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: 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: A unit container for a treatment fluid comprises a sealed enclosure of which one wall section thereof is formed with at least one opening. The enclosure is pressuriseable to discharge its contents through the opening or openings, which is or are of sufficient diameter to enable the generation of a jet and/or discrete droplets of treatment fluid discharged therefrom. The one wall section is typically a flat section of the enclosure wall, and the enclosure is typically a blister pack, with the wall section at a planar base of the blister. However, the one wall section may be dome-shaped and formed with at least one opening in the top region of the dome. Containers of the invention may be provided in packages, for example in strip form or in planar arrays. Dispensing devices are described for discharging their contents in treatment.

Abstract: A process for the preparation of a solid pharmaceutical dosage form comprising a carrier and, as active ingredient, a compound which exists, in solution, in an equilibrium between a free acid or free base form and a salt form, and for which there is a difference in volatility between the free acid or free base form and the salt form. The process includes the steps of solidifying a mixture of the compound and carrier in a solvent, and subsequently removing the solvent from the solidified mixture. A pH modifier is added to the mixture prior to solidification to shift the equilibrium to favor the less volatile form of the active ingredient.

Abstract: This invention is directed to an oral solid, rapidly disintegrating, freeze-dried dosage form containing coarse particles of a pharmaceutically active material which are uncoated or coated with a polymer or lipid material. Preferably, the oral dosage form comprises coarse particles having a size in the range of 50 micron to 400 micron. The oral solid rapidly disintegrating dosage form according to the present invention preferably disintegrates in the oral cavity in less than 10 seconds.

Abstract: A softgel-compatible composition containing retinol comprises retinol-impregnated microparticles. The composition may include an optionally thickened silicone oil, or may include an emulsion comprising a silicone oil. Ascorbic acid may be present as ascorbic acid-impregnated microparticles and/or within the emulsion. Such compositions are compatible with softgels, and may also be used in other dispensing containers, such as sachets, tubes, and airless pumps.

Abstract: A coated capsule is disclosed comprising a gelatin shell with a flavored coating. A sugar or sugar substitute is included in the material of the shell and that of the coating to stabilize both compositions and the junction therebetween.

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: To increase the solubility of acidic medicines a high concentration solvent system to be encapsulated comprisesa) 10-80% by weight acidic medicine,b) 0.1-1.0 mole hydroxide ions for one mole equivalent of said medicine, andc) 1-20% by weight water.included in polyoxyethylene sorbitan fatty acid ester as the solvent.

Abstract: A delivery device for delivering an active substance to a patient at a predetermined time after administration comprises a male hydrogel plug engaged in the neck of a female body. An expandable excipient such as a hydrogel powder or a pharmaceutical disintegrant in powder, slug or tablet form is provided beneath the active substance. In contact with an aqueous medium, the excipient absorbs water and swells such as to rapidly expel the active substance and effectively deliver it from the device.

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: Process for preparing an oral rapidly disintegrating dosage form of a hydrophobic pharmaceutically active substance comprising forming a suspension of the hydrophobic pharmaceutically active substance in a solvent containing a pharmaceutically acceptable surfactant together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension and removing solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the hydrophobic pharmaceutically active substance is formed.

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 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: 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: 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.