Consumer Healthcare Key Details Flashcards
What goes into the formulation for antiperspirant.
What is the code for where you would find details on what to include in antiperspirant.
Title 21 of U.S. Code of Federal regulations, concerning food and drugs.
According to the US monograph 350 subpart B section 350.10.
What is the requirement associated with the US monograph antiperspirants.
What anti-dandruff active can be used.
What is added to head n shoulder to give the sensation of the shampoo working.
Menthol
What claims can be made for anti-dandruff shampoo.
For the relief of’ or ‘Controls’. Can also use ‘fights’, ‘reduces’, ‘helps eliminate’, ‘helps stop’, ‘controls
recurrence of’, ‘helps prevent recurrence of’, and ‘helps eliminate recurrence of’.
– ‘The symptoms of’. Can also use ‘itching’, ‘irritation’, ‘redness’, ‘flaking’ and ‘scaliness associated with’. – ‘dandruff, sebborrheic dermatitis and/or psoriasis’
What labelling must be included with anti-dandruff shampoo.
Must include ‘For external use only’.
– Must include ‘Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water’.
– Must include ‘If condition worsens or does not improve after regular use of this product as directed,
consult a doctor’.
What are the requirements for sunscreen in US monograph (The 4 W’s)
What is the difference between cosmetics in US vs EU.
What are the requirements for sunscreen in US monograph (The 4 W’s)
What are the requirements for sunscreen in EU regulation
What are the two thickening agents that can be added to affect the rheology/viscosity of a toothpaste formulation.
Xanthan and Carrageenan.
How is pump ability of toothpaste measured.
Rheometer: where shear rate is a function of stress.
How is viscoelasticity and time dependence measured for toothpaste. (What a re the desired properties for toothpaste)
Thixotropy is where time is a function of phase angle. Slow thixotropic recovery in toothpaste can cause problems in manufacture if not accounted for as thousands of tubes of carefully designed packaging is no longer suitable for the rheology of the toothpaste it contains.
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.
Define extractable
Extractable is compounds that can be extracted from the closure container system (CCS) when in the presence of a solvent.
Define leachable
Leachables as compounds that leach into the drug product formulation from the container closure as a result of direct contact with the formulation.
What are the six main objectives packaging must meet.
- Containment determined by what the packaging holds.
- Security: special temper evidence/seals.
- Protection: strength and durability especially during transport and handling.
- Convenience: potability, display, opening, closing, usability or reusability, determine its position in the market.
- Information: consumer on what is a product, how to use it, when and how not to use it.
- Marketing: right visual language which connects intellectually and emotionally to the consumer with the product.
How is friability of solid dosage form assessed. Why is assessed.
Drum that rotates with a spin and the %weight is lost during mechanical shock is assessed. Important to assess how much weight is lost due to mechanical shock during the entire manufacturing, transportation and delivery. Or, it is performed to check the durability of tablets and mass loss of tablet powder through chipping.
What is the abrasive range for whitening product on the market?
RDA>150
What agent cleans the plaque of teeth and how does it work.
Sodium tripolyphosphate removes cross-linked Mg2+/Ca2+ from the tooth pellicle and does this gently.
What surfactants can be added to aid with lustrous foam formation.
Sodium dodecyl sulphate and cocamidopropyl betaine.
What were the claims of Sensodyne TRUE white.
Sensodyne TRUE white was x10 less abrasive than any whitening toothpaste.
Whitened your teeth prevent staining.
Provide sensitivity relief.
How was abrasively of Sensodyne true white measured? What were the findings?
By contact profilometry.
Statistical significance between TRUE white and the moderate/high abrasive toothpaste.
What test was conducted to determine whitening affect was achieved.
Whitening was determined by the amount of stained removed in comparison to the moderate and low abrasive toothpaste and true white it was still able to remove stains effectively.
How was fluoride delivered in Sensodyne TRUE white.
Achieved by adding sodium fluoride
What agent was added to provide anti-sensitivity effect.
Potassium nitrate (5%) added to desensitise the nerve.
What test was conducted to see if SENSODYNE TRUE white was still providing anti sensitivity effect. What were the findings.
Relative dentine hypersensitivity measured by evaporative air stimulus with visual analogue scale [VAS] in mm. In the TRUE white formulation there was no decreased efficacy seen with the addition of potassium nitrate with the other excipients. Anti-sensitivity effect was still able to be achieved.
◉ From 60 mm —>40mm over 8 weeks.
What is the accelerated testing conditions required to determine the stability of formulation.
40°C/75% RH according to ICH guidelines.
What is the code for the EU regulation on Sunscreen.
EU 2006/647/EC
How does the EU2006/647/EC define sunscreen as.
What was the product margin achieved with Sensodyne True White.
Who did it surpass in sales.
Surpassed repair and protect with a profit margin of over $19 million.
What is the name of the design patent for voltarol cap
Easy to open cap
What is the name of Sensodyne Pronamel cap
Easy to clean nozzle
what is European Cosmetic Regulation (EC) No 1223/2009.
the main regulatory framework for finished cosmetic products when placed on the EU market. It strengthens the safety of cosmetic products. [However it does not act in the same way the US monograph does]
In the product testing phase, what in vitro testing can be employed?
In the microbial testing, what tests can be carried out.
Challenge testing that assess the cosmetics ability to resist microbial development (for example, typically 28 days at 32.5°C.
What is the stability zone for UK vs Africa?
ICH Stability Zone 1: UK
ICH Stability Zone 4: Africa
What is the estimated number of potential (conventional) drug targets? Historically how many drug targets have we found?
Give an example of technology that can be used to aid target identification.
Cas9/CRISPR
In vitro assay in drug discovery
What are the 5 P’s GMP
good manufacturing practices which involve procedure, people, product, process, premises.
When comparing de novo drug discovery v cosmetics/OTC what part of drug discovery is NOT required in OTC/cosmetics
What was the whitening and surfactants used in Sensodyne true white
What was the RDA of STW
13
What was the format of STW.
Toothpaste
Was STW water based or non-aqueous.
Water-based: 70% water.
How was STW thickened to become semi-solid.
What was the colour STW and what opacifier was avoided.
Less white and little runny to get the feel of natural. Thus opacifier titanium dioxide was avoided.
What are flavours dictated by.
What humectants were added to STW.
What packaging was opted for with STW.
Virgin Board
Silver embossing
What must claims be.
What must one consider when making a claim.
One must bear in mind the classification of the product (cosmetic, medicine or medical device).
What microbes are not allowed in non-sterile cosmetic products.
What microbial test must be performed on cosmetics.
‘Preservative efficacy’ testing
What are the limitation of Before you Call Perez rethink, cut, and switch man innovation.
Benefit visualisation: may not be understood by consumer or expert if if the accurately visualised as intended.
Claim: Inaccurate/untruthful are subject to regulatory and competition scrutiny. If untrue or it is to a medical claim then regulators can force remove the product.
Packaging: The innovation may have decreased value as it is not what consumers need.
Conventional NPD: SKU proliferation resulting in deadstock, increase capital expenditure with the lines used in manufacture and loss in profit e.g. Covonia.
Switch: No market exclusivity, generics can also enter market too.
What are the limitation of Before you Call Perez rethink, cut, and switch man innovation.
Benefit visualisation: may not be understood by consumer or expert if if the accurately visualised as intended.
Claim: Inaccurate/untruthful are subject to regulatory and competition scrutiny. If untrue or it is to a medical claim then regulators can force remove the product.
Packaging: The innovation may have decreased value as it is not what consumers need.
Conventional NPD: SKU proliferation resulting in deadstock, increase capital expenditure with the lines used in manufacture and loss in profit e.g. Covonia.
Switch: No market exclusivity, generics can also enter market too.
