As we approach the finish line, we are focusing on the accuracy of the TICKER® X PEN. Specifically, we are examining each click and assessing the dosage-per-click. Below, you'll find preliminary accuracy data obtained by a pharmacy technician using PCCA's Lipoderm base.
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Preliminary Accuracy Data with Lipoderm®
Data obtained from an accuracy study using the TICKER® PEN dispenser showed the following:
Median = 0.051g
Average = 0.05g
Standard Deviation = 0.005g
Sample Size (N) = 35
The data was collected on 7/18/24 following the detailed methodology outlined in the materials and methods section below. This preliminary information marks the beginning of a comprehensive data collection effort aimed at developing robust accuracy data sets. Future data collections will cover a broader range of bases with varying viscosities sourced from multiple compounding wholesalers, including Fagron, PCCA, Xenex Labs, and more. Additionally, we will gather data from mixtures containing several types of transdermal drugs like, methimazole, fluoxetine, progesterone, and testosterone. Furthermore, upcoming data collections will also include TICKER® PEN from the 3rd Article of Inspection, incorporating minor tooling changes designed to improve accuracy and enhance the user-friendliness of the novel metered dispenser.
Materials and Methods
The data above was collected in a USP-800 HD room using the following equipment and materials:
OHAUS® Adventurer Pro digital scale
Centrimix® 8S Planetary Mixer
PCCA's Lipoderm® base (Lot# 9539282)
Ticker® Pen (Lot# 162524 from the 2nd article of inspection)
Other items as described below
A pharmacy technician was instructed to fill a TICKER® PEN dispenser with 15 grams of Lipoderm base and cap the unit with a dispenser lid to contain the base inside the chamber. The capped TICKER-X chamber-complex was then placed inside a two-part TICKER PEN adapter and subsequently placed in the centrifugal planetary mixer to deair, running for one minute at 2000 RPM. After spinning, the chamber and piston were examined for any signs of leakage from the upper chamber.
Next, the unit was partially primed from the bottom of the chamber using a thin rod to expel air until the base began to emerge from the outlet of the dispenser lid. A drug indicator was placed inside the lower chamber of the TICKER PEN to differentiate it from other containers. A rotator-base complex was attached to the lower end of the chamber, thus metering the unit. The unit was rotated for a total of five clicks to expel additional base or possible air pockets. The tip of the dispenser lid was cleaned using a Kleenex tissue until no visible base remained.
The OHAUS digital scale was sanitized and allowed to air dry for two minutes before taking the first measurement. For the first measurement, the TICKER PEN was placed on the center area of the digital scale's load cell plate. The unit was tared, zeroed, and removed from the plate. One click was dialed by turning the rotator-base to the right, allowing the base to exit through the outlet. Fifteen seconds later, the expelled base that collected at the tip of the applicator was cleaned with a Kleenex tissue in a single wipe, ensuring no Lipoderm base residue was left behind. The TICKER PEN dispenser was then placed back on the digital scale, and the weight difference was recorded as a positive number. The scale was tared and zeroed again, and the process was repeated for a total of 35 entries. The TICKER PEN was examined carefully after the conclusion of the test for signs of leakage or other discrepancies, as is standard for any dispenser or container assessed for data collection.
Other materials used included:
Kleenex scent-free tissue
HD Gloves and personal PPE per company policies
Stopwatch
Notepads and pens
Isopropyl alcohol
Learn more about the TICKER® PEN here.
Why TICKER PEN?
Dr. Moses, the visionary behind TICKERWORKS Inc., received feedback from numerous pharmacists and veterinarians who were dissatisfied with the current options for transdermal dispensers. They expressed concerns about the high cost of existing pet dispensers, the difficulty of working with micro pens, the excessive time required to fill each container, and the overall bulkiness of the devices, particularly the 9mL size. In response to these issues, Dr. Moses decided to take action, leading to the creation of the TICKER PEN