Abstract: Tablet and capsule formulations with a similar in vitro drug release profile for whole tablet and when broken and/or a bioequivalent drug release profile when taken whole or when broken are provided. In addition, coated splittable tablets are provided. Methods for production of these formulations and tablets and their administration are also provided.

Abstract: The invention provides a composition containing particulate composite of a polymer and a therapeutic agent. The composition also contains a complexing agent. The polymer interacts with the complexing agent in a host-guest or a guest-host interaction to form an inclusion complex. A therapeutic composition of the invention may be used to deliver the therapeutic agent and to treat various disorders. Both the polymer of the particulate composite and the complexing agent may be used to introduce functionality into the therapeutic composition. The invention also relates to a method of preparing a composition. The method combines a therapeutic agent, a polymer having host or guest functionality, and a complexing agent having guest or host functionality to form the therapeutic composition. The complexing agent forms an inclusion complex with the polymer. The invention also relates to a method of delivering a therapeutic agent.

Abstract: A dosage form comprises at least one active ingredient, a first portion which comprises an exterior surface and one or more cavities defining at least one interior surface having indentations and an exterior surface, and a second molded portion which is inlaid into the cavities of the first portion and has an exterior surface. The first and second portions are in contact at an interface, the second portion comprises a solidified thermoplastic material, and the second portion resides substantially conformally upon the indentations of the first portion. In another embodiment, a dosage form comprises at least one active ingredient, a core having an outer surface and a shell residing on at least a portion of the core outer surface, wherein the shell comprises a first shell portion and a second molded shell portion which is inlaid into the first shell portion.

Abstract: Described is a layered or segmented controlled release pharmaceutical tablet adapted for separating one segment from another by breaking through a segment.

Abstract: A subject of the invention is a tablet for pharmaceutical use, particularly for veterinary use, particularly suitable for the chronic treatment of hepatic insufficiency, comprising at least one S-Adenosyl-Methionine salt. Said tablet has the advantage of being divisible and being capable of including an appetizing agent.

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 tablet (4) for pharmaceutical use has on at least one part of its surface a diffractive microstructure (11) which generates diffraction effects which can be perceived in the visible spectral range and which serve as visual safety feature. The tablet (4) consists of a plurality of individual powder particles, where the diffractive microstructures (11) are impressed into the surface of the individual powder particles. A compression tool (1, 1a, 1b, 3) to produce such tablets (4) has on one pressing surface of the compression tool (1, 1a, 1b, 3) micro-structures (11), where said microstructures (11) have dimensions which are smaller than the dimensions of the individual crystallites (30) of the material of the pressing surface of the compression tool (1, 1a, 1b, 3). The micro-structures (11) of the compression tool can be produced for example by ion etching or by imprinting.

Abstract: The invention provides a rapidly disintegrating dosage form comprising a partially-coated tablet having at least one elongated groove along its surface, such that a portion of the at least one elongated groove extends beneath the coating.

Abstract: The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

Abstract: The present invention relates to high dose oral pharmaceutical compositions of artemether and lumefantrine, and process for preparation thereof. The compositions comprise of artemether and lumefantrine comprising artemether in an amount of from about 40 mg to about 80 mg, lumefantrine in an amount of from about 240 mg to about 480 mg. The compositions are useful for treatment of uncomplicated infections with Plasmodium falciparum, including strains from multi-drug-resistant areas.

Abstract: Provided are pharmaceutical dosage forms within structures such as hollow capsules, gelcaps, or sachets, adapted to allow ingestion of a whole dose or a preferably predetermined fraction of said dose when desired.

Abstract: A method and apparatus for drug product tracking (or other pharmaceutical, health care or cosmetics products, and/or the packages or containers they are supplied with) using diffraction grating-based encoded optical identification elements includes an optical substrate having at least one diffraction grating disposed therein. The encoded element may be used to label any desired item, such as drugs or medicines, or other pharmaceutical or health care products or cosmetics. The label may be used for many different purposes, such as for sorting, tracking, identification, verification, authentication, anti-theft/anti-counterfeit, security/anti-terrorism, or for other purposes.

Abstract: Dividable galenical form for the modified release of active ingredient, wherein the non-subdivided galenical form and a portion of said form obtained by subdivision have identical dissolution profiles. Medicaments.

Abstract: An automatic inflator comprising a body for receiving a dissolvable pill, said dissolvable pill including an upper surface and a lower surface, at least one of said surfaces including an undulating configuration.

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: The present invention provides a tablet comprising a plurality of drug-containing parts and at least one connecting part adhered to the drug-containing parts, and having a scored line capable of dividing the whole tablet on the connecting part; particularly, a coated tablet in which a connecting part and a coating layer have the same or different drug release controlling functions; a tablet having an insoluble coating on a drug-containing part having a scored line, wherein the drug-containing part has a structure or composition such that the drug is substantially released after the tablet is divided along the scored line and then ingested; and a tablet comprising a plurality of drug-containing parts and at least one connecting part adhered to the drug-containing parts, wherein at least two drug-containing parts have different compositions.

Abstract: The present invention relates to a pharmaceutical preparation of high photostability which contains pitavastatin, which is an HMG-CoA reductase inhibitor, a salt of pitavastatin, or an ester of pitavastatin. The pharmaceutical preparation contains a pitavastatin compound, titanium oxide, and a colorant having a maximum absorption wavelength of 400 nm to 500 nm.

Abstract: A system and method of removing material from pharmaceutical tablets, utilizing mechanical or laser energy and a conveyance, to produce a score or other defect in said tablet.

Abstract: A pharmaceutical tablet having two segments, one of which is a top segment and the other of which is a bottom segment, said tablet having at least one side wherein said tablet is provided with a separation mark or marks.

Abstract: Accurate means of dosing with a compressed, segmented pharmaceutical tablet, and tablettes formed from said tablets, is disclosed.

Abstract: A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.

Abstract: Dosage forms containing torsemide as the active ingredient, preferably provided at a relatively low dose or strength, are disclosed. The dosage forms can, be formulated as a tablet having a novel scoring pattern enabling division of the tablet to provide unique doses and dosing regimens to be administered to a patient in need of treatment or prevention using torsemide.

Abstract: A modified release dosage form comprising at least one active ingredient and at least two cores surrounded by a shell is provided. The shell comprises at least one opening and provides for modified release of active ingredient upon contacting of the dosage form with a liquid medium. At least one of the cores is distal from the opening. In a preferred embodiment, the dosage form has a pulsatile release profile.

Abstract: Deeply scored pharmaceutical tablets are disclosed, along with pharmaceutical tablets with a score in a segment that adjoins a segment lacking a pharmacologically effective dose of any drug.

Abstract: The invention provides novel scoring patterns for a wide variety of tablets that contain specific drugs or contain drugs in certain drug classes, and methods of treatment with layered tablets and fractional tablets derived from breaking said tablets.

Abstract: An immediate release compressed pharmaceutical tablet that has two or more segments and a top and a bottom and has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides.

Abstract: An immediate release compressed pharmaceutical tablet that has two or more segments and a top and a bottom and has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides.

Abstract: The subject invention provides compositions and methods of use of a single dosage form which includes therapeutic or subtherapeutic doses of a dihydropyridine calcium channel blocker (CCB), such as amlodipine, and a diuretic, preferably a thiazide-type diuretic, such as chlorthalidone.

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Abstract: The invention provides a composition containing particulate composite of a polymer and a therapeutic agent. The composition also contains a complexing agent. The polymer interacts with the complexing agent in a host-guest or a guest-host interaction to form an inclusion complex. A therapeutic composition of the invention may be used to deliver the therapeutic agent and to treat various disorders. Both the polymer of the particulate composite and the complexing agent may be used to introduce functionality into the therapeutic composition. The invention also relates to a method of preparing a composition. The method combines a therapeutic agent, a polymer having host or guest functionality, and a complexing agent having guest or host functionality to form the therapeutic composition. The complexing agent forms an inclusion complex with the polymer. The invention also relates to a method of delivering a therapeutic agent.

Abstract: A pharmaceutical composition with ?-sheet microcrystalline cellulose with improved potency life and methods of preparation therefor. Improved thyroid hormone pharmaceutical compositions comprising 50 weight % or more of ?-sheet microcrystalline cellulose.

Abstract: A pharmaceutical composition for slow release of active ingredient in the gastrointestinal tract, comprising a plurality of active ingredient-containing particles coated with a material insoluble in gastric and intestinal juices, where the particles have as core a homogeneous mixture comprising an active pharmaceutical ingredient and a polymer insoluble in gastric and intestinal juices, with an average internal pore diameter not exceeding 35 ?m, makes efficient and pH-independent delaying of release possible even with comparatively small amounts of polymer. It is additionally distinguished by a long shelf life and is particularly suitable also for nonspherical particles.

Abstract: Oral progesterone unit dosage forms comprising micronized progesterone and a solid polymeric carrier are provided. The dosage forms, upon oral administration, provide a therapeutically effective blood level of progesterone to a subject. The therapeutically effective blood level of progesterone may range from about 0.1 ng/ml to about 400 ng/ml. The dosage forms can be prepared for immediate as well as sustained release. The oral progesterone dosage form can be combined with an estrogen dosage form to provide combination hormone therapy.

Abstract: Methods and compositions are provided comprising ingestibles and a thermochromic composition which is informative as to the temperature history of the ingestible, either prior or contemporaneous with use. Various solid or liquid ingestible compositions are provided for determining storage temperature, temperature of the user, temperature of the ingestible, particularly comestibles, and the like. Of particular interest are polydiacetylene polymers which may be formulated to provide compositions having transition temperature over a broad temperature range.

Abstract: There is provided a method and associated kit for reducing the normal dosage of a pharmaceutical given to a patient for the treatment of a disorder without substantially reducing its effectiveness. During a first predetermined time period, a substantially full dosage of the pharmaceutical is administered to the patient, preferably with a placebo. During a second predetermined time period, a reduced dosage of the pharmaceutical is administered to the patient, also with a placebo. The second predetermined time period is subsequent to the first predetermined time period. Preferably, the placebo has a distinctive indicia. The placebo, in association with the decreased pharmaceutical, augments the effectiveness of the pharmaceutical by heightening the patient's conditioned response and expectation of effectiveness.

Abstract: The invention relates mainly to an element suitable for being ingested, the element including at least one air-passing channel making it possible to avoid choking in the event of being swallowed the wrong way. The present invention applies to the food industry and also to the pharmaceuticals industry.

Abstract: The invention describes a tablet with two end faces and a circumferential face, in which the mutually opposite end faces of the tablet a) overall are nonplanar and are arranged at least approximately parallel to one another, and b) are each provided with a score on the top and bottom sides, the scores lying in the center of the tablet parallel to and above one another.

Abstract: Pharmaceutical gastroretentive drug delivery systems for the controlled release of an active agent in the gastrointestinal tract are disclosed, which comprise: (a) a single- or multi-layered matrix comprising a polymer that does not retain in the stomach more than a conventional dosage form selected from (1) degradable polymers that may be hydrophilic polymers not instantly soluble in gastric fluids, enteric polymers substantially insoluble at pH less than 5.5 and/or hydrophobic polymers and mixtures thereof; (2) non-degradable polymers; and any mixtures of (1) and (2); (b) a continuous or non-continuous membrane comprising at least one polymer having a substantial mechanical strength; and (c) a drug; wherein the matrix when affixed or attached to the membrane prevents evacuation from the stomach of the delivery system for a period of time of from about 3 to about 24 hours.

Abstract: The invention relates to pharmaceutical dosage forms with rapid disintegration in the mouth and to their process of preparation. These pharmaceutical dosage forms comprise at least one active principle dispersed in a mixture of excipients and are characterized in that the mixture of excipients comprises at least one weakly compressible diluting agent other than trehalose and a copolymer of 1-vinylpyrrolidin-2-one and of vinyl acetate. Applications: oral administration of a great many active principles (analgesics, antispasmodics, agents used in gastroenterology, agents for combating motion sickness, antimigraines, &bgr;-blockers, antihistaminics, antibiotics or antibacterials, antivertigos, hypnotics, and the like).

Abstract: The invention involves a medication for weight loss by means of appetite suppression and a method for administering this medication to humans and other mammals. The medication comprises potassium butyrate or closely related chemical compounds, together with chemicals which facilitate the dispersion of the medication in the stomach.

Abstract: Methods and compositions are provided comprising ingestibles and a thermochromic composition which is informative as to the temperature history of the ingestible, either prior or contemporaneous with use. Various solid or liquid ingestible compositions are provided for determining storage temperature, temperature of the user, temperature of the ingestible, particularly comestibles, and the like. Of particular interest are polydiacetylene polymers which may be formulated to provide compositions having transition temperature over a broad temperature range.

Abstract: A multiplex drug delivery system suitable for oral administration containing at least two distinct drug dosage packages, which exhibit equivalent dissolution profiles for an active agent when compare to one another and when compared to that of the entire multiplex drug delivery unit, and substantially enveloped by a scored film coating that allows the separation of the multiplex drug delivery system into individual drug dosage packages can provide a convenient and cost effective drug delivery unit, particularly for patients with a regimen of prescribed dosages that varies during their treatment period.

Abstract: Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant.

Abstract: A subject-matter of the invention is a sweet of boiled sugar type, characterized in that it exhibits a rough texture intended for the treatment of halitosis.

Abstract: The present invention is directed to an active agent dosage form and methods of its fabrication 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 one or more insoluble bands located in complementary grooves. The invention is also directed to articles of manufacture, methods and systems for fabricating the active agent dosage form.

Abstract: A dividable tablet is not chipped, can be divided easily and accurately, has excellent impact resistance and rarely causes twining in the film-coating step, wherein a dividing line is formed along a center line on the upper surface of the tablet, ridgelines are each located on an inner side of the peripheral portion of the tablet to surround the dividing line in two areas defined by the dividing line on the upper surface of the tablet, the lower surface of the tablet gradually rises from the peripheral portion of the tablet toward the center portion thereof, and areas around the ridgelines are each formed by a convex surface.

Abstract: A topical insect repellent with extended duration of protection was obtained from mixtures of molecules based on two or more volatile repellent organic molecular species occurring naturally on the human skin surface. The novel repellent comprises mixtures of lower, intermediate, and higher volatility organic molecules. Active ingredients for formulations are obtained from homologous series of carboxylic acids, alcohols, ketones, and lactones which span a similar range of volatility and which occur naturally on the skin surface. Volatile silicone fluid imparts mildness and water repellency to the repellent formulations. The new natural repellent exhibits the longevity and repellency that is comparable to N,N-diethyl-m-toluamide (DEET), a synthetic compound employed in almost all commercial formulations, but the inventive natural repellent is more acceptable than DEET, which has an unpleasant odor and imparts a greasy feel to the skin.

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 invention discloses a two-step process for recovery of thuringiensin, comprising adsorbing the thuringiensin from fermentation broth by calcium silicate, and dissociating the thuringiensin by dibasic sodium phosphate. The resulting thuringiensin can be further purified by using semi-preparative HPLC and electrodialysis to remove the excess salts from the recovered thuringiensin solution.

Abstract: This invention relates to a bioadhesive tablet containing at least one bioadhesive adjuvant and at least one lubricant, with at least one surface of the tablet comprising concentric or parallel, straight and/or curved depressions, and to a method for producing the bioadhesive tablets as well as to pharmaceuticals in the form of the bioadhesive tablets.