DISPOSAL OF MEDICAMENTS

Abstract

Composition to aid in the sequestration and/or disposal of unused human or animal pharmaceutical drug or medication. The composition comprises a disposal composition material that contains a gelling or massing agent and optionally other components, and can be in the form of pellets, beads, beadlets, granules, or the like. The disposal composition material can be incorporated into a sachet or other disposal container or its cap to prevent the use of the medicament or the removal/extraction of active agent(s) from a pharmaceutical dosage form intended for disposal, to an appreciable extent and/or rate. With in the disposal agent, or fill material there may also be additional ingredients to promote mixing, sequestration or destruction of the active agent. The disposal composition is contained in a sachet and dispensed with a medicament for use when the patient has finished with the medication and there is material left over for disposal. In addition, the sachet could be made available for use with non-prescription drugs and other materials.

Claims

1-45. (canceled)

46. A disposal composition comprising: a carrageenan, an alginate, a polyvinyl alcohol, a chitosan, or a combination thereof; and a solvent-activated calcium cross-linking agent, a solvent-activated potassium cross-linking agent, or a combination thereof; wherein the composition is capable of, when combined with a medicament and a hydrophilic solvent, forming a solidifying gel or solid to sequester the medicament within one hour after combination with the solvent, wherein the solvent activates the calcium cross-linking agent, potassium cross-linking agent, or a combination thereof in the disposal composition to cross-link at least one of the carrageenan the alginate, the polyvinyl alcohol, or the chitosan to form the solidifying gel or solid.

47. The disposal composition of claim 46, wherein the solvent-activated calcium cross-linking agent or the solvent-activated potassium cross-linking agent comprises a carbonate, a chloride, a sulfate, a phosphate, a gluconate, or a combination thereof.

48. The disposal composition of claim 46, wherein the disposal composition further comprises a calcium sequestrant.

49. The disposal composition of claim 48, wherein the calcium sequestrant comprises a phosphate, a citrate, or a combination thereof.

50. The disposal composition of claim 46 further comprising a massing agent.

51. The disposal composition of claim 46 further comprising hydrochloric acid, boric acid, adipic acid, ammonium hydroxide, acetic acid, citric acid, lactic acid, ammonium carbonate, sodium bicarbonate, sodium bisulfate, sodium carbonate, sodium hydroxide, trolamine, potassium hydroxide, magnesium hydroxide, glutamate buffer, phosphate buffer, or a combination thereof.

52. The disposal composition of claim 46 further comprising an inverse agonist of the medicament, an antagonist of the medicament, or a combination thereof.

53. The disposal composition of claim 52, wherein the medicament is an opioid.

54. The disposal composition of claim 46, wherein the composition consists of components that are generally recognized as safe (GRAS).

55. The disposal composition of claim 46, wherein the composition is in the form of a powder, a pellet, a bead, a beadlet, a granule, or a combination thereof.

56. The disposal composition of claim 46, wherein the solidifying gel or solid is formed within about ten minutes after mixing with the solvent.

57. The disposal composition of claim 46, wherein the medicament dissolves upon contact with the solvent.

58. The disposal composition of claim 46, wherein the solvent comprises a fruit juice, a vegetable juice, water, milk, alcohol, vinegar, bleach, or a combination thereof.

59. The disposal composition of claim 46, wherein the medicament comprises a prescription drug, an over-the-counter drug, a controlled substance, a vitamin, a nutritional supplement, a plant-derived product, a fermented supplement, or a combination thereof.

60. The disposal composition of claim 46, wherein the solvent activates the calcium cross-linking agent in the disposal composition to cross-link the carrageenan to form the solidifying gel or solid.

61. A matrix comprising: a carrageenan, an alginate, a polyvinyl alcohol, a chitosan, or a combination thereof; a solvent-activated calcium cross-linking agent, a solvent-activated potassium cross-linking agent, or a combination thereof, a hydrophilic solvent; and a medicament; wherein the matrix is cross-linked such that the medicament is unavailable for extraction.

62. The matrix of claim 61, wherein the solvent-activated calcium cross-linking agent or the solvent-activated potassium cross-linking agent comprises a carbonate, a chloride, a sulfate, a phosphate, a gluconate, or a combination thereof.

63. The matrix of claim 61 further comprising hydrochloric acid, boric acid, adipic acid, ammonium hydroxide, acetic acid, citric acid, lactic acid, ammonium carbonate, sodium bicarbonate, sodium bisulfate, sodium carbonate, sodium hydroxide, trolamine, potassium hydroxide, magnesium hydroxide, glutamate buffer, phosphate buffer, or a combination thereof.

64. The matrix of claim 61 further comprising an inverse agonist of the medicament, an antagonist of the medicament, or a combination thereof.

65. The matrix of claim 65, wherein the medicament is an opioid.

66. The matrix of claim 61, wherein the solvent comprises a fruit juice, a vegetable juice, water, milk, alcohol, vinegar, bleach, or a combination thereof.

67. The matrix of claim 61, wherein the medicament comprises a prescription drug, an over-the-counter drug, a controlled substance, a vitamin, a nutritional supplement, a plant-derived product, a fermented supplement, or a combination thereof.

Description

DETAILED DESCRIPTION OF THE EXAMPLE EMBODIMENTS

[0051] The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present compositions and methods are disclosed and described, it is to be understood that this invention is not limited to the specific compositions and methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. The following description of the invention is provided as an enabling teaching of the invention in its best, currently known embodiment. To this end, those skilled in the relevant art will recognize and appreciate that many changes can be made to the various aspects of the invention described herein, while still obtaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be obtained by selecting some of the features of the present invention without utilizing other features. Accordingly, those who work in the art will recognize that many modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not in limitation thereof.

[0052] The present invention relates to a composition for the sequestration and/or disposal of unused human or animal medicaments, such as drugs or medications. The present invention also relates to a method of sequestering and/or disposing of unused medicament, comprising mixing the unused medicament with a disposal composition material and a solvent.

[0053] The composition enables the safe and proper disposal of unused medicaments to reduce misuse of drugs and medications, and/or to lower the amount and/or rate of active agents that can be extracted when the medicament is acquired by an individual for whom the product has not been prescribed or intended. By destroying the medicament and/or reducing the amount of the extractable active agent, those misusing the product may be prevented from experiencing the euphoric, pleasurable, reinforcing, rewarding, mood altering, and/or toxic effects of the active agent. And by reducing the extraction rate, those misusing the product may be deterred from continuing because of the length of time required for the extraction process.

Definitions

[0054] The term disposal composition material refers to a component of the disposal composition of the invention that can render a medicament unusable according to the use instructions and/or unavailable for extraction for abuse.

[0055] The term disposal composition agent refers to an agent that interacts with a solvent to gel, form a mass, increase viscosity, etc.

[0056] The term disposal composition container refers to a container in which the disposal device material can be dispersed and/or contained.

[0057] The term medicament refers to any product or therapy that contains one or more active agents. A medicament may be a prescription or non-prescription drug product, or it may be an alternative therapy (e.g., vitamin or nutritional supplement).

[0058] The term medicament container refers to the container or enclosure in which the medicament is provided (e.g., sold, transported, etc.).

[0059] The term abusable drug refers to any active agent that is known to have the potential for abuse. An example of an abusable drug is an opioid agonist.

[0060] The term misuse refers to the use of a medicament in a manner that is not consistent with the use information. Misuse includes administering the medicament at an undirected (e.g., unprescribed) dosage or frequency; in an undirected route of administration or combination with other treatments; or for an undirected purpose or duration. Misuse also includes administration after the medicament is expired, or accidental use.

[0061] The term accidental use refers to the use of a medicament without intent. Examples include administering the medicament while believing it was another product, or administering the medicament inadvertently (e.g., unintended exposure to an inhalant or puncture by a syringe), or ingesting the medicament without appreciating what it is (e.g., a child swallowing a pill believing it is candy).

[0062] The term use information refers to information that directs the use of the medicament, such as prescribing information or directions.

[0063] The term tampered or tampering refers to any manipulation by mechanical, thermal and/or chemical means that changes the physical properties of the dosage form, for example, to liberate the active agent for immediate release if it is in a sustained release formulation, or to make the active agent available for inappropriate use such as administration by an alternate route, for instance, parenterally. The tampering can be, for example, by means of crushing, shearing, grinding, mechanical extraction, solvent extraction, solvent immersion, combustion, heating or any combination thereof.

[0064] The term abuse in the context of, for example, medicament abuse or drug abuse, refers to use, of the effects thereof: (i) in quantities or by methods and routes of administration that do not conform to standard medical practice; (ii) outside the scope of specific instructions for use provided by a qualified medical professional; (iii) outside the supervision of a qualified medical professional; (iv) outside the approved instructions on proper use provided by the medicament's legal manufacturer; (v) which is not in specifically approved dosage formulations for medical use; (vi) where there is an intense desire for and efforts to procure same; (vii) with evidence of compulsive use; (viii) through acquisition by manipulation of the medical system, including falsification of medical history, symptom intensity, disease severity, patient identity, doctor shopping, prescription forgeries; (ix) where there is impaired control over use; (x) despite harm; (xi) by procurement from non-medical sources; (xii) by others through sale or diversion by the individual into the non-medical supply chain; and (xiii) for medically unapproved or unintended mood altering purposes. Abuse can be in the context of intermittent use, recreational use and chronic use, including drug combinations.

[0065] The terms abuse resistant, abuse deterrent, and deter abuse may be used interchangeably and include formulations and methods that resist, deter, discourage, diminish, delay and/or frustrate (i) the intentional, unintentional or accidental physical manipulation or tampering of the dosage form (e.g., crushing, shearing, grinding, chewing, dissolving, melting, needle aspiration, inhalation, insufflation, extraction by mechanical, thermal and chemical means, and/or filtration); (ii) the intentional, unintentional or accidental use or misuse of the dosage form outside the scope of specific instructions for use provided by a qualified medical professional, outside the supervision of a qualified medical professional and outside the approved instructions on proper use provided by the medicament's legal manufacturer (e.g., intravenous use, intranasal use, inhalational use and oral ingestion to provide high peak concentrations); (iii) the intentional, unintentional or accidental conversion of an extended release dosage formulation of the invention into a more immediate release formulation; (iv) the intentional and iatrogenic increase in physical and psychic effects sought by recreational drug users, addicts, and patients with pain who have an addiction disorder; (v) the attempts at surreptitious administration of the dosage form to a third party (e.g., in a beverage); (vi) the attempts to procure the dosage form by manipulation of the medical system and from non-medical sources; (vii) the sale or diversion of the dosage form into the non-medical supply chain and for medically unapproved or unintended mood altering purposes; and (viii) the unintentional or accidental attempts at otherwise changing the physical, pharmaceutical, pharmacological and/or medical properties of the dosage form from what was intended by the manufacturer.

Disposal Composition

[0066] The disposal composition may comprise a disposal composition material that can render a medicament unusable according to the use instructions and/or unavailable for extraction for abuse and/or unavailable for leaching into water supplies or landfills. The disposal composition material, when combined with a solvent and the medicament, may form a gel or mass, i.e., a substance of high viscosity so that it is not easily pourable, transferable, or mixable, and generally remains in the container in which it is formed, such that the medicament is no longer useable for administration as directed in the use information, cannot be misused or accidentally used, or subject to abuse. As a result, the gel/mass will deter use of the medicament by an individual for whom the medicament was not intended, such as prevent an abuser from modifying the product to be used in a manner that is not consistent with the prescribing information or instructions for use.

[0067] The disposal composition may comprise a disposal device container that houses the disposal composition material. The disposal device container may serve different roles in the use of the disposal device. For example, the disposal device container may serve to house the disposal composition material, such that, during implementation, the material may be removed, in full or in part, from the disposal composition container to be added, perhaps along with a solvent, to the medicament container or to a separate container; or, during implementation, the unused medicament may be added, perhaps along with a solvent, to the disposal composition container. Alternatively, the disposal composition container may serve to introduce the disposal composition material to the unused medicament, such that, during implementation, the disposal composition container is added to the medicament container or to a separate container in which the unused medicament is placed; the disposal composition and medicament may then dissolve, such as upon addition of a solvent, to expose the disposal device material to the unused medicament. Or, the disposal composition container may be used to separate the disposal composition material from the unused medicament until implementation of the disposal device; for instance, the disposal composition container may be a membrane that separates the material from the medicament, and, during implementation, a solvent may be added to dissolve or breach the membrane to thereby expose the medicament to the material. One further application is to place the disposal composition container in the medicament container's lid or cap so that it can be dispensed into the medicament container.

[0068] Once the disposal composition is implemented and the gel/mass is formed of the medicament, subjecting the gel/mass to tampering, such as by crushing the gel/mass and/or and using aqueous or alcoholic solvents to extract the active agent for filtering and/or vaporizing the medicament for inhalation, may result in a gel/mass material that is not filterable or that has a filter rate that is diminished to an appreciable extent or that is prevented from being vaporized. In certain embodiments, the mechanism of action of the disposal composition material may involve intermolecular interactions of the disposal composition material with the active agent of the medicament, thereby preventing the active agent from passing through the filtration system or being vaporized.

Disposal Composition Material

[0069] The disposal composition material may have a polymer with reactive functional groups and a chemical cross-linker, such that the material forms a mass after mixing with water over a suitable period of time. This mass would then deter, slow, or even prevent, to an appreciable degree the extraction of the active agent by aqueous or alcoholic means or vaporization.

[0070] The disposal composition material may comprise one or more disposal composition agents (active agents), which may include one or more gelling or massing or sequestering agents. An example of a massing agent is sodium borate, which can also neutralize the drug through its pH and chemical action.

[0071] General examples of disposal composition agents are provided in Table 1:

TABLE-US-00001 TABLE 1 Disposal composition agents according to the present invention. Disposal composition agent Function Sequestering Encapsulating and immobilizing the drug(s) to limit Polymer(s) physical and functional access to drug Cross-linking Chemically (ionic or covalently) link or bind the agent polymer(s) into a viscous gel network pH Modifier Adjust pH to optimize conditions for cross-linking Active Blocks or inhibits the pharmacological action of the pharmaceutical drug(s) to be disposed agent

TABLE-US-00002 TABLE 2 Examples of disposal composition Sequestering Polymers according to the present invention. Disposal Composition Sequestering Polymer(s) Viscosity (CPs)* Polyvinyl Alcohol 400-350,000 Carageenan(s) 500-450,000 Alginate(s) 200-400,000 Chitosan(s) 100-350,000 *The viscosity numbers given are general numbers and are affected by different characteristics of the materials, most importantly the molecular weights of the polymers. The concentration of the polymer in water can be adjusted to increase viscosity.

[0072] Potential gelling or massing agents can also, but are not required, to perform one or more of the following actions: [0073] destroy or dissolve a capsule or tablet; [0074] reduce the waste disposal costs by expanding in volume by less than 1%; [0075] will not release trapped contaminants if solute evaporation occurs; [0076] have a strong ion exchange capability allowing for binding; [0077] will not release free liquids when subject to freeze-thaw cycles, [0078] will not allow for vaporization of medicaments.

[0079] In additional embodiments, a disposal composition agent may interact with the medicament by neutralizing or otherwise diminishing its therapeutic effect. For instance, a disposal composition agent may be an acid or base that can degrade the medicament through contact. Examples include, but are not limited to, hydrochloric acid, boric acid, adipic acid, ammonium hydroxide, acetic acid, citric acid, lactic acid, ammonium carbonate, sodium bicarbonate, sodium bisulfate, sodium carbonate, sodium hydroxide, trolamine, potassium hydroxide, magnesium hydroxide, glutamate buffer, or phosphate buffer.

Polyvinyl Alcohol (PVA)

[0080] The viscosity of most PVAs are measured using a 4% solution (according to the pharmacopoeias). The molecular weight ranges (g/mol) for PVA can be between 31,000 and 145,000 and the degree of hydrolysis can be between 88 and 99%. The higher the hydrolysis grade of PVA, the higher the average molar mass, the better the thickening effect, the higher the sequestering effect on drug. The higher the viscosity, the higher the tensile strength of the hydrogel, the stronger the gel scaffold (# H-bonds), the higher the sequestering effect on drug.

Carrageenan

[0081] Carrageenan is a naturally-occurring family of carbohydrates. Kappa carrageenan is soluble in hot water. The addition of potassium and calcium cross-linkers induces the formation of a durable, brittle gel; it also increases the gelling and melting temperatures.

[0082] Iota carrageenan exhibit thixotropic characteristics and are soluble in hot water. The addition of calcium and potassium cross-linkers will induce the formation of a durable, elastic gel, and increase gelling and melting temperatures. Limited aggregation contributes to elasticity, no syneresis, is freeze/thaw stable and insoluble in most organic solvents.

Alginates

[0083] Alginate, or an alginate-containing mix, is gelled by a calcium cross-linker. Calcium ions diffuse into the mix containing alginate forming a calcium alginate gel when the calcium ions react with the alginate. Alternatively, a slowly soluble calcium salt and a suitable calcium sequestrant, such as a phosphate or citrate can be employed. The sequestrant is needed to bind free calcium and prevent pre-gelation of the alginate during the time the product is mixed. The shorter the mixing time, the lower the level of sequestrant needed. The gellation process may be performed at neutral or acid pH. The acidity may be obtained by the addition of an acidifier, which will accelerate the solubility of calcium salts. In some embodiments, the disposal composition material may contain colorants and/or opacifying agents.

[0084] In some embodiments, the disposal composition agents may provide their own therapeutic effect upon administration that neutralizes or antagonizes the therapeutic effect of the medicament. For example, the disposal composition agent may block or inhibit or override the therapeutic action of themedicament.

[0085] In certain embodiments, for cases when the medicament comprises an opioid, a disposal composition agent may be one or more opioid inverse agonists. The opioid inverse agonist may be non-selective such as, but not limited to, naloxone. Naloxone is often used to counter the effects of opiate overdose, for example heroin or morphine overdose. Naloxone is particularly used to counteract life-threatening depression of the central nervous system and respiratory system. In general, naloxone may be present in the disposal composition material in amounts ranging from about 1 mg to about 50 mg. Other materials may be present in other amounts as necessary to be effective.

[0086] The opioid inverse agonist may be selective, for example, having a high affinity for particular opioid receptors, such as a g-opioid receptor, a-opioid receptor, K-opioid receptor, or o-opioid receptor.

[0087] In other embodiments, a disposal composition agent may be one or more opioid antagonists. The opioid antagonist may be non-selective such as, but not limited to, naltrexone, which is often used to help patients overcome opioid addiction by blocking the opioids' euphoric effects. Alternatively, the opioid antagonist may selective such as, but not limited to cyprodime, which is a selective g-opioid receptor antagonist; naltrindole, which is a selective o-opioid receptor antagonist; and norbinaltorphimine, which is a selective K-opioid receptor antagonist.

[0088] In certain embodiments, the disposal composition agent may comprise a combination of non-selective or selective opioid inverse agonists or antagonists.

Disposal Container

[0089] Ideally, the disposal container is the same container or vial that the medicament was dispensed with, to the patient. Additionally, the disposal container may comprise a disposal device that houses the disposal composition material. The disposal container may be separate from the medicament container or may be incorporated into the medicament container, such as within, or attached to, the medicament container walls, bottom, and/or lid.

[0090] The disposal container can be in the form of a sachet, packet, straw, membrane enclosure, or other suitable container from which to house the disposal material. The disposal container can optionally be made as a re-sealable unit. The disposal container can also be in the form of a blister pouch or multiple pouches fused to the internal surface of the medicament container or the container's cap or lid. The disposal container may be a suitable container into which disposal composition material can be transferred to for the purposes of mixing the unused medicament with the disposal composition material. The disposal composition container can optionally be made as a re-sealable unit, such as a zip-lock bag.

[0091] The sachet, packet, straw or other suitable container can be square, round, rectangular or other suitable shape for either fitting into a medicament container. The blister pouch or pouches may be polygon, ovoid, serpentine, other suitable shape, or combination of various shapes. The shape of the blister pouch or pouches may be incidental or may confer functionality in the release of the disposal composition material.

[0092] The size of the disposal composition container, system and its contents can be scaled to accommodate a 30-, 60- or 90-day supply of the medicament contemplated for disposal. Typical sizes of pharmacy dispensing bottles can range from 30 ml to 100 ml. The disposal composition, including the container, can be scaled according to the pharmacy container size in anticipation of the volume of water to be added to the bottle. Thus, for a smaller quantity of medicament dispensed, a smaller unit of the disposal composition may be dispensed; with a larger quantity of the medicament dispensed, a larger unit, or multiple units of the disposal composition may be dispensed.

[0093] The disposal composition container in the form of blister pouch or pouches fused with the medicament container may be positioned within the medicament container or container cap so as to accommodate various fill levels of the medicament container.

[0094] The pharmacist may dispense the medicament, then depending on the size of medicament container, the pharmacist can then select 1, 2, 3 of the disposal composition to be co-dispensed. Alternatively, the pharmacist may select the medicament container fabricated with the disposal composition container that accommodates the fill level of dispensed medicament.

[0095] The disposal composition container can be manufactured by methods known to those skilled in the art, and be made from standard paper, plastic, polymers, etc. or specialty materials that confer functionality.

[0096] The disposal composition container can be made of material that dissolves upon contact with water or other solvent, thereby releasing the contents of the disposal composition container into the medicament container or a separate container of unused medicament. Examples of materials used for the disposal composition container are gelatin, ethyl cellulose, and other materials that are soluble on contact with water or partially hydrophilic solutions. In the case of blister pouches fused with the medicament container, multiple pouches may be made of various materials to affect a sequence of disposal composition materials.

[0097] Alternatively, the disposal composition container suitable for adding unused medicament to it can be made of plastic, waxed board like a milk carton, or other suitable container capable of holding both liquid and solid materials.

Method of Sequestering and/or Disposing of Unused Prescription Product

[0098] The present invention relates to a method of sequestering and/or disposing of unused medicament, comprising mixing the unused medicament with a disposal composition material and a solvent, such as a hydrophilic diluent. In some embodiments, the solvent is a fruit or vegetable juice, juice cocktail, water, milk, alcohol, distilled spirits, vinegar or bleach. In certain embodiments, the unused medicament and the disposal composition material as well as the solvent if a solvent is added, may be mixed, such as by an instrument or mixing composition known in the art, or by shaking or swirling the contents of the medicament container or the separate container.

[0099] In embodiments of the invention, the disposal composition material may be housed in the disposal composition container and, during implementation, the disposal composition material is removed from the disposal composition container and is added to the medicament container or lid or to a separate container. The solvent may also be added to the medicament container or the separate container. In some embodiments, the unused medicament and disposal composition material, and the solvent if a solvent is added, may be mixed.

[0100] In certain embodiments, the disposal composition material may be housed in the disposal composition container and, during implementation, the unused medicament may be added to the disposal composition container. The solvent may also be added to the disposal composition container. In some embodiments, the unused medicament and disposal composition material, and the solvent if a solvent is added, may be mixed.

[0101] In embodiments of the invention, the disposal composition material may be housed in the disposal device container and, during implementation, and the disposal composition container may be added to the medicament container or to a separate container that has the unused medicament. The solvent may also be added to the medicament container or the separate container. In some embodiments, the unused medicament and disposal composition material, and the solvent if a solvent is added, may be mixed.

[0102] As an example, FIGS. 2A-D depicts embodiments in which the disposal composition container is a sachet, and the sachet contents are poured into the medicament container. A solvent such as water can then be added to the medicament container to mix with the sachet and any unused medicament in the medicament container. The medicament container may be covered with a lid or cap and then mixed.

[0103] In further embodiments, the disposal composition container may be a part of the medicament container. For example, the disposal composition container may be attached to the inside of the medicament container, such as on the bottom, the side walls, or the lid of the medicament container. Or, the disposal composition container may be incorporated or embedded into the bottom, the side walls, or the lid of the medicament container; in this case, the disposal composition container may be in the form of: for instance, a blister or rib, and may comprise a membrane that prevents the disposal composition material from contacting the medicament unless it is breached or dissolved in full or in part.

[0104] For an oral dosage form such as, but not limited to, a tablet, capsule, or other solid oral product, once the patient has completed the course of therapy, whether that constitutes using the entire medicament dispensed to the patient or not, the disposal composition material may be added to the medicament container having any unused portion of the medicament, along with the solvent. The medicament container can then be deposited in the household, industrial or other suitable waste container for disposal. Alternatively, the unused medicament can be added to the disposal device container, along with the solvent. In other embodiments, the disposal composition material, the solvent, and the unused medicament may be mixed in a separate container that is neither the disposal device container nor the medicament container.

[0105] If the medicament is in the form of an injectable, solution, suspension, or other liquid dosage form, any remaining solution (for an injectable, the remaining solution would have to be removed from its medicament container, e.g., vial) may be added to the disposal composition container. A solvent may be added, if necessary.

[0106] Those who use medicaments in the form of a patch are often directed to flush the patch down the toilet for disposal. As an alternative, the patch can be placed in a vessel (e.g., jar, vial, etc.) with the disposal composition material, or placed in a vessel with the disposal composition container having the disposal composition material. The vessel can then be filled with water. This is especially useful for water soluble active containing products. Inhalants may similarly be disposed of using the disposal composition.

[0107] For instances when the medicament is an injectable, the injectable can be added to the disposal device container in addition to water or other solvents such as a fruit or vegetable juice, juice cocktail, water, milk, alcohol, distilled spirits, vinegar or bleach.

[0108] A further advantage of the composition is the sequestration of the active ingredients into a matrix from which it is not easily extracted or leached into groundwater upon disposal into the garbage/landfill. The disposal container is the same container or vial that the medicament was dispensed with, to the patient. In some embodiments, the material that is suitable for the disposal composition comprises including, but not limited to polyvinyl alcohol, carrageenans, chitosans, sodium alginate, or combinations thereof. In some embodiments, the disposal composition agents may provide their own therapeutic effect upon administration that neutralizes or antagonizes the therapeutic effect of the medicament.

[0109] The disposal composition can be utilized with any substance that may be harmful or toxic to ingest or otherwise be administered. For instance, the disposal composition may be utilized with one or more medicaments, including pharmaceutical products such as prescription drugs and OTC drugs, or alternative therapies. Pharmaceutical products that may be used with the disposal composition may include, but are not limited to, anti-infectives, such as ambecides, aminoglycosides, anthelimintics, antifungals, antimalarial agents, antituberculosis agents, antiviral agents, cephalosporins, penicillins, quinolones, sulfonamides, and tetracyclines; antineoplastics, such as alkylating agents, antimetabolites, monoclonal antibodies, thalidomide and analogs, and VEGFN EG FR inhibitors; biologicals, such as antitoxins, antivenins, and recombinant human erythropoietins; cardiovascular agents, such as agents for hypertensive emergencies or pulmonary hypertension, antiadrenergic agents, antiarrhythmic agents, calcium channel blocking agents, catechcholamines, diuretics, vasodilators, or vasopressors; central nervous system agents, such as analgesics, anticonvulsants, anxiolyticssedatives, hypnotics, cholinergic agonists, or muscle relaxants; chelating agents; coagulation modifiers, such as anticoagulants, antiplatelet agents, heparin antagonists, or platelet-stimulating agents; gastrointestinal agents, such as antacids, digestive enzymes, functional bowel disorder agents, gallstone solubilizing agents, GI stimulants, laxatives, or proton pump inhibitors; genitourinary tract agents, such as impotence agents, tocolytic agents, urinary pH modifiers, or uterotonic agents; hormones, such as 5-alpha-reductase inhibitors, adrenal cortical steroids, antiandrogens, antidiuretic hormones, aromatase inhibitors, calcitonin, estrogen receptor antagonists, gonadotropin-releasing hormone antagonists, progesterone receptor modifiers, sex hormones, or thyroid drugs; immunologic agents, such as immunostimulants or immunosuppressive agents; metabolic agents, such as antidiabetic agents, antigout agents, antihyperlipidemic agents, bone resorption inhibitors, glucose elevating agents, or lysosomal enzymes; psychotherapetutic agents, such as antidepressants or antipsychotics; respiratory agents, such as antihistimines, bronchodilators, decongestants, expectorants, or respiratory inhalant products; smoking cessation agents; or topical agents, such as antiseptics, dermatological agents, germicides, nasal preparations, ophthalmic preparations, or vaginal preparations. In certain embodiments, the OTC drugs may be, for example, aspirin, Advil, or Tylenol. In some embodiments, the alternative therapies may be vitamins, nutritional supplements, natural/plant derived products, yeast and other fermented supplements, or other naturally derived therapeutic agents.

[0110] The disposal composition can be utilized with one or more medicaments comprising abusable drugs such as schedule I, II, or III drugs. These drugs include opiate and opiate derivatives, hallucinogenic or psychedelic substances, depressants, and stimulants. Examples of abusable drugs include, but are not limited to, alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, cyclazocine, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydroetorphine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, etorphine, fentanyl, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacylmorphan, 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, pharmaceutically acceptable salts thereof, prodrugs thereof, or combinations thereof.

[0111] The medicament may be water soluble drugs such as alfentanil, allylprodine, butorphanol, codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, pentazocine, tramadol and pharmaceutically acceptable salts thereof, prodrugs thereof, or combinations thereof. Other water soluble drugs include treatments for seizures, depression, fibromyalgia, migraine headaches and neuropathic pain such as gabapentin and analogs.

[0112] The medicament may also be highly potent drugs (such as morphine, alprazolam, and chlorpromazine) or drugs with strong side effect profiles such as chemotherapeutics (e.g., bendamustine, cisplatin, paclitaxel, and topotecan).

[0113] Examples of household animal medicaments that may benefit from a disposal composition are flea and tick treatments. These treatments are often left over after a pet is deceased, and are considered poisonous if ingested by small children. The medicaments may be drugs that are past their expiration date.

[0114] The invention will now be further described by way of the following non-limiting examples, which further illustrate the invention; such examples are not intended, nor should they be interpreted, to limit the scope of the invention.

TABLE-US-00003 Examples 1. Gelcarin GP-812 1.5% Calcium carbonate 1.5% Water q.s. 100% 2. Gelcarin GP-812 1.5% Potassium gluconate 1.5% Water q.s. 100% 3. Gelcarin GP-379 1.5% Calcium carbonate 1.5% Water q.s. 100% 4. Gelcarin GP-379 1.5% Potassium gluconate 1.5% Water q.s. 100% 5. Protanal CR 8133 1.5% Calcium carbonate 0.75% Citric Acid 0.75% Water q.s. 100% 6. Protanal CR 8233 1.5% Calcium carbonate 0.75% Citric Acid 0.75% Water q.s. 100% 7. Manucol LKX 1.5% Calcium carbonate 0.75% Citric Acid 0.75% Water q.s. 100% 8. PVA 26-88 5.0% Sodium Borate 5.0% Water q.s. 100% 9. PVA 26-88 10.0% Sodium Borate 10.0% Water q.s. 100% 10. PVA 40-88 5.0% Sodium Borate 5.0% Water q.s. 100% 11. PVA 40-88 10.0% Sodium Borate 10.0% Water q.s. 100% 12. PVA 28-99 5.0% Sodium Borate 5.0% Water q.s. 100% 13. PVA 28-99 10.0% Sodium Borate 10.0% Water q.s. 100% 14. PVA 26-88 5.0% Boric Acid 5.0% Water q.s. 100% 15. PVA 26-8 10.0% Adipic acid 10.0% Water q.s. 100% 16. Chitosan Low MW 20.0% Calcium chloride 10.0% Water q.s. 100% 17. Chitosan Medium MW 15.0% Calcium chloride 7.5% Water q.s. 100% 18. Chitosan Medium MW 20.0% Calcium chloride 10.0% Water q.s. 100% 19. Chitosan High MW 10.0% Calcium chloride 5.0% Water q.s. 100% 20. Chitosan High MW 15.0% Calcium chloride 7.5% Water q.s. 100%

Screening Disposal Composition Agents

[0115] Pharmaceutical excipients were screened for their ability to increase the viscosity of aqueous solutions and their potential use in disposal composition material. Table 3 lists samples of disposal composition agents tested with or without additional excipients, and qualitative results of these agents on solutionviscosity.

[0116] The screening was performed using an extraction/filtration test. Briefly, 0.5 grams of powder were transferred into a container and 10 ml of water (tapped water at a temperature between 26 and 28 C.) was added. The mixtures were vigorously shaken until they were homogeneous, aided by a spatula when necessary to complete homogenization. The resulting suspensions were immediately filtered through a standard coffee filter (GK Connaisseur). Viscosity increase was evaluated by visual inspection, while filtration rate was evaluated by comparing the amount of liquid added to the filter to the amount of liquid recovered in the filtrate after 10 minutes of filtration. In all of the examples listed in Table 3, no filtrate could be obtained, and thus drugs could not be recovered by extraction using filtration. Accordingly, an abuser would have to overcome a significant hurdle to extract the drug from the activated disposal composition.

TABLE-US-00004 TABLE 3 Disposal Composition Cross Linking Agents/Excipients Screening Study: Disposal Example Composition Con. % Initial (5 mins) Filtration after Number Agent(s) (W/W) Other Agents or Excipients Appearance 10 minutes Carageenans (Grade) 1 Gelcarin GP-812 1.5 Calcium carbonate (1.5%) Stiff gel - no flow Unfilterable 2 Gelcarin GP-812 1.5 Potassium gluconate (1.5%) Stiff gel - no flow Unfilterable 3 Gelcarin GP-379 1.5 Calcium carbonate (1.5%) Stiff gel - no flow Unfilterable 4 Gelcarin GP-379 1.5 Potassium gluconate (1.5%) Stiff gel - no flow Unfilterable Alginates (Grade) 5 Protartal CR 8133 1.5 Calcium carbonate (0.75%); Effervescent gel - Unfilterable Citric Acid (0.75%) Slow flow 6 Protanal CR 8233 1.5 Calcium carbonate (0.75%); Effervescent gel - Unfilterable Citric Acid (0.75%) Slow flow 7 Manucol LKX 1.5 Calcium carbonate (0.75%); Stiff effervescent gel - Unfilterable Citric Acid (0.75%) No flow Polyvinyl Alcohols (Grade) 8 PVA 26-88 5.0 Sodium borate (5%) Spongy stiff gel - Unfilterable No flow 9 PVA 26-88 10.0 Sodium borate (10%) Spongy stiff gel - Unfilterable No flow 10 PVA 40-88 5.0 Sodium borate (5%) Spongy stiff gel - Unfilterable No flow 11 PVA 40-88 10.0 Sodium borate (10%) Spongy stiff gel - Unfilterable No flow 12 PVA 28-99 5.0 Sodium borate (5%) Spongy stiff gel - Unfilterable No flow 13 PVA 28-99 10.0 Sodium borate (10%) Spongy stiff gel - Unfilterable No flow 14 PVA 26-88 5.0 Boric Acid (5%) Spongy stiff gel - Unfilterable No flow 15 PVA 26-88 10.0 Adipic Acid (5%) Spongy stiff gel - Unfilterable No flow Chitosans (Grade) 16 Chitosan Low MW 20.0 Calcium chloride (10%) Stiff gel - no flow Unfilterable 17 Chitosan Medium 15.0 Calcium chloride (7.5%) Stiff gel - no flow Unfilterable MW 18 Chitosan Medium 20.0 Calcium chloride (10%) Stiff gel - no flow Unfilterable MW 19 Chitosan High MW 10.0 Calcium chloride (5%) Stiff gel - no flow Unfilterable 20 Chitosan High MW 15.0 Calcium chloride (7.5%) Stiff gel - no llow Unfilterable

[0117] Other examples are as follows:

TABLE-US-00005 TABLE 4 Examples 21-23 Example 21 Example 22 Example 23 wt wt wt w/w (g) w/w (g) w/w (g) Polyvinyl Alcohol 58.0% 1160 40.0% 800 75.0% 1500 (87-83 Hydrolyzed), high MW, fine PS Carageenan Sodium Alginate 28.0% 560 46.0% 920 10.0% 200 Boric Acid Sodium Borate 6.5% 130 5.0% 100 9.0% 180 Calcium Carbonate Calcium Chloride 6.5% 130 8.0% 160 5.0% 100 Calcium Sulfate w/Tetrasodium Pyrophosphate (1:1) Potassium Carbonate Potassium Chloride Potassium Phosphate Fumed Silica.sup.1 0.50% 10 0.50% 10 0.50% 10 FD&C Red #2.sup.1 0.50% 10 0.50% 10 0.50% 10 100% 2000 100% 2000 100% 2000

TABLE-US-00006 TABLE 5 Examples 24-26 Example 24 Example 25 Example 26 wt wt wt w/w (g) w/w (g) w/w (g) Polyvinyl Alcohol 58.0% 1160 40.0% 800 75.0% 1500 (87-89 Hydrolyzed), low MW, fine PS Carageenan Sodium Alginate 28.0% 560 46.0% 920 10.0% 200 Boric Acid Sodium Borate 6.5% 130 5.0% 100 9.0% 180 Calcium Carbonate Calcium Chloride 6.5% 130 8.0% 160 5.0% 100 Calcium Sulfate w/Tetrasodium Pyrophosphate (1:1) Potassium Carbonate Potassium Chloride Potassium Phosphate Fumed Silica.sup.1 0.50% 10 0.50% 10 0.50% 10 FD&C Red #2.sup.1 0.50% 10 0.50% 10 0.50% 10 100% 2000 100% 2000 100% 2000

TABLE-US-00007 TABLE 6 Examples 27-29 Example 27 Example 28 Example 29 wt wt wt w/w (g) w/w (g) w/w (g) Polyvinyl Alcohol 58.0% 1160 40.0% 800 75.0% 1500 (98-99 Hydrolyzed), high MW Carageenan Sodium Alginate 28.0% 560 46.0% 920 10.0% 200 Boric Acid Sodium Borate 6.5% 130 5.0% 100 9.0% 180 Calcium Carbonate Calcium Chloride 6.5% 130 8.0% 160 5.0% 100 Calcium Sulfate w/Tetrasodium Pyrophosphate (1:1) Potassium Carbonate Potassium Chloride Potassium Phosphate Fumed Silica.sup.1 0.50% 10 0.50% 10 0.50% 10 FD&C Red #2.sup.1 0.50% 10 0.50% 10 0.50% 10 100% 2000 100% 2000 100% 2000

TABLE-US-00008 TABLE 7 Examples 30-32 Example 30 Example 31 Example 32 wt wt wt w/w (g) w/w (g) w/w (g) Polyvinyl Alcohol 58.0% 1160 40.0% 800 75.0% 1500 (98-99 Hydrolyzed), low MW Carageenan Sodium Alginate 28.0% 560 46.0% 920 10.0% 200 Boric Acid Sodium Borate 6.5% 130 5.0% 100 9.0% 180 Calcium Carbonate Calcium Chloride 6.5% 130 8.0% 160 5.0% 100 Calcium Sulfate w/Tetrasodium Pyrophosphate (1:1) Potassium Carbonate Potassium Chloride Potassium Phosphate Fumed Silica.sup.1 0.50% 10 0.50% 10 0.50% 10 FD&C Red #2.sup.1 0.50% 10 0.50% 10 0.50% 10 100% 2000 100% 2000 100% 2000

General Use of the Disposal Composition by the Patient

[0118] The quantities and duration of treatment are selected at random for this example and by no means indicates any limit on this invention.

[0119] In general, the sachet is filled with an appropriate amount of disposal composition material to form a solid mass in a prescription vial or other suitable container with the addition of water. Larger or smaller containers would need to have the amount of the disposal composition material adjusted accordingly.

[0120] As for the disposal composition action, subsequent gelling and massing occurs in the product container while in the household waste. Within 30 minutes to one hour, the remaining drug product is dispersed and the mass has solidified.

[0121] While specific embodiments of the subject invention have been discussed, the above specification is illustrative and not restrictive. One skilled in the art will appreciate that numerous changes and modifications can be made to the invention, and that such changes and modifications can be made without departing from the spirit and scope of the invention. The full scope of the invention should be determined by reference to the claims, along with their full scope of equivalents, and the specification, along with such variations.

NOTES

[0122] 1. T. Catan & E. Perez, A Pain-Drug Champion Has Second Thoughts. The Wall Street Journal (Dec. 17, 2012, 11:36 AM ET), http://online.wsj.com/article/SB10001424127887324478304578173342657044604.html. [0123] 2. See S Shah, As Pharmaceutical Use Soars, Drugs Taint Water and Wildlife, Yale Environment 360 (Apr. 15, 2010), http://e360.yale.edu/feature/as_pharmaceutical_use_soars_drugs_taint_water_and_wildlife/2263/ [0124] 3. C G Daughton, Drugs and the Environment: Stewardship & Sustainability. National Exposure Research Laboratory, Environmental Sciences Division, US EPA, Las Vegas, Nev., Report NERL-LV-ESD 10/081, EPA/600/R-10/106 (Sep. 12, 2010), http://www.epa.gov/nerlesd 1/bios/daughton/APM200-2010.pdf [0125] 4. See U.S. patent application Ser. No. 10/457,562, Publication No. 2004/0033255 and (published Feb. 19, 2004); see also U.S. patent application Ser. No. 12/412,144, Publication No. 2009/0180936 (published Jul. 16, 2009) [0126] 5. See U.S. Pat. No. 3,773,955 (issued Nov. 20, 1973); see also U.S. Pat. No. 3,966,940 (issued Jun. 29, 1976) [0127] 6. See U.S. Pat. No. 6,696,088 (issued Feb. 24, 2004) [0128] 7. See U.S. Pat. No. 7,332,182 (issued Feb. 19, 2008) [0129] 8. See U.S. Patent Application No. 20140183070A1 [0130] 9. See U.S. Patent Application No. 20140187842A1