Abstract: Solid drug forms are produced by mixing and melting at least one pharmacologically acceptable polymeric binder and at least one pharmaceutical active ingredient, with or without conventional pharmaceutical additives, in the absence of a solvent to give a plastic mixture and shaping the mixture to the required drug form by extrusion, where the shaping takes place in two steps, with the extrudate being broken into shaped articles in a first step, and these shaped articles being rounded off in a second step in the plastic state.

Abstract: The present invention is directed to an active agent dosage form that is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has an insoluble material circumscribing a portion of the surface of the matrix. The invention is also directed to a method of making the active agent dosage form.

Abstract: A new oral pharmaceutical dosage form comprising a core material that contains a proton pump inhibitor, one or more alkaline reacting compounds and optionally pharmaceutical excipients having a water soluble separating layer and an enteric coating layer. The core material as such is alkaline reacting and the separating layer between the alkaline reacting core material and the enteric coating layer is formed in situ as a water soluble salt between the alkaline reacting compound(s) and the enteric coating polymer. The invention also describes a new efficient process for the manufacture of such a dosage form comprising two functionally different layers in one manufacturing step, and its use in medicine.

Abstract: A process for the production of divisible tablets by melt calendering in which two molding rolls are combined together, at least one of which has depressions with at least one bar which extends up to the surface line of the molding roll and forms a score.

Abstract: A process for producing solid combination tablets which have at least two phases comprises molding a melt of a polymeric binder with or without at least one active ingredient, there being at least one solid product, which may contain an active ingredient incorporated into the still plastic composition during the molding step.

Abstract: A new chewing gum with teeth whitener for helping whiten and brighten teeth while helping freshen the breath. The inventive device includes an elongate gum member having a central bore extending along its longitudinal axis. Extending through the central bore to substantially fill the central bore is a whitening gel which includes a whitening agent for whitening teeth while chewing the gum. The elongate gum member is divided along its length into a plurality of separable chewing portions such that each chewing portion includes portion of the gum member and a portion of the whitening gel member.

Abstract: The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine, comprising:a. a safe and effective amount of a therapeutically active agent incorporated into a compressed, bi-convex tablet, with a maximum diameter of about 4 mm to about 10 mm;b. a non-pH dependent smoothing coat applied to the tablet to provide a smooth tablet surface free from edges or sharp curves; andc. an enteric polymer coating material comprising at least one inner coating layer and only one outer coating layer;wherein the therapeutically active agent is released at a point near the inlet to, or within the colon; each of the inner coating layer(s) is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 5 to about 6.

Abstract: A new pharmaceutical multiple unit tableted dosage form containing omeprazole or one of its single enantiomers or an alkaline salt of omeprazole or one of its single enantiomers, a method for the manufacture of such a formulation, and the use of such a formulation in medicine.

Abstract: This invention relates to devices useful for the controlled delivery of one or more beneficial agents to an environment of use. More specifically, this invention concerns such devices which are powered by hydrogel. This invention also relates to the controlled delivery of one or more beneficial agents to an aqueous environment of use through the use of such hydrogel powered dispensing devices. Also disclosed are methods for the controlled delivery of one or more beneficial agents to an aqueous environment of use which comprises administering to or otherwise placing the devices of this invention in the environment of use.

Abstract: A solid pharmaceutical tablet having a predetermined dosage that can be divided into a plurality of sub-dosage units by applying a minimal amount of force to the tablet. The tablet comprises a solid body having a top surface, a bottom surface, an outer surface, and an inner surface. The inner surface defines an aperture having a shape corresponding to the shape of the tablet. The area of the aperture is at least 15% of the area of the tablet. Impressed within the top surface of the tablet are a first plurality of symmetrical score lines and impressed within the bottom surface of the tablet are a second plurality of symmetrical score lines. The score lines extend from the aperture to the outer surface of the tablet. Finally, each of the sub-dosage units has a dosage that is a fraction of the predetermined dosage of the tablet.

Abstract: The present invention is a process for forming a low density compression dosage unit to provide increased strength. The process of the present invention includes compacting under bi-level compaction pressure to provide a continuous-volume dosage unit which has a first volume defining an edge portion of the unit and a density which is greater than a density of a second volume defining a non-edge portion of the unit. The present invention also includes the product resulting from the process and apparatus used to make such units.

Abstract: A veterinary tablet promotes the ingestion of medicinal substances by domestic animals, especially by cats. The tablet possesses an oblong shape completely lacking rotational symmetry.

Abstract: A mechanical configuration for a tablet, and a method for manufacturing the same, which allows an enteric coating to be applied to an embossed bio-compatible tablet, for identification purposes. The enteric coating remains uniform over the entire tablet allowing for release of the drug as designed.

Abstract: The present invention is directed to an active agent dosage form which is useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a matrix that has on its surface two or more insoluble bands. The invention is also directed to the method for making the active agent dosage form.

Abstract: A method of laser drilling a delivery port (37) in a beneficial agent dispenser (30) is disclosed. A dispenser (30) has a compartment (32) formed by a wall (31) for containing a beneficial agent (33) to be delivered. A laser beam is employed for burning at least partially through the wall (31). The laser beam and the dispenser (30) are positioned relative to one another such that the laser beam is aimed at a predetermined port site (35) on the dispenser (30). The laser beam is turned off (unenergized) during the positioning period. The laser beam is then energized and moved relative to the dispenser (30) for scribing a delivery port (37) proximate the port site (35). The scribing motion moves the laser beam from the port site (35) along a course (37). Preferably the course (37) is closed. The scribing motion causes the burning of the wall (31) by the laser beam to scribe the delivery port (37). The positioning motion and the scribing motion are controlled by a scanning system (16).

Abstract: A drug delivery device is disclosed for delivering a drug to the intestine and the colon. The device comprises external means for delaying the delivery of drug in the stomach, and hydrophobic means for preventing the passage of fluid through the delay means.

Abstract: Controlled release pharmaceutical tablet having a lenticular form consisting of three layers of which the central one or core (a) contains the active principle and the two outer layers or barriers (b) and (c) comprise gellable and/or erodible polymeric material, said barrier layers being equal or different among themselves for composition and/or thickness, while the central layer has a limited external annular surface exposed to the dissolution medium, through which the active principle is released.

Abstract: The present invention relates to an aqueous pharmaceutical suspension composition comprising: from about 0.2% to 20% of a substantially water insoluble pharmaceutical active, e.g. ibuprofen; a suspension stabilizing effective amount of xanthan gum, pregelatinized starch and polyoxyethylene sorbitan monooleate; an effective amount of taste masking composition; and water, as well as a process for producing such aqueous pharmaceutical suspensions.

Abstract: This invention is comprised of printed shaped bodies and sheets comprising gelatin or having at least an outer surface comprised of at least 5% gelatin or chemically modified gelatin, the shaped bodies and sheets being printed with ink by an ink jet. In particular, the ink applied to the shaped bodies and sheets by the ink jet contains an aluminum and/or calcium compound in addition to dyes and/or pigments, or an aluminum and/or calcium dye compound, and optionally non-volatile proportions of solubilizers and/or dispersants. Further, where the ink contains an aluminum compound, the ink is preferably adjusted to alkaline condition. The invention allows shaped bodies or sheets of gelatin to be printed with ink that is unlikely to be transferred in the form of "ghost images" to adjacent shaped bodies or sheets.

Abstract: A tablet having first and second surfaces opposite to each other and a side surface lying perpendicular to any one of the first and second surfaces. A peripheral tablet edge delimited between each of the first and second surfaces and the side surface is chamfered to provide a respective inclined peripheral edge face over the entire perimeter of the tablet. This tablet also has at least a first generally V-sectioned score defined in the first surface so as to leave two tablet divisions of uniform size on respective sides of the V-sectioned first score. A pair of generally V-sectioned side scores are defined in the side surface of the tablet at respective locations opposite to each other and are continuous with opposite ends of the V-sectioned first score. The tablet can be divided along the V-sectioned score in the first surface by the application of a minimized finger pressure. The tablet of the invention is particularly suited to the pharmaceutical field.

Abstract: Non-volatile organic components of interest in the urine of humans using diapers are assayed by carrying out the following sequence of steps at least once and up to as many times as the diapers are changed in a given 24-hour period, namely: removing the outer cover and any extraneous material from a used diaper so as to leave only diaper pulp with absorbed urine, estimating the amount of water in the used diaper, extracting a weighed portion of the diaper pulp with a water-miscible organic solvent, in which the diaper pulp is insoluble, to give an extract containing a component of interest, and determining the amount of the component of interest per unit volume of urine absorbed on the diaper pulp by analyzing an aliquot of the extract. The method may be applied e.g. to the prevention of sudden infant death syndrome in infants, by selecting infants for medication with melatonin where diaper urine indicates a deficiency of its metabolite 6-sulfatoxymelatonin in a 24-hour period.

Abstract: A melt granulating method for the production of pellets (spheres) which contain a therapeutically active substance of high-dosage type. The method is characterized by: (i) mechanically working a mixture which contains (a) the active substance in cohesive form and (b) a binder (melting point 40.degree. C.-100.degree. C.) while supplying sufficient energy for the binder to melt and to form spherical overwetted pellets; (ii) adding further cohesive substance, while maintaining the mechanical working; (iii) interrupting the mechanical working and supply of energy and cohesive substance when the desired mean particle size of dry pellets (spheres) has been achieved; and (iv) removing the smallest and largest particles and dividing the remaining pellets into dosage batches. A novel pharmaceutical composition containing a dosage of 300-500 mg of pellets is obtainable from this process.

Abstract: A softgel having a texture on at least a portion of its surface and a process and apparatus for the manufacture thereof.

Abstract: A method of highlighting intagliations in white or colored coated tablets by spraying onto said tablets a suspension comprising a filling material having a different color, a waxy material and a solvent, and removing the solvent and the excess of filling material and waxy material.

Abstract: A medicinal tablet mechanical configuration is provided that permits prolonged absorption of a medicinal dosage through the gastro-intestinal tract of warm blooded animals. The tablet is formed with a solid core unit that contains the medically beneficial drug and an outer unit that maintains its physical and chemical integrity during the dosage life of the core unit. The medicinal tablet is formed in a die by first placing a quantity of powder from which the outer unit is formed into the die. The core unit is next positioned within the die so that portions of the surface of the core unit abut the die. The remainder of the powder to form the outer unit is then placed in the die and the contents of the die are subjected to a compressive force by die punches inserted into the die so that the tablet is formed.

Abstract: The present invention relates to an aqueous pharmaceutical suspension composition comprising: from about 0.2% to 20% of a substantially water insoluble pharmaceutical active, e.g. ibuprofen; a suspension stabilizing effective amount of xanthan gum, pregelatinized starch and polyoxyethylene sorbitan monooleate; an effective amount of taste masking composition; and water, as well as a process for producing such aqueous pharmaceutical suspensions.

Abstract: A controlled release pharmaceutical composition in oral dosage unit form comprising a tablet comprising a therapeutically effective number of active spherical granules comprising an effective amount of active medicament, a pharmaceutically acceptable normally solid diluent adapted to form a diffusable matrix for the active medicament and an optional pharmaceutically acceptable excipient; and a number of compressible spherical granules comprising a mono- or di-saccharide, an optional pharmaceutically acceptable normally solid diluent adapted to form a diffusable matrix, an optional active medicament and/or an optional pharmaceutically acceptable excipient wherein the average compressive yield of the compressible spherical granules is less than the average compressive yield of the active spherical granules is provided. A method for the preparation and for the administration of the above defined composition is provided as well.

Abstract: A dosage form for administering physiologically active substances to animals, especially ruminant animals. The dosage unit includes a core which contains the active substance and a coating. The coating has selected areas which are thinner than the average thickness of the coating and/or areas which are predetermined rupture sites. These thin areas or predetermined rupture sites are constructed and arranged so as to detach and/or rupture under the conditions which are present after oral administration of the dosage form. As a result, the delayed release of the physiologically-active substance is accelerated. For example, the coating may be formulated to not be affected in the first stomach of a ruminant but to rapidly disintegrate in the animal's second stomach.

Abstract: Azelastine-containing pharmaceutical compositions which provide controlled release of the active substance using a sustained release component. The compositions contain azelastine or a physiologically acceptable salt of azelastine, together with 0.001 to 800 parts of sustained release component for each part by weight of azelastine (calculated as base) and the release rate of azelastine is between 0.05 and 5 mg per hour.

Abstract: The invention relates to a process for producing an administration and/or dosage form for medicament active substances using a printing process, in which the printing process used is a pad printing process.

Abstract: This invention relates to devices useful for the controlled delivery of one or more beneficial agents to an environment of use. More specifically, this invention concerns such devices which are powered by lyotropic liquid crystals. This invention also relates to the controlled delivery of one or more beneficial agents to an aqueous environment of use through the use of such lyotropic liquid crystal powered dispensing devices. Also disclosed are methods for the controlled delivery of one or more beneficial agents to an aqueous environment of use which comprise administering to or otherwise placing the devices of this invention in the environment of use.

Abstract: Thisinvention relates to a process for the preparation of tablets readily soluble and/or splitable in water comprising introducing, into the preparation ready to be pressed, a sufficient amount of a liquid agent having a boiling point between 35.degree. C. and +50.degree. C. selected from within the halogenated hydrocarbons or mixtures thereof, proceeding with the comprising step and, finally, eliminating the volatile liquid which leads to a porous structure.

Abstract: A mixture of one or more pharmaceutical active compounds and one or more thermoplastic polymers is tabletted by a process in which the mixture is extruded and the still moldable extrudate is pressed to give tablets, between two belts, or a belt and a roller, which make contact in parts, rotate in opposite directions and run parallel along the contact zone, the shape-imparting indentations, which may be present in complementary pairs, being located in both or in only one of the revolving shape-imparting elements.

Abstract: There are described novel dispersible cimetidine tablets containing 30 to 90% by weight of one of the polymorphous modifications of cimetidine A, B or C, 5 to 55% by weight of one or more disintegrationg agents, 0.05 to 5.0% by weight of a surfactant, such as sodium lauryl sulphate together with other common adjuvants. The process for the manufacture of dispersible cimetidine tablets is effected on the basis of known methods by granulating the ingredients and by compressing the granulate to tablets. Dispersible tablets disintegrate when brought in contact with water at room temperature within less than 1 minute to yield a fine dispersion, which facilitates the oral application. Therefore such tablets are particularly suitable for certain groups of patients, especially for the aged and children. Dispersible tablets containing cimetidine excell by their improved rate of dissolution and good bioavailability.

Abstract: A tri-scored drug tablet having an elongated tablet body with a length greater than its width. The body has a bottom facing surface with a pair of concavities therein. Each concavity is equal in size and has parallel major and minor axes, each concavity further having a smooth and uninterrupted arcuate surface extending between the opposite longitudinal ends of said body and a longitudinally central part of said tablet. The opposite longitudinal ends of the body and the longitudinally central part are of a thicker dimension than the thickness of the body measured at an apex of each of the concavities. Aligned breaking grooves are formed in the top and bottom surfaces at both of the concavities and between the concavities at said longitudinally central part, each of breaking groove extending laterally across the width of said tablet at said apex of each of said concavities and at said longitudinally central part to divide the tablet into four quarter sections of equal size.

Abstract: A coating material for controlling drug release, useful for long acting formulations--e.g. for once-a-day administration, and to a long acting granular composition comprising a drug (especially one conventionally difficult to prepare in long acting form) coated with the coating material. This composition may be mixed with other granular drug formulations. The drug-release controlling coating material comprising, in a specific ration, one specific water-insoluble and low water-permeability polymers and two materials differing from each other in the pH-dependency of their solubility (pH-dependent polymer-materials).

Abstract: A dosage form is disclosed for delivering the beneficial drugs pseudoephedrine and brompheniramine to a biological environment of use.

Abstract: A pharmaceutical tablet that is readily divisible into sub-dosage units of two and three equal parts, said tablet comprising two surfaces on opposite sides of the tablet each having scoremarkings thereon, the scoremarkings on the one surface dividing the tablet into two equal parts and the scoremarkings on the second surface dividing the tablet into three equal parts, said tablet having an approximately triangular cross section in the plane of said scoremarked surfaces.

Abstract: Direct tableting auxiliaries essentially consists of(A) from 88 to 96% by weight of pulverulent carrier conventionally used for the preparation of tablets and consisting of lactose, or lactose together with not more than the same amount of another carrier,(B) from 2 to 6% by weight of polyvinylpyrrolidone having a K value of from 20 to 40, and(C) from 2 to 10% by weight of crosslinked, insoluble polyvinylpyrrolidone, all percentages being based on the direct tableting auxiliary, and are obtained by spray drying, spray granulation or wet granulation.The novel direct tableting auxiliaries exhibit good flow and good compressibility under low pressure, and the tablets produced using the said auxiliaries possess excellent disintegration properties coupled with great hardness and low abrasion.

Abstract: Disclosed are tablets having clear marks including letters, figures and the like which are impressed thereon wherein a material different in color tone from the portion other than the mark portion is deposited in the impressed valley portion and if necessary, these tablets are further applied with a coating and a method for producing the tablets.

Abstract: A sustained release oral pharmaceutical composition consists essentially of a recompressed mixture of a water-sensitive pharmaceutical agent, a high molecular weight hydrophilic cellulose polymer, and a lubricant. The mixture is compressed into a unitary mass, comminuted, and recompressed into tablets without the use of solvents.

Abstract: The present invention is a multidose capsule. The capsule consists of a longitudinally extending tube and caps for each end thereof. An intermediate section of the longitudinally extending tube is severable so that the capsule may be broken into two separately administrable components.

Abstract: A dosage form is disclosed comprising a wall that surrounds a compartment with an exit means in the wall. The compartment comprises a first or fast releasing lamina and a second or short releasing lamina that are delivered through the exit means over two different periods of time.

Abstract: A dosage form is disclosed for delivering the beneficial drugs pseudoephedrine and brompheniramine to a biological environment of use.

Abstract: A dosage form is disclosed comprising a wall that surrounds a compartment with an exit means in the wall. The compartment comprises a first or fast releasing lamina and a second or short releasing lamina that are delivered through the exit means over two different periods of time.

Abstract: This invention relates to an improved polymeric film coating for a ranitidine Hydrocholride (HCl) tablet in which the plasticizer triacetin had been added to the polymeric film coating medium. A tablet of this invention has been found to have great stability than a tablet coating with a polymeric film which does not contain triacetin.

Abstract: The instant invention is directed to a multiparticulate osmotic pump, for the controlled release of a pharmaceutically active agent to an environment of use, said pump comprising:(I) a carrier medium which does not maintain its integrity in the environment of use;(II) a multiple of tiny osmotic pump elements each consisting essentially of:(A) a core comprises at least one pharmacologically active agent soluble in an external fluid, or a mixture of an agent having a limited solubility in the external fluid with an osmotically effective solute that is soluble in the fluid, which exhibit an osmotic pressure gradient across the wall against the external fluid surrounded by(B) a rate controlling water insoluble wall, having a fluid permeability of 6.96.times.10.sup.-18 to 6.96.times.10.sup.14 cm.sup.3 sec/g and a reflection coefficient of less than 0.5, prepared from:(i) a polymer permeable to water but impermeable to solute and(ii) 0.

Abstract: A capsule shaped tablet containing a pharmaceutically active ingredient in which the tablet has a cap portion and a body portion physically bound to each other; the cap portion having a larger outside diameter than the body; the tablet may be provided with a coating of a film forming polymer to simulate a hard gelatin capsule dosage form.

Abstract: A divisible matrix table structure with or without coating, having controlled and delayed release of the active substance, and having first and second body parts, each having top and bottom facing surfaces joined together at a perimeter of an edge means. A breakable connecting structure is provided for joining together the first and second body parts. The breakable connecting structure is formed by depressions in the top and bottom facing surfaces of the first and second body parts. Each of the depressions is directly opposite the other and have first and second score surfaces facing each other.

Abstract: The disclosure herein describes a controlled release tablet which includes a core formed of a solid mixture having a hydrophilic releasable agent; the core has a central hole and is coated, on all faces except that bordering the hole with a hydrophobic material. The thickness of the core gradually increases from the hole to the outer border, this being a factor in the rate of release of the mixture through the hole. One application of such a tablet is for the controlled release of a therapeutic agent in the field of drug delivery systems.