Abstract: A system for filling a blow-fill-seal (BFS) container is provided. The system includes a first fluid circuit constructed to selectively deliver a purge fluid to an open BFS container. A second fluid circuit selectively delivers a product to the open BFS container. A third fluid circuit, having a vent line in fluid communication with the open BFS container and to the ambient, directs a bulk fluid comprising at least the purge fluid from the container when the purge fluid is introduced into the BFS container. The second circuit selectively delivers product when the first fluid circuit selectively does not deliver the purge fluid, and the second circuit selectively does not deliver product when the first circuit selectively delivers the purge fluid.

Abstract: The invention provides pharmaceutical compositions comprising a therapeutically effective amount of meloxicam, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical compositions are in the form of a fast disintegrating dosage form suitable for releasing meloxicam rapidly in the oral cavity. Also provided are processes for preparing a pharmaceutical composition of the invention. Further provided are methods of treating arthritis or pain in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical composition according to the invention.

Abstract: Provided herein is a film-forming composition for use in the preparation of a soft capsule, which comprises (a) acid-decomposed waxy corn starch; (b) a gelling agent; and (c) a plasticizer. A soft capsule comprising a shell produced using the film-forming composition disclosed herein has excellent characteristic properties with respect to physical strength, disintegration ability, odor, taste, color and lack of adhesion and also exhibits excellent stability with time.

Abstract: A bi-phasic pharmaceutical composition for oral administration including one or more solid active ingredient containing particles dispersed within a semi-solid carrier formulation. The solid particles include a coating with pH-triggered drug release properties and the semi-solid carrier formulation is formulated at a pH that is different than the pH at which the active ingredient release properties of the coating are triggered. Also described is a delivery system for delivery of the bi-phasic pharmaceutical composition including the bi-phasic pharmaceutical composition described above and a dispenser pouch formed from flexible laminate sheets. Further, a process for manufacturing the two-phase pharmaceutical delivery system is described including the filling the bi-phasic pharmaceutical composition into flexible dispenser pouches, which allows the patient to squeeze and dispense the contents of the package directly into the oral cavity.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: The invention provides allergen containing pharmaceutical products and in particular fast-dispersing solid allergen dosage forms. In particular, fast-dispersing, non-compressed solid dosage forms suitable for oromucosal administration comprising a matrix and at least one allergen are provided. Suitable matrices are gelatine, starch and mannitol. Methods for the dosage forms are also provided.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: A fast-dissolving dosage form (FDDF) for the delivery of a vaccine is prepared using a formulation containing a starch, optionally, along with at least one additional matrix forming agent, preferably, a combination of gelatin and mannitol, wherein an immune response is induced in a patient in need thereof.

Abstract: A softgel capsule containing microencapsulated probiotic bacteria is manufactured such that the softgel capsule is stable for at least about 24 months at room temperature.

Abstract: The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is at least one fish gelatin predetermined on the basis of the molecular weight profile of the gelatin. In some embodiments, particularly when the concentration of carrier comprises a relatively lower percentage of the total composition, the carrier may be exclusively a high molecular weight fish gelatin, or may be comprised of a mixture with standard molecular weight gelatin in which high molecular weight gelatin comprises a predominant portion. In those embodiments where the concentration of carrier comprises a relatively larger percentage of the total composition, the carrier may be an exclusively standard molecular weight fish gelatin, or may be comprised of a mixture in which standard molecular weight gelatin comprises a predominant portion. Thus, compositions may be designed to optimize performance for various required gelatin concentration formulations.

Abstract: A capsule dusting system is designed to expose capsules to a dusting agent in a controlled manner. The system incorporates a tumbling basket positioned within an enclosure. The tumbling basket is loaded with capsules and is rotatably connected to a drive shaft. A dust injection system meters the dusting agent into the dust injection system. The dust injection system may include a dusting injector that translates between two positions. At one position, the dusting injector is loaded with dusting agent by a powder supply system. At the other position, the dusting injector is positioned to inject the dusting agent into the tumbling basket. A gas is fluidly connected to the dusting injector to cause the dusting agent to disperse into the tumbling basket. The enclosure contains the dusting agent within the system to reduce the environmental, health, and safety hazards associated with airborne particulates.

Abstract: A drop dispenser has a substantially conical sleeve member with a narrow upper end and a wide lower end. Centrally located at the apex of the upper end of the sleeve member is an aperture which has an inner diameter and is circumscribed by a raised ridge. The aperture and the ridge form a nozzle. The interior space of the substantially conical sleeve member forms a substantially conical chamber between the narrow upper end and wide lower end of the sleeve member. The nozzle is in liquid communication with the chamber through the aperture. The drop dispenser may have external threads at the lower end of the sleeve member for engaging a cap having a protuberance centrally located at its internal top end for hermetically engaging the aperture of the nozzle when the cap fully engages the sleeve member.

Abstract: The invention herein relates to a method and apparatus for forming (or cold-forming) an embossed blister from a laminated film wherein an indicia is formed on the base of the blister. In particular, the invention involves a single pass process of combining the formation of a blister and the formation of an indicia (embossing) on the blister, wherein the blister-forming pin contains a face with an indicia and is adapted to controllably stretch the laminated film during blister formation to minimize stretching of the film at the base of the blister. The invention is particularly useful in manufacturing processes which involve the formation of blisters having laminated films which contain a metal foil and polymer layer, wherein improved control in the stretching of the laminate during blister formation is desirable.

Abstract: The invention described herein relates to a pharmaceutical composition containing vinorelbine as an active ingredient which is suitable for encapsulation in soft capsules. The liquid oral pharmaceutical composition suitable for a liquid fill composition for a soft capsule dosage form comprises: vinorelbine or a pharmaceutically acceptable salt thereof; ethanol; water; glycerol; and polyethylene glycol. In a preferred embodiment, the tartrate salt form of vinorelbine is used in the composition. The invention also provides for a method of treating cancer comprising orally administering, to a patient in need of treatment thereof, a soft capsule comprising the pharmaceutical composition of the invention.

Abstract: A peelable pouch 50 for containing a single dosage product P having a top layer 100 joined to a bottom layer 200 by at least one seal 500 thereby creating a primary compartment 300. The primary compartment 300 houses the product P, sealed from the exterior environment. The peelable pouch 50 includes a tear promoting surface condition 600 on the top layer 100 and the bottom layer 200 intersected by a fold-over line 700. When the pouch 50 is folded about the fold-over line 700 the tear promoting surface condition 600 permits a user to easily tear off a portion of the pouch 50 and expose a portion of the primary compartment 300 allowing the product P to be removed from the pouch 50. Alternative embodiments incorporate a product retention edge 350 that requires supplemental separation of the top 100 and bottom 200 layers to gain access to the product P, as well as a secondary compartment 400 formed between the top 100 and bottom 200 layers.

Abstract: A nozzle device is disclosed that may be used with a fluid-bed dryer apparatus or system. Such a nozzle device includes, in one embodiment, an intake block, an inner tube, an outer tube, a tip and an air cap. The tubes are connected to the intake block to form a passage for liquid and a passage for gas. The tip connects to the inner tube, and the air cap connects to the outer tube, so that at the output the fluid is atomized by the gas. Flow of the liquid and gas through the nozzle is unimpeded, and the nozzle provides substantially constant atomization characteristics.

Abstract: A child resistant senior friendly medication storage and distribution package including a blister portion and a blocking substrate sandwiched between a dispensing substrate and a backing substrate. The procedure to access the medicament is easy for an adult to understand and accomplish, yet difficult for most children. The blister portion contains a base layer and a blister layer. The blister layer includes an article receiving blister designed for holding the medicament. The dispensing substrate has a dispensing substrate blister receiver. The blister receiver is configured to cooperate with the blister so it extends through the dispensing substrate. The blocking substrate includes a gate that initially covers a portion of the blister. The gate must be moved, or slid, out of the way in order to eject the medicament. The user applies a force to the gate causing it to translate between the backing substrate and the dispensing substrate.

Abstract: A storage and dispensing apparatus designed to contain pre-measured amounts of a substance(s). The apparatus comprises at least one compartment, preferably at least two compartments, for storing the substance(s) that is partially enclosed by a frangible seal, an applicator or dispensing conduit, and an expandable chamber designed to accept and dissipate the hydraulic force created when pressure is applied to the at least one compartment rupturing the frangible seal, and expelling the substance(s) into the chamber. The applicator is attached to the chamber with an applicator bond area. The expandability of the chamber is conferred by expandability of the chamber walls and of the applicator, when present, and is varied in different embodiments by altering the ratio between the area of the applicator bond area and the area of the applicator. The frangible seal, in one of many embodiments, may be a chevron shape stress riser with a point of inflection oriented towards the compartment.