Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: The present invention relates to a multilayered coated tablet comprising at least three layers, i.e., first, second and third layer wherein the first and third layers contain at least one active pharmaceutical ingredient and the second layer is either a placebo or an immediate-release drug layer. Further, the tablet has a delayed-release coating, wherein the coating may contain one or more pore-forming agents and/or orifices on one or both sides. Furthermore, it may contain an immediate-release layer of the drug over the delayed-release coating layer. The present invention further relates to processes for preparing such a multilayered coated tablet.

Abstract: Drugs are formulated as oral dosage forms for controlled release in which the release rate limiting portion is a shell surrounding the drug-containing core. The shell releases drug from the core by permitting diffusion of the drug from the core. The shell also motes gastric retention of the dosage form by swelling upon imbibition of gastric fluid to size that is retained in the stomach during the postprandial or fed mode.

Abstract: The invention relates to an orodispersible tablet comprising the components pharmaceutically acceptable sildenafil salt (a), polymeric adsorbent (b), in particular cation exchanger resin, sweetener (c), and flavoring (d) and, preferably, mucilage (e) and glidant (f). The invention furthermore relates to a process for the preparation of orodispersible tablets comprising a pharmaceutically acceptable sildenafil salt and to the use of a combination of cation exchanger resin and mucilage for masking the flavor of medicaments for treating erectile dysfunction.

Abstract: The present invention features a method of making a coated tablet by dipping a core comprising an active agent into a coating liquid and drying said dipped core to form a outer-coating on the core, wherein the coating liquid contains at least one a starch having an amylose content of at least about 50 percent by weight of said starch.

Abstract: Aspects of the present invention are directed to abuse resistant oral dosage forms comprising a compressed microtablet that is coated with a water-retardant polymer. Additional aspects of the present invention are directed to an oral dosage form comprising an opioid agonist and at least one compressed microtablet coated with a water retardant polymer. The compressed microtablet may comprise an opioid antagonist.

Abstract: A tablet for oral administration comprises a matrix of progressive and continuous released magnesium. For the administration of 90 to 110 parts by weight of magnesium, the matrix comprises 180 to 190 parts by weight of hydroxypropylmethylcellulose, 19.8 to 22.2 parts by weight of glyceryl behenate, 10 to 12 parts by weight of lactose and 10 to 12 parts by weight of colloidal silica. A non-enteric protective coating that slows down the gastric dissolution of the magnesium may comprise 15 to 75 parts by weight of shellac, cellulose ether or a mixture thereof. The tablet may be administered to patients in need thereof.

Abstract: The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.

Abstract: The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.

Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

Abstract: Aspects of the present invention are directed to oral dosage forms comprising a compressed microtablet, wherein said microtablet has a major dimension that is between about 0.25 mm and about 1.0 mm and comprises at least about 0.01 weight percent of at least one pharmaceutically active agent that is distributed substantially throughout said microtablet. Additional aspects of the present invention are directed to methods for producing compressed microtablets having a major dimension that is between about 0.25 mm and about 1.0 mm.

Abstract: It is an object to provide a coating composition, which is used for an orally-administered preparation, the administering property of which has been improved, and/or an easily administrable preparation that does not affect dissolution property. The aforementioned object can be achieved using a coating composition comprising a first thickener selected from the group consisting of a carboxyvinyl polymer and sodium alginate, a polyvalent metal compound, and at least one type of a second thickener selected from the group consisting of xanthan gum, guar gum and sodium alginate, with the proviso that when the first thickener is sodium alginate the second thickener is not sodium alginate, or using a coating composition comprising, as thickeners, hydroxypropylmethylcellulose and sugar or sugar alcohol having a solubility at 20° C. of 30 or more.

Abstract: The present invention is related to the use of a non-cellulosic cationically modified polysaccharide in cleaning compositions and more particularly to a surfactant based cleansing composition comprising, a surfactant, a non-cellulosic cationically modified polysaccharide and a solvent for use in personal care composition, household care composition or an institutional care composition.

Abstract: Dual release oral tablet compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

Abstract: A solid composition in the form of a tablet that generates and releases a biocidal solution comprising at least chlorine dioxide with an enhanced weight percent yield is presented. The composition comprises reactants capable of in-situ generation of chlorine dioxide comprising a chlorite donor that is coated with a gel-forming material that slows the rate of dissolution of the high solubility chlorite donor, a free halogen donor, and an acid source, resulting in an unexpectedly high weight percent yield and providing a controlled release of biocidal solution. The compositions of the invention show improved environmental stability which can reduce the cost of packaging and significantly increase the utility of the composition. The controlled release allows the use in multi-tablet chemical dispensers which may otherwise induce potentially explosive conditions or allow rapid release of the biocidal solution thereby inducing a spike in chemical concentration rather than a controlled and sustained release.

Abstract: This invention relates to a pharmaceutical dosage form for the phase-controlled and chronotherapeutic delivery of at least one and, preferably, several pharmaceutically active ingredients. The dosage form has a carrier platform which,—preferably, is a polymer having known biodegradable characteristics. The platform may include a pharmaceutically active ingredient'which is released over a predetermined period of time as the platform polymer degrades. At least one pharmaceutically active ingredient in the form of a disc is embedded in the platform and, once the polymer of the platform has degraded, the disc is released and releases its ingredient in the same location as that of the platform or it travels to another region of the body where it releases its ingredient.

Abstract: A solid composition in the form of a tablet that generates and releases a biocidal solution comprising at least chlorine dioxide with an enhanced weight percent yield is presented. The composition comprises reactants capable of in-situ generation of chlorine dioxide comprising a chlorite donor that is coated with a gel-forming material that slows the rate of dissolution of the high solubility chlorite donor, a free halogen donor, and an acid source, resulting in an unexpectedly high weight percent yield and providing a controlled release of biocidal solution. The compositions of the invention show improved environmental stability which can reduce the cost of packaging and significantly increase the utility of the composition. The controlled release allows the use in multi-tablet chemical dispensers which may otherwise induce potentially explosive conditions or allow rapid release of the biocidal solution thereby inducing a spike in chemical concentration rather than a controlled and sustained release.

Abstract: The invention relates to a gastric juice-resistant device for releasing active substance excipients having delayed intestinal passage from a gastric juice-resistant enclosure, and which serves to increase the active substance concentration in the intestines. The inventive device is characterized in that the active substance excipient containing at least one active substance is provided in the form of a multiparticulate preparation whose individual particles have mucoadhesive properties. The invention also relates to a method for producing said device.

Abstract: Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

Abstract: A method of forming a tablet includes the steps of pre-blending an active pharmaceutical ingredient susceptible to tackiness and a blending additive with a first mixing effort to form a pre-blend mixture, wherein the first mixing effort and a second mixing effort, resulting from mixing at least one excipient with the pre-blend mixture, form a blend suitable for direct compression and compressing the blend to form the tablet. One way of achieving the first mixing effort is to pre-blend for an extended period of time. The method allows for directly compressing the blend without the need for a granulation step or roller compression. One such active pharmaceutical ingredient susceptible to tackiness is ibuprofen.

Abstract: A composition of an oral medicine or an oral medicine which can prevent an unpleasant taste of the medicine is herein disclosed. It is granules, powders, syrups and the like which is prevented from an unpleasant taste, comprising a basic medicine having an unpleasant taste and an anionic polymer such as carrageenan.

Abstract: The invention relates to the combination of polyvinyl acetate and water-insoluble, acid-insoluble, or alkali-insoluble polymers used for producing film coatings for forms of administration in which agents are released in a controlled manner, and methods for the production thereof. The controlled-release properties can be specifically adjusted by means of said combinations, resulting in films having excellent mechanical stability and storage stability. In particular, agents are released independent of the pH by means of the inventive forms of administration.

Abstract: In one aspect, the present invention features a method of making a coated tablet, by dipping a core including an active agent into a coating liquid and drying the dipped core to form a outer-coating on said core, wherein the coating liquid includes (i) at least one copolymer of polyvinyl alcohol and polyethylene glycol, (ii) at least one gum, and (iii) a solvent for the at least one copolymer of polyvinyl alcohol and polyethylene glycol and the at least one gum and coated tablets manufactured by such method.

Abstract: This invention relates to solid and stable dispersions of a hydrosoluble derivative of vinca alkaloids in at least one polyethyleneglycol with a molecular mass between 800 and 30,000.

Abstract: Sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; methods for making the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; and methods for using the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof to treat patients suffering from pain are provided.

Abstract: A coated drug-ion exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The drug-ion exchange resin complex is in admixture with a release retardant. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.

Abstract: Disclosed herein is a oral extended release dosage form comprising a plurality of granules of an effective amount of a pharmaceutically active compound, at least one amino acid, and an intragranular polymer in which the granule is dispersed within a hydrophilic extragranular polymer matrix which is more rapidly hydrating than the intragranular polymer. The amino acid is selected for hydropathy characteristics depending on solubility characteristics of the active compound.

Abstract: The invention provides sustained release formulations of metformin or a pharmaceutically acceptable salt thereof, and methods of treating diabetes by administering to a patient a therapeutically effective amount of a sustained release formulation of metformin or a pharmaceutically acceptable salt thereof.

Abstract: A pharmaceutical composition of anti-tubercular drugs for oral use comprising Rifampicin and/or Isoniazid wherein the bioavailability of Rifampicin and/or other drugs is enhanced. Preferably the bioavailability of Rifampicin is enhanced by preventing its degradation caused by presence of Isoniazid. Rifampicin and/or Isoniazid may be present in delayed release and/or extended release form such that minimal amount of the drug is dissolved between pH 1 and 4. preferably delayed release of Rifampicin and/or Isoniazid is achieved by treating the drugs with pH sensitive polymers.

Abstract: This invention refers to: multiparticulate formulations of Lithium salts for oral administration constituted by either modified release granules or mixtures of modified and conventional release granules, suitable for once-a-day administration also at high strengths of Lithium salts, and to the preparation process of said formulations.

Abstract: A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and at least one carrageenan is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, to provide burst release of active ingredient contained therein.

Abstract: The invention provides a process for coating a branded pharmaceutical dosage form for the purpose of covering any embossed or printed matter or any colored coating by the application of an amount of a sugar based coating which is sufficient to obscure any identifying indicia without compromising the stability or releasability of the drug that is contained in the dosage form.

Abstract: The present invention provides an ink composition for use in ink jet printing on food items, candy, particularly dark candy, such as chocolate, and to a method of forming printed images on such food items by use of the ink compositions. The compositions of the present invention comprise a pigment, a binder, and an aqueous carrier.

Abstract: There are provided an aqueous shellac coating agent comprising shellac, a basic amino acid and/or a basic phosphate, as well as a production process therefor; a coated food and a coated drug that have been coated with such a coating agent; a glazing composition for oil-based confectionary which is in a liquid form and comprises an aqueous shellac solution (A) containing shellac, a basic amino acid and/or a basic phosphate dissolved in water, a thickener (B), and/or a sugar (C); a process for glazing oil-based confectionary in which this glazing composition is applied to oil-based confectionary to be glazed, thereby generating a glaze; and glazed oil-based confectionary produced using this process for glazing oil-based confectionary.

Abstract: An oral composition which is adapted to be dispersed in an aqueous carrier substantially immediately prior to administration comprises a multiplicity of particles comprising an active substance, the particles being combined with one or more gelling or swelling agents capable of forming a viscous medium around the particles in an aqueous carrier as well as being provided with a masking surface layer when dispersed in the aqueous carrier. This serves to mask uneven surfaces on the particles and prevent them from adhering to oral mucosa when the composition is ingested and thus makes it easier to administer large dosages of an active substance. The masking surface layer is preferably provided by an increased viscosity of the viscous medium in the immediate vicinity of the particles relative to the viscosity of the surrounding aqueous carrier. A ready-to-use composition is prepared by mixing the composition with an aqueous carrier substantially immediately prior to administration of the composition.

Abstract: Sustained release oral solid dosage forms comprising agglomerated particles of a therapeutically active medicament in amorphous form, a gelling agent, an ionizable gel strength enhancing agent and an inert diluent, as well as processes for preparing and using the same are disclosed. The sustained release oral solid dosage forms are useful in the treatment of hypertension in human patients.

Abstract: The invention relates to an oral pharmaceutical composition which has excellent drug release-controlling ability in the mouth even 5 to 10 minutes after its administration and also has excellent drug releasing ability in the digestive tract without using capsules. It also relates to an oral pharmaceutical composition which comprises one or more drugs having a bitter taste, one or more solid proteins, and one or more pharmaceutically acceptable polymer bases, wherein the proteins are present in the polymer bases preferably as particles.

Abstract: The present invention relates to a controlled release pharmaceutical composition comprising amounts ranging from about 0.1 to about 4.5% w/w, of one or more of rate controlling cellulosic ether polymers.

Abstract: A pharmaceutical tablet is provided comprising an intraorally disintegratable core and an excipient coating adherent thereto, wherein the coating comprises gellan gum. The tablet is suitable for intraoral administration, for example for delivery of a drug contained in the core of the tablet to a subject, at least in part by absorption of the drug via oral mucosa of the subject.

Abstract: A method and controlled release oral unit dosage form of acetylsalicylic acid (aspirin) delays the release of the drug until a predetermined time interval after ingestion. This enables the drug to reach optimal therapeutic blood levels at a time in the early morning when the events leading up to a vascular obstruction culminating in a heart attack or stroke are most commonly occurring after the drug is taken in the evening. The convenience of taking the drug every evening should enhance compliance. By arranging for the optimal blood level to coincide with the peak incidence of strokes, a much smaller total dose of the drug may be used than is normally prescribed. This may reduce the incidence of side effects that are dose related. This will make the prophylactic use of aspirin available to more of the population.

Abstract: A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.

Abstract: The present invention relates to a cosmetic or pharmaceutical composition comprising, in a physiologically acceptable medium, a purified natural or synthetic epidermis-specific polypeptide which is involved in horny layer cell cohesion. The invention also relates to a cosmetic or pharmaceutical composition comprising a mixture of polypeptides derived from the proteolysis of the purified polypeptide of the present invention. The present invention further relates to a method for strengthening horny layer cell cohesion which comprises applying the cosmetic or pharmaceutical composition of the present invention to the skin. Finally, the present invention relates to a method for reducing horny layer cell cohesion, and thereby promoting exfoliation, wherein said method comprises applying to the skin a cosmetic or pharmaceutical composition comprising an effective amount of at least one protease active on the polypeptide of the present invention.

Abstract: A film coated tablet wherein the tablet is film coated with a gellan gum coating composition containing gellan gum, a plasticizer, and a disintegration aid. Optionally a slip enhancer is added to the composition. A method for coating a tablet with the gellan gum composition wherein the composition is applied as a solution. A method of administering the gellan gum film coated tablet as a pharmaceutical.

Abstract: A pharmaceutical composition comprising a tablet having a dried coating thereon, wherein the composition has a total weight of about 100 mg to about 1.5 g, the dried coating comprises about 0.

Abstract: A pharmaceutical tablet is provided comprising a core and a coating adherent thereto, wherein (a) the core comprises solid particles of a water-soluble dye distributed in a matrix, and (b) the coating comprises gellan gum. The tablet is suitable for peroral or intraoral administration, for example for delivery of a drug contained in the core of the tablet to a subject. The tablet has a speckled appearance that renders the tablet readily identifiable.

Abstract: The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.

Abstract: Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.

Abstract: A drug delivery system for oral administration in solid dry form of greasy/oily/sticky substance(s) and pharmaceutically active substance(s) or pharmaceutically active substance(s) which itself/themselves is/are greasy/oily/sticky) characterized by having a plurality of solid, polymeric matrix beads comprising considerable amounts of greasy/oily/sticky substances and having fast release characteristics and a process for the preparation of such solid, polymeric matrix beads comprising greasy/oily/sticky substances.

Abstract: Granular materials are obtainable by pressing mixtures of at least one pulverulent, rheology-modifying, carboxyl-containing polymer as main component and at least one oil-soluble component.

Abstract: In accordance with the present invention, there are provided composition and methods useful for the in vivo delivery of a pharmaceutically active agent, wherein the agent is associated with a polymeric biocompatible material.