Test 8 Stability/ Reg Aspects In DD Flashcards by Ghosn Al-Khulaidi

General rule of decomp for pharma products

All pharma products decompose

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What is decomposition

Less active or worse compared to parent drug

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Three types of decomposition and explanation

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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True definition of FDA for stability

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

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Define instability

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

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When is stability assessed

Its continuous from preformulation to stage 4 clinical trials

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Define shelf life

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

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What is expiry date

When shelf life ends and drug is unsafe for use

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3 types of chemical stability

Hydrolysis
Photolysis
Oxidation

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In relation to stability, what happens in hydrolysis

Splitting by water or breaking bond with water

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Which functional groups are most prome to hydrolysis

Ester
Amides

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Give examples to hydrolysis reactions and drugs

Aspirin
Chloramphenicol
Diamorphine hydrochloride ampoules
Penicillin

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In relation to stability, define oxidation

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

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Give examples of drugs that undergo oxidation reaction

Phenols
Catecholamines
Polyunsat fats
Ascorbic acid

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In relation to stability, define photolysis

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

Eg ketoprofen

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Complete sentence…
Rate of photodegradation depends on

Rate of light absorption

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What is physical stability

No change to appearance or organleptic properties etc

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Why is physical stability significant

Affect pharma elegance, drug uniformity, bioavailability

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Likely physical instability and effects of formulation

Precipitation, crystal growth, polymorphic changes

Leading to

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

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Physical instability and effects of suspension

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

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Physical instability and effects of emulsions

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

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Physical instability and effects of tablets

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

Microbial instability

Must not suffer microbial attacks
Must have same contamination and sterility

Protection against instability

Buffering agents
Protection from light
Antioxidants
Reformulation
Preservatives
Free radical scavengers

Define zero order

Rate of reaction independent of concentration of reactants

If half life is 0.693/k what does it show

Plot of algorithm of drug remaining against time linear

When concentration is vs time, what is it

Zero order

What is the most common type of drug degredation

Hydrolysis

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

Oxidation C=C most susceptible e.g polyunsat fats

The MHRA rules that all drugs must be

Good quality Safe Effectice

Whats the main role of regulatory affairs

Protect public health

Briefly list non clinical disciplines of DD

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

Factors validating to quality products must be..

Interactive and take all into consideration MUTUALLY

List factors validating to quality lroducts

Personnel Validated process Procedures Equipment Premises Environment Packing materials Raw materials

What is GLP

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

What does the GLP certify

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

Principles of GLP

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

What is GMp

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

What can happen if GMP is not followed

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

What are the two types of GME

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

What can uncontrolled environment cause

Product degredation & contamination = loss of product/ profit

What are contaminats

Products other than manufactured products

Examples of contaminants

Foreign objects Particulate matter Microorganisms Endotoxins (degraded microorganism)

What is GCP

Desgining conducting recording and reporting of studies

What does the GCP set

Minimum quality standards, regilatiosn and guidelines for conduct of research

Main outcome of ICH

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

Principles of ICH GCP

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

Good distribution practice GDP

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

List Determinants of medicine qualtiy

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

Who ensures medicine quality

Pharmacy Drug reg authority Hospital Pharmacist Physicicians

Tests gor liquid dosages

Uniformity of dose Contents Stabikity Sedimentation volume

Test for solid

Tablet hardness Friarbility test Diameter thickness Weight variation Disintegration

Tests for capsules

Moisture content Single wall thickness Dissolution Visual inspection