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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.
Abuse-Deterrent Formulation Technologies

Capsugel Dosage Form Solutions offers abuse-deterrent formulation approaches based on our proprietary liquid-fill hard shell 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:

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 Dosage Form Solutions can provide any liquid-fill 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).

Additional Resources

Abuse Deterrent Technology

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