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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
widely accepted theory of the antiperspirant action	1 Soluble antiperspirant active ingredient diffuses into the sweat duct 2 slow neutralization of the acidic metal salt 3 produces a gelatinous and insoluble polymeric aluminium hydroxide-protein gel 4 partial obstruction of orifice of the sweat gland, reducing flow of axillary persipiration
USP XXIII has established 28 official monographs covering antiperspirant actives. Some of the actives included are:	1. Aluminum Chlorohydrate 2. Aluminum Chlorohydrate Solution 3. Aluminum Sesquichlorohydrate 4. Aluminum Chlorohydrex PG 5. Aluminum Zirconium Trichlorohydrate 6. Aluminum Zirconium Trichlorohydrex GIy 7. Aluminum Zirconium Tetrachlorohydrate 8. Aluminum Zirconium Tetrachlorohydrex GIy 9. Aluminum Zirconium Tetrachlorohydrex GIy Solution 10. Aluminum Zirconium Pentachlorohydrate
was issued by the FDA in August 1982 lists allowed active ingredients, labelling claims, minimum effectiveness requirements, and warning statements.	Tentative Final Monograph (TFM) for Antiperspirant Drug Products
The Monograph allows the use of these at levels: 1 aluminium chlorohydrates at __ percent 2 aluminium zirconium chlorohydrates at __ percent	. 1) 25% 2) 20%
are NOT permitted in aerosol forms because of a possible inhalation risk.	aluminium zirconium chlorohydrates a third more effective than aluminium chlorohydrate
aluminium zirconium chloride hydroxide glycine complexes MAXIMUM AUTHORIZED CONCENTRATION in the finished cosmetic product 1 as anhydrous aluminium zirconium chloride hydroxide 2 as zirconium	. 1) 20% 2) 5.4%
The Monograph states that in order for an antiperspirant to be labelled as such it must meet a minimum of	20% sweat reduction in at least 50% of the test population
1 test where perspiration is stimulated by high levels of heat and humidity. 2 The basic protocol indicates that gravimetric measurement of axillary perspiration rates be conducted in a hot room at (temp & humidity)	1 hot room study or antiperspirant effectiveness study 2) 1000F (37.5°C), 35% relative humidity
Roll-ons and solids based on __ provide a 25-40% increase in perspiration reduction compared to similar ACH-based formulations.	20% AZCH aluminium zirconium chlorohydrates
1 Even higher levels of efficacy can be achieved with activated AZCH in __ form. Sweat reduction levels of 50-60% can now be achieved. 2 In the case of the aerosol, the original powder-in-oil suspension reduces perspiration by __%	1 powder 2) 20-30%
CLAIMS AND JUSTIFICATION Claims are normally grouped into one of the following categories	1 PERFORMANCE 2 MILDNESS 3 FEEL 4 ONSET
If such claims as 'UNBEATABLE WETNESS PROTECTION', 'MOST EFFECTIVE FORMULA', 'NONE BETTER' and 'MAXIMUM PERFORMANCE' are used, they must now be supported by HOT ROOM EFFICACY TRIALS of the total formulation.	PERFORMANCE
The claim of '24 hour protection' is made for products which use active ingredients at levels recommended in the Monograph. similar claims such as 'ALL-DAY PROTECTION', 'DAY-LONG FRESHNESS', 'WORKS ALL DAY', 'KEEPS YOU FRESH ALL DAY' can also be justified.	Performance - duration
Non-specific claims are usually justified by the exclusion of known irritants such as alcohol, the careful selection of non-irritant perfumes, and the inclusion of emollients or other known skin-friendly ingredients. One claim in this area is 'pH BALANCED', which may reassure the customer but has no scientific basis since all stable formulations are pH balanced	Mildness
Alcohol is a primary irritant and is the source of the stinging sensation. Excluding alcohol from the formulation will reduce the level of stinging. The addition of emollients or aloe, allantoin, etc., will also help to reduce any stinging sensation	Feel
This claim revolves around statements such as 'works when you need it most', 'body responsive', 'heat activated'. These claims centre around the fact that antiperspirant actives are inert in dry form and react with perspiration only when they are dissolved by it.	Onset
1 a primary irritant and is the source of the stinging sensation. 2 The addition of __., will also help to reduce any stinging sensation. 3 a function of formulation and drying time.	1 Alcohol 2 emollients or aloe, allantoin, etc 3 Stickiness
1 In quick-dry formulations, __accelerate drying so it is almost instantaneous. 2 Are at the other extreme of slow drying, and DO NOT go through a sticky stage 3 are truly NON-STICKY. the active goes on dry - aerosols, solid sticks, soft solid suspensions	1 alcohol and volatile silicones 2 Oil-in-water or water-in-oil emulsions 3 Anhydrous formulations