Abstract: A multi-compartment capsule may include a body, a diaphragm between, which seals off the body and provides a first compartment to hold an ingredient, and a cap applied to the body whereby a space between the inner portion of the cap and the diaphragm defines a second compartment for holding an oil. A two-compartment capsule may include a body, a diaphragm between, which seals off the body and provides a first compartment to hold an oil, and a cap applied to the body whereby a space between the inner portion of the cap and the diaphragm defines a second compartment for holding an ingredient. The ingredient may have increased bioavailability after exposure to the oil. This disclosure also provides particular formulations for use in such a capsule.

Abstract: There is disclosed an oral pharmaceutical formulation of bitter compounds that are agonists of taste receptor type 2 (TAS2R) receptors for the function of appetite suppression for the treatment of obesity. More specifically, the present disclosure provides an anti-obesity oral formulation comprising a bitter agent selected from the group consisting of denatonium salts including benzoate (DB), chloride (DC), acetate (DA), citrate (DCl), saccharide (DS), tartarate (DT), maleate (DM), 3-caffeoylquinic-1,5-lactone (3-CQL), chlorogenic acids (CGA), combinations thereof, and pharmaceutical excipients to facilitate a sustained release during transit through the gastrointestinal (GI) tract. Preferably, the oral pharmaceutical formulation further comprises either or both a sweet antagonist selected from the group consisting of lactisole, gymnemic acid, ziziphin, hodulcine, and combinations thereof, and a sour organic acid.

Abstract: The present disclosure relates to a separable hard capsule for containing a medication. The capsule may be opened by finger force and used, for example, by pediatric and geriatric patients.

Abstract: A controlled release delivery device for controlled release of an active ingredient comprising: (i) a core particle comprising the active ingredient homogenously dispersed or dissolved therein; and (ii) an organosol polymeric coat comprising a homogenous mixture of, (a) a water soluble gel forming polymer and a water insoluble organosoluble polymer in a dry weight ratio of from about 20:80 to about 50:50, (b) an organosolvent, and (c) an anti-tacking agent; the organosol polymeric coat being applied directly to and substantially enveloping the core particle.

Abstract: A controlled release delivery device for controlled release of an active ingredient comprising: (i) a core particle comprising the active ingredient homogenously dispersed or dissolved therein; and (ii) an organosol polymeric coat comprising a homogenous mixture of, (a) a water soluble gel forming polymer and a water insoluble organosoluble polymer in a dry weight ratio of from about 20:80 to about 50:50, (b) an organosolvent, and (c) an anti-tacking agent; the organosol polymeric coat being applied directly to and substantially enveloping the core particle.

Abstract: The present disclosure relates to a separable hard capsule for containing a medication. The capsule may be opened by finger force and used, for example, by pediatric and geriatric patients.

Abstract: The present invention provides a banding composition for hard capsules using hydroxypropylmethyl cellulose (HPMC) as a base comprising (1) low viscosity HPMC; (2) a component selected from the group consisting of methanol, ethanol, isopropanol, 1-propanol, acetone and/or ethyl acetate; (3) a surfactant; and (4) water; and a method for banding hard capsules using hydroxypropylmethyl cellulose as a base by using the banding composition described.

Abstract: The present technology provides intravaginal devices designed to deliver lubricants to the vagina for a sustained period of time. The intravaginal devices include a first segment comprising an outer surface and a lumen containing a lubricant, wherein the first segment is configured to deliver the contents of the lumen to the outer surface, and the first segment comprises a polymer selected from the group consisting of a hydrophilic, semi-permeable elastomer and a hydrophobic elastomer. The lubricant may be an aqueous lubricant. The present technology further provides an intravaginal device including a solid first segment that includes a hydrophilic semi-permeable elastomer, an outer surface and an aqueous lubricant, wherein the first segment is configured to deliver the aqueous lubricant to the outer surface.

Abstract: The present technology provides intravaginal devices designed to deliver lubricants to the vagina for a sustained period of time. The intravaginal devices include a first segment comprising an outer surface and a lumen containing a lubricant, wherein the first segment is configured to deliver the contents of the lumen to the outer surface, and the first segment comprises a polymer selected from the group consisting of a hydrophilic, semi-permeable elastomer and a hydrophobic elastomer. The lubricant may be an aqueous lubricant. The present technology further provides an intravaginal device including a solid first segment that includes a hydrophilic semi-permeable elastomer, an outer surface and an aqueous lubricant, wherein the first segment is configured to deliver the aqueous lubricant to the outer surface.

Abstract: The invention provides a multi-compartmented container suitable for the delivery of pharmaceuticals, medicines, vitamins, and the like.

Abstract: A capsular design is disclosed for self-administered delivery of a pre-determined amount of liquid medication. The capsular design can be constructed as having either a single piece or two piece capsular wall construction where a portion of the liquid medication contained within can be administered sublingually and the remaining portion can be subsequently swallowed for gastro-intestinal absorption.

Abstract: Methods and apparatus for providing a leak-proof seal for two-piece capsules containing oil-based liquids or other compositions by a two-stage process. The capsule cap and capsule body are combined by a nitrogen purge instant bonding (NPIB) system. An overlay medium is applied to selected portions of the capsule, including near the seam formed by the interconnection of the capsule cap and capsule body to provide a substantially leak-proof seal. The overlay medium is made from materials that make up the capsule cap and capsule body, including gelatin, starch, cellulose or polysaccharides, among others, which are dispersed in a hydro-alcoholic, aqueous or organic solution. The overlay medium includes additives to impart desired qualities to the capsule and include taste-enhancers, taste-maskers, odor-enhancers and odor-maskers. The additives may include color additives, aroma additives and taste additives.

Abstract: An encapsulation system is provided comprising nitrogen-purge, instant bonding encapsulation method. Specifically, the encapsulation system comprises a composition, a two-piece capsule comprising a capsule cap and a capsule body; a gas to purge oxygen from the composition within the capsule; and a sealing solution to seal the capsule cap to the capsule body. Associated methods for encapsulating compositions using the encapsulation system are also provided.

Abstract: This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.

Abstract: The present invention relates to a hard capsule composite formulation comprising a capsule having a hemispherical closure at each end and an interior space; and one or more tablets encapsulated in the capsule, wherein the tablet or the tablets as a whole have a shape conforming to the internal space of the capsule. The hard capsule composite formulation can efficiently charge pharmaceutical compositions inside the limited interior space of the capsule, and hence, it allows packing a high-dose of pharmaceutical composition in a relatively small-sized capsule, which increases productivity and patient compliance. Also, the composite formulation exhibits good dissolution rate because pharmaceutically active ingredients contained in the capsule are separated from one another, and thus, the ingredients are less affected by the dissolution rate of one another, allowing good storage stability which can optimize the therapeutic effects.

Abstract: A gelatin capsule is disclosed that is designed to impart less tensile stress on the component parts when it is in the closed position and experiences less spontaneous breakage particularly when fill with hygroscopic liquids. The gelatin capsule comprises a cap portion and a body portion. The cap portion includes an annular ring and the body portion includes an annular groove. Together, the annular ring and the annular groove comprise a locking ring, which are designed to reduce the capsule cap and body contact force and stress raisers. The invention includes a cap locking ring inner diameter that is same as body locking ring outer diameter or slightly smaller to make the contacting force at the locking ring lower than current capsule designs. The body portion also includes a tapered ring configured such that, in the closed position the rim of the body portion does not contact the cap portion.

Abstract: Described embodiments include a final dosage form for administering a medicament to an animal, an article of manufacture, and method. A described final dosage form includes a dosage portion having a medicament and a release element in a first medicament-release state. The medicament has a first bioavailability to the animal. The release element is modifiable ex vivo to a second medicament-release state by an exposure to a stimulus, wherein the medicament has a second bioavailability to the animal. The final dosage form includes another dosage portion having another medicament and another release element in another first medicament-release state. In the another first medicament-release state, the another medicament has another first bioavailability to the animal. The another release element is modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal.

Abstract: The invention provides a method of manufacturing and packaging a room temperature stable cannabinoid dosage in an oil-based carrier, wherein the method employs the use of blister packaging and an inert gas atmosphere during blister packaging. The invention also provides a room temperature stable cannabinoid dosage prepared by the methods of the invention.

Abstract: The invention relates to a capsule comprising a hollow tubular body (2), a hollow cap (3) telescopically engageable on the body (2), the body (2) and the cap (3) defining an inner volume therebetween and being provided with complementary snap-fit means (12, 21) for locking the cap (3) on the body (2) in the fully closed final position, the complementary snap-fit means (12, 21) comprising a locking ring (12) formed on the body (2) and a complementary ridge member (21) formed on the cap (3), at least one air-vent (14) formed as an axial recess on the outer surface of the body (2) and suitable for ensuring fluid communication between the inner volume and the atmosphere.

Abstract: A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.

Abstract: Disclosed in certain embodiments is an oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse; and an effective amount of an irritant to impart an irritating sensation to an abuser upon administration of said dosage form after tampering.

Abstract: Capsule shells for use in multi-part dosage forms have generally cylindrical shell members with a snap fit component on an interior surface adjacent an open end, for connection to a linker part of the dosage form. The shell member also has a plurality of spaced apart integrally formed thin (relative to circumferentially adjacent shell member portions) panels located adjacent a closed shell member end, for preferential dissolution and release of pharmaceutical compositions from the shell member interior. The ratio of the thickness of the panels to the thickness of the shell member ranges from about 0.2 to about 0.6. The panels can be integrally formed together with the shell member as reliefs or depressions on the inner surface of the shell member by injection molding, and panel thicknesses as thin as about 0.1 mm can be achieved.

Abstract: A multi-component pharmaceutical dosage form comprising a plurality of drug substance—containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: A container and more specifically a container such as a capsule used to deliver dosages of pharmaceuticals, medicines, vitamins, etc. to an individual is discussed. In one embodiment, the invention includes a container comprising: a cap; a body slidably engagable inside the cap; and a fluid gap positioned between the cap and the body adjacent an end of the cap, wherein a first channel of the cap and a first channel of the body form a snap fit joint and a second channel of the cap and a second channel of the body form a fluid stop joint whereby a sealing fluid is substantially restricted to the fluid gap by the fluid stop joint.

Abstract: The present invention relates to capsules for holding pharmaceutical preparations for powder inhalers with increased drug safety and capsules for pharmaceutical preparations for powder inhalers with improved adaptation to their use in powder inhalers. The capsules consist of water-insoluble hydrophobic synthetic materials which do not significantly affect the pharmaceutical quality of the contents themselves, but which improve the usability of the filled capsules with regard to their function, their longevity, and/or the geographic location of their use, and are advantageous at various stages from manufacture up to utilization.

Abstract: A method of sealing parts of a plastic capsule by forming a weld seam in an overlapping region of the parts of the capsule, wherein the capsule comprises a capsule cap having an open end and a capsule body having an open end, and capsules formed by such method. The capsules produced by the process according to the invention are disposable and preferably contain a single dose of a pharmaceutical formulation in the form of a powder or liquid intended to be administered by inhalation and are suitable by their form and function for use in powder inhalers or liquid nebulizers for producing aerosols. Aerosols thus produced can be inhaled, for example, in order to administer a pharmaceutical formulation to the lungs.

Abstract: A method of fabricating a drug-transfer device includes forming a package having a first component retaining multiple volumes of a drug and a second component retaining an agent. The first component and the second component are integrally formed together. The agent is configured to suppress a physiological effect of the drug when the agent contacts the drug or is coadministered with the drug. The method allows exterior surfaces of the first and second components to be cleanable (e.g., prior to final assembly). After such cleaning, either no or substantially no amount of drug and agent is present outside the package. According to some embodiments, the package may be fabricated such that either no or substantially no amount of the drug is present within the second component and such that either no or substantially no amount of the agent is present within the first component.

Abstract: Novel diterpene compounds, in particular, hypoestoxide-related compounds, are provided in pure form or as contained in the native plant source, for treatment and prophylaxis of cancer, inflammatory diseases, hyperlipidemias, malaria, and diabetes mellitus. Embodiments also pertain to methods for using the hypoestoxide-related compounds to treat various diseases and symptoms associated with those diseases.

Abstract: The present invention provides a dosage form that prevents misuse of the medicament contained within. The dosage form contains an inactivating substance in combination with the medicament, wherein the two substances are separated by a permeable or semi-permeable partition. The partition becomes impermeable upon activation by a medical professional, thereby effectively sequestering the inactivating substance from the medicament and allowing for the intended administration of the medicament to the patient. Unless activated, however, the inactivating substance and medicament remain commingled in the dosage form, and any attempt to dispense the medicament before activation will result in the release of inactivated medicament.

Abstract: A gelatin capsule is disclosed that is designed to impart less tensile stress on the component parts when it is in the closed position and experiences less spontaneous breakage particularly when fill with hygroscopic liquids. The gelatin capsule comprises a cap portion and a body portion. The cap portion includes an annular ring and the body portion includes an annular groove. Together, the annular ring and the annular groove comprise a locking ring, which are designed to reduce the capsule cap and body contact force and stress raisers. The invention includes a cap locking ring inner diameter that is same as body locking ring outer diameter or slightly smaller to make the contacting force at the locking ring lower than current capsule designs. The body portion also includes a tapered ring configured such that, in the closed position the rim of the body portion does not contact the cap portion.

Abstract: The invention relates to a capsule comprising a hollow tubular body (2), a hollow cap (3) telescopically engageable on the body (2), the body (2) and the cap (3) defining an inner volume therebetween and being provided with complementary snap-fit means (12, 21) for locking the cap (3) on the body (2) in the fully closed final position, the complementary snap-fit means (12, 21) comprising a locking ring (12) formed on the body (2) and a complementary ridge member (21) formed on the cap (3), at least one air-vent (14) formed as an axial recess on the outer surface of the body (2) and suitable for ensuring fluid communication between the inner volume and the atmosphere.

Abstract: A multi-component pharmaceutical dosage form comprising a plurality of drug substance—containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: A multi-component pharmaceutical dosage form comprising a plurality of drug substance—containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: The present invention provides a pharmaceutical that includes, in combination, a resinate and an aversive agent. The resinate includes an ion exchange resin and an drug. The drug is a controlled substance. In variants of the invention, both the aversive agent and the controlled substance are loaded onto the ion exchange resin; the aversive agent is loaded onto the ion exchange resin, and the controlled substance is not loaded onto the ion exchange resin; the controlled substance is loaded onto the ion exchange resin, and the aversive agent is not loaded onto the ion exchange resin; or, the controlled substance is loaded onto a first ion exchange resin, and the aversive agent is loaded onto an ion exchange resin different from the first ion exchange resin.

Abstract: A linker for multicomponent dosage form has a preformed drug substance tablet and an injection molded jacket including one or both axial jacket ends open for dispensing the preformed drug substances. The jacket has snap-fit connection elements on the outer surface adjacent each end for engagement with complementary snap-fit element on capsule-type and cap-type dosage form units. Another multicomponent drug form linker is injection molded with a raised circumferential band and snap-fit elements between the band and respective ends engageable with complementary snap-fit elements on dosage form units to provide compressive abutting contact between ends of the units and the band. The band can have an axially tapered outer surface to accommodate dosage form units of different diameters. Still another multicomponent dosage form linker has separable male and female parts each engageable with, and separately sealing, respective dosage form units to be linked.

Abstract: This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.

Abstract: The present invention provides a band seal for hard capsules filled with PEG, particularly a low-molecular-weight PEG, PEG 200 to 600, the band seal being capable of effectively preventing content leakage through the gap between the body and cap of the capsule; and a liquid for preparing the band seal. The present invention further provides a hard capsule filled with PEG, particularly a low-molecular-weight PEG, PEG 200 to 600, the filled capsule being prevented content leakage through the gap between the body and cap of the capsule. The band seal can be prepared using a polyvinyl alcohol, a polyvinyl alcohol copolymer, or a mixture thereof as a main component.

Abstract: The present invention relates to capsules for holding pharmaceutical preparations for powder inhalers with increased drug safety and capsules for pharmaceutical preparations for powder inhalers with improved adaptation to their use in powder inhalers. The capsules consist of water-insoluble hydrophobic synthetic materials which do not significantly affect the pharmaceutical quality of the contents themselves, but which improve the usability of the filled capsules with regard to their function, their longevity, and/or the geographic location of their use, and are advantageous at various stages from manufacture up to utilization.

Abstract: Effective stimulation of immune responses is achieved through the use of a group A streptococcal antigen combined with proteosome adjuvant. The compositions are provided in particular for intranasal administration. The vaccine compositions are provided for use in inducing an immune response in an individual for the treatment or prophylaxis of group A streptococcal infection in an individual, preferably via prevention or reduction of colonisation of the throat following intranasal administration.

Abstract: This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.

Abstract: A multi-component pharmaceutical dosage form comprising a plurality of drug substance-containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Abstract: An osmotic delivery system for controlled delivery of a beneficial agent includes an implantable capsule containing a beneficial agent and an osmotic engine that swells on contact with water, thereby causing the release of the beneficial agent over time. The osmotic delivery system has a membrane material that allows a controlled amount of fluid to enter from an exterior of the capsule, while preventing the compositions within the capsule from passing out of the capsule. The osmotic delivery system is designed to meet at least the operating pressures of 1000 psi. The membrane material is cast, calendered or extruded followed by machining (i.e., die-cutting, stamping or otherwise cutting to shape) to provide a uniform nonribbed membrane material. The capsule also includes a membrane material-retaining means that is positioned at a fluid uptake end to retain the membrane material within the capsule, even under periods of high pressure.

Abstract: The present invention provides provide a dosage form that prevents misuse of the medicament contained within. The dosage form contains an inactivating substance in combination with the medicament, wherein the two substances are separated by a permeable or semi-permeable partition. The partition becomes impermeable upon activation by a medical professional, thereby effectively sequestering the inactivating substance from the medicament and allowing for the intended administration of the medicament to the patient. Unless activated, however, the inactivating substance and medicament remain commingled in the dosage form, and any attempt to dispense the medicament before activation will result in the release of inactivated medicament.

Abstract: The invention provides a drug delivery system for delivering a drug to either the small intestine (enteric) or the colon comprising a HPMC capsule containing the drug and wherein the HPMC capsule is provided with a suitable coating such that the drug is released from the capsule either in the small intestine or the colon.

Abstract: The invention concerns polyvinyl alcohol (PVA) compositions for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard capsules. Compared with hard gelatine capsules (HGC) capsule films consisting of PVA have extremely low water vapour permeability and much lower water content.

Abstract: The invention herein provides for an oral pharmaceutical composition adapted for use in capsular dosage forms comprising acetaminophen and a lactate salt alone or in combination with an acetate salt. Compositions of the invention exhibit improved solubility characteristics of the active ingredient per given fill volume, thereby permitting the use of smaller capsule sizes to deliver a given effective dose of the active ingredient. Compositions of the invention also exhibit improved clarity per concentration of active ingredient. The invention also provides for a capsular dosage form containing the composition.

Abstract: The invention concerns Gelatin compositions for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard gelatin capsules wherein the gelatin used is of non-bovine and non-pig origin and preferably derived from fish, poultry or plant sources. Especially preferred are film compositions for hard gelatine capsules prepared from fish gelatin.

Abstract: An oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a first population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a first rate; a population of a basic substance; and a second population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a second rate. In another embodiment, the oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a population of a pharmaceutical active; a population of a basic substance; a population of enteric coated pharmaceutical active; and a population of enteric coated basic substance. The composition can provide multiple site specific delivery of a pharmaceutical active in a rapid, delayed and/or sustained release manner into the plasma.

Abstract: The invention concerns Gelatin compositions for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard gelatin capsules wherein the gelatin used is of non-bovine and non-pig origin and preferably derived from fish, poultry or plant sources. Especially preferred are film compositions for hard gelatine capsules prepared from fish gelatin.

Abstract: The present invention relates to a novel modified release pharmaceutical composition comprising the coated capsule body, coated or uncoated capsule cap, at least one tablet and granulate comprising active substance.