Tamper-proof narcotic delivery system
First Claim
1. A composition for administration to a subject, the composition comprised of three components that have independent pharmaceutical potential and action to provide unobstructed narcotic analgesic action to a legitimate subject with moderate to severe pain, when taken as written and prescribed and absolutely no analgesic or euphoric potential and action once subjected to tampering and adulteration to liberate and isolate the narcotic component, wherein the composition consists of:
- (a) an immediate or time released narcotic agonist component;
(b) a narcotic antagonist component comprising at least one antagonist, of comparable milligram and dosage potential of the agonist to negate any analgesic potential of the selected agonist, and to be sequestered and released, if and only if, the composition is subjected to tampering or adulteration; and
(c) an immediate acting antagonist removal component from a group consisting of pharmaceutical agents, botanical agents, and mixtures thereof, to ensure the elimination of the sequestered antagonist component from the gastrointestinal tract of the subject, combined in a combination for oral administration in a formula creating a tamper-proof narcotic delivery system only when subjected to tampering and adulteration;
wherein, the agonist having a narcotic effect is selected from and may be alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, benzitramide, bupernorphine, butorphanol, clonitazcene, codeine, cyclazocine, desomorphine, dextromoramide, dexocine, diampromide, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacyl morphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propiram, propoxyphene, sufentanil, tramadol, tilidine, salts thereof or mixtures thereof,wherein the antagonist component is selected from the narcotic antagonist group and consisting of naltrexone, nalmefene, and a mixture thereof,wherein the antagonist removal component methylnaltrexone.
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Accused Products
Abstract
A composition for oral, transdermal or subdermal administration to a subject is described. The composition contains: (a) an agonist component; (b) an antagonist component containing at least one antagonist and having a delayed time of release; and (c) an immediate release antagonist removal component, where the subject includes a gastrointestinal tract and the antagonist removal component is present in an amount sufficient to substantially remove the antagonist component from the gastrointestinal tract of the subject before the time of release of the antagonist component. The composition may be delivered to the subject by a method which includes the step of administering the composition orally, transdermally or subdermally to the subject. When the composition of the present invention is administered orally, the method of the present invention may include the step of administering a potassium compound to the subject.
113 Citations
19 Claims
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1. A composition for administration to a subject, the composition comprised of three components that have independent pharmaceutical potential and action to provide unobstructed narcotic analgesic action to a legitimate subject with moderate to severe pain, when taken as written and prescribed and absolutely no analgesic or euphoric potential and action once subjected to tampering and adulteration to liberate and isolate the narcotic component, wherein the composition consists of:
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(a) an immediate or time released narcotic agonist component; (b) a narcotic antagonist component comprising at least one antagonist, of comparable milligram and dosage potential of the agonist to negate any analgesic potential of the selected agonist, and to be sequestered and released, if and only if, the composition is subjected to tampering or adulteration; and (c) an immediate acting antagonist removal component from a group consisting of pharmaceutical agents, botanical agents, and mixtures thereof, to ensure the elimination of the sequestered antagonist component from the gastrointestinal tract of the subject, combined in a combination for oral administration in a formula creating a tamper-proof narcotic delivery system only when subjected to tampering and adulteration; wherein, the agonist having a narcotic effect is selected from and may be alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, benzitramide, bupernorphine, butorphanol, clonitazcene, codeine, cyclazocine, desomorphine, dextromoramide, dexocine, diampromide, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacyl morphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propiram, propoxyphene, sufentanil, tramadol, tilidine, salts thereof or mixtures thereof, wherein the antagonist component is selected from the narcotic antagonist group and consisting of naltrexone, nalmefene, and a mixture thereof, wherein the antagonist removal component methylnaltrexone. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method for the delivery to a subject, the method comprising the step of administering the composition to the subject as written and prescribed orally wherein the composition comprised of three components that have independent pharmaceutical potential and action to provide unobstructed narcotic analgesic action to a legitimate subject with moderate to severe pain, when taken as written and prescribed and absolutely no analgesic or euphoric potential and action once subjected to tampering and adulteration to liberate and isolate the narcotic component, wherein the composition consists of:
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(a) an immediate or time released narcotic agonist component; (b) a narcotic antagonist component comprising at least one antagonist, of comparable milligram and dosage potential of the agonist to negate any analgesic potential of the selected agonist and to be sequestered and released, if and only if, the composition is subjected to tampering or adulteration; and (c) an immediate acting antagonist removal component from a group consisting of pharmaceutical agents, botanical agents, and mixtures thereof, to ensure the elimination of the sequestered antagonist component from the gastrointestinal tract of the subject, combined in a formula for oral administration in a composition creating a tamper-proof narcotic delivery system only when subjected to tampering and adulteration; wherein, the agonist having a narcotic effect is selected from and may be alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, benzitramide, bupernorphine, butorphanol, clonitazcene, codeine, cyclazocine, desomorphine, dextromoramide, dexocine, diampromide, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacyl morphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propiram, propoxyphene, sufentanil, tramadol, tilidine, salts thereof or mixtures thereof, wherein the antagonist component is selected from the narcotic antagonist group and consisting of naltrexone, nalmefene, and a mixture thereof, wherein the antagonist removal component is methylnaltrexone. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification