Immediate release abuse deterrent liquid fill dosage form
Inventors
Thompson, Edwin R. • Thompson, Eric R. • Myslinski, Nicholas R. • Kemeny, Steven F. • Hart, Matthew N.
Assignees
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Publication Number
US-9707184-B2
Publication Date
2017-07-18
Expiration Date
Abstract
The present disclosure relates to an oral, immediate release, abuse deterrent liquid filled capsule containing polyethylene glycol and at least one active pharmaceutical ingredient susceptible to abuse. The dosage form is abuse deterrent to parenteral administration. The present disclosure also relates to processes of preparing the dosage form.
Core Innovation
The invention relates to an immediate release, abuse deterrent capsule comprising an active substance susceptible to abuse, a first polyethylene glycol (PEG) having an average molecular weight of 35,000 Daltons, and a second PEG having an average molecular weight of 3350 Daltons, where the ratio of the first PEG to the second PEG is less than about 1:4 w/w. The disclosure further describes oral immediate-release abuse-deterrent liquid-fill capsules formed using two PEG excipients with specified molecular weights.
The disclosed capsule is described as providing resistance to non-oral abuse by resisting grinding to below about 500 bcm particles. It also is described as reducing alcohol/water extraction purity by forming extracted residue having an abuse deterrent purity of at least about 50%. The disclosure additionally describes visual deterrence by including a grey dye blend.
A disclosed grey dye blend includes FD&C Blue #1, FD&C Yellow #6, and FD&C Red #40. The disclosure further describes that mixing/melting PEG yields immediate drug release while the described PEG composition supports abuse deterrence characteristics for intranasal and intravenous abuse routes.
Claims Coverage
The partial content identifies two independent claims. Each independent claim centers on a specific PEG excipient molecular-weight pairing with a first PEG to second PEG weight ratio less than about 1:4 w/w, applied either to the capsule composition or to a production process.
Immediate release abuse deterrent capsule with specific PEG molecular weights and ratio
An immediate release, abuse deterrent capsule comprising an active substance susceptible to abuse, a first polyethylene glycol (PEG) having an average molecular weight of 35,000 Daltons, and a second PEG having an average molecular weight of 3350 Daltons, wherein the ratio of the first PEG to the second PEG is less than about 1:4 w/w.
Production of an immediate release abuse deterrent capsule by forming a homogenized suspension and filling
A process for the production of an immediate release, abuse deterrent capsule comprising at least one active substance susceptible to abuse, comprising preparing a homogenized suspension of the at least one active substance susceptible to abuse, a first PEG having an average molecular weight of 35,000 Daltons, and a second PEG having an average molecular weight of 3350 Daltons, and filling the homogenized suspension into a capsule body to produce the capsule, wherein the ratio of the first PEG to the second PEG is less than about 1:4 w/w.
Across both independent claims, the main inventive concept is the combination of an abuse-susceptible active substance with two PEG excipients of specified average molecular weights, arranged so that the first PEG to second PEG weight ratio is less than about 1:4 w/w, implemented either as a capsule formulation or via a process that prepares a homogenized suspension and fills it into a capsule body.
Stated Advantages
Resisting non-oral abuse by resisting grinding to below about 500 bcm particles.
Reducing alcohol/water extraction purity by forming extracted residue with abuse deterrent purity of at least about 50%.
Providing visual deterrence using a grey dye blend including FD&C Blue #1, FD&C Yellow #6, and FD&C Red #40.
Enabling immediate drug release while supporting abuse deterrent characteristics.
Documented Applications
Treating pain by administering the capsule.
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