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PJ1310 Science Of Medicines Yr1 > Test 7 Emulsions/ > Flashcards

Test 7 Emulsions/ Flashcards

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1
Q

What is the name of two things that totally mix

A

Solution

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2
Q

What two things are needed to make a solution

A

Solute and solvent

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3
Q

Factors that suggest that suspension is unstable

A

Aggregation
Sedimentation

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4
Q

Substance distributed

A

Dispersed phase

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5
Q

What is another name for vehicle

A

Dispersing phase or dispersing medium

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6
Q

What makes a dispersed system

A

Dispersed phase and dispersing medium

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7
Q

List desirable properties of oral suspension

A

No grittiness
Uniform dispersion
Easy to pour but not watery
Particles should settle slowly
Readily redispersed when shook
Flocculated suspension
Palatable, good odour and colour
Insensitive to temp

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8
Q

Desirable suspeensions for injections

A

Synringeabiltiy
Sterile

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9
Q

Desirable characteristics for opthalmic susp

A

Smaller than 10um
Sterile

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10
Q

Desirable characteristics for topical

A

Fine particles avoid grittiness

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11
Q

Describe sedimentation behaviour

A

Settling of particles/floccules due to gravity

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12
Q

Ways of decreasing velocity

A

Smaller particle size
Increases viscosity and density of dispersion medium
Decrease density if dispersed phase

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13
Q

How do we ensure that a suspension is permanently well dispersed

A

Ask patient to shake bottle

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14
Q

Relationship between particle size wnd velocity

A

Directly proportional

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15
Q

Relationship between density dispersed and dispersion media wnd velocity

A

Directly proportional

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16
Q

Relationship between viscosity of dispersion medium wnd velocity

A

Inversely proportional

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17
Q

Define deflocculation

A

No flocs dominating repulsion forces

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18
Q

Define flocculations

A

Flocs formed attracting forces dominate

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19
Q

Repulsive forces are a result of

A

Electrostatic forces

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20
Q

Describe the effect of neutral forces in APIs

A

More van der waals attraction that electrostatic = form flocs

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21
Q

Describe the effect of charge in APIs

A

Electrstatic forces dominate=deflocs= cannot be easily redispersed due to repulsion

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22
Q

How would you know the difference between a flocculated and deflocc solution by looking at it

A

Flocc top layer will be clear
Defloc top layer cloudy

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23
Q

In a deflocc solution why is the top of the solution cloudy

A

Due to repulsive forces, and stokes law, sedimentation of larger psrticles happens first

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24
Q

Explain flocculation

A

Weak bonds forming fluffy conglomerates
Settle rapidly but will jot form a cake
Easily resuspended
Clear supernatant

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25
Q

Describe the speed of flocculated suspension

A

More rapid than deflocculated

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26
Q

What dies sedimentation depend on

A

Size and porosity if flocs

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27
Q

Describe energy in deflocculation

A

High repulsive energy

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28
Q

Aggregation of particles in deflocculation

A

Caking

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29
Q

Describe supernatant in deflocculation

A

Turbid supernatant

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30
Q

Describe speed of sedimentation in deflocculation

A

Rate of sediment slow with larger particles sedimenting first

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31
Q

In flocculated suspensions what particles settle first

A

All particles of size settle at same speed

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32
Q

In terms of particles explain the difference between flocculated and deflocculated system

A

Defloc remain independent
Flocc particles link together to form loose structure

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33
Q

In terms of sedimentation state the difference between floc and defloc solution

A

Floc - all sediment at same speed in loose structure
Deflo- large sediment first but slowly

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34
Q

In terms of supernatant describe different between flocculated and defloc system

A

Defloc- supernatant turbid for long time

Floc- supernatant quickly becomes clear

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35
Q

In relation to dispersion, compare floc and defloc system

A

Defloc- may form hard cake irreversible

Floc- sediment remains loose and easy to redisperse

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36
Q

What does the sediment volume of ratio show

A

Qual knowledge physical stabiliy of suspension

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37
Q

Equation for sediment of volume ratio

A

Volume of sediment /total volume

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38
Q

How can flocculation be controlled

A

Electrolytes- electrostatic stabilisation
Polymers - steric stabilisation

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39
Q

How are electrostatic electrolytes used in cotrolled flocculation

A

Electrolyte decrease the zeta potential

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40
Q

How are polymers used in controlled flocculation

A

Work by absorption Hydrophilic polymers such as cellulose alginates acacia gelatin sodium oleate

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41
Q

Which forces lead to attractive interactions between two identically charge oarticles

A

VDW

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42
Q

A flocculated suspension is associated with

A

A large sediment volume and a clear supernatant

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43
Q

What property is a characteristic of deflocc suspension

A

Close packing of sediment to form a cake

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44
Q

What will enhance yhe stability of a drug suspension

A

Reducing particle size and increasing the viscosity of the suspension

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45
Q

How are drugs approved

A

Benefits are deemed to outweigh their risks

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46
Q

Are drugs safe

A

No all drugs have risks many are serious

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47
Q

Do OTC drugs have risks

A

Yes although fairly rare

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48
Q

How does the patient evaluate benefit and risks

A

Personal values

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49
Q

How does the HCP evaluate benefit and risks

A

Risks for the patient

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50
Q

How does the MHRA evaluate benefit and risks

A

Risks for population

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51
Q

What does the mhra stand for

A

Medicine and healthcare product regulatory agency

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52
Q

Describe the rofecoxib scandal

A

Approve for arthiritis but increased risk if heart attack

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53
Q

Explain the effect of drug advertising on individuals

A

More exposure to meds which gives an impression of greater safety than actually exists
Take meds to maintain health

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54
Q

Definition of adverse drug reaction

A

Any harmful effect caused by admin of drug at NORMAL DOSAGE during NORMAL USE

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55
Q

Define risk/benefit ratio

A

Exposure to personal risk is recognise as a normal aspect of everyday life. We acceprs a certain level of risk in our lives as necessary to aschieve certain benefits

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56
Q

Frequency of ADR
Very common

A

10% or 1 in 10

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57
Q

Frequency of ADR
Common

A

1% to 10%
1 in 10 to 1 in 100

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58
Q

Frequency of ADR
Uncommon

A

0.1% to 1%
1 in 100 to 1 in 1000

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59
Q

Frequency of ADR
Rare

A

0.01 to 0.1
1 in a 1000 to 1 in 10,000

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60
Q

Frequency of ADR
Very rare

A

Less than 0.01% to less than 1 in 10,000

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61
Q

What is pharmacovigilance also known as

A

Post marketing surveillance

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62
Q

Major goal of pharmacovigilance

A

Detect a signal on an unkowm serious adverse drug reaction ASAP
Obtain additional info unknown to marketing

63
Q

Effect of pharmacovigilance on labelling and pateint

A

Improve labelling of drug
Improve patient care and patient safety

64
Q

Limitations of clinical trials

A

Limited no of patients
Narrow population
Narrow indications
Short duration
No pregnancy
Concomitant meds controlled

65
Q

What action can be taken from pharmacovigilance findings

A

Restriction in use
Changes in dose of med
Introduce specific warning
Change legal status of med from otc to pom
Product recall

66
Q

International collabs for reporting meds

A

WHO
Eu union- EMA
Fda in us
Uk MHRA- yellow card scheme

67
Q

Where are yellow carss completed

A

Online and in the BNF

68
Q

What does rhe yellow card scheme act as

A

Early warning system for identification of unrecognised reactions

69
Q

What does the yellow card scheme collect information from

A

Side effects
Medical devices
Defective meds
Fake meds
Safety concerns from e cigs

70
Q

What ADRs should be reported

A

Death or serious illness
Minor risk with new medicine
Minor risk if associate with a child or in pregnancy

71
Q

What does black triangle mean on BNF

A

New Drug monitored closely for minimum of two years black triangle not removed until safety of drug is established

72
Q

ADR can result in the following:

A

Result in death
Life threatening
Requires hospitalisation
Disability
Congenital anomaly or birth defect
Medically significant

73
Q

Who can report ADRs

A

Patients /relatives
HCPs
Pharma companies
Authority

Any member of general public

74
Q

What does pharmacovigilance heavily rely in

A

Passive surveillance

75
Q

In terms of discipline what is pharmacovigilance

A

Dynamic clinical and scientific discipline

76
Q

How is a drug deemed successful

A

Promise invitro demonstrating a beneficial effect in animal and models as well as pass through 3 phases of human clinical trials

77
Q

Difference between invitro and in vivo

A

Invitro in cells
In vivo in life

78
Q

What is formulation

A

Putting compound in suitable vehicle

79
Q

How do you test stability

A

Different temperatures and humidity
Making sure that nothing happens to the drug

80
Q

What does phase 1 test

A

Safety in humans

81
Q

What does phase 2 test

A

Efficacy in patients

82
Q

What does phase 3 test

A

Safety and efficacy larger scale

83
Q

What does phase 0 test for

A

Effect on body

84
Q

What does phase 4 test for

A

Long term safety

85
Q

IMPD

A

Investigational medicinal product dossier
Certifies approval for clinical trials to take place

86
Q

MAA

A

Marketing authorisation application
Must be approves at the end of clinical trials

Equivalent to NDA

87
Q

EMA

A

European medicine agency
Revies the commercialised products

88
Q

Why are new drugs needed

A

Unmet medical need
Cost of therapy
Sustain industrial activity

89
Q

Explain the unmet medical need

A

New diseases

Low efficacy such as dementia and cancer

Side effects of antidepressants/ antipsychotics

90
Q

Purpose of drug patents

A

Protect ideas in pharmaceutical company

91
Q

Definition of formulation science

A

Transforming API into a quality drug product in a specific dosage form

92
Q

Purpose of formulation

A

For stability ease of administration or patient acceptability

93
Q

What does formulating a drug and excipients into a dosage form allow

A

Manipulation of dosing frequency

94
Q

How is choice of formulation important

A

When dealing with vulnerable populations eg children elderly

95
Q

What does preformulation study involve

A

Characterisation of api eg solubility/melting point
Investigation fo physicochemical properties alone and with excipients

96
Q

Choosing quant formula and process is also known as

A

Formulation development

97
Q

Transferring the process from lab to industrial is known as

A

Scale up and process validation

98
Q

Learning before doing is…

A

Pre-formulation studies

99
Q

What do drug discovery and preclinical trials involve

A

Preformulation
Formulation support for preclinical test
Developing a formulation for clinical trials

100
Q

What do clinical trials involve

A

Scaleup activities
Ontime supply of clinical trial material
Formulation development

101
Q

Post marketing surveillance can lead to..

A

Reformulation
2nd generation launch
Pom to otc

102
Q

Preformulation main areas of focus regarding physicochemical properties

A

Organoleptic properties- colour/odor/taste
Particles size and shapes-solubility
Purity-impurtities can be toxic
Surface area - solubility and dissolution

103
Q

Preformulation main areas of focus regarding
Bulk characteristics

A

Crystallinity and polymorphism- stability and compatibility
Bulk density- measure volume / weight
Powder flow properties
Hygroscopicity- how much water absorbed from air

104
Q

Preformulation main areas of focus regarding
Solubility studies

A

Aqueous solubility - must dissolve in git prior to absorption
Ph solubility
Log p- drug across membrane
Dissolution

105
Q

Preformulation main areas of focus regarding
Stability studies

A

Solid state- stable storage conditions snd investigate effect of pH:/ cosolvent/ temp/light
Solution
Bulk
Compatibility - look at interaction with other drugs

106
Q

What are drug candidates becoming

A

More lipophilic and poorly soluble

107
Q

What does the comprehensive report include

A

Problems associated with molecule

108
Q

Formulation studies involve

A

Delivery of robust and stable drug product formulations that consistently deliver the desired API:

109
Q

List the steps of formulation studies

A

Formulation design
Process development
Formulation support for preclinical test
Clinical trials
Scale up
Package development
Ongoing stability studies

110
Q

How did covid develop quickly

A

Funding
Urgency
Demand

111
Q

How did covid vaccine trigger immune system

A

Spike protein

112
Q

How did covid get approved quickly

A

Temp approval for specific batches of pfizer vaccine based on efficacy

Rolling revies process

113
Q

Why was covid vaccine temporary

A

Dont need eu approval
Approval for 1 year
Allow companies to continue studies and submit evidence

114
Q

Where can you find information for drug disposal

A

EMC
Patient leaflet

115
Q

What are preclinical trials

A

Non clinical studies is the stage of research that begins before testing in humans

116
Q

What is the purpose of pre clinical trials

A

Determine a products ultimate safety profile

117
Q

In preclinical trials, what is the main purpose

A

Test drugs and devices to see if theyre safe and effective

118
Q

What types of products are used in preclinical tests

A

New drugs
Medical devices
Gene therapy solutions

119
Q

What do individuals consider before taking medication

A

Effectiveness
Doee
How often
Side effects
Any interactions
Is it a cure

120
Q

Main aim of preclinical trials

A

Gather enough info to decide whether drug is safe to proceed with human trials

121
Q

Animals used in preclinical trials

A

Zebra fish
Mice and rodent models
Rabbits
Fruit fly

122
Q

List importance of preclinical trials

A

Determine dose, toxic dose , pharmacological action ,

Requirement if reg body

Consider ethical viewpoint

Kinetic profile

Effective route if admin

123
Q

In general animal studies are conducted in two species

A

Rodent
Non rodent

124
Q

How are safety pharmacology studies used in preclinical studies

A

Determine the effects of drug on specialised organ system

125
Q

How are carcinogenicity studies used in preclinical studies

A

Determine effects of long term exposure to drug including ability to produce cancer
Not used for short term use drugs

126
Q

How are reproductive toxicity studies used in preclinical studies

A

Evaluate effects on reproductive function & ability to produce birth defects

127
Q

List the 3 types of scientific models used

A

Insilico- computational modelling
Invitro in test tube
In living animals
In living humans

128
Q

Non animal and non humans models

A

In silico and in vitro

129
Q

Conditions of in vitro experimentation

A

Aseptic techniques
Biosafety cabinet
Cells grown at 37c and 5% co2

130
Q

Journey of in vitro experiment

A

Grow cells in flask
Then add to 96 well plate
Then plot IC50

131
Q

Pros and cons of in vitro models

A

Less expensive than in vivo
Faster than in vivo

Difficult to mimic complex physio environments

132
Q

What do screening models test in vitro models

A

Cytotoxicity
Protein binding
Cyp inhibition/induction
Membrane permeability

133
Q

What is a model organism

A

Non human species studies used to provide insight into working of other organisms

134
Q

Why are mouse models favoured

A

Close model to humans
High degree of genetic similarity

135
Q

Why are c elegans favoured

A

Grown and manipulated with speed and ease but includes key complex features of an organism

136
Q

Fruit fly

A

Easy to manipukaye
Used to study development, physio and behaviour
Well conserved genes -homologues

137
Q

Why are Zebra fish used as animal model

A

Small size short life cycle
Readily produce mutations relevant to human health and disease
Embryonic development

138
Q

Disadvantages of animal models

A

Lack of appropriate drug target in preclinical animal model
Irrelevant target
Difference in metabolism
Unethical

139
Q

Animal trials…

A

Are not always predictive

140
Q

Ethical considerations in animal studies

A

Refinement- minimise pain and suffering
Reduction- using a few animals as possible
Replacement- use other models

141
Q

Alternatives to animal models

A

In vitro or computational modelling by law if as effective as using animals
Use lowest animal eg fly rather than mouse

142
Q

Study details of preclinical trials

A

Only few out of thousands reach stage
Safety in at least two animal species
Oral and parenteral routes

143
Q

What are screening test

A

Simple and rapid test performed to indicate presence or absence of a particle pharmacodynamic activity

144
Q

What are tests on isolated organs, bacterial cultures

A

Preliminary tests to detect specific activity, eg antihistaminic/ antisecretory

145
Q

What are tests on animal models of human disease

A

Animals to study different type of drugs

146
Q

What is a general observational test

A

Drug injected in 3 doses to small group which are observed for hidden effects

147
Q

What are confirmatory tests and analogous activities

A

Test for active compounds

148
Q

What are mechanism of action studies

A

Attempt to find our mechanism of action

149
Q

What is systemic pharmacology

A

Effect of drug on major organ systems

150
Q

What are quantitave tests

A

Dose response relationship, maximal effects

151
Q

What are pharmacokinetic test

A

Absorprion, tissue distribution, metabolism, excretion

152
Q

IND

A

Investigational new drug
How drug is manufactured
Appears
Formulation intended
Analysis for purity/concentration and stability
Safety

153
Q

Common technical document

A

Set of spec containing all the quality safety and efficacy information
Used with other ICh and reg agency MHRA

PJ1310 Science Of Medicines Yr1 (15 decks)

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