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Consumer Healthcare Flashcards

1
Q

Define a drug [ FDA]

A

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

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2
Q

Outline the drug discovery process.

A
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3
Q

XO Read the answer here and re-write what you remember

A
  1. Pharmaceutical companies evaluate the future direction and R&D activities on the basis of medical needs, market size, government policies and regulations, patent protection, and key competencies.
  2. Most diseases, apart from trauma and infections, have origins in the genes or the proteins associated with them, as well as the biochemical pathways and networks.
  3. Current approach to drug discovery starts with the identification of target or targets that cause or lead to disease.
  4. Microarray is a technology used to study gene interactions and control of biochemical pathways.
  5. Target validation is necessary to confirm the validity of a target as a representative of a disease model before too much investment and time is expended on it.
  6. Once targets are validated, potential drug candidates are designed to bind to and interact with these targets.
  7. The main drug targets are enzymes and receptors that are found on the cell surface or reside within the intracellular matrix.
  8. Drugs interact with enzymes and receptors mainly through van der Waals forces and hydrogen bonding; they need the correct shapes and sizes to fit into the active sites of the targets.
  9. Drugs work in two ways: as agonists and antagonists. Agonists activate the receptors whereas antagonists deactivate, block, or inhibit the receptors.
  10. After binding of drug and receptor, a cascade of signal transductions occurs
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4
Q

Give detail difference between rational and irrational drug discovery approach?

A

Irrational approach involves the collection of natural products that have sufficient biodiversity with different and diverse chemical compositions so that many potential variations of chemical compositions and structures can be extracted for testing. The next step is the screening of thousand of these compounds to find lead compounds or potential drug molecules that bind with the receptor and modulate disease pathways. The compound libraries are screened and this can be done using HTS or ultra-HTS. Following the ‘hits’ lead compounds are purified using chromatographic techniques and their chemical composition are identified via spectroscopic and chemical means (X-ray crystallography and NMR).

Whereas rational approach involves drug discovery based on knowledge of the 3D structure and the amino acid of the chosen receptor that would reveal potential binding sites for drug molecules. Structural activity relationship could be developed and the pharmacophore elucidated. The standard technique for 3D structural determination involves X-ray crystallography and NMR spectroscopy. Computational chemistry (in silico) methods and mining through bioinformatics is another means. Once modelled drug is elucidated it can be synthesised using combinatorial chemistry and screened against HTS system.

Both approaches end up undergoing Drug Metabolism and Pharmacokinetic studies to optimise the lead compound.

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5
Q

Give an example of drug developed from irrational approach?

A

Enalapril from venom of south American snake.

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6
Q

What is HTS

A

Robotic system that delivers accurate and fast liquid samples into miniaturised well plate (384-/ 1536-) that has the assay reagent in so that the screened compound show signal if it binds with desired drug target.

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7
Q

Explain how computational chemistry works and what rule can be used to better increase selectivity of good lead compounds.

A

Lipinski’s rule states that, in general, an orally active drug has no more than one violation of the following criteria: No more than 5 hydrogen bond donors (the total number
of nitrogen–hydrogen and oxygen–hydrogen bonds), No more than 10 hydrogen bond acceptors (all nitrogen or oxygen atoms), A molecular mass less than 500 daltons, An octanol-water partition coefficient log P not greater than 5.
Using this rule a ligand library can be developed and computational docking, ranking or screening of the compound can be conducted.

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8
Q

What is combinatorial chemistry?

A

Combinatorial Chemistry generates a multitude of chemically related(”congeneric”) compounds, so-called combinatorial libraries.

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9
Q

How does a combinatorial chemistry work: Solid phase synthesis…

A

Resin is the bead at the end of the reaction that will be ‘washed off’, It is an insoluble polymeric inert support that can swell in excess reagent and removed in purification step. Linker/anchor: covalently bound to the resin and it has the starting material attached to the other end. Linker is detachable from starting material. For example amines and this can be then reacted with carboxylic acid which produces amide. Unreacted carboxylate us removed and then amides are released from solid support using UV light for example.

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10
Q

What is established in the pre-clinical testing?

A

Pharmacokinetics, Pharmacodynamics and toxicology testing is carried out and it is data submitted to the regulatory agency.

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11
Q

Give an example of pre-clinical testing in vitro, in vivo and toxicology testing….

A

In vitro test to assess drug metabolic stability is liver microsomal stability assay with NADPH to assess Phase I oxidations by CYP and FMO. High-throughput (HTP) assay provides clearance (mL/min/g liver). (Other examples on slide 55 MDD).

In vivo would be assessing the pharmacokinetic parameters in monkey to calculate volume distribution and the drug clearance.

Toxicology test involves carrying out acute testing, sub-chronic and chronic to establish the safety profile of the drug. Gross clinical signs of toxicity such as appearance, body weight changes in animals and gross pathology such as organ weight changes: hepatomegaly, enlargement of the spleen.

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12
Q

What does medicine development involve?

A

Formulation of the drug product, which includes active pharmaceutical ingredients and excipients, into a final form suitable to be administered to patients.
Study of drug delivery systems to improve the effective presentation of the drug to patients for enhancing certain characteristics and improving patient compliance.

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13
Q

Why are excipients added to the formulation?

A

Control the release of drug substance in the body
Improve the half-life of the drug substance (refer to Exhibit 4.9)
Improve the assimilation process and bioavailability
Enhance drug dissolution as disintegration promoters
Extend the stability and shelf-life of the drug as antioxidants or preservatives
Improve flow properties of the bulk powder.
Mask unpleasant taste of active ingredients.

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14
Q

Give examples of the use of excipients in oro-dispersible dosage form: improved disintegration?

A

Microcrystalline cellulose (MCC) is excipient used to improve disintegration profile of medicine.

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15
Q

Give examples of the use of excipients in oro-dispersible dosage form: lubricant?

A

Magnesium stearate will be added after granule formation as lubricant to prevent adherence to tablet press.

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16
Q

Give examples of the use of excipients in oro-dispersible dosage form: surfactant and taste-masking agent?

A

Polysorbates 80 is non-ionic surfactant added to function as a dispersing agent.
Cyclodextrin would function as a taste masking agent

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17
Q

Before clinical testing what must the regulatory agency be given?

A

Documents must be submitted through IRAS system containing the covering letter, manufacturing authorisation, investigation medicinal product dossier and final protocol in English.

The dossier contains pre-clinical testing information (if not provided in the investigator brochure).

Medicinal product must be manufactured to GMP standard.

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18
Q

What are the two checks the regulatory department do?

A

The regulatory agency have ethics committee, then also a review of the science involved in with the IMP. The ethics committee assess the studies rights, safety, dignity and well-being of research participants, whilst facilitating and promoting ethical research.

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19
Q

What is involved in Phase 1 study (recall, rewrite what you have just seen)…

A
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20
Q

What is involved in Phase 2 study (recall, rewrite what you have just seen)…

A
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21
Q

What is involved in Phase 3 study (recall, rewrite what you have just seen)…

A
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22
Q

What does SEQ stand for?

A

Safety Efficacy and Quality.

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23
Q

Usually Two large Phase III trial are required.
a. True
b. False

A

True

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24
Q

What is involved in Phase IV studies…

A
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25
What are the types of innovation seen in cosmetic and OTC medicine? Define each one.
26
Which one is this: a. Benefit visualisation b. Claims innovation c. Packaging innovation d. Repurposing of formulation e. Conventional ‘NPD’ f. Switch
a
27
Which one is this: a. Benefit visualisation b. Claims innovation c. Packaging innovation d. Repurposing of formulation e. Conventional ‘NPD’ f. Switch
a
28
Which one is this: a. Benefit visualisation b. Claims innovation c. Packaging innovation d. Repurposing of formulation e. Conventional ‘NPD’ f. Switch
c Voltarol no mess cap
29
Why is this a claims innovation and why is it successful in market?
New data about antiperspirant performance has been conducted in order to validate claims made for example the standard time and at what temperature does the antiperspirant provides protection. Success due to to consumers assuming that the longer the duration of antiperspirant action the better...
30
Testing protocol for antiperspirant
For efficacy: Gravimetric measurements of axillary sweat rate have been used to quantify antiperspirant efficacy, according to FDA guidelines 21 CFR 350.60. Absorbent pads have been used to collect sweat during the collection period. The test is conducted for 24 hr at 40 ° C.
31
What is difference between antiperspirant and deodorant
Deodorant is masking smell and test protocol would involve quantifying sweat odour intensity according to ASTM 1207-14 standard. Malodour intensity has been evaluated by indirect sniffing using a panel of 6 selected and trained sniffers. Whereas antiperspirant is acting to prevent sweat and it efficacy is assessed by the amount of sweat collected by pads.
32
Why can packaging innovation be beneficial in OTC and cosmetics?..
The packaging may meet consumer need for example Pandol purse like packaging allows for consumer to readily travel with it in purse or handbag making it advantageous compared to box of paracetamol tablets.
33
Give an example and explain repurposing a formulation ( what studies needed to be conducted)
The original Sensodyne formulation in Australia in 1960’s had strontium chloride in the formulation. The primary aim of the repurposing was to provide a formulation that provided instant relief. Studies were conducted to see if strontium chloride provided rapid relief in the new Sensodyne rapid relief formulation. Studies were conducted and measurements such as air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use was measured. The studies concluded that rapid relief was established after 60 seconds making it rapid relief formulation just by adding strontium chloride.
34
What are the disadvantages with conventional product development, give an example…
Disadvantage is a company can fall into stock keeping unit (SKU) proliferation where there is some many formulations of the said brand that leads to rising carrying costs due to slow-moving or dead stock. The price of manufacturing and productions runs increase. For example Covonia is an example of SKU proliferation where there is some many versions of chesty/dry/tickly cough aids that it may overwhelm the consumer. Since BronchoStop, a herbal cough remedy, entered into the market the sales of Covania fell because this market competitor is able to meet the consumer need which is one medicine to deal with all types of cough.
35
Which one is an example of switch innovation. a. Chloramphenicol b.Mometasone C. diclofenac sodium d. All the above
d
36
What is the potential downside of switch innovation…
There is no market exclusivity so other generics can compete with named brands.
37
Rewrite the table out
38
What is the drug discovery process for Consumer Healthcare Products. (12 steps)
39
Give a few sources of consumer insights.
40
What is the next step after consumer insight has been collected.
41
What is product concept ?
It has required inputs to the creation process: form, technology and benefit. The form is the physical item to be created. Technology is the source by which the form was attained, and benefit/need is what benefit to the consumer for which the consumer sees a need or desire (information can be attained from qualitative and quantitative data collection).
42
What is a product brief.
A short document that outlines all the requirements, goals, and specifications needed to build and launch a product.
43
What are the steps done to reach product brief.
44
What is contained in product brief?
45
What are factors that need to be considered in a product design.
46
Which on is regulated as cosmetic claim. a.Sensodyne is designed to relieve the pain of sensitive teeth. b. Sensodyne is designed to give relief from sensitive teeth.
b. Falls within cosmetic claim.
47
What is the cause of sensitive teeth?
Dentine hypersensitivity is thought to be caused by exposure of dentine to the trigger stimuli, which can be osmotic or thermal fluid. The fluid moves through tubules and stimulates pulp nerves resulting in short sharp pain. Gingival recession exposes the dentine resulting in increased exposure to stimuli.
48
CASE STUDY TIME: Sensodyne True white 1. What was the information was collected from consumers that provided insight on their needs? 2. What is deemed as a highly abrasive toothpaste?
1. Top priority of consumers: Consumers wanted white teeth but feared using whitening agents due to it high abrasive nature which they believed would worsen their already sensitive teeth. 2. Approved toothpaste that had relative dentine abrasion (RDA) 250-120 were deemed abrasive.
49
What is included in pre-formulation studies?
50
What is included in analytical method development?
51
What is included in analytical method development?
52
What is included in formulation development
53
What is a design space.
The  multidimensional  combination  and  interaction  of  input  variables  (e.g.,  material attributes) and process parameters that have been demonstrated to provide assurance of quality
54
What are the factors that affect the choice of packaging?...
55
What are the factors that affect the choice of packaging.
56
What is included in setting of specification?
57
What is required in product testing step?
58
What is a pivotal study?
A pivotal trial or pivotal study is a clinical trial or study that intends to provide the ultimate evidence and data to regulatory body (like phase III trial more assessing the efficacy of the claim).
59
What are the consideration required at the process development step?
Process development involves the scale up of the initial manufacture on lab-scale equipment (e.g. 5-10 kg) to be at 1/10th scale (tonnes). The considerations required when developing process is will the current manufacturing equipment able to carry out certain formulation processes and this is done to minimise the capital expenditure as much as possible. Another consideration is the handling and safety of the excipients: particulate dispersal and the seriousness of it for example it is on the skin or inhaled. For example, silicone when inhaled can cause silicosis.
60
Is stability testing required for cosmetics? A. YES B.NO
B
61
What are the conditions according to ICH that consumer healthcare products need to be conducted at?
62
Scale up, manufacture and launch stage: For cosmetics, no approval from the regulatory authorities is required A. True B. False
True No dossier is required unlike in drug discovery of NME
63
Scale up, manufacture and launch stage: For monographed medicines no prior approval is required as long as within the monograph. A. True B. False
A
64
For solid dosage form what would the setting specification be?
For a solid dosage form (for example), would typically include active level, degradants, friability, dissolution, content uniformity, appearance, tablet hardness etc. Some of these parameters stipulated by regulatory authorities (e.g. active assay 95-105% of target).
65
For OTC product what would determine the setting specification?
Dictated by monographs (EP,ESP)
66
What sensory testing would be conducted during the product testing stage for cream?
Specialist panel can rate the product wetness, spreadability, stickiness and slipperiness etc at rub-out.Then the product rating by the panel between two products can be statistically measured using ANOVA. Reference: https://allcivilstandard.com/wp-content/uploads/2019/02/E-1490.pdf
67
How can new OTC medicine be entered in the US?
The EU doesn’t have monograph system. For introduction of OTC medicine, without the need for new drug application form to be submitted, the OTC medicine must obey the set parameters in the US FDA monograph system.
68
How can new OTC medicine be entered the US?
The EU doesn’t have monograph system. For the introduction of OTC medicine, without the need for the new drug application form to be submitted, the OTC medicine must obey the set parameters in the US FDA monograph system.
69
Why are antiperspirant considered drug according to the FDA definition (USE MAO).
The FDA an antiperspirant is a drug because it can alter the ‘function of the body of man or other animals.’ Antiperspirants work by diffusing into the pores of the armpit suppressing eccrine sweating. It acts as antimicrobial because it abolished the growth of bacteria flourishing in the humid and warm microenvironment of the axillae and prevent the formation of the odoriferous substances generated from apocrine sweat by the action of bacteria. [ reference; https://link.springer.com/chapter/10.1007/978-3-642-57145-9_24]
70
What would the US antiperspirant monograph contain? Think of the 4 Whats…
71
What actives can be in antiperspirant ?
72
What a product has to do in order to be classified as a antiperspirant
– Test conditions are stipulated (100°F at 30-35% relative humidity) – 20% sweat weight reduction in at least 50% of the test population
73
What claims can be made for the product (and what claims can’t be made) Antiperspirant
Allows, for example, the use of ‘reduces’, ‘decreases’, and ‘lessens’ either ‘underarm perspiration’ or ‘underarm wetness’ Prohibits the use of ‘stop’, ‘check’, ’end’, or ‘eliminate’ Prohibits use of ‘complete protection’ or ‘completely guards your family’ Advertising (press, tv etc) has to comply with the usual standards, that it must be ‘truthful’ and ‘non-misleading’
74
What labelling there must be on the product
This labelling applies to all OTC medicines.
75
What is contained in the general EU cosmetics regulation: EU (…?..)
76
Definition of Sunscreen according to EU.
Defined as: ‘any preparation (such as creams, oils, gels, sprays) to be placed in contact with the human skin with a view to exclusively or mainly protecting it from UV radiation by absorbing, scattering, or reflecting radiation.
77
UVB/UVA consequences if not protected
UVB: greatest role in causing skin cancers. Penetrates deeper resulting in ROS. UVA: Photoaging
78
What does the EU 2006/647/EC recommend?
Sunscreens should protect against UVA and UVB radiation and UVA protection should be a minimum of 1/3rd of UVB protection.
79
What claims should not be made in sunscreens according to the the EU 2006/647/EC
A. 100% protection (e.g. labelling as ‘sunblock’ or providing ‘total protection’). B. No need to re-apply (e.g. ‘all day protection’).
80
What statements should be made on sunscreen according to the EU 2006/647/EC?
A. Do not stay too long in the sun, even while using a sunscreen product. B. ‘Keep babies and young children out of direct sunlight’
81
What MUST a sunscreen provide according to the EU 2006/647/EC?
MUST provide a sun protection of factor 6 or more under defined testing conditions: Definitions of low (6-14.9), medium (15-29.9), high (30-50), and very high (>50) protection
82
How many ingredients are permissible in the US monograph sunscreen
16
83
What ingredients have been added since 1999 to the US monograph for sunscreen? What grading system was used?
Introduced the requirement for the GRASE status (Generally safe and Effective). Only 2 of the compounds on 1999 monograph have GRASE status: zinc oxide and titanium dioxide
84
85
Why do you do accelerated testing. And what point do you do accelerated testing.
Accelerated testing is conducted in pre-formulation testing and cis conducted to determine the type of degradants products which may be found after long-term storage.
86
What is the concept behind pre-formulation.
For a drug to be successfully formulated we need to know the fundamental physical and chemical properties of the drug. Thus we need to gather information about the physical and chemical properties of the product in development.
87
At what stage is design space consider in conventional NPD.
Formulation and testing
88
At what stage is lab scale testing performed and at what stage is scale up of conventional NPD conducted.
Lab scale formulation and testing: performed in formulation and testing section Scale up: Process development.
89
At what stage is microbial robustness first considered.
Product design.
90
At what stage is release testing first considered in conventional NPD development.
Analytical method development.
91
Why is novelty of packaging considered in choice of packaging.
So there is a guarantee that a me-too can’t be made.
92
Why is ease of use in factory considered in choice of packaging.
Because you need to know if the lines can handle the packaging it will moving during manufacture.
93
What is the setting specifications stipulated for active assays.
95-105% of active target.
94
At what stage is SEQ considered in conventional NPD.
Setting of specification.
95
Why must current manufacturing equipment be considered during the process development phase.
Attempt to minimise capital expenditure as much as possible.
96
What claim is this: Product relieves pain from sensitive teeth.
Painkiller—> medicinal claim
97
What claim is this: Design to give relief from sensitive teeth.
Cosmetic claim.
98
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