Abstract: Apparatus for producing image bearing filled gelatin capsules (12 and 16) for directing gelatin ribbon (2,4) from respective casting drums to an encapsulation station (6). Along the path of at least one ribbon (4) is a transfer station (18) at which images are applied to the ribbon. The images are applied in a pattern which corresponds to the pattern of capsules formed from the ribbon at the encapsulation station (6). Both the rollers (8) at the encapsulation station, and a support roller at or adjacent the transfer station are positively drive, and a control system ensures that the peripheral speed of a support roller (16) in the transfer station (18) is the same as the speed of the ribbon into and through the encapsulation station. The drive motor for the respective support roller in the transfer station is preferably a stepping motor, adjustable to advace or retard relative to the ribbon spped in the encapsulation station (6).

Abstract: The invention herein relates to a method and apparatus for forming (or cold-forming) an embossed blister from a laminated film wherein an indicia is formed on the base of the blister. In particular, the invention involves a single pass process of combining the formation of a blister and the formation of an indicia (embossing) on the blister, wherein the blister-forming pin contains a face with an indicia and is adapted to controllably stretch the laminated film during blister formation to minimize stretching of the film at the base of the blister. The invention is particularly useful in manufacturing processes which involve the formation of blisters having laminated films which contain a metal foil and polymer layer, wherein improved control in the stretching of the laminate during blister formation is desirable.

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: The present invention relates to fast dispersing solid dosage forms that preferably dissolve in the oral cavity within sixty (60), more preferably within thirty (30), most preferably within ten (10) seconds. A novel feature of the solid dosage forms according to the invention reside in the fact that the composition is essentially free or absolutely free of mammalian gelatin. It has been discovered that the use of certain modified starches at concentrations from 20 to 90% by weight of the solid dosage form prepares dosage forms that are mechanically and chemically stable and are able to deliver higher concentrations of an active ingredient than the heretofore utilized gelatin based fast dispersing solid dosage forms. Further, the solid dosage forms according to the invention are obtainable by removing a solvent, such as water, from a mixture comprising an active ingredient, a modified starch and a matrix forming agent via freeze drying.

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: The invention permits the application of an identifying mark onto a fast-dissolving dosage form without the need for application of pressure or printing directly onto the dosage unit. The invention comprises preparing of a fast-dissolving dosage unit that is embossed with an identifying mark such as a manufacturer's logo, medicinal component strength, or other information relating to the unit. The desired identifying mark is first embossed onto the base of the container such as a blister pocket. Liquid suspension is then filled into the container and solidified, e.g., freeze-dried, therein. The resulting dosage unit in the container is thereby embossed with a substantial copy of the identifying mark that was embossed on the base of the container. The embossed identifying mark on the base of the container remains thereon as well thereby affording the ability to learn the identifying mark on the enclosed unit without opening the packet.

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: This invention relates to 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: (i) forming a solution or a suspension in a solvent of a water soluble or water dispersible carrier, a filler and the pharmaceutically active substance with the unacceptable taste in association with a lipid, the weight ratio of the pharmaceutically active substance to the lipid being in the range of from 1:1 to 1:10 and the weight ratio of the carrier to the lipid being in the range of from 5:1 to 1:15; (ii) forming discrete units of the suspension or solution; and (iii) removing the solvent from the discrete units under conditions whereby unit dosages are formed comprising a network of carrier/filler carrying a dosage of the pharmaceutically active substance in association with the lipid; oral solid rapidly disintegrating dosage forms prepared by such a process are also provided.

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: 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: 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 softgel formulation containing retinol comprises a soft gelatin shell and a fill material within that shell containing retinol-impregnated microparticles. The fill material may be an optionally thickened silicone oil, or may be an emulsion comprising a silicone oil. Ascorbic acid may be present as ascorbic acid-impregnated microparticles and/or within the emulsion.

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 composition for use in the shell of a comestible capsule comprising Gelatin and a plasticiser such as Glycerol together with a further component which forms a secondary matrix for the plasticiser. The provision of this secondary matrix enables the relative amount of the gelatin to the plasticiser to be reduced which shortens disintegration time in the mouth. The further component is typically unbleached potato starch acetate.