answer 19

pH of ophthalmic preparations

Question 20

physical and chemical stability of sterile formulations should be maintained during storage.

Answer 20

stability

Question 21

Commonly used non-aqueous vehicles

Answer 21

alcohols and oils

Question 22

properties of sterile dosage forms

Answer 22

sterility
isotonicity
free from pyrogens
free from foreign particles
pH of ophthalmic preparations
stability

Question 23

general process of sterile dosage forms

Answer 23

accumulation and selection of components
production facilities and procedure
control
packaging and labeling

Question 24

vehicles, solutes, containers, and closures

Answer 24

accumulation and selection of components

Question 25

the sequential steps of preparing the product, filtering the solutions, filling containers, and sterilizing the product

Answer 25

production facilities and procedures

Question 26

evaluation and determination of components

Answer 26

control

Question 27

all steps necessary to properly identify the finished product.

Answer 27

packaging and labeling

Question 28

the component present in largest quantity. Normally, a it has no therapeutic value and is non-toxic. Nevertheless, it is of great importance in the formulation since it presents to the body tissues in the form of active ingredients or constituents’ absorption.

Answer 28

Vehicle

Question 29

packaged in single-dose containers not larger than 1 L. it must be pyrogen- free but does not have an allowable endotoxin level, not more than 0.25 USP EU/mL.

Answer 29

water for injection, usp

Question 30

sterile water for injection containing one or more suitable antimicrobial agents. It is packaged in prefilled syringes or in vials containing not more than 30 mL of the water.

Answer 30

bacteriostatic water for injection, usp

Question 31

may not contain any added substances.

Answer 31

water for injection

Question 32

may not contain any antimicrobial agent or other added substances.

Answer 32

sterile water for injection

Question 33

these are used primarily to effect solubility of certain drugs and to reduce hydrolysis.

Answer 33

water-miscible vehicles

Question 34

these are often used as isotonic vehicles. The additional osmotic effect of the drug may not be enough to produce any discomfort when administered.

Answer 34

aqueous vehicles

Question 35

Fixed oils are the most important group of this and used particularly for certain hormones.

Answer 35

non aqueous vehicles

Question 36

factors that determine the quality of solutes for parenteral preparations

Answer 36

solutes

Question 37

Preparation in containers are required to contain bacteriostatic or fungistatic agent in adequate amount at the time of use to prevent the multiplication of microorganisms inadvertently introduced into the preparation when withdrawing a portion of it.

Answer 37

antimicrobial agents

Question 38

Must be evaluated for their activity in the total formula to assure their activity when needed at the time of use.

Answer 38

antimicrobial agents

Question 39

Common Antimicrobial agents with their concentration limits:

Answer 39

Phenylmercuric Nitrate and Thimerosal - 0.1% Benzethonium Chloride and Benzalkonium Chloride - 0.1% Phenol and Cresol - 0.5% Chlorobutanol - 0.5%

Question 40

Preserves the balance of acidity and alkalinity of a solution. Used to stabilize a solution against a chemical degradation that would occur if there is a mark change in pH.

Answer 40

Buffers

Question 41

Commonly employed buffers

Answer 41

acid salts: acetates, citrates, phosphates

Question 42

most commonly used antioxidant

Answer 42

sodium bisulfate 0.1%

Question 43

has been found to enhance the activity of antioxidant in some cases apparently by chelating metallic ions that would otherwise catalyze the oxidation reaction.

Answer 43

Sodium salt of Ehtylenediamine Tetra Acetic acid

Question 44

known as bacterial endotoxins, are organic metabolic products shed from gram-negative bacteria, which can cause fever and hypotension in patients when they are in excessive amounts in intravenous injections.

Answer 44

pyrogens

Question 45

These are products of the growth of microorganisms, chemically lipids in nature, sometimes containing phosphorus, and is attached a polysaccharide or a protein or both.

Answer 45

pyrogens

Question 46

They are unwanted contaminants which are difficult to remove without affecting the product. This cause a febrile reaction in human being; these are rarely fatal but produces discomfort.

Answer 46

pyrogens

Question 47

the greatest potential source of pyrogens

Answer 47

water

Question 48

it will absorb pyrogens from water

Answer 48

ion-exchange resins

Question 49

the most reliable method for eliminating pyrogens from water as they do not distill over.

Answer 49

distillation

Question 50

this will remove pyrogens by absorption, but once the fibers are saturated, the rest of the pyrogens are no longer absorbed

Answer 50

Filtration with Asbestos filters

Question 51

It also introduces pyrogens especially reused containers

Answer 51

Equipment

Question 52

it may also contain pyrogens, hence must be purified by recrystallization, precipitate, washing or other means.

Answer 52

solutes

Question 53

at present the use of these containers is limited to components of disposable injection units where in contact with the solution is brief.

Answer 53

plastic

Question 54

the container of choice for most injections. The basic structural network of glass is formed by Silicon oxide tetrahedron and boric acid enters the structure.

Answer 54

glass

Question 55

glass container in general, will be suitable for all products, although sulfur oxide treatment is done to increase its resistance.

Answer 55

Type I Borsilicate glass

Question 56

may be suitable for a buffered solution or one that has an acid reaction or is not reactive with glass.

Answer 56

Type II Soda-Lime treated glass

Question 57

suitable for anhydrous liquids or dry substances.

Answer 57

Type III soda-lime glass

Question 58

glass container not suitable for parenterals.

Answer 58

NP - Non-Parenteral Soda-lime glass

Question 59

Commercially available vary in size from

Answer 59

0.5 ml to 1,000 mL

Question 60

sizes obtained as ampoules and vials

Answer 60

up to 1000 mL

Question 61

size of single-dose container

Answer 61

1,000 mL

Question 62

size of multiple dose containers

Answer 62

30 mL

Question 63

are made up primarily of natural rubber (latex), a synthetic polymer or both.

Answer 63

closures

Question 64

in pharmaceutical preparations, means destruction of all living organisms and their spores or their complete removal from the preparation.

Answer 64

Sterilization