Specialized analytical testing that minimizes the potential for abuse
Developing a new drug product with a high potential for abuse requires the development of specialized formulations that minimize the potential for non-medical use as well as requires rigorous testing prior to commercialization. In-vitro abuse-deterrent testing ensures that the drug products are evaluated for all potential routes of misuse. Adare’s experts integrate abuse-deterrent testing by replicating basic and multi-step methods that an abuser may use to prepare the product for recreational misuse or abuse. Our CAT.one laboratory scientists possess the expertise and knowledge of current FDA Guidance on the evaluation of abuse-deterrent and manipulation-resistant formulations, allowing us to efficiently handle all your category 1 in-vitro testing needs. Our in-vitro testing services include:
API ASSAY QUALIFICATION / VALIDATION
Using our state-of-the-art category 1 testing laboratory, Adare conducts robust assay qualification designed to provide confidence in the analysis of API recoveries in all downstream category 1 experiments.
PHYSICAL MANIPULATION & PARTICLE SIZE REDUCTION
To reduce the size of a solid oral formulation for abuse, drug users utilize a wide range of household tools as to cut, crush, grate, or grind the tablet into a powder. Recreational users often use knives, razor blades, coffee grinders, and hammers, or any other household tool that is available. After particle size reduction, an abuser may swallow, insufflate, inject, or smoke the powder to obtain rapid euphoria. Adare’s scientists utilize both simple and advanced methods of physical manipulation to characterize the manipulation resistant properties and characteristics of each formulation.
LARGE VOLUME EXTRACTION
Abusers will use readily available solvents to extract the API from the matrix materials. Adare uses a variety of organic and inorganic solvents as well as various conditions and pretreatment methods to assess resistance to common and advanced extraction techniques.
The capability of extracting the API in small volumes of solvents suitable for injection, otherwise known as syringeability, is a common and dangerous method of abuse. Category 1 testing assesses the ability to draw into and expel out of syringes with various needle gauges. Through injection studies, the API content in the expelled volume can be determined, and the solution’s viscosity can be assessed.
SMOKING and VAPING
Heating a drug/tab product to vaporize the API for inhalation is another common method of abuse. Using proprietary devices that simulate smoking or vaping, our scientists can assess the amount of API released after heating and vaporization.
Abusers chew tablets and capsules to quickly release the API. Adare simulates this practice by using a mechanical chewing device, which allows our scientists to assess the API release of chewed formulations over various time points.
ISOLATION AND PURIFICATION OF API
Skilled abusers will use advanced laboratory methods to isolate and purify the API from the formulation’s matrix components. Our scientists rigorously evaluate the methods, time, and effort required to effectively purify the API from a abuse-deterrent formulations.
DATA AND REPORTS
Adare understands that comprehensive and precise reporting is essential for successful category 1 testing. We provide you with a complete dataset and quality-assured reports. In addition, the reports include detailed descriptions of analytical methods along with observations and conclusions from each study. The data we provide can be used for a variety of purposes is acceptable to the FDA for regulatory filings. Abuse-deterrent testing meets and surpasses regulatory expectations, helping to get comprehensively evaluate novel for abuse potential and facilitate regulatory approval and commercialization.