hrticker topical applicator - accuracy study with humco base

SMART Metered Dose Applicator - Accuracy Study Innovaon Science Art S m a r t M D A ® Average 0.249 Median 0.249 SD 0.008 (N) 240 g All applicator units were filled with composion to the max; ~37g Accuracy and Precision Study Priming: 4g of composion expelled, (80 CLICKS). For this study, flowable transdermal composion 1 was transferred to the HRTicker™ applicator, packaged and labeled, then allowed to sele ovenight in order to eliminate air pockets. On the day of the study, each applicator unit was tapped for 30 seconds to further remove air pockets, and a visual test was conducted to confirm removal. Data Collecon: August 22-26, 2014 Volumetric Output Measured in weight as grams (g) Base Examined: Humco HRT Base (Heavy) Calibrated Balance Used: OHAUS® Adventurer Pro BIOSRX 5-CLICKS (90 Degrees rotation) A (g) B (g) C (g) D(g) 0.23 0.226 0.238 0.234 0.235 0.234 0.236 0.25 0.244 0.269 0.246 0.247 0.248 0.245 0.24 0.245 0.241 0.25 0.239 0.249 0.243 0.25 0.25 0.245 0.255 0.241 0.226 0.248 0.262 0.237 0.24 0.256 0.248 0.248 0.232 0.227 0.237 0.25 0.24 0.249 0.239 0.248 0.245 0.228 0.244 0.254 0.251 0.248 0.262 0.249 0.239 0.251 0.243 0.274 0.245 0.251 0.253 0.24 0.24 0.243 0.248 0.25 0.229 0.22 0.253 0.252 0.245 0.243 0.244 0.242 0.251 0.246 0.274 0.255 0.257 0.245 0.243 0.227 0.238 0.238 0.256 0.243 0.247 0.253 0.249 0.24 0.253 0.241 0.254 0.289 0.25 0.254 0.256 0.257 0.253 0.253 0.251 0.257 0.244 0.24 0.242 0.247 0.251 0.25 0.253 0.257 0.257 0.253 0.253 0.248 0.245 0.247 0.259 0.243 0.239 0.241 0.235 0.25 0.247 0.254 0.258 0.257 0.252 0.255 0.253 0.235 0.251 0.254 0.257 0.245 0.234 0.239 0.241 0.253 0.255 0.241 0.253 0.25 0.249 0.249 0.257 0.248 0.248 0.255 0.255 0.242 0.232 0.246 0.241 0.247 0.253 0.248 0.264 0.252 0.254 0.255 0.252 0.253 0.244 0.249 0.258 0.245 0.259 0.24 5 0.245 0.285 0.24 0.25 0.257 0.218 0.241 0.25 0.254 0.243 0.24 0.248 0.262 0.249 0.262 0.242 0.242 0.241 0.249 0.253 0.258 0.242 0.252 0.252 0.252 0.259 0.253 0.249 0.256 0.256 0.256 0.249 0.248 0.247 0.249 0.252 0.254 0.26 0.253 0.248 0.255 0.246 0.245 0.25 0.258 0.254 0.255 0.246 0.245 0.243 0.242 0.259 0.261 0.257 0.257 0.253 0.259 0.251 0.243 0.242 0.245 0.247 0.251 0.251 0.247 0.249 0.241 0.253 0.26 0.255 0.252 0.242 0.26 0.246 0.257 0.247 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 HRT HEAVY PROPERTIES pH 7.5 Specific Gravity 1.04 g/ml Viscosity 165,000 cps Physical Format Cream Color White Transdermal Penetraon 50% API Compability Lipophilic – 20% Typical Applicaons Male & Female Hormone Replacement

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Accuracy and precision study for the HRTicker Topical Applicator and the HUMCO HRT Base (Heavy)

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Page 1: HRTicker Topical Applicator - Accuracy Study with Humco Base

SMART Metered Dose Applicator - Accuracy Study

Innovation Science Art

S m a r t M D A®

Average 0.249Median 0.249SD 0.008(N) 240

All applicator units were filled with composition to the max; ~37g

Accuracy and Precision StudyPriming: 4g of composition expelled, (80 CLICKS).For this study, flowable transdermal composition1 was transferred

to the HRTicker™ applicator, packaged and labeled, then allowed to settle ovenight in order to eliminate air pockets. On the day of the study, each applicator unit was tapped for 30 seconds to further remove air pockets, and a visual test was conducted to confirm removal.

Data Collection: August 22-26, 2014

Volumetric Output Measured in weight as grams (g)Base Examined: Humco HRT Base (Heavy)

Calibrated Balance Used: OHAUS® Adventurer Pro

BIOSRX

5-CLICKS(90 Degrees rotation)

A (g) B (g) C (g) D(g)0.23 0.226 0.238 0.234

0.235 0.234 0.236 0.250.244 0.269 0.246 0.2470.248 0.245 0.24 0.2450.241 0.25 0.239 0.2490.243 0.25 0.25 0.2450.255 0.241 0.226 0.2480.262 0.237 0.24 0.2560.248 0.248 0.232 0.2270.237 0.25 0.24 0.2490.239 0.248 0.245 0.2280.244 0.254 0.251 0.2480.262 0.249 0.239 0.2510.243 0.274 0.245 0.2510.253 0.24 0.24 0.2430.248 0.25 0.229 0.220.253 0.252 0.245 0.2430.244 0.242 0.251 0.2460.274 0.255 0.257 0.2450.243 0.227 0.238 0.2380.256 0.243 0.247 0.2530.249 0.24 0.253 0.2410.254 0.289 0.25 0.2540.256 0.257 0.253 0.2530.251 0.257 0.244 0.240.242 0.247 0.251 0.250.253 0.257 0.257 0.2530.253 0.248 0.245 0.2470.259 0.243 0.239 0.2410.235 0.25 0.247 0.2540.258 0.257 0.252 0.2550.253 0.235 0.251 0.2540.257 0.245 0.234 0.2390.241 0.253 0.255 0.2410.253 0.25 0.249 0.2490.257 0.248 0.248 0.2550.255 0.242 0.232 0.2460.241 0.247 0.253 0.2480.264 0.252 0.254 0.2550.252 0.253 0.244 0.2490.258 0.245 0.259 0.2450.245 0.285 0.24 0.250.257 0.218 0.241 0.250.254 0.243 0.24 0.2480.262 0.249 0.262 0.2420.242 0.241 0.249 0.2530.258 0.242 0.252 0.2520.252 0.259 0.253 0.2490.256 0.256 0.256 0.2490.248 0.247 0.249 0.2520.254 0.26 0.253 0.2480.255 0.246 0.245 0.250.258 0.254 0.255 0.2460.245 0.243 0.242 0.2590.261 0.257 0.257 0.2530.259 0.251 0.243 0.2420.245 0.247 0.251 0.2510.247 0.249 0.241 0.253

0.26 0.255 0.252 0.2420.26 0.246 0.257 0.247

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HRT HEAVY PROPERTIESpH 7.5

Specific Gravity 1.04 g/mlViscosity 165,000 cps

Physical Format CreamColor White

Transdermal Penetration 50%API Compatibility Lipophilic – 20%

Typical Applications Male & Female Hormone Replacement

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