The USP 800 Guidelines have made the compounding of liquid formulations of NIOSH list medications more cumbersome and costly. Many institutions have updated facilities, revised standard operating procedures, and trained staff at much expense in order to continue to offer this service to their patients. For some, the high costs of the upgrades have led to contracting out or stopping hazardous compounding services.
After extensive design, engineering, and research, Patients’ and Consumers’ Pharma introduced the QuartetRx Compounding System, an automated process for compounding tablets, capsules, and bulk pharmaceutical ingredients into liquid formulations. The engineering controls of the technology are designed to keep the compounder safe from unanticipated exposure to hazardous medications.
The patented QuartetRx system features a specialized bottle along with a small bench-top milling unit. The bottle compounds, stores and dispenses the formula. In other words, the QuartetRx compounding system is completely self-contained. The technology allows for the following efficiency and safety benefits when compounding hazardous medication formulas:
- Whole capsules (e.g. tacrolimus and hydroxyurea), tablets and pharmaceutical powders are used. Therefore, the need to manually open capsules and/or transfer hazardous medications during and post compounding from one container to another is eliminated.
- Compounding inside the closed bottle eliminates exposure of the compounder to hazardous medications. The closed system eliminates aerosolization of hazardous medications.
- The single-use bottle eliminates concerns of cross-contamination for patients. As the bottle is designed to compound, store, and dispense, the risk of exposing patients to residue from past compounded hazardous compounds is eliminated.
Data presented at the 2017 and 2019 ASHP Midyear Clinical Meetings demonstrate the ability of QuartetRx to deliver on these efficiency and safety benefits when compounding hazardous medications.
- A poster entitled, “Using Automation to Eliminate Exposure to Aerosolized Powders During the Compounding of Oral Liquids”, presented data that showed the elimination of the aerosolization of powders when using the QuartetRx technology using a worst case analysis.
- A poster entitled, “Compounding of oral liquid formulas of two hazardous drugs, tacrolimus 1 mg/mL and hydroxyurea 100 mg/mL, using unopened capsules and a safe self-contained technology” coupled with data from the University of Wisconsin Zeeh Pharmaceutical Experimental Station demonstrate the ability of QuartetRx to compound stable formulations of hazardous medications using whole capsules and tablets.
The data confirm the QuartetRx system as a cost-efficient, safe, and technically viable alternative to the traditional procedures used to compound hazardous medications while protecting pharmacy staff.
The following hazardous medications have been compounded with the QuartetRx system:
- Tacrolimus (from whole capsules)
- Hydroxyurea (from whole capsules)
- Methotrexate (from tablets)
- 6-Mercaptopurine (from tablets)
- Topiramate (from tablets)
- Spironolactone (from tablets)
- Azathioprine (from tablets)
QuartetRx®: The Technology
QuartetRx is a closed, automated system featuring a small bench-top milling unit, a specialized container with a designed internal abrasive surface, and sachets of flavored excipients for the MaestroRx ® formulas.
The QuartetRx employs physical forces to provide efficient wet milling. The system can simultaneously compound up to four formulas. The technology is based on the principle of a colloid mill and was developed using reverse engineering and miniaturization principles.
The entire compounding process takes place within the specialized bottle. Tablets, capsules or pharmaceutical powders are placed in the bottle with an appropriate diluent. The capped bottle is placed in the milling unit and spun at a high RPM using a planetary motion. The wet milling process produces formulas with fine, uniform and rounded particles that resuspend well and yield accurate dose uniformity.
A comparison of native Rifampin particles originating from capsules relative to those from manual trituration and wet milling with the QuartetRx system is depicted to the left.
The QuartetRx system can be used to compound formulations using multiple diluents, with water being the most efficient in terms of energy transfer for wet milling. The MaestroRx formulary (specifically designed to be utilized with QuartetRx) employs water and flavored sachets of excipients. The excipients contain ingredients that allow for appropriate viscosity, pH, stability, and taste. They were developed using flavor science to match medication tastes and patient needs with a specific corresponding flavor to optimize taste masking. The excipients are dye, gluten and sugar free and include the following natural and artificial flavorings: Peppermint, Pediatric Orange Vanilla, Chocolate Caramel & More. and Aromatic Bananas Foster. Other ingredients specifically include: a) Mannitol USP – bulking agent; b) Corn-based Starch – viscosity enhancer; c) Sodium Methyl and Propyl Parabens NF – preservatives; d) Citric Acid USP – pH Adjuster; and e) Sucralose NF – Sweetener.
Specific compounding instructions must be developed for formulations outside of MaestroRx.