Abuse-Deterrent Formulation Technologies
Various controlled drug products such as opioids and morphine derivatives, antidepressants and stimulants are at risk of abuse by melting or solubilizing the product and directly injecting it, crushing and snorting it, or chemically extracting the active compound.
Capsugel offers abuse-deterrent formulation approaches based on our proprietary liquid-filled hard capsule technology to achieve the target release profile to be met while deterring the potential abuser from being able to extract the drug substance, due to the specific characteristics of the formulation. Excipients are chosen to provide the optimal deterrence to potential routes of abuse. Fill materials may be soft, hard, waxy, paste-like, water-insoluble or contain up to 40% suspended solids, which prevents powdering at room temperature and resistance to snorting.
The following approaches are used alone or in combination, depending on the particular compound:
- High-melting-point excipients - Resist heating and injecting
- Taste modifiers - Resist covert administration, snorting and dose dumping
- Water insolubles - Resist extraction and drink adulteration
- Waxy excipients - Resist snorting
- Viscosity modifiers - Resist dissolution, injection and dose dumping
- Low-density excipients - Resist drink adulteration
- Dyes - Resist adulteration
Capsugel abuse-deterrent approaches allow release profiles to provide immediate-, delayed- or controlled-release profiles. These profiles can be manipulated by selecting the appropriate excipients, capsule size and drug loading to provide an effective pharmaceutical product to the patient with built-in abuse-deterrent properties. Internal development work and current customer projects have demonstrated improved abuse deterrence compared with original formulations.
Capsugel can provide any liquid-filled hard capsule product from development through commercial scale from its manufacturing sites worldwide. These sites are accredited by the U.S. Food and Drug Administration (FDA) and Medicines and Healthcare Products Regulatory Agency (MHRA) and have controlled-substance licenses and high-containment handling capabilities in place (through OEB 5).