The ability to move quickly and cost-effectively from candidate selection to first-in-human clinical trials is a theme that comes up often from clients. One way which we strive to do this is through services offered from our compounding pharmacy in Miami, FL.
The compounding pharmacy is part of our clinical pharmacology services in Miami, FL, where we conduct Phase I trials with healthy volunteers.
In this article, learn about the capabilities of our Miami, FL on-site compounding pharmacy, and ideal uses for pharmacy compounding to accelerate FIH to POC trials.
What are the advantages of choosing pharmacy compounding for FIH trials?
Quotient Sciences simplifies the drug development supply chain, acting as a single partner with integrated project team and services. We can help through all stages of development.
At our Miami site, fit-for-purpose pharmacy preparation can be used to quickly start FIH trials. In this approach, a FIH trial using a simple and cost-effective dosage form, such as powder- in-capsule or bottle (also called PIC or PIB, or drug in capsule/bottle), solution or suspension, has the benefit of improving timelines to the clinic while still providing maximum dose flexibility to achieve Phase I objectives of obtaining PK and safety data.
Emerging clinical data within the FIH study itself can be used to inform formulation technologies (such as solubility enhancement) enabling selection of a technology and/or drug product to move forward with. This means that simultaneously, we can develop and manufacture solid oral drug product, like a tablet, for Phase 2 patient trials within the same program. This allows for POC patient trials to begin with immediate GMP clinical trial material supply.
The ability to manufacture and dose multiple formulation types in real-time, coupled with the ability to use smaller batch sizes and abbreviated data packages, ensures that we can carefully manage CMC investments and minimize API usage.
Are there certain programs that benefit from choosing pharmacy compounding?
We have used compounding for a range of drug candidates including small molecules, peptides, fusion proteins, and monoclonal antibodies. These have been across oral and intravenous dosage forms, and for a range of therapeutic areas.
As discussed, compounding delivers significant benefits for accelerating to FIH programs and when transitioning from FIH to POC. A simple drug in capsule or drug in bottle for reconstitution at bedside is the quickest route to clinic with compounding and dosing occurring within 24 hours.
Compounding is beneficial on any early clinical program where there is a desire to get data rapidly and keep dose flexibility throughout the trial. In addition to FIH single and multiple ascending dose (SAD/MAD) studies, pharmacy compounding has used in other study types, including:
- Absolute Bioavailability and Relative Bioavailability studies
- Drug Drug Interaction (DDI) studies
- TQT studies
- Food Effect and PK studies
- Studies in special populations (e.g. Elderly)
- Device trials
- Formulation screening studies
Sterile compounding with sterilization by aseptic filtration is another quick route to clinic as proof of concept especially for chronic indications such as HIV infections, CNS indications, oncology, viral infections, certain rare diseases, and metabolic conditions.
Another advantage of pharmacy compounding is its adaptability in dose-finding studies for combination therapies, where precise modulation of each active pharmaceutical ingredient (API) is essential. This approach is well suited to drug delivery systems requiring an initial burst release followed by sustained drug exposure. By systematically varying the proportions of immediate-release and modified-release components, the optimal formulation for therapeutic efficacy can be efficiently identified.
In molecules with limited stability, compounding allows for early assessment of their potential for further development.
For small molecules that have solubility and bioavailability challenges, we help clients select the right formulation technology for their poorly soluble molecules. We apply a data-driven process based on the physicochemical and biopharmaceutic properties of the API with a full range of solubility enhancement technologies including lipidic systems, micronization, spray drying, and hot melt extrusion.
Finally, the best formulation, with accompanying formulation technology, can be selected and a new solid oral dosage form manufactured, ready for packaging and shipment for patient trials.
When was the compounding pharmacy at Quotient Sciences – Miami last renovated?
In 2020, we upgraded the Miami compounding pharmacy to add more IP storage space, including refrigerated storage space at 2 to 8°C and freezer storage at -20°C.
Clean rooms in the facility were built to ISO Class 7 air quality standards with ISO Class 5 Primary Engineering Controls (PEC), which include laminar airflow workbenches (LAFWs) and biological safety cabinets (BSCs), allowing us to handle potent APIs and Hazardous investigational products
The laboratory space also expanded to support our new pharmacy and provide efficient processing of higher volumes of biological samples.
What dosage forms can be handled at Quotient Sciences – Miami?
Within the pharmacy and clinic, we can handle a variety of dosage forms including active pharmaceutical ingredients (APIs) or processed intermediates in oral solutions, suspensions, powder-in-capsule (PIC) or powder-in-bottle (PIB), and sterile preparations for parenteral delivery.
More about Quotient Sciences – Miami pharmacy compounding and clinical pharmacology
Learn more about our pharmacy compounding capabilities in our info sheet and see a preview of the Miami pharmacy in this video.