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Pharmaceutics Year 1 Term 1 > Parental Prodcuts > Flashcards

Parental Prodcuts Flashcards

1
Q

Parenteral routes of administration

A
  1. Intravenous (IV): into a vein
  2. Intramuscular (IM): into a muscle
  3. Subcutaneous (sub-Q): under the skin
  4. Intradermal (ID): into the skin
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2
Q

What are the two methods of parental administration?

A

Injection

Infusion

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3
Q

What are three types of administration devices?

A

Syringes
Needles
Catheter

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4
Q

What are the three types of catheters?

A

Rigid-produces more infilitration
Butterfly-for a one time or short term
Flexible-when it needs to be there fro a while

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5
Q

The primary use of an i.v. injection is to ______

It is also used for ___ ____ and ___

A

provide a rapid and immediate drug action.

fluid, electrolye, and nutrient supplement

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6
Q

Where are two injection sites for IV Drugs?

A

Basilic and Cephalic veins on back of hands

dorsal forearm veins

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7
Q

What is the max injection volume for adults

Kids?

A

3L

Less than 3

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8
Q

IV administration is subdivided into three categories?

A
  • IV Bolus Push
  • Intermittent Infusion
  • Continuous infusion
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9
Q

Intravenous Bolus (IV push)
How much?
Problem?
When is it used?

A

drug is injected into vein via syringe or needle in short time

  • 1-2 mls
  • Drug is given in short time toxicity could occur
  • emergencies
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10
Q

Intermittent Infusion
How much?
Problem?
Why is it used?

A
  • Drug is diluted at an intermediate volume of fluid 25 to 100 ml infused from 15-60 mins and spaced at 6 hrs
  • less consistent drug plasma level than continuous
  • Method is safer than IV bolus
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11
Q

Continuous infusion

How much?

A
  • slowly and continuously administered into a vein

- drug is added to a large volume parenteral fluid (up to 1000 mL)

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12
Q

Advantages to Continuous Infusion?

A

fluid and drug therapy to be administered at same time
It provides an excellent control of drug plasma level.
Problems associated with drug toxicity and irritation are minimized.

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13
Q

Disadvantages to Continuous Infusion?

A

unstable drugs cannot be administered by this means because of extended run times.
It cannot be used in fluid-restricted patients because of the large volume of administration.
It cannot be used to admix poorly soluble drugs dissolved in water-miscible drugs.

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14
Q

Intramuscular route?

A

IM injection is made deep into the layers of muscle

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15
Q

What are three areas for IM injection?

Amounts?

A

Butt (up to 5 ml)
Deltoid (up to 2 ml)
Thigh (up to 2 ml)

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16
Q

In IM injection

The needles used for the injections are generally ____

A

1/2 inch to 1 1/2 inches long and are 19-23 gauge in size.

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17
Q

In IM injection

The point of injection should be as far as possible from major nerves to

A

avoid neural damage.

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18
Q

In IM injection

result in

A

lower but more sustained blood concentrations than after IV administration due to an absorption step.

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19
Q

Subcutaneous route

A

Admin beneath skin, between dermis and muscle

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20
Q

What are injection sites for SubQ

A

1) upper arm
2) anterior surface of the thigh
3) the lower portion of the abdomen
4) the upper back

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21
Q

What is the volume for all Sub Q needles?

A

Less than 2 ml

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22
Q

In Sub Q

Needles are generally

A

3/8 to 1 inch in length and 24 to 27 gauge in size.

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23
Q

In Sub Q

If frequent injections are required

A

the injection sites must be rotated.

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24
Q

In Sub Q

The vascularity in the subcutaneous tissue is less than that of muscle tissue, and therefore

A

absorption may be slower than after intramuscular administration.

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25
Q

What are most common drugs used in subQ

A

Heparin and insulin are the most important drugs routinely administered by this route.

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26
Q

Intradermal route

A

ID administration involves injections just beneath the epidermis, within the dermal or skin layer

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27
Q

Injection sites for ID

A

Anterior surface of forearm

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28
Q

What is volume limit for Intradermal?

A

.1 ml

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29
Q

In Intradermal injections

Needles are generally

A

3/8 inches long and 25 to 28 gauge.

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30
Q

In Intradermal injections

The onset of action and the rate of absorption of medication from this route are

A

slow

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31
Q

In Intradermal injections

Drugs that are intradermally injected are agents for

A

diagnostic determinations, desensitization, or immunization.

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32
Q

Example of ID injections

A

tuberculin skin test agent, diphtheria toxin and various allergens

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33
Q

What are three things all parental products must have?

A
  • Sterile
  • Pyrogen limited
  • Free from extraneous insoluble material
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34
Q

Sterility

A

absence of life or the absolute freedom of living organism. No growth of organisms, bacterial, fungal, viral, parasites, etc.

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35
Q

Pyrogen (bacterial endotoxin)

A

bacteria made, produces fever and hypotension when introduced or released into the blood

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36
Q

extraneous insoluble materials

A

any foreign particles, such as glass, fibers, precipitates, and any floating materials.

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37
Q

Where can pyrogens come from

A

microbes that get destroyed during sterilization

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38
Q

Sources of particulate may come from

A

raw materials, processing and filling equipment, the container, and environmental contamination

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39
Q

Various forms of parenteral products are available for use

4

A
  • Solutions
  • Lyophilized Solids
  • Emulsions
  • Suspensions
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40
Q

The form in which manufacturer prepares a given drug for parenteral use depends on the

A

nature of the drug itself with respect to its physical and chemical characteristics and on certain therapeutic considerations.

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41
Q

According to the USP, injectable materials are separated into five general types:

A 
Injections
For Injection
Injectable Emulsion
Injectable Suspension
For Injectable Suspension
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42
Q

Injections:

whats special?

A

Liquid preparations that are drug substances or solutions.

The solution is the fastest acting form and is therefore often used to provide an immediate drug action.

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43
Q

For injection:

Whats special?

A

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

  • The solids include drugs that are not stable in liquid media and are prepared by a freeze-drying process.
  • The solids are reconstituted with an appropriate vehicle before administration to form solution.
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44
Q

Injectable emulsion:

Whats special?

A

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

Drugs that are oily or insoluble in an aqueous medium are often formulated as emulsion.

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45
Q

Injectable suspension:

Whats special?

A

Liquid preparations of solid suspended in a suitable liquid medium

If the drug is insoluble or unstable in water an injection may be prepared as an aqueous suspension

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46
Q

excipients

A

Injectable products contain active drug and inactive ingredients

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47
Q

What can be excipients?

A
  1. Vehicles
  2. Buffering Agents
  3. Preservatives
  4. Antioxidants
  5. Chelating Agents
  6. Tonicity Agents
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48
Q

Vehicles

A

is the medium in which formulation is prepared

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49
Q

most commonly used vehicle for parenteral preparations

A

water

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50
Q

Water for Injection, USP

A

is pyrogens-free, purified water and contains no more than 1 mg/100 mL of trace elements.

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51
Q

How is water for injection prepared?

What should be noted with regards to sterility?

A
  • It is prepared by distillation or reverse osmosis and is intended to be used within 24 h.
  • It is not required to be sterile when used in the manufacture of injectable products. However, the final products requires the terminal sterilization.
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52
Q

Sterile water for Injection, USP

A

is water for injection that has been sterilized.

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53
Q

Sterile water for Injection, USP

It may contain slightly more than 1mg/100 mL of solids because of the leaching of solids from

A

the glass container during sterilization.

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54
Q

Sterile water for Injection, USP

It is stored in single-dose containers

A

no larger than 1L

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55
Q

Sterile water for Injection, USP is commonly used as a vehicle for?

A

dry-powder injectable products.

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56
Q

Bacteriostatic water for Injection, USP

A

is sterile water for injection that contains one or more antimicrobial agents (e.g. 0.9% benzyl alcohol).

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57
Q

Bacteriostatic water for Injection, USP

The container label must state the

A

names and proportions preservatives.

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58
Q

Bacteriostatic water for Injection, USP

is packed in prefilled syringes or in vial containing not more than

A

30 mls.

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59
Q

Bacteriostatic water for Injection, USP

Its use in large volume injectable is limited because of

A

potential toxicity associated with preservatives.

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60
Q

Bacteriostatic water for Injection, USP

USP labeling requirements demand that the label state

A

Note for use in Neonates

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61
Q

Sodium chloride injection, USP

A

is sterile isotonic solution of sodium chloride (0.9 %) in water for injection, which contains no antimicrobial agents.

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62
Q

Sodium chloride injection, USP

It is often used as a vehicle in preparing

A

parenteral solutions and suspensions.

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63
Q

Sodium chloride injection, USP

is also used as a catheter or IV line flush

A

to maintain patency.

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64
Q

Bacteriostatic Sodium chloride injection, USP

A

is sterile isotonic solution of sodium chloride (0.9 %) in water for injection, which contains antimicrobial agents

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65
Q

Bacteriostatic Sodium chloride injection, USP

is packed in containers containing not larger

A

30 mL.

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66
Q

Bacteriostatic Sodium chloride injection, USP is

often used as a vehicle in preparing __________ and as a a _________ or ____________

A

parenteral solutions
catheter or
IV line flush

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67
Q

5% Dextrose Injection, USP (D5W)

A

is isotonic with blood and uses as a water source and vehicle.

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68
Q

Ringer’s Injection, USP

A

is a sterile solution of sodium chloride, potassium chloride, and calcium chloride in water. Ringer’s is employed as a vehicle for other drugs or alone as an electrolyte replenisher and plasma volume expander

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69
Q

Some parenteral fluids are __________ (less than 240 mOsm/L) or h__________ ( greater than 340 mOsm/L).

A

hypotonic

hypertonic

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70
Q

Hypotonic solutions can be used

A

to dilute excess serum electrolytes as in hyperglycemia (high blood sugar).

71
Q

Patients receiving hypotonic solutions should be monitored closely, as these solutions may cause

A

hemolysis

72
Q

Hypertonic solutions can be used

A

to correct electrolytes imbalance, as in loses from excess vomiting and diarrhea.

73
Q

Patients receiving hypertonic solutions should be monitored to prevent ____________, especially if the solutions are extremely concentrated or are being given at rapid speed.

A

body fluid overload

74
Q

Two main reasons for use of a Non-aqueous vehicle are:

A
  1. Limited water solubility of the drug

2. Susceptibility to hydrolysis

75
Q

Water immiscible vehicles

A
  1. Fixed oils
  2. Ethyl oleate
  3. Isopropyl Myristate
  4. Benzyl benzoate
76
Q

Water miscible vehicles (cosolvents)

A
  1. Propylene glycol
  2. Glycerol
  3. Ethyl alcohol
  4. Polyethylene glycol (PEG 200 and PEG 400)
77
Q

Barbiturates are readily ________ by water

A

hydrolyzed

78
Q

Digitoxin has______ water solubility

A

Digitoxin has poor water solubility

79
Q

Non-aqueous vehicles Requirements

A
  1. Non toxic in the amounts administered
  2. Nonirritating
  3. Non-sensitizing
  4. It must not exert a pharmacological activity
80
Q

Non-aqueous vehicles must have

A
  1. Physical and chemical stability at various pH level
  2. Viscosity (suitable for use in syringes)
  3. Fluidity (must be maintained over a temperature range)
  4. Boiling point (should be high to permit heat sterilization)
  5. Constant purity or easy of purification
81
Q

Fixed oils must never be administered ___ and are mostly administered __.

A

iv, IM

82
Q

USP restricts oils for _________ use which do not remain clear when cooled to 10 ⁰C.

A

parenteral

83
Q

Fixed oils must not contain__________ or_______, as these materials are not adsorbed by body tissue.

A

mineral oil or paraffin

84
Q

Some patients exhibit _______ to specific oils. Thus, when vegetable oils are employed in parenteral products, the label must state the specific oil.

A

allergic reactions

85
Q

The concentration of co-solvent used should be ________________ within the formulation but should not be irritant or toxic to the patient.

A

sufficient to render the drug soluble

86
Q

Co-solvents should not be diluted with water or ___________ may occur

A

precipitation

87
Q

Preservatives

A

are substances added to dosage forms to protect them from microbial contamination

88
Q

USP requirement: One or more suitable antimicrobial preservatives must be added to parenteral
products that are packaged in multiple dose containers regardless of the method of sterilization, unless

A

a) Otherwise directed in the individual monograph

b) Injection’s active ingredients are themselves bacteriostatic

89
Q

What are the 5 most common antimicrobial perservatives?

A 
Antimicrobial preservatives Concentration (%)
1 Benzyl alcohol 2.0
2 Methyl paraben 0.18
3 Propyl paraben 0.02
4 Phenol 0.5
5 Benzalkonium chloride 0.01
90
Q

Because they may have inherent ______ for the patient, the USP prescribes maximum concentration
limits for preservatives.

A

toxicity

91
Q

When are preservatives contraindicated?

A
  • Neonates

- Parenteral products with volume greater than 30 mL

92
Q

When is not necessary to add a preservatives?

A

The preparation will be used immediately
No water is present
The pH of the medium is either 9

93
Q

Microorganism require ______ for growth

A

water

94
Q

Certain resistant molds can grow in media with pH below ________

A

Three

95
Q

Properties of the ideal preservatives

A
  • Effective at a low, nontoxic concentration against a wide variety of organisms
  • Chemically stable under normal conditions of use
  • Soluble at the required concentration
  • Compatible with a wide variety of drugs and excipients
  • Nontoxic and non-sensitizing
  • Free from objectionable odor, taste, color or stinging
96
Q

Buffering agents are used to adjust and maintain pH to increase ___ , ____ , and _____

A

drug stability, solubility, and absorption

97
Q

Buffers in injections must allow ______ to change the product pH after injections

A

body fluids

98
Q

The acceptable pH range of parental products is ___ to ____ for iv and ___ to ___ for other routes?

A

3-10

4-9

99
Q

Extreme pH’s may cause complications especially when _____________

A

administered locally in large amounts

100
Q

pH above 10 can cause ____ while below 3 can cause______

A

tissue necrosis

severe pain

101
Q

Buffering Agents Requirements

A
  • Ingredients to buffer of adjust pH must be nontoxic
  • Agents should be nonirritating at the needed concentration
  • Agents must be in sterile form or must be rendered sterile
102
Q

Antioxidants are

A

substances added to dosage forms to protect them from oxidative degradation.

103
Q 
True antioxidants (oxygen radical scavengers)
have\_\_\_\_\_\_\_\_\_\_\_\_ than the drugs and are preferentially oxidized
A

lower oxidation potential

104
Q

Examples of True anitoxidants

A

Butylatedhydroxyanisole (BHA)
Butylatedhydroxytoluene(BHT)
Sodium formaldehyde sulfoxylate (SFS)
Tocopherol

105
Q

Reducing agent they _____________ that has been oxidized

A

reduced a drug or excipient

106
Q

What is the another way to control oxidation in drugs?

A

Displacing the air (oxygen) in and above the solution by purging with an inert gas, such as
nitrogen, also can be used as means to control oxidation of a sensitive drugs.

107
Q

Chelating Agents

A

compounds that form complexes with metal ions and inactivate their catalytic activity in the oxidative properties

108
Q

____________ may be present even in high-quality compounding ingredients and on the surface of compounding equipment and packaging material.

A

Metal ions

109
Q

___________ of drug in solution is mediated either by free radicals or by molecular oxygen and catalyzed by metals.

A

Oxidative degradation

110
Q

______________ sequester heavy metals and prevent catalysis of oxidation reaction

A

chelating agents

111
Q

___________ can be used alone or with antioxidants

A

chelating agents

112
Q

_____________ Dextrose, NaCl, KCl are commonly used to achieve _________ in a parental formulation

A

Tonicity agents, isotonicity

113
Q

All parenteral products must be ________.

A

sterile!

114
Q

Sterility is assured by a three-step process:

3

A
  • use of sterile materials and process equipment
  • use of aseptic techniques in drug product manufacture
  • Sterilization of post manufacture, preferably in final sealed containers
115
Q

What are methods of sterilization?

A
  1. Dry heat sterilization
  2. Steam sterilization
  3. Filtration
  4. Gas sterilization
  5. Radiation
116
Q

What is dry heat sterilization?

A

Dry heat sterilization is conducted at 150°C to 170°C for 2 to 4 hrs

117
Q

What are things that can be sterilized with dry heat?

A

Thermostablepowders, Fixed oils and Glassware

118
Q

What are disadvantages with dry heat sterilization?

A

It can not be used with materials that heat sensitive
Non-uniform heat distribution
It requires higher temperature and longer exposure time

119
Q

Steam sterilization

A

is carried out in an autoclave, which is airtight jacketed chamber designed to maintain a high pressure of saturated hot steam (120°C)

120
Q

What is the rules of the autoclave?

A

10 lb 115.5 °C 30 min
15 lb 121.5 °C 20 min
20 lb 126.5 °C 15 min

121
Q

What can undergo autoclave?

A

Materials that can withstand 120 °C and are penetrated by moisture: Solutions sealed in ampules, bulk solutions, glassware, surgical dressing…

122
Q

What are advantages?

A
  • With moisture, microorganism are destroyed at lower temperature
  • Heat exchange by steam is more rapid than by dry heat
123
Q

What are disadvantages?

A

It can not be used with materials that heat and moisture sensitive and are not penetrated by moisture (oils, fats)

124
Q

Filtration

A

depends on physical removal of microorganism by absorption on the filter medium or by sieving mechanism

125
Q

What are two ways to sterilize products with a filter?

A

0.22 mm To remove microorganism

5 mm To remove particulate matter

126
Q

What types of solutions are good to be filtered?

A

Thermoliablesolutions of low viscosity

127
Q

What are advantages to filtration?

A
  • Simplicity and convenience

- Ability to sterilize thermoliablematerials

128
Q

What are disadvantages to filtration?

A
  • Macromolecules such as proteins may be damaged by filtration
  • Some filters adsorb drugs
  • Time consuming for large volume solution
129
Q

Micro-filtration (0.1 to 2 microns): removes

A

bacteria, fungi, bacteriophages, and parasites.

130
Q

Ultra-filtration (0.01 to 0.1 microns): removes

A

viruses.

131
Q

Nano-filtration (0.001 to 0.01 microns): removes

A

organic compounds in the molecular weight range of 300-1000 Da (almost all pyrogens).

132
Q

Reverse osmosis (

A

virtually all viruses, bacteria, pyrogens, organic

molecules, 90-99% of all ions.

133
Q

Gas sterilization

A

is accomplished by exposure to gas (ethylene oxide) that kills microorganism

134
Q

What does a Gas sterilization oven need to have?

A

Ethylene oxide concentration:500 –1000 mg/mL
Relative humidity: 30 –60 %
Temperature: 55 °C
Time: 6 hrs

135
Q

What materials work best with Gas Sterilization?

A

Thermoliablepowders (e.g. penicillin), instruments, plastic syringes, needles, catheters

136
Q

What are advantages to Gas Sterilization?

A

Ability to sterilize thermoliableand moisture-sensitive materials

137
Q

What are disadvantages to Gas Sterilization?

A

Some drugs (e.g. thiamine, riboflavin, streptomycin) lose potency

138
Q

____________ is accomplished by UV light or high-energy ionizing radiation such as gamma rays

A

Radiation sterilization

139
Q

When is radiation sterilization good to use?

A

Thermoliabledrugs such as penicillin, streptomycin, thiamine, riboflavin

140
Q

When is radiation sterilization not good to use?

A

highly specialized equipment required

Some materials sensitive to irradiation

141
Q

Parenteral products are packaged as _____ volume and _____ volume parenterals

A

Large and Small

142
Q

Large volume parenteral dosage form

A

A single-dose injection that is intended for intravenous use and is packaged in containers labeled as containing more than 100 mL

143
Q

Small volume parenteral dosage form

A

An injection packaged in containers labeled as containing 100 mL or less

144
Q

LVP solutions are packaged in containers holding more than _____ ml.

A

100 ml

145
Q

Why are plastic LVP bags good to use?

A

Do not break
Weigh less
Take up less storage space

146
Q

Why are plastic LVP bags not good to use?

A
  • Some drugs adsorb to the plastic

- Some solutions leach a plasticizer out the plastic

147
Q

When are glass bottles good to use for LVP?

A

To administer drugs that are incompatible with plastic bags

148
Q

LVP are usually administered in volumes of 100 mL to 1L or more per day by slow IV infusion
and are commonly used for:

A
  • Maintenance Therapy
  • Replacement Therapy
  • Drug Vehicle
149
Q

Maintenance Therapy

A

is used for fluid and electrolyte balance

150
Q

Replacement Therapy

A

is used for replacements of fluid and electrolytes

151
Q

Drug Vehicle

A

for administering other drugs

152
Q

Because of the large volumes administered, LVP must not contain_____________.

A

bacteriostatic agents

153
Q

SVP solutions are usually _________ and are packaged in different containers.

A

100 ml or less

154
Q

Small volume liquid parentals are usually found in _____, _______, and _______

A

ampules,prefilled syringes and vials

155
Q

What are powdered drugs supplied in?

A

vials

156
Q

SVP may not be isotonic because?

A

large volume of blood rapidly dilutes them

157
Q

SVP’s pH can vary since the blood buffering system rapidly readjusts the pH due to

A

small volume of Small Volume parental

158
Q

What do Multi-dose vials usually have?

A

preservatives

159
Q

The preparations of intravenous admixture

A

involves the addition of one or more drugs to large

volume sterile fluids such as sodium chloride injection, dextrose injection, and TPN fluid.

160
Q

Drug incompatibilities

A

refers to interactions between two or more substances which lead to changes in chemical, physical, therapeutic properties of the pharmaceutical dosage form.

161
Q

What are two types of drug incompatibilities?

A
  1. Physical incompatibility

2. Chemical incompatibility

162
Q

The unitended precipitation and toxic products due to incompatibilities can cause

A

problems from thrombophlebitis to multi organ failure

163
Q

Physical incompatibility

A

Interaction between two or more substances that causes change in solubility, precipitation, color, odor, viscosity, and morphology

164
Q

What are three causes of physical incompatibility?

A
  1. pH effect
  2. Dilution of mixed solvent systems
  3. Cation-anion interactions
165
Q

may affect the safety, efficacy and appearance of pharmaceutical preparation.

A

Incompatibilities

166
Q

The buffering capacity of the aqueous media of the large volume parenteral solutions is _______ and, therefore, pH changes often follow from the addition of the drugs to an infusion fluid.

A

small

167
Q

Why is having a small buffering capacity a problem?

A

This decrease or increase in pH may then produce physical (e.g. precipitation) or chemical (e.g. hydrolysis) in the system.

168
Q

The sodium salts of weak acids, such as phenytoin sodium or phenobarbital sodium, precipitate as _______ when added to intravenous fluids with an acidic pH.

A

free acids

169
Q

Precipitation on dilution in aqueous iv fluids is common with

A

non-ionized drugs

170
Q

Cation-anion interactions

A

Can cause Precipitation

171
Q

______________ are the most common causes of drug incompatibility as precipitation of nonionizeddrug forms.

A

Acid-base reactions

172
Q

Decomposition of a drug substance from combination of parental dosage forms is called ____________.

A

chemical incompatibility.

173
Q

Most chemical incompatibilities result from:

A
  1. oxidation
  2. Hydrolysis
  3. others
174
Q

While it impossible to predict and prevent all parenteral incompatibilities, their occurrence can be ________.

A

minimized!

Pharmaceutics Year 1 Term 1 (3 decks)

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