Abstract: The invention herein provides for an improved dye composition for encapsulation in casing structures adapted for projectile motion and rupture upon contact with a target surface, such as paint balls. The dye composition adapted for use in an impact-rupturable capsule of the invention comprises a water-soluble dye and a lipophilic carrier having an oil and an emulsifier, said emulsifier comprising ethoxylated mono- and diglycerides. The invention further provides for an impact-rupturable capsule containing the dye composition. Advantages of the dye composition of the invention include improved consistency and reduced separation of ingredients; greater viscosity and thickness; greater “smearability” and splattering of dye on target surface upon impact and rupture of the casing; and greater water solubility and improved machine washability.

Abstract: A formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

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 formulation of a sparingly water-soluble, crystalline pharmaceutically active agent wherein the active agent is converted to and stabilized in its amorphous form as a solid solution of a normally hydrophobic vehicle is described. The amorphous state is stabilized by the composition of the formulation, providing long shelf life of the improved composition. This stabilized formulation also provides increased solubility and bioavailability of the active agent. Solutions of the active agent are stabilized by the composition, preventing recrystallization and precipitation of the less soluble, crystalline form of the active agent from aqueous solutions thereof.

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: Disclosed herein are compositions comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.

Abstract: The invention disclosed herein includes a vitamin composition encapsulated in a soft or hard shell capsule, said vitamin composition comprising water soluble vitamin particles suspended in a fill liquid, wherein said water soluble vitamin particles are coated with a material that is substantially insoluble in the fill liquid and the shell of the capsule, but soluble in the gastrointestinal tract of a mammal, and the coated water soluble vitamin particles are of a size that are suitable for encapsulating as a suspension in said capsule. The invention also includes a process for manufacturing the same. Vitamin containing capsules according to this invention are discoloration-resistant.

Abstract: A laminated film in which a metal foil is sandwiched between two polymeric films is cold formed to define one or more blisters, and the base of the blister stamped with indicia, in two discrete stages. The blister is formed in the first stage using a standard technique of advancing a pin in a direction transverse relative to the plane of the film. According to the invention, once the blister forming stage is completed, indicia are stamped into the base of the blister in the second stage by advancing a die from one side thereof to clamp the blister base against a mold held against the other side. The direction of the die and disposition of the die and mold may be selected such that the indicia project inwardly or outwardly from the blister base.

Abstract: The invention disclosed herein is a process for increasing the achievable concentration of a pharmaceutically active ingredient relative to fill composition viscosity for dosage units. The process is particularly useful in the preparation of soft gelatin capsules containing ibuprofen, naproxen, indomethacin, and acetaminophen, as the pharmaceutically active ingredient. As a result of the process, lesser quantities of composition ingredients other than the pharmaceutically active ingredient are needed to accomplish the same therapeutically effective dosage, thereby significantly increasing the concentration of the pharmaceutically active ingredient resulting in either a reduction in overall fill volume and dosage unit size or an increase in concentration of pharmaceutically active ingredient per dosage form.

Abstract: The use of a pharmaceutical composition for oral administration comprising a carrier and active ingredient selected from a dopamine agonist, testosterone and mixtures thereof, the composition being in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity for the manufacture of a medicament for treatment of male erectile dysfunction.

Abstract: Disclosed herein are compositions comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.

Abstract: A method and apparatus for manufacturing pharmaceutical capsules use an aqueous solution of a thermogelling cellulose ether composition and use capsule body pins and capsule cap pins as molds. The method involves heating the pins, dipping the pins into the solution to cause the solution to gelatinize on the surface of the pins, removing the pins and drying the gelatinized solution on the surface of the pins to form capsule bodies and capsule caps. Pins are heated pre-dip and post-dip to facilitate gelating. Counterflow air is applied to provide drying from the inside. Capsule parts are removed by gripping. Capsule parts may have a thick wall and a stiffening ring.

Abstract: In one embodiment, this invention relates to a pharmaceutical composition for oral administration consisting essentially of a gelatin at a concentration up to 5% by weight as a carrier, a solvent, and, as an active ingredient, a dopamine agonist. Alternatively, the invention relates to a composition that takes the form of a solid, unitary fast-dispersing dosage form comprised of a network of an active ingredient after and a water-soluble or water dispersible matrix forming agent or carrier which is inert towards the active ingredient after subliming solvent from the composition in the solid state. The dosage is designed to completely disintegrate within 1 to 30 seconds of being placed in the oral cavity. Compositions which further comprise an anti-emetic and/or an opioid antagonist are also provided herein.

Abstract: This invention relates to pharmaceutical compositions for oral administration comprising a carrier and, as active ingredient, an ophthalmologically active compound, characterized in that the composition is formulated to promote pre-gastric absorption of the ophthalmologically active compound. A process for preparing such compositions and the use of such compositions for the treatment of ophthalmic diseases, particularly diseases caused by elevated intro-ocular pressure, such as ocular hypertension and glaucoma, are also provided.

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.