Dosage Forms Ii Exam 2: Parenterals Part3

Front 1

Air-eliminating filters, ____ um, can eliminate air and larger particulates.

Back 1

0.2

Front 2

The ideal isotonic range for an IV is?

Back 2

240-340 mOsm/L

Front 3

If an IV's osmolarity is > 500 mOsm/L what would be the preferable injection site?

Back 3

Centrally

Front 4

A ________ solution can cause crenation.

Back 4

Hypertonic

Front 5

A ________ solution can cause hemolysis.

Back 5

Hypotonic

Front 6

The acceptable pH range for IM & SC injections is ___

Back 6

4-9

Front 7

The acceptable pH range for peripheral IV injections is _____.

Back 7

5-9

Front 8

The acceptable pH range for central IV injections is___

Back 8

3.0-10.5

Front 9

PH often determines a drugs_____ & _____

Back 9

Ionization & degradation

Front 10

Both product tonicity & pH are serious considerations for ____ injections.

Back 10

CNS

Front 11

_____, such as propylene glycol, help reduce water polarity.

Back 11

Organic cosolvents

Front 12

______ solubilize semi-polar and non-polar drugs by dispersing them in micelles.

Back 12

Surfactants

Front 13

For parenterals, ionic or non-ionic surfactants are preferred?

Back 13

Non-ionic, they are less toxic than ionic

Front 14

Multi-dose containers must contain a _____ b/c they are repeatedly entered.

Back 14

Antimicrobials (Preservatives)

Front 15

A drug containing what preservative agent should never be used in an infant? Why?

Back 15

Benzyl alcohol, b/c their liver is too immature to detoxify

Front 16

Why wouldn't you add a colorant to a parenteral?

Back 16

It would interfere w/product inspection

Front 17

What is the most important component of a Clean Room?

Back 17

Clean air, normal air has microbes

Front 18

______ filters the air that enters a room down to 0.3 um

Back 18

HEPA

Front 19

You would want to make a chemotheraputic agent in a horizontal or vertical flow hood?

Back 19

Vertical

Front 20

Which plastic provides less of a leaching problem: polyvinylchloride or polyethylene

Back 20

Polyethylene

Front 21

Type __ glass has its surface treated to improve chemical resistance.

Back 21

II, treated soda-lime glass

Front 22

Which type of glass is best suited for parenterals?

Back 22

Type I

Front 23

Potential leachables in glass to what to the product?

Back 23

Can raise the pH

Front 24

The term, _____, was eliminated from the titles of injectable products with the exception of appropriate monograph titles for WATER that are intended for parenteral use.

Back 24

Sterile (reading pg 427)

Front 25

What is the osmolarity of D5W?

Back 25

252 mOsm/L

Front 26

Why do concentrations of dextrose > 20% increase the chance of phlebitis?

Back 26

b/c they are hypertonic

Front 27

What is the osmolarity of NS?

Back 27

310 mOsm/L

Front 28

Why are Ringer's & Lactated Ringer's (LR) a classified as balance fluids?

Back 28

b/c the approximate extracellular electrolyte content

Front 29

What is the difference between Ringer's & LR?

Back 29

They both contain NaCl, KCl, CaCl2, but only LR contains Sodium Lactate

Front 30

If you wanted to use an IV fluid for systemic alkalization, which one would you choose?

Back 30

LR

Front 31

What are lipid emulsions used for?

Back 31

Calories

Front 32

What type of emulsion should an IV emulsion be?

Back 32

O/W

Front 33

Why shouldn't you mix other products with an IV emulsion?

Back 33

May destabilize the emulsion

Front 34

T/F NPH insulin is mainly for prolonged action, but is can be administered via IV.

Back 34

False, it is NOT for IV use

Front 35

What is the main reason that manufacturer would chose to make a drug a reconstitutable solid?

Back 35

Stability

Front 36

In this type of sterile solid production, pores will remain where the water crystals were.

Back 36

Lyophilization

Front 37

Where is one setting that prefilled syringes can be useful?

Back 37

ER

Front 38

The air velocity of Laminar Flow Hoods is checked using the ____________.

Back 38

Dioctyl phthalate (DOP) smoke test

Front 39

An important drug incompatibility that has been associated w/deaths is.

Back 39

Calcium & Phosphate

Front 40

Nitroglycerin is an example of a drug that is readily absorbed in _____ containers.

Back 40

PVC, must be made in glass

Front 41

_____ from PVC is an example of leaching, and it is thought to be toxic.

Back 41

Phthalates

Front 42

Name 3 organic cosolvents

Back 42

1. Propylene glycol 2. Ethanol 3. PEG 400

Front 43

What are 2 examples of surfactants?

Back 43

1. Tween 80 2. Polysorbate 80

Front 44

What are some examples of preservatives?

Back 44

1. Chlorobutanol 2. Cresol 3. Phenol 0.5% 4. Benzyl Alcohol 1%

Front 45

What are 3 important properties of IV emulsions?

Back 45

1. Type 2. Particles must be below embolic size 3. Stability

Front 46

What are the two types of Laminar flow hoods?

Back 46

1. Vertical 2. Horizontal

Front 47

The six other requirements for the labeling of parenterals according to the reading on pg 427

Back 47

1. The name of the preparation
2. For a liquid preparation, the % content of drug, or the amount of drug present in a specified volume. For a dry preparation, the amount of active ingredient present and the volume of liquid to be added to the dry preparation to prepare a solution or suspension.
3. The route of administration
4. A statement of storage conditions and an expiration date.
5. The name of the manufacturer & distributor.
6. An identifying lot number, which is capable of yielding the complete manufacturing history of the specific package, including all manufacturing, filling, sterilizing, and labeling operations.

Front 48

Why are parenteral products formulated outside the ideal range?

Back 48

for stability & solubility

Front 49

When does parenteral tonicity & pH become serious considerations?

Back 49

CNS injections.

Front 50

Why are CNS injections have a very narrow pH range?

Back 50

The area is very sensitive & there is slow circulation w/ low volume of CSF

Front 51

What pH are we looking at w/ the intrathecal route?

Back 51

7-7.6

Front 52

Parenteral products include what 4 things?

Back 52

solutions, suspensions, emulsions, & reconstitutables

Front 53

What can be said about the vehicle w/ parenteral products?

Back 53

has no therapeutic activity & is nontoxic

Front 54

What are the 2 main vehicles for parenterals? w/c is the MC?

Back 54

water & oil w/ water being the MC vehicle used

Front 55

Oil as a vehicle in parenteral products is mainly for what? how does this work?

Back 55

insoluble drugs & or depot injectables. it spreads slowly & retard drug diffusion

Front 56

How is oil injectables administered?

Back 56

IM.. NEVER IV b/c oil droplets will become emboli

Front 57

What is the reason substances are added to a parenteral preparation?What is this substance called?

Back 57

it's to improve or safeguard the quality of the product, they are ka excipients

Front 58

What are examples of added substances to parenteral products?

Back 58

solubilizer, preservatives, buffers, antioxidants, & tonicity adjusters

Front 59

What is the function of solubilizers? name the solubilizers?

Back 59

they enhance solubility. organic cosolvents, surfactants, cyclodextrins, salt formation, & prodrugs can all act as solubilizers.

Front 60

For parenterals, what is the MC organic cosolvents? how do they work? what is an important point to remember about cosolvents?

Back 60

ethanol, propylene glycol, & PEG 400; they work by reducing water polarity. It's important to remember that they will irritate when injected IM or SC

Front 61

T/F: In most cases, parenteral fluids could be any toncity and any pH?

Back 61

FALSE: parenteral fluids should be isotonic with body tissues and should fall within a physiologically acceptable pH range

Front 62

pharmaceutical preparations meant for the application to delicate membranes of the body must be adjusted to approximately the same ________ _______ as that of body fluids?

Back 62

osmotic pressure

Front 63

What is the ideal IV range in mOsm/L?

Back 63

240-340mOsm/L

Front 64

T/F: isotonic fluids will cause no swelling or contraction of the cells & tissues w/ w/c they come in contact?

Back 64

True

Front 65

What is the consequence of non-isotonic parenterals locally?

Back 65

tissue irritation, pain on injection, & extravasation damage.

Front 66

What is the ideal pH for parenteral fluids?

Back 66

between 7-7.8

Front 67

What are the consequences of nonphysiological pH in parenteral fluids?

Back 67

tissue irritation, pain on injection, & extravasation damage

Front 68

what is the usual dosage for dextrose injection? this infusion can cause what?

Back 68

pH 3.5-5.5 w/c could lead to phlebitis since it's an acid pH.

Front 69

What are the pH ranges for IM & SC injections? Central IV? Peripheral IV?

Back 69

IM & SC: 4-9. Central IV: 3-10.5 b/c of dilution & blood buffers. peripheral IV 5-9

Front 70

ow do surfactants work?

Back 70

they have polar Y nonpolar regions so they solubilize semi-polar & non-polar drugs by dispersing them in micelles.

Front 71

For parenterals, w/c surfactants are preferred? What are they?

Back 71

nonionic b/c they are less toxic. These are Tween 80 & polysorbate 80.

Front 72

When should preservatives be added to parenterals? what kind of effect do they have?

Back 72

they must be added in preparations that are contained in multiple dose containers; they are bacteriostatic or fungistatic

Front 73

What is the [ ] of preservatives used & how & why do we know how much to use?

Back 73

they must be present in adequate concentrations at the time of use to prevent the

Front 74

What preservative must not be given to neonates? why?

Back 74

benzyl alcohol b/c their liver is too immature to detoxify it.

Front 75

What are the main uses of LVP? (6)

Back 75

1) hydration, 2) electrolytes, 3) basic nutrition, 4) TPN, 5) vehicles, 6)Keep vein open (KVO)

Front 76

The slow IV infusion of a fluid for the purpose of keeping the vein open in anticipation of future therapy?

Back 76

KVO such as D5W at a rate of 10-15ml/hr

Front 77

What are some examples of LVP?

Back 77

Ringer's, Lactated Ringers, lipid emulsions

Front 78

What is the difference in composition between ringer's & lactated ringer's LVP?

Back 78

Ringer's has NaCl, KCl, CaCl2 while Lactated ringer's has those plus sodium lactate

Front 79

What is SVP & give examples?

Back 79

fluids administered in small volumes. These can be drugs, biologics, diagnostics, allergenci extracts, & radiopharmaceuticals

Front 80

What are the dosage forms of SVP? w/c is the most common & w/c is the least common?

Back 80

solutions, emulsions, suspensions, & reconstitutable solids. There are many solutions such as regular insulin injection but there are very few emulsions like propofol

Front 81

SVP suspensions are administered how? why this way? give an example?

Back 81

they are injected IM b/c particles can be embolic; an example is NPH

Front 82

Define reconstitutable solids? main purpose of these? stability quality?

Back 82

solids abailable that are intended to be reconstituted before admixture or injection. Their main purpose is for unstable drugs; once reconstituted, product stability is usually poor so must be used quickly

Front 83

What are 2 techniques of producing sterile reconstitutable solids?

Back 83

aseptic crystallization & lyophilization

Front 84

W/ this technique, the drug product is crystallized & filled under sterile conditions?

Back 84

aseptic crystallization

Front 85

This sterile solid technique is used to add bulk & protect product from freeze dry damage?

Back 85

lyophilization

Front 86

What can be used in lyophilization to stabilize the product?

Back 86

excipients

Front 87

What are some examples of premixed parenteral products?

Back 87

mini-bags, ADD Vantage system by Abbott,

Front 88

What are premix mini-bags usually used for?

Back 88

intermittent therapy

Front 89

Describe the ADD-Vantage System?

Back 89

it has 2 parts: an IV bag filled w/ solution & a vial of powder or liquid drug. These 2 are combined & mixed prior to usage

Front 90

What are some examples of convenience parenterals?

Back 90

disposable prefilled syringes & double chambered vials

Front 91

Disposable prefilled syringes can be used in what settings?

Back 91

hospital use & home use

Front 92

Describe the double chambered vials of parenterals?

Back 92

it has separate chambers for drug & diluent