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.

Abstract: The invention relates to a tamper-resistant tablet comprising (i) a matrix material in an amount of more than one third of the total weight of the tablet; and (ii) a plurality of coated particulates in an amount of less than two thirds of the total weight of the tablet; wherein said particulates comprise a pharmacologically active compound and a physiologically acceptable polymer, preferably a polyalkylene oxide; and form a discontinuous phase within the matrix material; which preferably provides under in vitro conditions immediate release of the pharmacologically active compound in accordance with Ph. Eur.; and method of using said tablet to treat pain and other conditions.

Abstract: The invention is directed to an immediate release capsule which mitigates the abuse of Tapentadol or physiologically acceptable salt thereof by direct intravenous injection. The capsule comprises a tamper resistant formulation which when mixed with water and heated, results in a turbid, bubbling mixture that is not injectable with a standard insulin syringe.

Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Abstract: The present invention relates to oral pharmaceutical dosage forms comprising buprenorphine with the dosage form releasing buprenorphine instantly upon oral, preferably sublingual, application of the dosage form. The present invention also relates to the use of such dosage forms for treating pain in a human or animal or for drug substitution therapy in drug-dependent human subjects.

Abstract: A method of manufacturing a cigarette and its constituent components including one or more formulations of filler materials and one or more rolling papers each printed with indicia indicative of the respective formulations of filler material. Also the provision of printed material that associates the particular indicia with its associated formulation.

Abstract: The invention relates to a self-destructing transdermal therapeutic system (TTS), preferably in the form of a transdermal patch, that includes an active ingredient, an agent rendering the active ingredient useless, and a perforation mechanism. The perforation mechanism allows a mobile phase to reach the agent that is capable of rendering the active ingredient useless after removing the TTS after use. The agent then comes into contact with the active ingredient and destroys the active ingredient in the presence of the mobile phase.

Abstract: A dual release oral dosage system/dosage form comprising an immediate release component/composition and a delayed release component/composition is described. Each of the immediate release component/composition and delayed release component/composition comprises one or more of doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof, and one or more of pyridoxine, a salt thereof, a metabolite thereof and/or a salt of the metabolite. The dual release oral dosage system/dosage form exhibits an improved pharmacokinetic profile relative to the current Diclectin® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting in pregnancy (NVP).

Abstract: A method for administering an active pharmaceutical agent (APA) is provided that includes the steps of: a) providing a medicine having a dose of at least one APA and at least one active botanical agent (ABA) or dietary supplement; and b) dosing the APA within the medicine such that within each subsequent dose of the medicine, the amount of the APA decreases and the amount of the ABA increases, or remains the same, or decreases relative to an earlier amount. A trace of the APA may or may not remain in the pill toward the end of medicine application.

Abstract: The present invention relates to a verification method for tracking and tracing tablets, particularly pharmaceutical tablets. It further relates to a visible secure marking or information that is a part of such tablet (10). The invention further relates to tablets suitable for such verification method, processes for manufacturing such tablets, and methods for reading the information.

Abstract: An abuse-resistant controlled release pharmaceutical composition comprising a pharmaceutically effective amount of discrete particles of an active capable of abuse, wherein surfaces of said particles are wetted with a water insoluble coating material, and preferably wherein said composition comprises a matrix, in which said particles are distributed, and which renders the abuse-capable compound within the matrix difficult to separate from the matrix; and a method for the preparation of a controlled release pharmaceutical composition having a reduced potential for abuse, comprising applying a pressure force to a mixture comprising a water insoluble material, and particles of a pharmaceutically active compound capable of inducing in a subject a reaction that is physiologically or psychologically detrimental if administered in an immediate release dosage form, thereby resulting in surface coated particles, and incorporating said surface coated particles into a pharmaceutical composition.

Abstract: The invention is a pharmaceutical product which may be authenticated, comprising identifying markers disposed in the pharmaceutical product. The pharmaceutical product is selected from the group consisting of a pill, a tablet, a caplet, and a capsule. The identifying markers are gel pellets made from a hydroscopic medium having an indicia imprinted thereon and expand volumetrically when contacted with a liquid.

Abstract: Disclosed is a pharmaceutical composition in the form of a tablet suitable for dissolution in the buccal cavity, said composition comprising i) an effective amount of a narcotic active ingredient, and ii) a pharmaceutically acceptable amine having a pK of about 8 or greater, wherein the molar ratio of amine:active ingredient is at least about 5:1.

Abstract: The present invention relates to rapidly dissolving edible film dosage form incorporating a physical-chemical identifier and/or indicia. The physical-chemical identifier and/or indicia may correspond to an active ingredient that may be evenly distributed throughout the film. The physical-chemical identifier and/or indicia may be associated with at least one section of the film composition and/or associated with a sealed pouch or package containing the film composition and provide information to the consumer, practitioner, producer or regulator that is relevant to the edible film dosage form.

Abstract: Water-insoluble matrix tablets based on oxycodone or one of its pharmaceutically acceptable salts and capable of prolonged release of oxycodone to the body, exhibiting a crush resistance of at least 4 MPa.

Abstract: Orally disintegrating tablets containing colored granules of a water-soluble sugar which give them a speckled appearance are described. The orally disintegrating tablets with speckled appearance are readily and easy identifiable by physicians, nurses and patients.

Abstract: The present invention is directed to a capsule comprising a water-soluble compound suitable for the capsule, and a mixture of colorant agents, wherein the color of the capsule may be in the range of 15<L<90; ?30<a<+75; ?37<b<+46 as measured in accordance with the Lab color space. The present invention further includes capsules containing a filling such as food, medicine, cosmetics, agrichemicals, feed or active biological ingredient.

Abstract: The invention relates to a self-destructing transdermal therapeutic system (TTS), preferably in the form of a transdermal patch, that includes an active ingredient, an agent rendering the active ingredient useless, and a perforation mechanism. The perforation mechanism allows a mobile phase to reach an agent that is capable of rendering the active ingredient useless after removing the TTS after use. The agent then comes into contact with the active ingredient and destroys the active ingredient in the presence of the mobile phase.

Abstract: The present invention is directed to a capsule comprising a water-soluble compound suitable for the capsule, a non-water soluble excipient suitable for the capsule; and suitable for the capsule, and a mixture of colorant agents, wherein the color of the capsule may be in the range of 15<L<90; ?30<a<+75; ?37<b<+46 as measured in accordance with the Lab color space. The present invention further includes capsules containing a filling such as food, medicine, cosmetics, agrichemicals, feed or active biological ingredient.

Abstract: An authenticable and machine readable coating for pills, tablets and other ingestible materials is provided. The disclosure also relates to methods of authenticating the same. The coatings are formed from a lattice of particles stacked to cause selective diffraction such that each pill or tablet has an optical signature. The signature associated with each coating can be read and authenticated. In one embodiment, the particles are substantially spherical and self-organized. In one embodiment, generally recognized as safe (GRAS) materials are used to form the particles.

Abstract: The present invention is directed to a capsule comprising a water-soluble compound suitable for the capsule, a non-water soluble excipient suitable for the capsule; and suitable for the capsule, and a mixture of colorant agents, wherein the color of the capsule may be in the range of 15<L<90; ?30<a<+75; ?37<b<+46 as measured in accordance with the Lab color space. The present invention further includes capsules containing a filling such as food, medicine, cosmetics, agrichemicals, feed or active biological ingredient.

Abstract: A pharmaceutical dosage form [11, 11g] has reduced susceptibility to counterfeiting, due to the forming directly thereon of a pattern or base layer [10, 10g] of a Moiré pair, wherein a Moiré effect is visually observable by looking through a revealing layer [12, 12g] positioned closely to and superimposed on the base layer [10, 10g]. The pattern fanned on the pharmaceutical dosage form [11, 11g] may be formed by embossing, oblation, inkjet printing, or tampon printing. The revealing layer [12, 12g] of the Moiré pair can be part of a blister package containing the pharmaceutical dosage form [11, 11g], so that the Moiré effect is observable while looking at the pharmaceutical dosage form [11, 11g] as it remains within the package.

Abstract: Disclosed herein are gustatory and/or olfactory aversion compositions comprising one or more bitterants and appropriate adhesives or tackifiers, and the like, which provide a long-lasting effect. The compositions are useful for behavior modification, especially in animals, such as pets or livestock.

Abstract: A method for labeling a UV-fluorescing substrate includes positioning a UV-fluorescing substrate adjacent to an inkjet material dispenser, and selectively jetting an edible, invisible, non-UV fluorescing ink onto the UV-fluorescing substrate with the inkjet material dispenser.

Abstract: A pharmaceutical dosage form [11, 11g] has reduced susceptibility to counterfeiting, due to the forming directly thereon of a pattern or base layer [10, 10g] of a Moiré pair, wherein a Moiré effect is visually observable by looking through a revealing layer [12, 12g] positioned closely to and superimposed on the base layer [10, 10g]. The pattern fanned on the pharmaceutical dosage form [11, 11g] may be formed by embossing, oblation, inkjet printing, or tampon printing. The revealing layer [12, 12g] of the Moiré pair can be part of a blister package containing the pharmaceutical dosage form [11, 11g], so that the Moiré effect is observable while looking at the pharmaceutical dosage form [11, 11g] as it remains within the package.

Abstract: The present invention relates to a coated dosage form having openings to expose the core material or an intermediate coating layer. The invention also relates to methods for manufacturing such coated dosage forms.

Abstract: The present invention relates to a verification method for tracking and tracing tablets, particularly pharmaceutical tablets. It further relates to a visible secure marking or information that is a part of such tablet (10). The invention further relates to tablets suitable for such verification method, processes for manufacturing such tablets, and methods for reading the information.

Abstract: A pharmaceutical dosage form comprising at least one active ingredient and destined for administration to pregnant women. The pharmaceutical dosage form bears pregnancy-friendly indicia apt to improve patient compliance with medically recommended dosage regimen resulting in improved product effectiveness. The pregnancy-friendly indicia is also apt to diminish the incidence of erroneous dispensing of or erroneous ingestion of pharmaceutical dosage forms not intended for pregnant women. Also disclosed is a method for achieving improved patient compliance resulting in improved product effectiveness. Also disclosed is a method for diminishing the incidence of erroneous dispensing of or erroneous ingestion of dosage forms not intended for pregnant women. Said methods comprising providing a pharmaceutical dosage form, intended for use by pregnant women, bearing pregnancy-friendly indicia apt to graphically distinguish dosage forms intended to be used during pregnancy from others.

Abstract: Small scale and nanoscopic identification features can be fabricated for pharmaceutical capsules. A composition comprising a capsule component, wherein the capsule component comprises a gelled pharmaceutical capsule material and at least one surface, wherein the at least one surface comprises at least one integral feature with a lateral dimension smaller than about 100 microns, or less than one micron. Methods of making the same are described by gelation with heating or cooling. The compositions and methods can be used for anti-counterfeiting.

Abstract: The present invention provides a method for treating a solid dosage form to improve the printability and abrasion resistance of a print to be produced on a surface of the solid dosage form, which includes treating the surface of the solid dosage form with a polyethylene glycol-containing aqueous solution before printing; a production method of a solid dosage form with a printed surface, which includes printing on the surface after the aforementioned treatment; and a solid dosage form having a print improved in abrasion resistance on its surface, which can be obtained by the aforementioned production method.

Abstract: Methods and arrangements for forming a color gradient on a pharmaceutical dosage forms such as tablets are disclosed. In preferred aspects of the invention, a coating layer is applied to a tablet core so that the coating layer is different from the color of the tablet core. The coating layer is etched by one or more lasers to remove selected portions thereof and reveal the core. Removal of selected portions of the coating layer, while other portions remain unetched by the laser(s), causes a variation in the color of the coating layer. The color of the tablet core may be visible at locations at which portions of the coating layer have been entirely removed while the color of the coating layer, i.e., the color of any of the color coatings thereof, is visible at locations at which portions of the coating layer have been only partially removed or not removed at all.

Abstract: The various embodiments provide methods and apparatus high-throughput reading and decoding of information-encoding features (especially identification features) on pharmaceutical compositions for the purpose of e.g. counterfeiting detection and inventory tracking/tracing. A preferred embodiment provides high-throughput imaging of regular arrays of pharmaceutical tablets with a scanning electron microscope. Another preferred embodiment provides video-rate scanning probe imaging of pharmaceutical compositions and especially atomic force microscopy imaging thereof.

Abstract: Overt anti-counterfeiting features on objects and compositions, especially pharmaceutical compositions. In a preferred embodiment, a counterfeiting-proof overt feature that presents a visually distinctive optical variable or invariable effect is manufactured on a pharmaceutical composition using a purely physical process. Further preferred are counterfeiting-proof, overt features that comprise at least one engineered array of micro- or nanostructures. Also provided are methods and apparatus for the manufacturing of said overt features on said objects and compositions, including pharmaceutical compositions, and for verifying the authenticity of said features. The inventive features do not reside in the method of making the stamp or the instrument used for stamping.

Abstract: Orally disintegrating tablets containing colored granules of a water-soluble sugar which give them a speckled appearance are described. The orally disintegrating tablets with speckled appearance are readily and easy identifiable by physicians, nurses and patients.

Abstract: The invention provides a novel “separation marking” on a tablet as a means for assisting in the identification of a region on the tablet that is desired to be able to be broken from time to time. Said breaking allows production of smaller dosage forms known herein as tablettes. In a preferred embodiment, the separation mark will be a printed mark that is made on the tablet surface.

Abstract: A unit assembly including a plurality of individual film strips, each film strip having an active within a polymer matrix, the film strips having respective perimetrical edges, the plurality of individual film strips being alternatingly positioned next to one another such that a film strip perimetrical edge is at least partially offset from a subsequent film strip perimetrical edge, wherein the respective perimetrical edges of the film strips are directly adjacent to each other.

Abstract: The invention is an article of manufacture, comprising an identifying marker disposed in a pharmaceutical product. The pharmaceutical product may be selected from the group consisting of a pharmaceutical liquid, a pill, a tablet, a caplet, and a capsule. The identifying marker may be a hydroscopic medium having an indicia imprinted thereon or within, where the marker expands volumetrically when contacted with a liquid.

Abstract: Hard shell capsules filled with a pharmaceutical medicament and at least one modifier, selected to prevent abuse of the medicament are described. The modifier may have a high melting point, and therefore melt at a temperature too high to inject or be insoluble in liquid, having a density less than 1, to prevent “spiking” of drinks. The modifier may also be a waxy substance which cannot be crushed, a viscosity modifier, a dye or a taste modifier.

Abstract: The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment.

Abstract: The present invention relates to a coated dosage form having openings to expose the core material or an intermediate coating layer. The invention also relates to methods for manufacturing such coated dosage forms.

Abstract: The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone may be increased in patients with hepatic impairment.

Abstract: The present invention relates to a verification method of tablets, in particular pharmaceutical tablets. It further relates to an invisible secure marking or information which is a part of such tablet. The invention further relates to tablets suitable for such verification method, to processes for manufacturing such tablets and methods for reading the information.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: A security device having: a base having a pattern thereon; a mobile component disposed in contact with the base, the mobile component containing a plurality of reversibly adsorbable particles; and a cover attached to the base around the mobile component to maintain the mobile component in contact with the base; wherein the adsorbable particles are mobile and reversibly changeable between a first state where the adsorbable particles are adsorbed to at least a predetermined percentage of the pattern and a second state where the adsorbable particles are adsorbed to less than the predetermined percentage of the pattern.

Abstract: A medical device is loaded with a number of therapeutic agents using a corresponding method to apply a medicated ink mark. The resulting medical device can include surface activation of an immobilizing medication, controlled medication release, and the ability to use dyes or pigments to delineate different active ingredients by location and dosage. The active medicinal compounds can be placed on selective areas of the medical device. The medical device having the medicated ink mark can provide a detectable and dosemetric controllable delivery to a specific targeted and localized location to provide the maximum therapeutic benefit. The medicated ink may be applied to the medical device by a number of different methods, by a manufacturer or by the user at the time of medical device use. Dimensions of the markings printed onto the medical device can further serve to control and identify to the user the dosage amount of the medical agent available on the marked medical device.

Abstract: Drug formulations having reduced abuse potential which contain one or more of (1) a bittering agent, (2) a bright deterrent/indicator dye and (3) fine insoluble particulate matter. The bittering agent and dye are in a form which does not affect proper administration of the drug, but the bittering agent creates a bitter side effect when the dosage form is crushed or chemically extracted and nasally, orally, buccally or sublingually administered and the dye produces a bright color when crushed and contacted. The fine insoluble particulate matter hinders extraction of the drug from the dosage form and, when crushed, can deter intravenous injection because of the presence of the insoluble particles or hinder injection by blocking an intravenous needle. The bright color of the dye, when extracted, also has a psychologically deterrent effect on intravenous abusers.

Abstract: Novel micro-encapsulated topical analgesics are provided to treat pain and may be applied via sleeves having dosed therapeutic sections, especially to joints and extremities. Sleeves may be prepared inside-out and inverted when positioned by the wearer.

Abstract: Compositions and methods are provided for the treatment of pain. Compositions and methods are further provided for inhibiting the development of tolerance to addictive therapeutic agents (especially narcotic analgesics) in patients treated with such agents; for minimizing adverse effects (e.g., dependence) resulting from treatment with such addictive agents; and for enhancing pain relief resulting from narcotic analgesic administration. The compositions generally comprise a nontoxic VR1 antagonist, optionally in combination with an addictive therapeutic agent. Patients may be treated with a VR1 antagonist before, during or after administration of the addictive therapeutic agent to prevent, decrease the severity of, delay or treat tolerance and/or other adverse effects of the addictive agent in the patient.