Abuse resistant capsule
AssigneeR.P. Scherer Technologies, LLC
InventorSimone Wengner
Life of this patent
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Abstract
The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquillizers, stimulants and narcotics.
Claims10
An immediate release parenteral abuse resistant capsule comprising a parenteral abuse resistant liquid and a shell, the parenteral abuse resistant liquid comprising:
- (a) an abuse-susceptible active pharmaceutical ingredient which is at least one stimulant;
- (b) 2 to 5 wt. % xanthan gum;
- (c) polysorbate 80 and optionally sorbitan monolaurate;
- (d) 10 to 70 wt. % medium chain triglycerides;
- and
- (e) 1 to 5 wt. % colloidal anhydrous silica;
- wherein the wt. % values are based on the total weight of the parenteral abuse resistant liquid;
- such that a mixture of about 250 to about 1000 milligrams of the abuse resistant liquid with 5 milliliters of water at the mixture's boiling point forms a viscous phase, wherein about 33% or less of the pharmaceutically active ingredient can be recovered from the viscous phase drawn up into a 25 millimeter needle having an inner diameter of 0.60 millimeters,
- wherein the capsule releases more than 80% of the active pharmaceutical ingredient within the gastrointestinal tract within 30 minutes of administration.
Dependencies are inferred from the claim text.