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ETMM > Consumer healthcare > Flashcards

Consumer healthcare Flashcards

1
Q

What are the 13 steps of drug discovery process for consumer products?

A
  1. Consumer insight
  2. Product brief
  3. Product design
  4. Analytical method development
  5. Pre-formulation
  6. Formulation and testing
  7. Choice of packaging
  8. Setting specification
  9. Product testing (in use/sensory and clinical)
  10. Process development
  11. Stability
  12. Scale up
  13. Approval, manufacture and launch
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2
Q

What is involved in the consumer insights process for consumer products? (sources)

A

Can emerge from several sources:

a) focus groups- to get target consumers, user insight, what people like/want, feedback from existing products
b) Views from experts
c) Survey data
d) Home contacts- one to one contact
e) Product testing
f) Competitor products- what are other companies and brands doing that you could do?

Once this has been done, product concepts can be tested on groups (qualitative and quantitative)

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3
Q

What is involved in the product brief process for consumer products?

A

Once a concept has been validated

Includes:

a) Efficacy
b) Product aesthetics (size, shape, colour, flavour)
c) Packaging- e.g. toothpaste in a can, was a cool idea but no benefit and was more expensive so sales dropped
d) Potential claims - may not be a new formulation but have a new claim e.g. 24 hour deodorant to 48 hours
e) Cues for claimed benefit e.g. adding menthol to nasal sprays so the person feels like something is happening

You want them to rebuy the product

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4
Q

What is involved in the product design process for consumer products?

A

Consider several factors:

ϖ Format

ϖ Appearance

ϖ Product function and choice of function ingredients

ϖ Cost

ϖ Raw material sourcing- don’t just want one supplier due to risk

ϖ Regulatory status

ϖ Desired claims

ϖ Microbial robustness – is a preservative needed?

ϖ Stability and shelf life- minimum shelf life is 2 years but 3 is ideal

ϖ Manufacturing process

ϖ Are you going to be able to manufacture repeatedly in the same factory you have up and running?

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5
Q

What is involved in analytical method development for consumer products?

A 
ϖ Levels active and key excipients:

- Pre-formulation studies

- Establishing of product specification

- Release testing

- Stability testing

ϖ Need to develop methods for pH, viscosity, friability and dissolution (for solid dosage forms), product density for liquids and semi-solids

ϖ Method must be suitable for use in a factory setting e.g. what machines do they have available? Unlikely they will have GC MS

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6
Q

What is involved in the pre-formulation process for consumer products?

A

ϖ A means of discovering if there any interactions between ingredients

ϖ Often done with binary mixtures

ϖ Thermal methods often used

ϖ Analytical methods to distinguish between total and free level of an active ingredient e.g. fluoride in a toothpaste

ϖ Accelerated testing often performed g. increase in temperature and humidity 
Accelerated testing = subjecting it to conditions in excess of its normal service parameters to uncover faults and potential modes of failure in a short amount of time

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7
Q

What is involved in the formulation process for consumer products?

A

ϖ Choice of ingredients based upon the characteristics and properties of the product

ϖ Lab scale formulation and testing

ϖ Testing using analytical and physical methods already developed

ϖ Stability under torture conditions often used

ϖ Choice of grade/manufacture of raw materials e.g. cosmetics usually use pharmacopeial grade to guarantee quality

ϖ Influence of raw material characteristics on properties of finished formulation

ϖ Establish a design space sets the specifications 
How much can you move within a certain level of criteria and still have that certain level of acceptability in the product?
How much leniency are you allowed?
e.g. mixing time affecting viscosity 
This is the parameters you can operate to give rise to an acceptable product

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8
Q

What is involved in the choice of packaging process for consumer products?

A

ϖ Nature of product

ϖ Benefits of packaging

ϖ Stability

ϖ Aesthetics – how expensive/good quality does the product feel?

ϖ Cost

ϖ Ease of use in factory

ϖ Novelty

ϖ Trade customer preferences

ϖ Product:pack interaction studies needed

ϖ Size- needs to fit on the shelves in the shop

E.g voltarol now have an osteo cap where it is easier to open and they have a massage cap to allow ease of application instead of getting it on your hands. It also needs to be airtight as the ingredients are volatile

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9
Q

What is involved in the setting of specification for consumer products?

A

ϖ Specifications of finished product needs to be set so you can know whether the product would be acceptable for release and on storage

ϖ Includes parameters that are important for safety, efficacy and quality of the product

ϖ Depends on dosage form

ϖ OTC products= parameters dictated by monographs. E.g. solid dosage forms:
- Active level and content uniformity 
- Degradants
- Friability, dissolution, tablet hardness 
Some of these parameters are stipulated by regulatory authorities e.g. active assay 95-105% of target

ϖ Important that the product has been manufactured on suitable machinery

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10
Q

What is involved in the product testing process for consumer products?

A

ϖ Once the product has been fixed, it is possible to manufacture to GMP standards

ϖ Sensory testing

ϖ Consumer testing for fit with product testing

ϖ Pivotal stability testing to determine shelf life

ϖ In vitro testing

ϖ Clinical testing
– in cosmetics you only do phase 3 not 1 or 2

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11
Q

What is involved in the stability part of the process for consumer products?

A

ϖ To ensure product is stable over shelf life

ϖ Release and stability specifications established

ϖ Requirements depend upon markets to be launched in

ϖ Testing conducted at release and then after storage at various conditions (ich guidelines)

ICH have different stability zones (1-4) in order of increasing climate e.g. African countries will be zone 3/4

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12
Q

What is involved in the process of scale up, manufacture, approval and launch for consumer products?

A

Following 10th scale pilot

ϖ For cosmetics, no approval from the regulatory authorities is required

ϖ In the US, monographed medicines do not need a prior-approval as long as it is within the monograph

ϖ Once all the relevant data has been generated, the product is transferred to the manufacturing site

ϖ First batch= pilot batch at full scale when successful testing is complete

ϖ Once the product has been fixed, it is possible to manufacture to GMP standards

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13
Q

When is a drug a blockbuster drug?

A

1 billion dollars ANNUAL SALE

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14
Q

What kind of molecules are top earning drugs?

A

Large molecules e.g. biologics

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15
Q

What is a patent cliff?

A

As soon as a drug comes off patent - patent cliff. Generics come in and take ½ - 2/3 business over night

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16
Q

Where is the developed pharmaceutical market?

A

Japan, USA, Western Europe

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17
Q

What is a pharmerging market and name some countries that are in this class?

A

Countries with greater than 1 billion spending growth

Where pharmaceutical use is growing rapidly

China, Brazil, India, Russia

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18
Q

What is the FDA definition of a drug?

A

Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease e.g. so head and shoulders (anti-dandruff) and toothpastes (anti-cavity) are seen as drugs

Articles intended to affect the structure or any function of the body of man/other animals- so in the US, deodorant changes the function of the body as it stops sweating= drug

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19
Q

What is a first in class drug and an example?

A

First in class- utilise new mode of action, novel kind of drug and you have to validate the target.

Enalapril

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20
Q

What are the 13 steps in the drug discovery process for pharmaceuticals?

A
  1. Disease identification
  2. Target identification
  3. Target validation
  4. Drug discovery
  5. Medicinal chemistry and QSAR
  6. Lead identification
  7. Pre-clinical (in vitro and vivo)
  8. Pharmaceutical development
  9. Manufacturing and GMP
  10. Clinical phase
  11. Regulatory applications
  12. Approval, manufacture and launch
  13. Post launch activities
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21
Q

What is involved in the disease identification step in pharmaceutical development?

A
  • Where do you want this drug to launch?
  • Where is there a clinical need?
  • What genes are associated with the disease? E.g. the bacteria, virus
  • Humans have 20,500 genes, with only 1.5% encoding proteins
  • Only hundreds have these have been identified as targets

Top 10 leading causes of death in the world:

  1. Ischaemic heart disease
  2. Stroke
  3. COPD

However, the leading causes of death change whether it is high or low income countries.

22
Q

What is involved in the target identification step in pharmaceutical development?

A

Established targets (G-coupled protein receptors, ion channels, enzymes, protein kinases, hormones, factors, nuclear receptors)

  • Another target is protein kinases – in chronic myeloid leukaemia, BCR-Abl is stuck on the “on position” à imatinib inhibits this which stops cell division and promotes cell apoptosis
  • Epidemiology – incidence, distribution and control of disease
  • Genotype
  • Phenotype
  • Chemo proteomics – approach to discovering mechanisms for regulating biological pathways for the purpose of designing new drugs
  • Imaging
  • Biomarkers

New molecular entities can launch from a novel mechanism, existing mechanism or be an orphan drug

Receptors:

  • Most current drug targets are proteins
  • Receptor= cellular molecule, or an assembly of macromolecules that is concerned directly and specifically in signalling between and within cells
  • Combination with a hormone, neurotransmitter, drug or intracellular messenger with its receptors initiates a change in cell function
23
Q

What is involved in the target validation step in pharmaceutical development?

A

Some targets are well validated - you have evidence to know it is the case e.g. ACEi Different companies can develop drugs going for the same established target

24
Q

What is involved in the discovery process? What two types of drug design is there?

A

Assay development

  • To develop an assay system, you need to screen compounds
  • Binding assays, enzyme-based or cell-based
  • Consists of receptors or mimics of receptors which are linked to an indicator which will show ligand-receptor interaction as some sort of signal e.g. Luciferase

Screening

  • Looking for compounds that will bind to certain receptors
  • Interaction= hit
  • Once identified, lead compounds are purified using chromatographic techniques and characterised à X-ray crystallography, NMR
  • These compounds can be chemically manipulated to optimise the properties and identify the pharmacophore (portion of the molecule biologically active)

High throughput screening

  • Optimise the screening processing using micro-well plates and robotics
  • Screens thousands of compounds in a short time frame
  • Looks for activity against a certain molecule or receptor à SAR
  • Industries often only have their own libraries, mainly consisting of small organic molecules
  • 384-well plates however, ultra HTS can use 3456-well plate
  • Utilise ink-jet technology to manipulate extremely low levels of reagents (nano-litres)

Irrational and rational drug design

25
Q

How does x-ray crystallography work for determining the protein structure?

A
  • Requires crystals of the purified protein
  • Diffraction pattern allows for clarification of the molecular structure
  • Publicly accessible databases hold all these characterised protein structures
26
Q

What is irrational drug design? Can you give an example?

A

Natural product collections – plants, animals and micro-organisms -
biodiversity is important

Screening of in house libraries e.g. national institutes

Not a logical process

Compound can be extracted using conventional solvents

e.g. Teprotide (snake venom) led to development of enalapril

27
Q

What is rational drug design?

A

Characterisation of target- based on 3D structure (NMR and x-ray crystallography) and amino acid sequence of chosen receptor Molecules are designed to fit this receptor

QSAR

Computational and combinatorial chemistry

HTS assays

Genomics and proteomics

28
Q

What is lead identification in pharmaceutical process?

A
  • You have a number of compounds
  • Modifications can be made to optimise certain properties once a pharmacophore has been identified
  • You want to minimise potential for side effects
  • After a lot of in-vitro testing in cell-based assays - in-vivo
29
Q

What is medicinal chemistry? (2 classes)

A

i) Computational chemistry:
* Can determine structure-activity relationships of ligand-protein receptor binding
* Aim= perform virtual screening using computer-generated ligands via a de novo drug design method
* Repetitive process where the ligand is modified on the computer to optimise interaction
* Need to look at strength of binding and other characteristics
* Consider Lipinski’s rule (logP <5, <10 H Bond acceptors (all N and O), <5 H bond donors (H-N and O-H), <500 Da
* Is the drug going to be stable?
ii) Combinatorial chemistry
* Chemical synthetic method that makes it possible to prepare a large number of compounds in a single process

  • E.g. amines and carboxylic acids:
    1. Amines attached to solid support (polystyrene beads) with linking groups
    2. XS amine is washed off
    3. Various carboxylic acids added and reacted to form amides
    4. Washed again to remove un-reacted carboxylates
    5. Amides released from solid supports via UV light
30
Q

What is pre-clinical testing?

A
  • Regulatory oversight is now of primary importance
  • In vitro and in vivo methods used to determine clinical pharmacology of the compound
  • PK (ADME)
  • PD (potency, effectiveness, TI, safety margin)
  • Toxicology
31
Q

What are caco-2 cells used for in pre-clinical in vitro testing?

A

Caco-2 colon carcinoma cell line used to estimate permeability across intestinal epithelium (important for drug absorption across gut)

32
Q

What are MDR1-MDCK cell lines used for in pre-clinical in vitro testing?

A

MDCK (model cell line) transfected with MDR1 gene, which encodes the efflux protein P glycoprotein. Can be used to predict intestinal and brain permeability

33
Q

What are hep G2 cells used for in pre-clinical testing in vitro testing?

A

Human hepG2 cells can act as a surrogate for effects of toxicity on human liver, an important cause of drug failure in the clinic

34
Q

What is the pharmaceutical development stage in the pharmaceutical process?

A
  • Is the drug stable?
  • Is the formulation stable?
  • Is the drug available?
  • Compliance?
  • Product aesthetics
  • Can the product be reproducibly manufactured to certain quality standards?
  • Hardly ever as a pure compound
35
Q

What is the clinical testing stage for pharmaceuticals?

A
  • Need body of evidence to show compound is safe
  • From in vitro, in silico, in vivo
  • Safety margin is established
  • Review process with regulators to ensure all supporting data has been generated and interpreted correctly
  • Proposed study protocol reviewed and approved

Phase 1:

  • First testing in man
  • Small groups of healthy volunteers
  • At a clinic with constant supervision
  • Dose- ranging studies conducted, starting with very low doses (guided from pre-clinical data)
  • Safety the primary endpoint
  • ADME determined
  • Sometimes patients are used e.g. cancer

Phase 2:
- where you determine efficacy at the dose found in Phase 1

  • Once a dose or dose range has been determined, aim to determine its biological activity
  • Hundreds (patient population)
  • Can be combined with phase 1

Phase 3:

  • Large, pivotal trials to establish efficacy and determine potentially less common side effects
  • Large, inexpensive multi-centre trials which last a significant time, and involves thousands of patients
  • Double blind, randomised placebo controlled trials
  • Often determines efficacy compared to the “gold standard” treatment
  • Response to medication can be monitored, and stopped if unexpected side effects are evident, or if it is clear the test drug is providing significant benefits versus other cells
  • Two large phase 3 are required to support registration. If successful, the phase 3 clinical trial results will be incorporated into a dossier to the regulatory authorities.

Dossier includes:

  • In vitro, pre-clinical and clinical data
  • Formulation and specifications
  • Stability
  • Manufacturing
  • Labelling and indications
  • SMPC (summary of medicinal product characteristics)
  • Quality
36
Q

What are the advantages of developing a brand?

A

Brand that gives a guarantee of quality. Takes a long time to create a brand but can be easily lost. Patent cliff doesn’t really happen with brands; people still ask for that brand. Patients often think generics won’t work as well compared to brand

Often shape and colour are trademarked

37
Q

What is the general specification for a medicine to be OTC?

A
  • Good safety profile
  • Self-limiting conditioning historically
  • Symptomatic relief historically
  • Conditions that can be easily diagnosed
  • Acute usage
  • Not complex to manage
38
Q

How did nurofen create a good brand?

A

The idea of creating a brand e.g. Nurofen now have many branches for different indications- however need to be careful if they have the same ingredients but different indications, need to charge same price

If there are different indications for nurofen, there will be more shelf space and stores are willing to give such a well known brand the space

Experimented with different combinations e.g. adding codeine, decongestant and salt forms e.g. lysine to work better and different formulations e.g. gel, liquid, patches

39
Q

Why did diclofenac and domperidone switch back to POM ?

A

QT prolongation risk

40
Q

What is the main difference when thinking about making a cosmetic vs a medicine?

A

Cosmetics need to be aesthetically pleasing, however for medicinal products, people will be more likely to use them if they are not aesthetically pleasing because they want to treat their condition

e.g. steroid creams for psioriasis are greasy and thick however people want their condition to be cured VS cosmetic skin cream- people have the choice and it is optional, therefore cosmetics focus more on aesthetics

41
Q

What is the definition of a cosmetic?

A

Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body for any part for cleansing, beautifying, promoting atrractiveness or altering the appearance

Substance/preparation intended to come in contact with the various suface areas of the body or with the teeth or buccal mucosae solely for cleansing, perfuming or protective purpose in order to modify their appearance and/or to improve body odour, and protect or maintain them in good condition

42
Q

What ingredients are used in a toothpaste to make it a semi-solid?

A

Carrageenan

Thickening silicas - can get small, sharp hard ones that are quite abrasive or big and fluffy ones

Xanthan

43
Q

What ingredient is used in toothpaste for sensitive teeth?

A

5% potassium nitrate as it numbs the nerve

44
Q

What is the role of SLS in toothpastes?

A

Foaming

and is a preserving agent against microbes

45
Q

What is the relative dentine abrasion for every day toothpastes?

A

70

46
Q

What is the relative dentine abrasion for whitening toothpastes compared to sensodyne true white?

A

150-250 vs 15

47
Q

How can you deliver fluoride in toothpastes?

A

Sodium monofluorophosphate – cheap one using chalk

Stannous (tin) fluoride à loses electrons to product stannic

Sodium fluoride – most active form so this was chosen for True White

Amine fluoride

48
Q

Why isn’t red a good colour for toothpaste?

A

Looks like they are spitting out blood

49
Q

What is the opacifier used in toothpaste

A

Titanium dioxide makes it white

50
Q

What is used in toothpastes to stop it from drying out?

A

Humectants e.g. PEG with lots of polar groups to attract water

51
Q

Toothpaste is not a sterile product but certain organisms need to be prohibited. True or false?

A

True

52
Q

What are the requirements for product claims?

A
  • Must be truthful and not misleading
  • Motivating for the customer
  • Often based upon clinical data
  • Meets guidelines of company and regulator and can be challenged by competitors and the regulator
  • Should the claim be on the pack?
  • Bear in mind the product classification- cosmetic, medical device, medicine etc.
  • Useful having the data to back this up (even though you don’t submit it) just in case another company challenges you
  • Different having claims on packaging vs advertising – if you need to take back a certain claim, with advertising you can just remove the advert/TV/Poster but with packaging you would have to recall all the products

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