Abstract: A recipient-dosage delivery system including shearlite particles of a bio-affecting agent for delivery to a recipient. The particles are provided in a metered dose and are packaged in a bi-functional vessel. The particles are produced under liquiflash conditions and exhibit sufficient flowability so as to allow administration of the metered dose to the recipient under the force of gravity.

Abstract: A child resistant tablet package accommodates low density pharmaceutical tablets. The package includes a blister tray having a plurality of blister depressions which accommodate the low density porous pharmaceutical tablets. The blister tray further includes a frangible tray extent spaced adjacent to each blister depression. The frangible tray extent may be manually punctured through the surface of the blister tray. A planar lid is removably sealed over the blister tray and encloses the tablets within the blister depressions. The blister lid includes frangible cover extents overlying each of the frangible tray extents. The cover extents and the tray extents may be frangibly displaced so as to establish a graspable peel tab to facilitate peelable removal of portions of the cover from the overlying disposition with respect to the blister depressions so as to expose the tablets for dispensing.

Abstract: A material processing apparatus and method for processing a solid feedstock material through a melt spin process including a spinner head having a spinner head chamber defined by a parametrical processing wall through which the solid feedstock material is processed. The apparatus includes a device for rotating the spinner head about an axis of rotation to cause the feedstock material to be repelled towards and through the processing walls. A heating source separate from and exterior to the spinner head is included for heating the feedstock material to an elevated temperature to cause the melt spin processing as the feedstock material is projected through the processing wall.

Abstract: The present invention deals with compositions and methods for preparing comestible units which disperse quickly in the mouth, especially when chewed. The present invention also includes the product made therefrom. The method includes initiating crystallization of shearform matrix with crystallization/bindig promoter and combining it with an additive to form flowable, compactible micro-particulates. The combination is then shaped to form a comestible unit having high structural integrity, good appearance, and excellent release characteristics.

Abstract: The present invention provides consumable, gummy delivery systems and methods of making the same. The gummy delivery systems include an active ingredient admixed with a glycerylated gelatin matrix prepared by heating an aqueous solution of gelatin and glycerin to a temperature and for a time sufficient to remove some of the moisture content of the initial aqueous solution. The active ingredient can be delivered from a shearform matrix carrier.

Abstract: The present invention is a method of preparing a comestible unit which disperses quickly in the mouth. The present invention also includes the product resulting from the method. The method includes initiating crystallization of shearform matrix and combining with an additive, either before or after initiating crystallization, to form flowable, compactible micro-particulates. The combination is then subjected to compacting to form a comestible unit having high structural integrity, good appearance, and excellent release characteristics.

Abstract: Vitamin E TPGS/drug compositions and methods are provided which obviate the need for surfactants or non-evaporated co-solvents because the active drug component is dissolved directly into Vitamin E TPGS to form a true molecular solution--not an emulsion or a micro-emulsion. The invention provides a slowly dissolving TPGS/Drug matrix that absorbs gastrointestinal fluid into the matrix at the dosage form/fluid interface, where a gel-like liquid crystal is formed. This gel front forms a liquid crystal boundary where drug dissolution is highest. At this liquid crystal/GI fluid boundary, a synchronization takes place in which the rate of formation of liquid crystals equals the dissolution rate of liquid crystals at the water interface, thereby giving controlled order release of the drug into the GI tract. The rate of dissolution is also controlled by the geometry of the dosage form.

Abstract: The present invention is a new mesomorphic polycrystallite product and a process for making the same. In the present invention amorphous sugar is transformed to a mesomorphic product having polycrystallites therein by a completely anhydrous process rather than by hydrating and then dehydrating the sugar. The product of the present invention is unique in shape and size, and possesses a high degree of uniformity. The properties of the polycrystallite make it possible to replace some or all of the fat in comestibles such as frostings and fillings and to provide fondants of extraordinarily fine grain.

Abstract: The present invention is a method of entrapping an additive within carbohydrate bodies. The additive is drawn into the internal structure as a fluid during transformation of the bodies from a substantially amorphous state to a crystalline state. The present invention is also a delivery system including a carbohydrate body having an internal free volume space defined by an at least partially crystalline structure at equilibrium conditions, and an additive loaded within the carbohydrate body.

Abstract: The present invention involves an apparatus for making comestible units. The comestible units made in accordance with the present invention can include active ingredients and are capable of dissolving in the mouth of the consumer within several seconds. They are particularly useful as antacids and as delivery vehicles for biologically active ingredients, especially those which are ideally combined with antacid ingredients.

Abstract: The invention relates to compositions useful for making tablets which can be formed using conventional tableting machines and which disintegrate rapidly when placed in the mouth. The compositions typically include partially hygroscopic shearform matrices which may be recrystallized using crystallization promoters.

Abstract: The present invention is a comestible composition including a new spheroidal polycrystallite product. In the present invention amorphous sugar is transformed to crystalline sugar by hydrating rather than dehydrating sugar.

Abstract: The present invention is a method of preparing rapidly dissolving comestible units such as tablets. The present invention also includes an apparatus for making the comestible units and the units themselves. The product prepared in accordance with the present invention can include active ingredients and is capable of dissolving in the mouth of the consumer within several seconds. The unit dosage forms prepared in accordance with the present invention are particularly useful as antacids and as a delivery vehicle for biologically active ingredients, especially those which are ideally combined with antacid ingredients in order to ameliorate the effects of antacid environment.

Abstract: An apparatus and method for continuously making chopped amorphous fibers that uses an air transport system. The apparatus includes a source of floss, a duct for transporting the floss while it is entrained in a stream of gaseous carrier medium, a chopper for chopping the floss, and a separator. In a preferred embodiment, the floss is chopped while it is entrained in the stream of gaseous carrier medium using a rotating ring chopper, and the chopped floss is subsequently separated using a cyclone separator.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

Abstract: The present invention is a method of preparing rapidly dissolving comestible units such as tablets. The present invention also includes an apparatus for making the comestible units and the units themselves. The product prepared in accordance with the present invention can include active ingredients and is capable of dissolving in the mouth of the consumer within several seconds. The unit dosage forms prepared in accordance with the present invention are particularly useful as antacids and as a delivery vehicle for biologically active ingredients, especially those which are ideally combined with antacid ingredients in order to ameliorate the effects of antacid environment.

Abstract: Controlled release dosage units containing water soluble active agents can be made using an active agent, an optional inert carrier, a cellulosic polymer and a lipophilic ingredient.

Abstract: The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

Abstract: A spinner head is used for spinning and processing feedstock material. The spinner head includes spaced tubular heating elements which are covered by annular housing that forms a material processing wall. The annular housing contains radially spaced slots which provide a passage way for the material to be expelled from the spinner head. Each slot contains a flow restricting insert removably insertable therein. The inserts include radially extending grooves which channel the feedstock material as it exits the spinner head. The insert further include latches extending therefrom which secure the inserts in the spinner head upon rotation.

Abstract: The present invention is a method of making discrete particles by subjecting an organic feedstock to liquiflash conditions whereby the feedstock is transformed instantaneously from solid to liquiform to solid. Liquiform is a transient condition wherein the feedstock has substantially unimpeded internal flow. Shear force is imparted to the liquiform feedstock in an amount sufficient to separate tiny masses of feedstock. The tiny masses solidify as discretized particles. The present invention also includes unique products resulting from the process, e.g., a monodispersed microsphere product and coated particles prepared therefrom.