Abstract: The invention herein relates to a pharmaceutical composition containing loratadine and derivatives thereof which is suitable for use in soft capsule dosage forms. A pharmaceutical composition according to the invention comprises loratadine and derivatives thereof in a pharmaceutically effective amount; and a solvent system comprising a mixture of medium chain fatty acids. The loratadine compositions exhibit good solubility and storage stability while maintaining bioavailability of the drug. The compositions also permit high concentrations of solubilized loratadine per total fill volume and thereby permit the use of smaller capsules to deliver the same dosage of drug.

Abstract: A reconfigurable surgical apparatus that includes a surgical instrument assembly that is formed with a hollow manipulation shaft. A linearly or rotationally movable prime mover is received within the shaft and is activated by an actuator located at a proximal end. A coupler is formed about a distal end of the shaft to have a capture ledge that is configured to releasably engage an interchangeable surgical tool that is formed with an anchor adapted to releasably mate to the capture ledge. The coupler may optionally incorporate a frangible portion that severs a portion of the coupler when the interchangeable surgical tool is removed from the apparatus to ensure single use operation of the tool.

Abstract: A container and storage apparatus with an attached, but functionally separate, labeling portion is provided. The apparatus has a primary chamber containing a predetermined agent separated from the labeling portion. An optional contamination barrier region may increase the separation. A preferred embodiment may be formed by a blow-fill-seal method from thermoplastic, allowing one piece molding of the apparatus. A removable cap allows a dispensing point to be opened into the primary chamber for removal of the agent. Indicia may be formed in or on the labeling portion, which may be smaller, larger, or the same in size and shape as the primary chamber. Inks, adhesives or other substances incidental to the indicia will be less likely to migrate across the apparatus wall and into the primary chamber due to the functional separation provided between the primary chamber and labeling portion.

Abstract: This invention relates to a method and apparatus for forming soft capsules and provides novel processing flexibility. The apparatus comprises a three-way valve injector wedge. This injector wedge allows for set-up of the encapsulation machine with a placebo fill and quick change over to active fill. This conserves use of the active ingredient.

Abstract: A dispensing and application apparatus designed to contain pre-measured amounts of a flowable substance. The apparatus comprises a compartment 130 for storing the substance that is partially enclosed by a frangible seal 210, an applicator 100, and an expandable chamber 170 designed to accept and dissipate the hydraulic force created when pressure is applied to the compartment 130, rupturing the frangible seal 210, and expelling the substance into the chamber 170. The applicator 100 is attached to the chamber 170 with an applicator bond area 180. The expandability of the chamber 170 is conferred by expandability of the applicator 100, and is varied in different embodiments by altering the ratio between the area of the applicator bond area 180 and the area of the applicator 100. The frangible seal 210, in one of many embodiments, may be a chevron shape stress riser 250 with a point of inflection 260 oriented towards the compartment 130. A removable cap may cover the applicator.

Abstract: An oil-in-water emulsion formulation containing hydroquinone and retinol, which comprises an oil-in-water emulsion containing free hydroquinone, hydroquinone entrapped in absorbent micro-agglomerates and/or impregnated in porous microparticles; and retinol-impregnated microparticles.

Abstract: This invention relates to a method and apparatus for forming soft capsules and provides novel processing flexibility. The apparatus includes extrusion dies as an alternative to spreader boxes and the use of melt-on-demand technology to enhance the long term stability of the film-forming materials. Preferred embodiments provide a positive displacement pump to transport the molten film-forming material from the melt-on-demand device to the extrusion device and preferably a reservoir means disposed between said extrusion device and said means to melt said film-forming material. The encapsulation apparatus may also include a valved injection wedge.

Abstract: A method and apparatus for producing filled gelatin capsules created from strips (4) of gelatin ribbon. The strips are led to an encapsulation station (6) where they are enclosed around the fill that is delivered thereto. Means are provided for controlling the lateral alignment of the strip in its path to the encapsulation station (6) preferably, such means comprises a pivotal guide bar assembly (52).

Abstract: This invention relates to a method and apparatus for forming soft capsules and provides novel processing flexibility. The apparatus comprises a three-way valve injector wedge. This injector wedge allows for set-up of the encapsulation machine with a placebo fill and quick change over to active fill. This conserves use of the active ingredient.

Abstract: A process for the preparation of a rapidly disintegrating dosage form a pharmaceutically active substance which has an unacceptable taste wherein there is formed a solution or a suspension in a solvent of a form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a water-soluble or water-dispersible carrier material. Discrete units of the suspension or solution are formed and the solvent is removed from the discrete units under conditions whereby a network of the carrier material carrying a dosage for the less soluble and more palatable form of the pharmaceutically active substance is formed.

Abstract: The invention herein relates to a pharmaceutical composition containing loratadine and derivatives thereof which is suitable for use in soft capsule dosage forms. A pharmaceutical composition according to the invention comprises loratadine and derivatives thereof in a pharmaceutically effective amount; and a solvent system comprising a mixture of medium chain fatty acids. The loratadine compositions exhibit good solubility and storage stability while maintaining bioavailability of the drug. The compositions also permit high concentrations of solubilized loratadine per total fill volume and thereby permit the use of smaller capsules to deliver the same dosage of drug.

Abstract: The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is fish gelatin and the composition is a fast-dispersing dosage form designed to release the active ingredient rapidly on contact with a fluid. In one embodiment, the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity on contact with saliva. The fish gelatin can be obtained from cold water fish sources and is preferably the non-gelling, non-hydrolyzed form. A process for preparing such a composition and a method of using fish gelatin in a fast dispersing dosage form are also provided.

Abstract: This invention relates to a pharmaceutical composition for oral administration comprising a carrier and, as active ingredient, an opioid (&mgr;receptor) agonist, such as fentanyl, or a salt thereof, characterized in that the composition is in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity. A process for preparing such a composition and the use of such a composition as an analgesic, for the treatment of chronic pain and/or breakthrough pain, as an anesthetic premedication, for the induction of anesthesia, as a sedative and/or for the treatment of anxiety are also provided.

Abstract: A surgical retractor securing apparatus includes an adjustable securing device which attaches the apparatus to the surgical accessory bar of a halo style head fixation device and a capture assembly that releasably engages the elasticized band of a scalp hook retractor. The adjustable securing device compressively grips along a portion the length of a surgical accessory bar or otherwise attaches to an external support, providing a plurality of attachment points. The capture assembly may include a pivotable cam that releasably grips the elasticized band of a scalp hook retractor by compressing the band between the gripping cam and the surgical accessory bar or other external support.

Abstract: The present invention provides a method for preparing a spray-dried, compressible granular formulation for preparing pharmaceutical tablets in which essentially water-insoluble, acidic, amphoteric, and basic pharmaceutically active agents are converted to more water-soluble salts which are granulated with hydrolyzed cellulose, drug-containing slurries, the resulting granulations, capsules containing granulations, and pharmaceutical tablets compressed from such granules. In these formulations there is employed from 1% to 85% by weight of the pharmaceutically active agent and its salt form, from 5% to 99% of hydrolyzed cellulose, based on the dry weight of the granulation, and optionally, conventional granulation and/or tableting additives such as surfactants, disintegrants, and antiadherents/flow aids. Said tablets have significantly increased dissolution of the pharmaceutically active agent at the pH of the gastrointestinal tract in comparison with the unconverted free pharmaceutically active agent.

Abstract: Disclosed herein are composition comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.

Abstract: The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90% by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.