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PJ1310 Science Of Medicines Yr1 > Test 8 Stability/ Reg Aspects In DD > Flashcards

Test 8 Stability/ Reg Aspects In DD Flashcards

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1
Q

General rule of decomp for pharma products

A

All pharma products decompose

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2
Q

What is decomposition

A

Less active or worse compared to parent drug

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3
Q

Three types of decomposition and explanation

A

Chemical- change in chemical structure of API or excipients mediated by temp/moisture/ light and oxygen

Physical- change to how it looks, colour smell texture etc

Microbial- microbes colonise - spoilage of drugs

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4
Q

True definition of FDA for stability

A

Ability of API and ingredients to stay in set limits for identity/strength/ purity for period of time

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5
Q

Define instability

A

Change in physical appearance & undesirable change in performance e.g bioavailability/ dissolution

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6
Q

When is stability assessed

A

Its continuous from preformulation to stage 4 clinical trials

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7
Q

Define shelf life

A

Time product stays in its chemical/ physical/ microbial stable in correct storage

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8
Q

What is expiry date

A

When shelf life ends and drug is unsafe for use

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9
Q

3 types of chemical stability

A

Hydrolysis
Photolysis
Oxidation

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10
Q

In relation to stability, what happens in hydrolysis

A

Splitting by water or breaking bond with water

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11
Q

Which functional groups are most prome to hydrolysis

A

Ester
Amides

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12
Q

Give examples to hydrolysis reactions and drugs

A

Aspirin
Chloramphenicol
Diamorphine hydrochloride ampoules
Penicillin

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13
Q

In relation to stability, define oxidation

A

Loss of hydrogen or addition of oxygen
Increase C=O bonds OR
decrease C-H bonds

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14
Q

Give examples of drugs that undergo oxidation reaction

A

Phenols
Catecholamines
Polyunsat fats
Ascorbic acid

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15
Q

In relation to stability, define photolysis

A

Decomposition by light, change in potency and affect appearance of formulation

Eg ketoprofen

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16
Q

Complete sentence…
Rate of photodegradation depends on

A

Rate of light absorption

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17
Q

What is physical stability

A

No change to appearance or organleptic properties etc

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18
Q

Why is physical stability significant

A

Affect pharma elegance, drug uniformity, bioavailability

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19
Q

Likely physical instability and effects of formulation

A

Precipitation, crystal growth, polymorphic changes

Leading to

Loss of uniformity, affect’s bioavailability, injection of precipitated drug is painful

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20
Q

Physical instability and effects of suspension

A

Settling
Caking
Crystal growth
Leading to
Loss of uniformity
Bioavailability
Loss of elegance

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21
Q

Physical instability and effects of emulsions

A

Creaming. Coalescence. Breaking
Leading to loss of uniformity , affect bioava’ , loss of elegance

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22
Q

Physical instability and effects of tablets

A

Changes in disintegration time, dissolution profile, hardness, appearance
Leading to chnage in drug release, affecting bioavailability

23
Q

Microbial instability

A

Must not suffer microbial attacks
Must have same contamination and sterility

24
Q

Protection against instability

A

Buffering agents
Protection from light
Antioxidants
Reformulation
Preservatives
Free radical scavengers

25
Q

Define zero order

A

Rate of reaction independent of concentration of reactants

26
Q

If half life is 0.693/k what does it show

A

Plot of algorithm of drug remaining against time linear

27
Q

When concentration is vs time, what is it

A

Zero order

28
Q

What is the most common type of drug degredation

A

Hydrolysis

29
Q

What is the second most common type of drug degredation and what is most susceptible

A

Oxidation
C=C most susceptible e.g polyunsat fats

30
Q

The MHRA rules that all drugs must be

A

Good quality
Safe
Effectice

31
Q

Whats the main role of regulatory affairs

A

Protect public health

32
Q

Briefly list non clinical disciplines of DD

A

Test invivo & invitro safety and efficacy
Develop pharm profile and toxicity from at least 2 animal species
Asses toxicity from 2 weeks to several months
Quality of reporting of data

33
Q

Factors validating to quality products must be..

A

Interactive and take all into consideration MUTUALLY

34
Q

List factors validating to quality lroducts

A

Personnel
Validated process
Procedures
Equipment
Premises
Environment
Packing materials
Raw materials

35
Q

What is GLP

A

Good lab practice
Guidelines for lab, studies must be safe planned monitored and archived

36
Q

What does the GLP certify

A

Whether every step is valid, QA, heavy emphasis on recording data

37
Q

Principles of GLP

A

Test systems
Facilities reporting of everything
Storage and retention of records/ materials

38
Q

What is GMp

A

Good manufacturing practice
Consistent high quality products, appropriate for intended use
Meet marketing authorisation

39
Q

What can happen if GMP is not followed

A

Adulteration where drug does not meet safety, identity, strength quality and purity of products

40
Q

What are the two types of GME

A

Personal- prevent contact with dusts/fume/ acceptable comfort condition

Environment- avoid dust discharge/ fume discharge/ effluent discharge

Product- no cross contamination, protect from ambient conditions, prevent contamination of staff/ correct temp& humidity

41
Q

What can uncontrolled environment cause

A

Product degredation & contamination = loss of product/ profit

42
Q

What are contaminats

A

Products other than manufactured products

43
Q

Examples of contaminants

A

Foreign objects
Particulate matter
Microorganisms
Endotoxins (degraded microorganism)

44
Q

What is GCP

A

Desgining conducting recording and reporting of studies

45
Q

What does the GCP set

A

Minimum quality standards, regilatiosn and guidelines for conduct of research

46
Q

Main outcome of ICH

A

safety, quality, efficacy , unify reg requirements for new products
Reduce DD cost & time

47
Q

Principles of ICH GCP

A

Conducted in accordance to ethical principle e.g decleration of helinski
Weigh risks and benefits before trial
Clinical/non clinical must be weighed to support trial

48
Q

Good distribution practice GDP

A

Wholesale distribution, quality, integrity of meds can be affected by lack of comtrol
Meds need to be obtained from licensed chain
Stored transported and handled under suitable conditions
QA controlled

49
Q

List Determinants of medicine qualtiy

A

Identity- api
Purity- uncontmainated
Potency- 90- 110 of labelled amount
Unifromity- consistent colour shape size
Bioavailability- interchangeable product- different forms
Stability- medicine active for stated period

50
Q

Who ensures medicine quality

A

Pharmacy
Drug reg authority
Hospital
Pharmacist
Physicicians

51
Q

Tests gor liquid dosages

A

Uniformity of dose
Contents
Stabikity
Sedimentation volume

52
Q

Test for solid

A

Tablet hardness
Friarbility test
Diameter thickness
Weight variation
Disintegration

53
Q

Tests for capsules

A

Moisture content
Single wall thickness
Dissolution
Visual inspection

PJ1310 Science Of Medicines Yr1 (15 decks)

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