Abstract: A unit dosage form, such as a capsule or the like for delivering drugs into the body in a circadian release fashion, is comprising of one or more populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release cardiovascular drug delivery system is designed to provide a plasma concentration—time profile, which varies according to physiological need during the day, i.e., mimicking the circadian rhythm and severity/manifestation of a cardiovascular disease, predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.

Abstract: A dry moisture barrier film coating composition for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, and optionally a flow aid, a colorant, and/or a suspending agent. A liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent. A method of coating pharmaceutical tablets and the like with a moisture barrier film coating comprises forming a liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprising polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent, applying the coating solution or dispersion onto the tablets to form a film coating on the tablets, and drying the film coating on the tablets.

Abstract: A tablet coating useful for coating an active selected from the group consisting of aspirin, ibuprofen, naproxin sodium, acetaminophen, celecoxib, sildenafil citrate, alendronate sodium, an analgesic in combination with one or more of an antitussive, antihistamine, decongestant and expectorant, oxaprozin, comprising gellan gum along with a process which comprises admixing gellan gum and water under effective shear conditions to prepare an aqueous gellan gum coating composition thereof whereby the aqueous gellan gum coating composition is applied in an adherent fashion to a placebo or a tablet containing an active to form a gellan gum coated placebo or gellan gum coated active.

Abstract: This invention in general relates to novel pharmaceutical compositions for acid labile substances as well as for methods of making such. Specifically, the invention provides a pharmaceutical composition comprising about 1 to 75% by weight acid labile compound, up to about 5% by weight disintegrant, at least one protector coat layer used to separate and protect the acid labile substance from acid reacting groups and gastric juice, and at least one enteric coat layer which surrounds the protector coating layer and ensures delivery of over 80% the acid labile substance to the small intestine.

Abstract: A nutritional tablet or caplet has a film coating that contains folic acid available for rapid release upon contact with gastric fluid. The film coating also includes a film forming polymer such as hydroxypropyl methylcellulose.

Abstract: It has been discovered that certain phosphoinositides demonstrate antibacterial activity. Particularly, these phosphoinositides have been discovered to prevent the adhesion of H. influenzae onto the nasopharyngeal cells of mammals, and, in particular, humans. Phosphoinositides useful with the present invention have the following formula: wherein R1 and R2 are selected from the group consisting of hydrogen and monounsaturated and saturated fatty acids having a carbon chain length of C6 to C20 and R1 and R2 can be the same or different; and R3 to R7 are selected from the group consisting of hydrogen or a phosphate moiety with at least two of R3 to R7 being a phosphate moiety; and hydrates and pharmaceutically acceptable salts thereof.

Abstract: The present invention provides an improved soft chewable multivitamin tablet in which vitamin C is separated from calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof in a core or multilaminate form and a process for preparing the same. The soft chewable multivitamin tablet of the present invention maintains its stability over a long-storage time in terms of the content and potency of vitamins while overcoming the problems of incompatibility, bad mouthfeel and palatability.

Abstract: The present invention provides an improved soft chewable multivitamin tablet in which vitamin C is separated from calcium pantothenate and/or minerals such as iron, copper, zinc and mixtures thereof in a core or multilaminate form and a process for preparing the same. The soft chewable multivitamin tablet of the present invention maintains its stability over a long-storage time in terms of the content and potency of vitamins while overcoming the problems of incompatibility, bad mouthfeel and palatability.

Abstract: A tablet coating comprising gellan gum is disclosed along with a process which comprises admixing gellan gum and water under effective shear conditions to prepare an aqueous gellan gum coating composition thereof whereby the aqueous gellan gum coating composition is applied in an adherent fashion to a placebo or a tablet containing a pharmaceutical to form a gellan gum coated placebo or gellan gum coated active drug.

Abstract: A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.

Abstract: A stable bleached shellac and an improved method for making stable bleached shellac is provided which involves precipitating bleached stable shellac from a pre-shellac solution at a pH of from 5.0 to 6.8, preferably from 5.0 to 6.5, most preferably from 5.0 to 6.0. The stable particulate shellac and the stable shellac solution, have a longer shelf life than conventional shellac. The stable shellac solution is comprised of solubilized particulate shellac in a solvent, most preferably ethanol. The stable particulate shellac and the stable shellac solution have a pH of from 4 up to less than 5 or from 5.0 to 6.8, more preferably from 5.0 to 6.5, even more preferably from 5.0 to 6.3, most preferably from 5.0 to 6.0.

Abstract: This invention relates to coatings employed to coat medicinal tablets. Such tablets include but are not limited to small pellet(s) of medication to be taken orally. In particular this invention relates to the use of alginates and/or gellan gum, mixtures thereof and the like as tablet coatings. More in particular, this invention relates to the use of alginate and gellan gum as tablet coatings for tablets which are useful for humans including coating(s) on medicinal tablets and to a process for making such coatings.

Abstract: The present invention pertains to a sustained release drug delivery system which comprises a core of active ingredient, an enteric coating, a second coating of active ingredient and lastly a readily gastric-soluble protective coating. In another embodiment, the sustained release drug delivery system comprises a core of active ingredient, an enteric coating; a second coating of active ingredient; a second enteric coating and a third coating of active ingredient The sustained release dosage form of this invention is useful for pharmaceutically active ingredients that have limited aqueous solubility, especially phenytoin sodium, and other pH dependent soluble drugs.

Abstract: This invention relates to a controlled-release combination drug product comprising troglitazone, e.g. its hydrochloride, and a biguamide, e.g. metformin. In particular, the product comprises a core of metformin, at least a portion thereof has a layer or coat thereon of troglitazone.

Abstract: This invention relates to an abuse resistant tablet containing two or more layers having one or more drugs and one or more gelling agents and its preparation. The drug(s) and gelling agent(s) are in separate layers of the tablet. The multilayer tablet is particularly suitable for the administration of drugs prone to abuse by unauthorized parenteral administration such as analgesics, hypnotics, and anxiolytics.

Abstract: This invention in general relates to novel pharmaceutical compositions for acid labile substances as well as for methods of making such. Specifically, the invention provides a pharmaceutical composition comprising about 1 to 75% by weight acid labile compound, up to about 5% by weight disintegrant, at least one protector coat layer used to separate and protect the acid labile substance from acid reacting groups and gastric juice, and at least one enteric coat layer which surrounds the protector coating layer and ensures delivery of over 80% the acid labile substance to the small intestine.

Abstract: A non-toxic, edible, enteric film coating, dry powder composition for use in making an aqueous enteric suspension which may be used in coating pharmaceutical tablets comprises a) an acrylic resin, said resin comprising i) from 20 to 85 percent by weight of at least one alkyl acrylate or alkyl methacrylate moiety, ii) from 80 to 15 percent by weight of at least one vinyl or vinylidene moiety having a carboxylic acid group capable of salt formation, and iii) from 0 to 30 percent by weight of at least one other vinyl or vinylidene moiety copolymerizable with i) and ii), b) an alkalizing agent capable of reacting with the acrylic resin such that, after reaction, 0.1 to 10 mole percent of the acidic groups in 1a-ii) are present in the salt form, and c) a detacktifier.

Abstract: A coated tablet and process for making the same is provided. A molten composition comprising at least 50 weight percent of a thermoplastic material having a melting point of less than about 120° C. is applied to the tablet, and the molten composition is solidified into a protective coating. If desired, one or more outer coatings may be applied over the protective coating.

Abstract: A dry film coating composition used to make a bright white film coating for nutritional supplements, pharmaceutical tablets, and the like, comprises dextrose, an auxiliary film-former, and titanium dioxide. Optionally, but advantageously, the coating composition also may include one or more of the following components: a plasticizer, a surfactant, a flow aid, and a preservative.

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: Methods and products for delivering a medicament or agent to an individual are provided as well as methods for producing the product. The product includes a coating having a medicament or agent. The medicament or agent is present within the coating that surrounds a tableted gum center (the water soluble portion and a water insoluble base portion). By chewing the gum, the medicament or agent is released from the product. Continuing to chew the chewing gum creates a pressure within the buccal cavity forcing the agent or medicament directly into the systemic system of the individual through the oral mucosa contained in the buccal cavity. This greatly enhances the absorption of the drug into the systemic system as well as the bioavailability of the drug within the system.

Abstract: A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.

Abstract: Disclosed herein is an aqueous enteric coating composition comprised of a solution of a water-soluble salt of an enteric coating polymer, with a hydrophobic compound containing 12 to 20 carbon atoms and a water-insoluble solid flake material dispersed in the aqueous solution. The enteric coating formed from the present composition has good mechanical strength and shows superior resistance to attack by atmospheric moisture and simulated gastric fluid, while being readily broken down under the alkaline conditions which exist in the intestine.

Abstract: Sustained release dosage forms of high dose insoluble drugs such as ibuprofen and methods for their manufacture are disclosed.

Abstract: The present invention relates to a chewable tablet containing a medicament in a core and a process for preparation thereof. In particular, the present invention relates to a chewable tablet comprising a core containing a medicament in the center of the tablet in a state of jelly or chewable base and an outer layer wrapping the core which is made up of chewable base such as a gum, a soft candy or a caramel. The chewable tablet is easy to take and has a good taste and nice chewing property due to the unique tablet form. In addition, the tablet has an advantage in bioavailability resulting from increased absorption rate and excellent stability due to unique preparation process. Therefore, the chewable tablet and the preparation process of the present invention can be used in pharmaceutical industry usefully.

Abstract: The present invention provides a rapid-release tablet of S1452 at least containing the following components:a. a principal agent comprising (+)-(Z)-calcium 7-[(1R,2S,3S,4S)-3-benzenesulfonaidobicyclo[2.2.1]hept-2-yl]-5-heptenoate dihydrate (S1452), andb. a dispersant in an amount enough to disperse the principal agent after the disintegration of the tablet.

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: A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.

Abstract: Uses of topical compositions comprising a 2-hydroxycarboxylic acid or related compound to alleviate or improve signs of skin, nail and hair changes associated with intrinsic or extrinsic aging are disclosed. 2-Hydroxycarboxylic acids and their related compounds include, for example, 2-hydroxyethanoic acid, 2-hydroxypropanoic acid, 2-methyl 2-hydroxypropanoic acid, 2-phenyl 2-hydroxyethanoic acid, 2-phenyl 2-methyl 2-hydroxyethanoic acid, 2-phenyl 3-hydroxypropanoic acid, 2,2-diphenyl 2-hydroxyethanoic acid, 2-hydroxybutane-1,4-dioicacid, 2,3-hihydroxybutane-1,4-dioic acid, 2-carboxy 2-hydroxypentane-1,5-dioic acid, 2-ketopropanoic acid, methyl 2-ketopropanoate, ethyl 2-ketopropanoate, and gluconolactone.

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 dry moisture barrier film coating composition for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, and optionally a flow aid, a colorant, and/or a suspending agent. A liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent. A method of coating pharmaceutical tablets and the like with a moisture barrier film coating comprises forming a liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprising polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent, applying the coating solution or dispersion onto the tablets to form a film coating on the tablets, and drying the film coating on the tablets.

Abstract: Devices for controlled release of active substances in the form of tablets, capsules and beads comprised of a porous substructure surrounded by one or more interfacial membranes.

Abstract: A once-a-day diltiazem dosage form which comprises: (a) a core element which is a compressed tablet which contains a therapeutic dose of diltiazem and an amount of a solubility modulating substance that controls the release of said diltiazem in order to provide a therapeutic level over a period of about 24 hours; and (b) on the outer surface of the core element, a sufficient amount of an enteric coating that causes the diltiazem to release at a rate that permits the use of once-a-day dosing to maintain steady state therapeutic levels of diltiazem.

Abstract: Pharmaceutical compositions for orally delivering a therapeutically effective amount of a drug to the colon without significant release of the drug in the upper GI tract after oral administration of the composition are described. The composition is a unit dosage in the form of a tablet that comprises about 0.01% by weight to about 10% by weight of the drug that is useful in treating a colonic disorder or that is absorbed from the colon; about 40% by weight to about 98% by weight of a hydrocolloid gum obtainable from higher plants; and about 2% by weight to about 50% by weight of a pharmaceutically acceptable binder. The compositions are useful for treating lower GI disorders in human subjects by administering a suitable amount to a subject in need thereof. A particularly preferred aspect is the process for preparing such composition in the form of a tablet.

Abstract: A pharmaceutical tablet composition for oral administration containing pseudoephedrine pellets admixed with a tablet mixture containing a second active drug substance, either alone or in combination with pseudoephedrine or a pharmaceutically acceptable salt thereof, is disclosed. The pellets provide an extended release of pseudoephedrine, whereas the tablet mixture provides an immediate release of the second active drug and any pseudoephedrine.

Abstract: A dietary supplement comprising herbs and herbal extracts, vitamins, minerals, and amino acids effective in modulating hematological toxicities, enhancing the immune system and maintaining appetite and weight.

Abstract: A new pharmaceutical multiple unit tableted dosage form containing as active ingredient an acid labile H.sup.+ K.sup.+ -ATPase inhibitor or an alkaline salt thereof or one of its single enantiomers or an alkaline salt thereof, a method for the manufacture of such a formulation, and the method of treatment with such a formulation in medicine.

Abstract: Pharmaceutical tablet consisting of a first layer containing one or more drugs with immediate or controlled release formulation, a second layer containing one or more drugs, either equal to or different from the first layer, with slow release formulation, and a low-permeability barrier-type layer coating said second layer or, alternatively, placed between the first and second layer and, if necessary, containing a drug.

Abstract: The invention provides a controlled release pharmaceutical unit dose composition for oral administration which comprises: (a) an internal phase which comprises captopril or a prodrug of captopril in admixture with a hydrogel forming agent; and (b) an external phase which comprises a coating which resists dissolution in the stomach.

Abstract: The invention relates to sugar-coated dosage units comprising a steroid having two hydrogen atoms at position 3 of the steroid skeleton, such as desogestrel, allylestrenol, ethylestrenol, or lynestrenol, to a process for the manufacture of such dosage units, and a use of sugar-coated compositions for providing stable dosage units comprising said steroid.

Abstract: The present invention pertains to a dual control sustained release drug delivery system which comprises a core and a porous coating layer over the core, wherein the coated core comprises (A) a core comprising in percentages by weight of the core composition (a) a medicament present in an amount from about 60% to about 90%; (b) an edible material having a melting point from about 25.degree. C. to about 100.degree. C. selected from the group consisting of (i) fatty acids having an iodine value from about 1 to about 10, (ii) natural waxes, (iii) synthetic waxes, and (iv) mixtures thereof, present in an amount from about 5% to about 40%; and (B) a porous coating layer over the core comprising in percentages by weight of the coating layer composition (a) a pH-independent water-insoluble polymer present in an amount from about 40% to about 80%; and (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%.

Abstract: An oral dosage form of azithromycin which does not exhibit an adverse food effect; Specific azithromycin oral dosage forms including tablets, powders for oral suspensions and unit dose packets; Methods of treating microbial infections with the dosage forms; And therapeutic packages containing the dosage forms.

Abstract: This invention describes a device for peroral administration of a therapeutic agent which is capable of existing in an unionized therapeutically active form. The device comprises a reservoir comprising the therapeutic agent in ionized form, which reservoir has a wall permeable to un-ionized material and impermeable to ionized material; and a solid material which upon uptake of water is converted to a buffer; the solid material having, on uptake of water, a pH which determines the rate of permeation of the therapeutic agent in un-ionized form through the reservoir wall. The device enables the release of the therapeutic agent to be controlled by the pH of the buffer and, if desired, the composition of the reservoir walls. The composition of the surrounding aqueous medium does not affect the rate of release.

Abstract: An improved controlled release tablet formulation for the release of potassium chloride through a differentially permeable membrane from which the release of potassium chloride can be accurately controlled to minimize the likelihood of producing high localized concentrations of potassium within the gastrointestinal tract.

Abstract: A controlled release tablet for oral administration is disclosed which has a tablet core including an insoluble therapeutically active agent having an aqueous solubility of less than or equal to about 5 mg/ml in a sufficient amount to render a therapeutic effect. The core provides rapid release of said therapeutically active agent upon exposure to aqueous solutions. The tablet core is coated with a controlled release coating permitting sustained release of said therapeutically active agent when said coated tablet is exposed to aqueous solutions.

Abstract: An improved wet powder, edible, film-forming composition for use in coating tablets and capsules consists essentially of powdered pigment particles, a film-forming, water soluble or water-dispersible, edible polymer and up to approximately 30% by weight of water. Such compositions are formed by blending the pigment particles and the polymer and applying the water onto the pigment-polymer blend in atomized form. Similar wet powder, edible, clear, film-forming compositions for use in coating tablets and capsules with a clear coating consist essentially of a film-forming, water soluble or water-dispersible, clear, edible polymer and up to approximately 30% by weight of water and are formed by applying the water onto the polymer in atomized form. The application of water in this manner preconditions the polymer and permits the preparation of smooth stable coating suspensions upon dilution with additional water and without the formation of fish eyes.

Abstract: Pharmaceutical preparation to be administered orally with controlled release of active substance and method for its manufacture. Pharmaceutical preparation to be administered orally with controlled release of active substance, containing a nucleus which itself consists at least of one pharmacologically active substance, or a nucleus of physiologically safe material which is enveloped by an active substance layer, containing at least one pharmacologically active substance, if needed, a first membrane, then an acid layer consisting at least of a physiologically safe acid and then a compound membrane consisting of a pH sensitive polymer and an insoluble polymer, as well as methods for its manufacture. The pharmaceutical preparation is applicable to all claimed types of medicine and to the therapy of illnesses.

Abstract: Pharmaceutical tablets releasing the active substance after a definite period of time, consisting of: a core containing the active substance and polymeric substances which swell and/or gel and/or erode on contact with water or with aqueous liquids; a layer applied externally to said core, suitable to prevent the immediate release of the active substance contained in the core and to allow the release of said active substance after a definite period of time, consisting of natural and/or synthetic polymeric materials of the class of the hydrophilic polymers which erode and/or gel and/or dissolve in an aqueous medium; a possible gastroresistant and enterosoluble coating.

Abstract: The present invention is directed to a controlled release dosage form which may be made using an osmotic core which contains a drug containing phase which includes a water swellable component and a continuous coating which comprises a major amount of a water resistant polymer and a minor amount of a non-toxic, water soluble, pharmaceutically acceptable compound.

Abstract: The present invention relates to a novel oral dosage form of a bisphosphonic active ingredient for use in treatment of diseases involving bone resorption and formulated in an enteric-coated form for administration to subjects exhibiting upper gastrointestinal tract sensitivity to bisphosphonic acid compounds.