Classifications

• • A—HUMAN NECESSITIES
  • A62—LIFE-SAVING; FIRE-FIGHTING
  • A62D—CHEMICAL MEANS FOR EXTINGUISHING FIRES OR FOR COMBATING OR PROTECTING AGAINST HARMFUL CHEMICAL AGENTS; CHEMICAL MATERIALS FOR USE IN BREATHING APPARATUS
  • A62D3/00—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances
  • A62D3/30—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances by reacting with chemical agents
  • A62D3/33—Processes for making harmful chemical substances harmless or less harmful, by effecting a chemical change in the substances by reacting with chemical agents by chemical fixing the harmful substance, e.g. by chelation or complexation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
  • A61K31/445—Non condensed piperidines, e.g. piperocaine
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
  • B01J15/00—Chemical processes in general for reacting gaseous media with non-particulate solids, e.g. sheet material; Apparatus specially adapted therefor
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D33/00—Details of, or accessories for, sacks or bags
  • B65D33/16—End- or aperture-closing arrangements or devices
  • B65D33/25—Riveting; Dovetailing; Screwing; using press buttons or slide fasteners
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
  • B09B—DISPOSAL OF SOLID WASTE NOT OTHERWISE PROVIDED FOR
  • B09B2101/00—Type of solid waste
  • B09B2101/65—Medical waste
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
  • B09B—DISPOSAL OF SOLID WASTE NOT OTHERWISE PROVIDED FOR
  • B09B2101/00—Type of solid waste
  • B09B2101/65—Medical waste
  • B09B2101/68—Transdermal patches
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
  • Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
  • Y02W30/00—Technologies for solid waste management
  • Y02W30/20—Waste processing or separation

Definitions

• the present invention relates generally to a disposal system for unused or expired medications. More particularly, the invention involves the use of binding agents to immobilize and prevent release of medications into the body of an abuser, or to the environment.
• a significant source of pharmaceutical environmental contamination lies with disposal of unused or expired medications (reference eMedicineHealth 3/21/08) .
• transdermal patch technology Of particular interest is the potential for abuse or environmental release associated with medications contained in transdermal patch technology. Unfortunately, with transdermal patches significant amounts of drug compound remain in the patches after patients have worn them for the prescribed period of time. The need for this excess amount of drug is well known; it is required to insure an adequate driving force in the transdermal application for the full wear time period. For example, in a published test of Duragesic (trademark of Johnson & Johnson) patches worn for the full 72-hour wear period, 28-84.4% of the original loading of fentanyl still remained in the patches. The authors of the study concluded that the residual dosage represented amounts sufficient for abuse and misuse and was even potentially lethal. (Marquardt et al , Ann Pharmacother, 1995, 29:969-71).
• inactivating agents include opioid receptors that bind the residual opioid into an insoluble ligand- receptor complex, opioid receptor antagonists, physical sequestering agents, or non-opioids with distressing or dysphoric properties.
• opioid receptors that bind the residual opioid into an insoluble ligand- receptor complex
• opioid receptor antagonists that bind the residual opioid into an insoluble ligand- receptor complex
• opioid receptor antagonists that bind the residual opioid into an insoluble ligand- receptor complex
• non-opioids with distressing or dysphoric properties include opioid receptors that bind the residual opioid into an insoluble ligand- receptor complex
• opioid receptor antagonists include opioid receptor antagonists, physical sequestering agents, or non-opioids with distressing or dysphoric properties.
• non-opioids with distressing or dysphoric properties.
• binding agent means a substance or combination of substances that immobilize or otherwise deactivate a medication on contact. They include adsorption substances that adsorb or chemisorbs or substances that chemically bind a medication of interest.
• the term "active" means that the substances begin to perform the immobilization or other deactivation immediately on contact with a medication.
• the binding agent may also contain an antagonist, oxidizing, or irritant compound which has been pre-adsorbed on a portion of the binding agent.
• Possible binding agents include, without limitation, zeolites, clays, silica gel, aluminum oxide and activated carbon.
• Preferred binding compositions include those binding agents which may be . adsorbents or chemisorption agents for the medication. These agents immobilize the medication and preclude future separation by normally available means.
• Activated carbon has been found to be a material particularly suitable for the adsorption or chemisorption of medication compounds, including synthetic opioids such as fentanyl . Thus, contacting these compounds with a suitable binding agent has been found to thereafter prevent extraction by normal solvents in abuse circumstances, or groundwater supplies for environmental contamination.
• Activated carbon has been found to be useful as a preferred adsorption substance in a binding agent for medication disposal purposes, however, it does have certain limitations that need to be overcome.
• One such limitation relates to shelf stability.
• activated carbon While activated carbon is known to be a near universal adsorbent for many compounds, its use has been generally limited to removal of trace contaminates through incorporation into filtration units of water or air supplies. Further, it has a finite capacity for adsorption. Once saturated, it loses effectiveness. If the activated carbon is exposed to normal atmosphere in shelf storage, it will eventually become deactivated due to adsorption of gaseous impurities found in air. Therefore, it has been found that activated carbon used in accordance with this invention requires protection from deactivation by contamination during storage conditions to preserve and prolong shelf life.
• the use of activated carbon as an adsorptive substance in a binding agent requires direct contact with the medication of interest.
• activated carbon and the species desired to be inactivated are both in solid form, deactivation may not be fully accomplished if contact between binding agent and medication is not complete. Further, since activated carbon is insoluble in water, it is not uniformly present in aqueous solutions.
• kits that includes a disposable container to receive the medication of interest.
• the disposable container contains an amount of activated carbon sufficient to adsorb or chemisorb a labeled capacity for medication.
• the container also includes an amount of gelling agent which enables suspension of the activated carbon and medication together in a viscous slurry to achieve intimate contact between the activated carbon and dissolved medication throughout the slurry. This has been found to be very efficient.
• One gelling agent that is preferred is HPMC (Hydroxypropylmethylcellulose) , at a concentration by weight of from 0.5 to 5.0% (w/w) when mixed with an amount of water.
• the process using a gelling agent has an additional advantage because the viscous gel helps retain the mixture, including medications in dissolved form, within the container, e.g. it will not leak out readily as would a non- viscous solution should there be a breach in the container.
• oxidizing agents include perborates, percarbonates, peroxides, and hypochlorites.
• the disposable containers are sealed while in storage prior to use and are kept substantially impermeable to gaseous organic compounds so that the activated carbon retains its adsorption capability.
• Each container is provided with a sealable opening (preferably resealable) , which when opened provides access to deposit the unused or expired medications. In the cases where the unused or expired medications are in solid form (pills, patches, etc,), an amount of water is added to the container sufficient to dissolve the medication.
• the amount of water added is approximately 20 fold greater than the amount of medication to become deactivated.
• Medications added to the device along with water slowly dissolve into the liquid, and, through diffusion within the liquid (or gelled slurry) , the medications will contact the activated carbon and become adsorbed (deactivated) .
• the sealable closure device for closing the container or pouch also provides a closed system for disposing of the used medication.
• the closure system may include an adhesive seal or plastic container reseal device such as those associated with the trademark Ziploc® to seal the deactivated medication in the container.
• One preferred container system includes a laminated foil stand up pouch, having a laminated seal with a tear notch to open and receive the medication and water, and a zipping reusable seal which serves to re-seal the contents within the pouch after insertion of the medication and water.
• An example of an acceptable stand up pouch is one 5" (12.7 cm) x 8" (20.3 cm) x 3" (7.6 cm) and is available from Impak Corporation of Los Angeles, CA as part number BBB03Z. In the case where the unused or expired medication is in the form of a liquid, the addition of water is not required.
• a further option that can be utilized to further prevent abuse of the contents of a disposable kit includes the incorporation of either antagonist or irritant compounds pre-adsorbed into a portion of the activated carbon.
• the antagonist and/or irritant is co- extracted along with the drug.
• suitable protection agents include naloxone or naltrexone as antagonists and capsaicin or ipecac as irritants.
• Figures 1 and 2 are simplified schematic front and side views of one embodiment of the invention showing a container system with parts omitted for clarity;
• Figure 3 is a plot showing a UV/VIS spectrophotometry scan of a 37.7 mg/1 solution of fentanyl citrate showing absorption from 200-240 nm;
• Figure 4 is a UV/VIS spectrophotometry scan plot of the solution of Figure 2, after 5 minutes of contact with activated carbon;
• Figure 5 is a UV/VIS spectrophotometry scan plot of a 50% ethanol solution utilized to attempt to extract adsorbed fentanyl citrate from the activated carbon used to adsorb the fentanyl citrate in Figure 3;
• Figures 6A and 6B are UV/VIS spectrophotometry scans of Untreated and Treated Lidocaine Hydrochloride as a Model Cotnpound.
• Figure 6C is a graphical extraction comparison of the Lidocaine that is treated vs Lidocaine that is untreated;
• Figures 7A and 7B are UV/VIS spectrophotometry scans of Untreated and Treated Diclofenac Potassium as a Model Compound.
• Figure 7C is a graphical extraction comparison of the Diclofenac that is treated vs Diclofenac that is untreated.
• FIGS. 1 and 2 depict front and side views of a medication disposal kit, respectively, which is in the form of a disposal pouch having an outer barrier substantially impervious to water and organic vapor with active binding agents incorporated within.
• the pouch is depicted generally by 10 and includes a seal layer 12 that can be opened using a tear notch 14. Further, the pouch includes a reusable zip lock seal 16 so that the pouch can be reclosed after insertion of the waste medications.
• the pouch has an outer barrier 18 that is of a material substantially impermeable to organic vapors such as aluminum foil. An amount of activated carbon and gelling agent is shown inside the pouch at 20 and a label is shown at 22.
• the tear notch 16 is used to unseal the pouch prior to use and expose an open volume for insertion of water and waste medications in pill or other solid form, liquid or skin patch form. After such insertions, the pouch is resealed by use of the zipping seal 16. While a pouch is depicted, it will be recognized and appreciated that other containers such as plastic or glass jars, etc. can also provide effective containment systems.
• the water dissolves the waste solid medications or combines with liquids, and thereafter, the activated carbon binds them through an adsorption or chemisorption process. The adsorbed or chemisorbed species then becomes substantially retained onto a solid substrate where it remains in a medically inactive state, and inhibited from dissolution or leaching into the environment .
• the activated carbon may be any of a variety of mesh sizes from finely divided to granular depending on the application. Although powder sized activated carbon can be used, a preferred range is from about 8 mesh to about 325 mesh. The particular preferred average mesh size will depend on the particular application of a disposal system or kit .and kits having a variety of average mesh sizes are contemplated.
• Alternative embodiments may include a gelling agent along with finely divided activated carbon, so that the medication is dissolved into a viscous, high-water content solution, with the gelling agent serving to help suspend the activated carbon throughout the mixture and prevent leakage of the mixture out of the pouch.
• Hydroxypropylmethylcellulose, or the like, gelling agent in concentrations of 0.5 to 5% (w/w) serves to promote suspension of the activated carbon in the medication mixture, and thus make it more effective while also speeding up the adsorption/chemisorption process.
• Other components may be useful, such as oxidizing agents which serve to break down the medication into inactive forms prior to the adsorption/chemisorption process. Oxidizing agents such as percarbonates, perborates, etc.
• Disposal of unused and expired medications with the kit of this invention includes the following steps: 1) open an impermeable seal so as to expose the kit contents, 2) add a volume of water (if the medication is in solid oral or patch form) , 3) add an amount of medication equal to or less than an indicated approximate medication capacity on the kit label, 4) re-seal the pouch and gently mix the components, and 5) dispose of the pouch in the normal trash.
• the volume of the pouch and amount of activated carbon contained in the pouch dictate the approximate medication treating capacity. For optimal results, it has been found that the volume of water added and the amount of activated carbon contained in the pouch should both be about three times or more the approximate medication capacity on a weight basis.
• the waste medication may be one indicated as clearly abusable,- this includes opioids such as fentanyl , morphine, hydromorphone , etc.
• the present concept provides a system where the medication cannot conveniently be recovered later from a used kit by others for abuse purposes .
• Figure 3 depicts a plot of a UV/VIS spectrophotometry scan of a 37.7 mg/1 solution of fentanyl citrate. The absorption from 200-240 nm is due to the presence of fentanyl citrate in the solution, and the magnitude of the absorbance is directly related to the dissolved concentration of that compound. It is readily seen that the concentration of the drug is significant.
• Figure 4 represents a second UV/VIS spectrophotometry scan plot of the solution of Figure 3 after 5 minutes of contact with activated carbon. A dramatic reduction in the amount of absorption from 200-240 nm is seen. The data shows that an estimated 97% of the fentanyl citrate had been removed from solution by 5 minutes of contact with activated carbon. Only 11 micrograms from the original content of 377 micrograms of fentanyl citrate remained in solution. To measure whether the fentanyl could thereafter be recovered into an abusable form, the activated carbon utilized to adsorb the fentanyl citrate from the solution of Figure 3 was then taken and placed in a 50% ethanol/water solution in an attempt to redissolve the adsorbed fentanyl citrate.
• the plot of Figure 5 represents another UV/VIS spectrophotometry scan of the 50% ethanol solution from which it appears that recovery of fentanyl citrate in the 50% ethanol solution was extremely low, i.e., less than 5% of the drug having been recovered. This indicates that the adsorption of the drug onto the activated carbon was not only almost complete, but also very tenacious. Of the 366 micrograms of fentanyl citrate that was bound, only 13 micrograms was successfully separated in the attempted extraction process.
• antagonist and/or irritant compounds might be incorporated into the package along with the activated carbon so as to further discourage abuse of the disposed medication.
• antagonist compounds include naloxone
• examples of irritant compounds include capsaicin.
• Example I As a test of a model compound, a medication kit in accordance with this invention was used to 'deactivate'
• Lidocaine is an anesthetic agent and a common ingredient in liquid, gels, creams and patch forms. The procedure was as follows:
• a control (Untreated) solution was prepared by mixing the same amount of Lidocaine HCl with water.
• FIG. 6A is the UV/VIS spectrophotometric scan of the untreated Lidocaine solution
• Figure 6B is the UV/VIS spectrophotometic scan of the treated Lidocaine
• Figure 6C is a graphical comparison of the untreated and treated group recoveries.
• Diclofenac is an anti- inflammatory agent and a common ingredient in oral, gel, and patch forms.
• the procedure was as follows: 1. To a mixture of 20 grams Activated Carbon (1500) and 2 grams of HPMC, 100 ml of water was added which resulted in a suspended gel slurry of Activated Carbon. 2.5 grams of Diclofenac potassium was added and the solution was mixed.
• a (Untreated) control solution was prepared by- mixing the same amount of Diclofenac potassium with water.
• FIG. 7A is the UV/VIS spectrophotometric scan of the untreated Diclofenac solution
• Figure 7B is the UV/VIS spectrophotometic scan of the treated Diclofenac
• Figure 7C is a graphical comparison of the untreated and treated group recoveries.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Animal Behavior & Ethology (AREA)
• Epidemiology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Dermatology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Mechanical Engineering (AREA)
• General Chemical & Material Sciences (AREA)
• Toxicology (AREA)
• Organic Chemistry (AREA)
• Business, Economics & Management (AREA)
• Emergency Management (AREA)
• Medicinal Preparation (AREA)
• Processing Of Solid Wastes (AREA)
• Accommodation For Nursing Or Treatment Tables (AREA)
• Bag Frames (AREA)
• Basic Packing Technique (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Solid-Sorbent Or Filter-Aiding Compositions (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Packages (AREA)

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• 2009
  • 2009-03-26 US US12/412,144 patent/US8535711B2/en active Active
• 2010
  • 2010-02-25 MX MX2011007888A patent/MX2011007888A/es active IP Right Grant
  • 2010-02-25 KR KR1020137019375A patent/KR101386047B1/ko active Active
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