Abstract: An anhydrous base composition including a branched hydrocarbon base oil having 9-16 carbon atoms and a viscosity adjusting agent suitable for use in the formulation of a cosmetic composition and which is compatible with a variety of capsule technologies. Also described is a storage stable anhydrous fill formulation compatible with a variety of different capsule technologies and which includes an anhydrous base composition including a base oil and a viscosity adjusting agent, as well as one or more UV components such as UV filters and, optionally, one or more UV defense boosters. Soft capsule formulations containing UV filters are also disclosed. The soft capsule formulations may include a soft capsule shell and an anhydrous fill material within the shell, which, when dispensed, provides a film including one or more sun protection ingredients.

Abstract: Disclosed is a method for shortening the drying time for drying an encapsulated material including a coating material containing water without causing deformation of the coating when drying. The method employs a fluidized bed dryer for drying coating materials that contain water and that form a coating when the water evaporates. A first drying step involves floating and fluidizing the encapsulated material and limiting a theorisable evaporating water content ?W so that dimples or deformation do not occur in the coating of the encapsulated granular material while measuring a water content or temperature of gas exhausted from the fluidized bed dryer; and a second drying step, performed after the measure water content is reduced below a prescribed amount or the measured temperature has increased, of blowing in gas to the fluidized bed dryer so that the theorisable evaporating water content ?W rises above that during the first drying step.

Abstract: A process and system for recovering gel-mass from a gel-mass-containing waste material. The process comprises retrieving the gel-mass-containing waste material from an encapsulation process; melting the retrieved waste material to provide an oil phase and a non-oil phase; retrieving the non-oil phase to produce a recovered gel-mass; and recycling the recovered gel-mass for combination with fresh encapsulating material to provide a combined encapsulating material for use in encapsulating a same lot of the same product which was being encapsulated in the step that produced the gel-mass-containing waste material from which the gel-mass was obtained. The system comprises a heated accumulator for receiving and melting the gel-mass-containing waste material to provide an oil phase and a non-oil phase; a pumping system; an optional mixer; and a control system.

Abstract: An encased-pellet tablet for an active pharmaceutical ingredient comprises an excipient layer on the outside and an inner core that is surrounded by the excipient layer. The inner core contains a plurality of coated pellets, and the coated pellets comprise pellets of the active pharmaceutical ingredient coated with a pellet coating. The excipient layer contains from about 1 wt. % to about 20 wt. % of at least one cushioning agent selected from polyhydroxyl compounds. A method for manufacturing the encased-pellet tablets involves compressing an excipient material to form a first layer; compressing a plurality of coated pellets containing an API on said first layer to form an inner core thereon and compressing additional excipient material around an exposed portion of said inner core thereby surrounding said inner core with excipient material.

Abstract: An ingestible composition contained in a soft gel or shard shell capsule includes a digestible odoriferous oil such as a fish oil which can cause reflux or eructation odor problems on the breath of a person taking the capsule. This is reduced by including in the ingestible composition at least one surfactant, preferably in an amount of about 2 to about 20% weight and at least one edible odor-masking ingredient such as parsley seed oil, lemon balm, lemon grass oil, fennel, peppermint oil and/or menthol.

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 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.