Abstract: The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquillizers, stimulants and narcotics.

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 shell-forming composition for a soft capsule comprising a non-gelatin component as the chief component, wherein the shell-forming composition is able to inhibit a decrease in physical strength (breaking strength) of the capsule when a phospholipid-containing oil with a phospholipid concentration of 20% or more by mass is used as the core of the capsule. The shell-forming composition for the soft capsule comprises (A) starch and/or dextrin, (B) a gelatinizer, (C) glycerin and (D) sorbitol, and the mass ratio of (C) glycerin:(D) sorbitol ranges from 100:30 to 100:120.

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: 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 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: 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: The invention relates to methods for selectively converting a cysteine residue in a peptide or protein to the dehydroalanine (Dha) residue. The method also works on selenocysteine and substituted cysteine and selenocysteine residues, resulting in the Dha residue which may be converted to any natural or unnatural amino acid residue desired without the alteration of the remainder of the peptide or protein. The invention also allows ligation of a desired peptide at any point rather than at a point where there should be a naturally occurring cysteine, thereby allowing native chemical ligation to be used in the synthesis of peptides that do not contain cysteine. The methodology allows for the synthesis of very large peptides.

Abstract: A method for blow-fill-seal (BFS) packaging of a product and a BFS package. The method forms a BFS package with a twist-off top, container body and information panel in a main mold. The container is filled via a fill opening located distal to the twist-off top and the fill opening is sealed with a base portion. This provides a container having a twist-off top that is more reliably secured to the container body. A plurality of containers may be attached to a single information panel. The BFS packaging system may employ a quick change insert to reduce lost production time when changing products or lots. The package includes an information panel integrally formed with a plurality of twist-off tops, each of which is removably attached to a container body whereby each container body can be removed from the package without removing the remaining container bodies from the information panel.

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 soft chewable capsule film suitable for medicament or foodstuff encapsulation, and a method of fabricating capsules from such a film. Such capsules demonstrate fast rupture in the oral cavity, good mouth feel and chewability, and rapid dissolution of the shell components. In particular, the modified starch is substantially ungelatinized, due at least in part to the processing temperature, and may act as a water retention agent to promote hydration. Additionally, gelatins are selected for bloom strengths that result in a robust capsules that may be fabricated at a thinner wall thickness than previously experienced in the art. Accordingly, such thin capsules have a smaller mass than traditional capsules of the same size and dissolve more quickly than chewable capsules having greater thicknesses. The capsules may be fabricated by a rotary die process at speeds greater than those generally known for soft chewable capsules.

Abstract: A method and system for cold blow-fill-seal packaging of a product. The method and system are directed to maintaining a relatively cold temperature of the product to be packaged during the flow-fill-seal process. This accomplished via the use of one or more of, for example, a heat-exchanger in the system, insulated flow lines and steps taken during the procedure to maintain the temperature of the product below a certain level.

Abstract: A package for delivering a single-dose product includes a softgel capsule which is comprised of at least one gelling agent selected from protein-based gelling agents and polysaccharide-based gelling agents. The capsule shell includes one or more areas of reduced thickness that are preferentially ruptured by exertion of a compressive force on the softgel capsule to create an opening in the capsule shell through which the fill composition can be delivered by spraying or squeezing. A method for manufacturing the softgel capsule having one or more areas of reduced shell thickness is also described.

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: A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described.

Abstract: Single use containers designed to store and dispense liquid substances having a wide variation in viscosities. The container includes a container body that defines a storage compartment for storing the liquid substance and is provided with a neck including a seal positioned in the neck to seal a liquid substance in the storage compartment during storage. The container also includes a cap defining a recess and being adapted for engaging the neck and including structure for piercing the seal and a channel which passes through the structure for piercing the seal to the recess. An applicator is located in the recess such that the applicator and recess together define a chamber between an end of the channel and the applicator to allow liquid to flow from said channel into said chamber.

Abstract: A process and system for sterilization of a product pathway of a blow-fill-seal machine. The process comprises steps of: (1) isolating a holding tank from the product pathway; (2) supplying a sterilizing agent to the product pathway of the BFS machine when the holding tank is isolated; (3) stopping the supply of sterilizing agent to the product pathway when a threshold is reached; and (4) supplying filtered compressed air to the product pathway when the supply of sterilizing agent is stopped. The process is preferably executed automatically without human intervention once initiated. Also described is a system for carrying out the process including a processor, valves and temperature and/or pressure sensors which provide information to the processor to determine when to open and close the valves to supply sterilizing agent and/or compressed air to the product pathway or holding tank.

Abstract: A process and system for sterilization of a product pathway of a blow-fill-seal machine. The process comprises steps of: (1) isolating a holding tank from the product pathway; (2) supplying a sterilizing agent to the product pathway of the BFS machine when the holding tank is isolated; (3) stopping the supply of sterilizing agent to the product pathway when a threshold is reached; and (4) supplying filtered compressed air to the product pathway when the supply of sterilizing agent is stopped. The process is preferably executed automatically without human intervention once initiated. Also described is a system for carrying out the process including a processor, valves and temperature and/or pressure sensors which provide information to the processor to determine when to open and close the valves to supply sterilizing agent and/or compressed air to the product pathway or holding tank.

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: This invention provides capsules and, more specifically soft capsules, wherein the fill material comprises an emulsified syrup. In particular, the present invention provides a means of encapsulating honey in a gelatin, modified-gelatin or gelatin-free shell material. Furthermore, the capsules described herein are capable of being manufactured using a rotary die apparatus.