Abstract: A controlled release capsule comprises a male plug (2) formed of a water swellable hydrogel which is engaged within a neck portion (4) of a female body (6). The capsule contains a pharmaceutically active material. In contact with an aqueous medium, such as in the gastrointestinal tract, the hydrogel plug swells and becomes disengaged from the body, thereby releasing the active material. In order to facilitate insertion of the male plug into the neck of the body, the body has a flared mouth portion (14) which is wider than the neck. The neck itself may be wider or narrower than the remainder of the body. A water-soluble cap (8) has detentes (18) which clip over the flared mouth portion so as to lock the cap thereto.

Abstract: A controlled release capsule comprises a male plug (2) formed of a water-swellable hydrogel which is engaged with a neck portion (4) of a female body (6). The capsule is intended to deliver two dosages of pharmaceutically active material at different times. A water soluble cap (8) is fitted over mouth (14) of the body, and defines a first volume (9) containing a first unit dosage (10). A second unit dosage (12) is contained within a second volume (11) defined by the plug and the female body. When the capsule is swallowed by a patient, the cap dissolves quickly in the aqueous medium within the gastro-intestinal tract and releases the first dosage. The aqueous medium then comes into contact with the hydrogel plug which swells and becomes disengaged from the body, usually in the intestine, thereby releasing the second dosage a predetermined time after the first dosage.

Abstract: Rotary die apparatus for producing filled gelatin capsules comprises two cylindrical rollers mounted with their longitudinal axes substantially parallel and defining a nip therebetween, with at least one roller having a plurality of recesses on its outer surface; and means for feeding gelatin ribbon to each roller surface and thereby to the nip. The apparatus includes a metering system for delivering particulate material between gelatin ribbons at the nip; and means for rotating the rollers in synchronism with the metering system such that particulate material is supplied over a recess in said at least one roller, and the juxtaposed ribbon sections close over the particulate material to form a capsule. Air mechanisms may be used to shape the gelatin ribbon into the roller recesses, and such mechanisms can also be used to facilitate the flow of particulate material in the metering system.

Abstract: A process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste which process comprises forming 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, forming discrete units of the suspension or solution and removing the solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable form of the pharmaceutically active substance is formed.

Abstract: A continuous solvent free gelatin encapsulation apparatus and process includes an oil roll back assembly (20) for applying a controlled amount of a food-approved lubricant to a first side of the gelatin ribbon and an applicator guide bar assembly (40) for applying a controlled amount of food-approved lubricant to a second side of the gelatin ribbon. Two opposing food-approved lubricant coated gelatin ribbons are then united in a die assembly (50) to form gelatin capsules which are then dried and recovered.

Abstract: An improved method for manufacturing freeze dried pharmaceutical tablets in blister packs is disclosed. Liquid dosages are introduced into a multilayer laminated blister sheet having an impermeable intermediate layer (14) that is positioned between first and second outer layer (16, 18) each of which has substantially the same coefficient of thermal expansion. The properties of the outer layers of the blister sheet are such that there are no inter-layer stresses that will cause curvature of the blister sheet when it is subjected to temperature changes during the freezing and freeze drying steps. Following the introduction of the dosages into the depressions (10) of the blister sheet, the dosages are frozen and freeze dried. A lidding sheet (32) is then attached to the blister sheet to seal the solid dosages into the blister pack.

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: Fragrances in soft gelatin capsules are disclosed. The desired fragrance is dissolved in a solvent system comprising a volatile solvent, a non-volatile cosolvent, or a combination of a volatile solvent and a non-volatile cosolvent or cosolvents. The resulting solution is then encapsulated by soft gelatin shell prepared with an odor-free, glycerol free gelatin plasticized with a partially dehydrated, hydrogenated glucose syrup.

Abstract: There is provided a carrier for hydrophobic drugs, and pharmaceutical compositions based thereon, which carrier comprises a digestible oil and a pharmaceutically acceptable surfactant component for dispersing the oil in vivo upon administration of the carrier, which comprises a hydrophilic surfactant, said surfactant component being such as not to substantially inhibit the in vivo lipolysis of the digestible oil.

Abstract: The present invention discloses an improved technique for preparing a rapidly dispersing pharmaceutic tablet of a granular therapeutic agent which has both relatively low solubility and relatively large particle size. Xanthan gum is added to a liquid admixture of solvent, carrier components, and the granular therapeutic agent. The xanthan gum not only facilitates suspension of the granular therapeutic agent in the liquid admixture, but, more surprisingly, does so without adversely effecting the dispersion qualities and texture of the tablet in the patient's mouth upon administration.

Abstract: A dosage form for pharmaceuticals, nutrient supplements and food products which is nontoxic and suitable for introduction into mammalian bodies comprising soft elastic gelatin capsule containing a colorless clear liquid carrier and an active ingredient. The capsule is rendered particularly tamper evident by color neutralizing its inherent amber/yellow color with edible dyes and pigments.

Abstract: A gelatin capsule that is generally resistant to humidity having a non-hygroscopic plasticizer and an elasticity reducing gelatin extender in the formulation of the gelatin capsule shell. The capsule is capable of being manufactured on conventional rotary die encapsulation devices and can readily hold liquid fill materials. The capsule is breakable with manual pressure.

Abstract: The present invention relates in general to products for topical application to the skin, and more particularly to improved stable emulsions for containing water soluble active ingredients, such as Vitamin C, glycolic acid, etc., which may nonetheless be packaged with gelatin capsules, and which have demonstrated improved stability.In particular, the invention relates to a novel polyethylene glycol-in-oil emulsion that is compatible with gelatin capsules.

Abstract: A dosage unit form comprises a biologically active agent, such as a pharmaceutical, nutritional supplement or diagnostic, dissolved or suspended in a carrier liquid encapsulated in a soft elastic gel capsule. The carrier liquid comprises maltitol syrup as a major component. Maltitol syrup may be the only component of the carrier liquid, or may be blended with other liquids and/or excipients.

Abstract: A gelatin capsule sheath in which a portion of the gelatin is replaced with a high amylose content starch to provide a dry capsule sheath having 3-60% by weight high amylose starch wherein the amylose content of the starch is at least 50% and preferably 90% high amylose starch. The capsules of this invention have textured frosted or satin finish which do not stick together, form strong seals, are resistant to changes in shape, and are more economical to manufacture.