Our 325,000ft² facility can manufacture up to 3 billion units. We supply oral pharmaceuticals to the U.S. market using our expertise in controlled release granules, serialization, blister and bottle packaging, powder packaging in stick packs, fluid bed operations, solvent processing, DEA controlled substances, high potency active ingredients and nanoparticle milling.
CAT.one IN VITRO ABUSE-DETERRENT TESTING
Whether it is an exploratory study to assess the abuse-deterrent properties of your compound or a full battery of tests for an NDA or ANDA abuse-deterrent product submission, Frontida BioPharm’s scientists have the knowledge and expertise to fulfill all your Category 1 needs.
API ASSAY QUALIFICATION / VALIDATION
Using state-of-the-art instruments, Frontida BioPharm conducts robust assay validation designed to provide confidence in the analysis of active pharmaceutical ingredient (API) recoveries in all downstream CAT.one experiments.
The first step for a drug abuser is to manipulate a dosage form using various tools such as grinders, hammers, knives, etc. This is to reduce the tablet or capsule into a form that can be used via sniffing, injection, dose dumping with alcohol, smoking or purification of the API. Frontida BioPharm scientists incorporate techniques from both novice and experienced abusers.
LARGE VOLUME EXTRACTION
Abusers will use readily available solvents to extract the API from the matrix materials. Frontida BioPharm uses a variety of organic and inorganic solvents as well as various conditions and pretreatment methods to assess the resistance to extraction techniques.
Extracting the API in small volumes of solvents suitable for injection is a common and dangerous method of abuse. CAT.one studies assess the ability to draw into and expel out of syringes with various needle gauges. Scientists also determine the API content in the drawn volume and measure the viscosity down to <1ml.
SMOKING and VAPING
Heating a drug product to release and inhale the API is another common method of abuse. Using a proprietary apparatus that simulates smoking, our scientists can assess the amount of API released after heating and vaporization.
Abusers chew tablets and capsules to quickly release the API. We use an apparatus—one of only a few available in the world—that simulates human mastication so that our scientists can assess API release of chewed tablets over various time points.
ISOLATION AND PURIFICATION OF API
Sophisticated abusers will use advanced methods to isolate and purify the API after extraction. Our scientists use these same techniques to assess the difficulty and success of using these methods.
DATA AND REPORTS
Frontida BioPharm understands that comprehensive and precise reporting is essential for a successful CAT.one study. We provide you with a complete dataset and quality-assured (QA’d) report. The report will include a detailed description of analytical methods, used along with observations and conclusions from each study conducted. The data we provide can be used and has been acceptable to the FDA for regulatory filings.
DISCUSS YOUR REQUIREMENTS
Frontida is a contract development and manufacturing organization that works collaboratively with clients to bring products to the pharmaceutical market. We offer formulation, analytical method development and validation, process development, commercial manufacturing packaging and more.
We strive to improve the pharmaceutical and biotechnology industries by working with scientists who are dedicated to coming up with the best solutions for clients and patients. Our team is also extensively experienced in the development and manufacturing of oral dosage forms, including tablets and capsules.