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: Granulation of microcrystalline cellulose with a granulating fluid consisting of water and a water-miscible, volatile, polar organic solvent yields porous granules which are comprised of particles that are larger than the ungranulated microcrystalline cellulose. This granulated microcrystalline cellulose is capable of cushioning controlled release particles and barrier coated particles from the compression forces used in tableting, thereby maintaining the physical integrity of the components of the tablet.

Abstract: The child-resistant blister pack for unit dosage forms has a blister film sheet with depressions therein, unit dosage forms within the depressions and a lidding sheet which overlies the depressions and which is secured to the film sheet so as to seal the unit dosage forms within the depressions. A network of lines of weakness in the pack define a plurality of dosage units. Each dosage unit includes one of said dosage forms and a peel region where part of the lidding sheet is not secured to the blister film sheet. Each peel region is disposed adjacent a respective one of the lines of weakness.

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: This invention is directed to pharmaceutical compositions for oral administration, wherein the drug or active ingredient is known to have stability problems associated with the use of free fatty acids. The compositions of the invention enhance the solubility of such compounds and improve the storage stability thereof and can be advantageously used in soft-gel and hard-shell capsular formulations. The liquid pharmaceutical compositions, according to the present invention, have a drug dissolved in a liquid vehicle. The liquid vehicle comprising a glyceride of a long chain fatty acid and a lypophilic surfactant having an HLB of less than ten. The composition, according to the invention, is also substantially free of free fatty acids.

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: An apparatus and a process useful for producing patterned gelatin ribbons for forming patterned soft gelatin capsules are disclosed. The apparatus and process use multiple spreader boxes to form a wide variety of possible patterns.

Abstract: A blister pack which confines the movement a dosage form in order to resist damage thereto during handling and transportation while permitting removal of the intact dosage form, and apparatus and methods for the same. In particular, the invention provides a blister pack wherein the blister includes a protruding region between the opening and the base, thereby producing a constricted area or “neck” in the blister. In a preferred embodiment, the protruding region comprises an inwardly directed annulus formed in the blister wall. Accordingly, vertical movement of the dosage form is confined as a result of the protruding region, thereby reducing the likelihood of damage to the dosage form caused by agitation of the blister pack. The invention is particularly useful in packaging frangible pharmaceutical dosage forms formed in situ within the blister, such as freeze dried dosage forms and rapidly dissolving oral dosage forms.

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: An apparatus and a process useful for producing patterned gelatin ribbons for forming patterned soft gelatin capsules are disclosed. The apparatus and process use multiple spreader boxes to form a wide variety of possible patterns.

Abstract: The invention herein provides for an improved dye composition for encapsulation in casing structures adapted for projectile motion and rupture upon contact with a target surface, such as paint balls. The dye composition adapted for use in an impact-rupturable capsule of the invention comprises a water-soluble dye and a lipophilic carrier having an oil and an emulsifier, said emulsifier comprising ethoxylated mono- and diglycerides. The invention further provides for an impact-rupturable capsule containing the dye composition. Advantages of the dye composition of the invention include improved consistency and reduced separation of ingredients; greater viscosity and thickness; greater “smearability” and splattering of dye on target surface upon impact and rupture of the casing; and greater water solubility and improved machine washability.

Abstract: A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

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.

Abstract: A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

Abstract: A unit container for a treatment fluid comprises a sealed enclosure of which one wall section thereof is formed with at least one opening. The enclosure is pressuriseable to discharge its contents through the opening or openings, which is or are of sufficient diameter to enable the generation of a jet and/or discrete droplets of treatment fluid discharged therefrom. The one wall section is typically a flat section of the enclosure wall, and the enclosure is typically a blister pack, with the wall section at a planar base of the blister. However, the one wall section may be dome-shaped and formed with at least one opening in the top region of the dome. Containers of the invention may be provided in packages, for example in strip form or in planar arrays. Dispensing devices are described for discharging their contents in treatment.

Abstract: A process for the preparation of a solid pharmaceutical dosage form comprising a carrier and, as active ingredient, a compound which exists, in solution, in an equilibrium between a free acid or free base form and a salt form, and for which there is a difference in volatility between the free acid or free base form and the salt form. The process includes the steps of solidifying a mixture of the compound and carrier in a solvent, and subsequently removing the solvent from the solidified mixture. A pH modifier is added to the mixture prior to solidification to shift the equilibrium to favor the less volatile form of the active ingredient.