Anti-overingestion dosage forms
AssigneeBanner Lifie Sciences LLC
InventorsChue Hue Yang, Tatyana Dyakonov, Nashwa El-Gendy, Jason M Vaughn, Justin R Hughey
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Abstract
Described herein are abuse deterrent oral pharmaceutical compositions, methods for making the same, and methods of treatment using such compositions. In particular, oral pharmaceutical compositions that mitigate the risk of overingestion of one or more active pharmaceutical ingredients are described.
Claims20
An oral pharmaceutical composition comprising an immediately releasing dry admixture of an opioid agonist or a salt thereof and one or more strong cation exchange resins at a mass ratio of about 1:2 to about 1:8 and optionally, one or more pharmaceutically acceptable excipients,
- wherein less than about 1% of the opioid agonist is bound to the strong cation exchange resin prior to solvation;
- and
- after solvation of two more doses of the composition simultaneously or successively over about a 4-hour period, the strong cation exchange resin adsorbs about 15% to about 70% by mass of the opioid agonist and impedes its absorption into a subject's systemic circulation, lowering Cmax for the opioid agonist by about 30% to about 50% as compared to an equivalent dose of the opioid agonist lacking a strong cation exchange resin.
An oral pharmaceutical composition comprising an immediately releasing dry admixture of hydrocodone or a salt thereof and polystyrene sulfonate or a salt thereof in a mass ratio of about 1:2 to about 1:8, and optionally, one or more pharmaceutically acceptable excipients,
- wherein less than about 1% of the hydrocodone is bound to the polystyrene sulfonate prior to solvation, and
- after solvation of two more doses of the composition simultaneously or successively over about a 4-hour period, the polystyrene sulfonate adsorbs about 15% to about 70% by mass of the hydrocodone and impedes its absorption into a subject's systemic circulation, lowering Cmax for the opioid agonist by about 30% to about 50% as compared to an equivalent dose of the opioid agonist lacking polystyrene sulfonate.
Dependencies are inferred from the claim text.