Abstract: Disclosed is an improved drug delivery device for delivering a fill pharmaceutical composition. The drug delivery device comprises a soft gelatin capsule having a shell comprising gelatin and plasticizer wherein the shell is dissoluble upon dispersion into warm water. The invention also discloses snip-off or twist-off soft gelatin capsules offering unit dose convenience. The composition of the shell used in constructing the soft gelatin capsules comprises gelatin in the range of approximately 40% to 48% and a plasticizer ranging in amount from approximately 14% to 25%.

Abstract: The present invention relates to a pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation has Pseudoephedrine HCl as the active pharmaceutical ingredient. The active pharmaceutical ingredient is embedded into an oily matrix, also the formulation comprises viscosity imparting agents, a surfactant; a suspending agent; and a suspension medium. The viscosity-imparting agents are partially hydrogenated vegetable oil and colloidal silicon dioxide, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. In one preferred embodiment, the formulation consists essentially of about 60 mg by weight of Pseudoephedrine HCl, about 15-25 mg by weight of partially hydrogenated vegetable oil, about 10-20 mg by weight of yellow beeswax, about 2-8 mg by weight of lecithin, about 2-8 mg by weight of silicon dioxide; and about 150-250 mg by weight of soybean oil.

Abstract: The present invention provides compositions and methods of treating hepatitis virus infection, particularly hepatitis C virus infection. The invention provides methods of treating a hepatitis virus infection, involving administering a first form and a second form of IFN-? to provide a multiphasic pharmacokinetic profile. The multiphasic antiviral agent serum concentration profile that is achieved effects an initial rapid drop in viral titer, followed by a further decrease in viral titer over time, to achieve a sustained viral response. The invention further provides compositions that are effective in achieving a multiphasic IFN-? profile. Compositions of the invention comprise at least a first form of interferon-? (IFN-?) that has a first pharmacokinetic profile and a second form of IFN-? that has a second pharmacokinetic profile, where the second form of IFN-? has a longer mean residence time than that of the first form of IFN-?.

Abstract: Embodiments of the present invention relate to an oily wax matrix suspension pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, where the pharmaceutical formulation comprises non-steroidal anti-inflammatory drugs (NSAIDs) including Ketoprofen, Naproxen, and Naproxen Sodium salt form as the active ingredient. The active pharmaceutical ingredient is embedded in an oily matrix, which also comprises a surfactant, a viscosity enhancer and a suspending agent.

Abstract: A multifunctional particulate material, fluid, or composition includes a predetermined amount of core particles with a plurality of coatings. The core particles have an average particle size of about 1 nm to 500 &mgr;m. The particulate material, fluid, or composition is capable of exhibiting one or more properties, such as magnetic, thermal, optical, electrical, biological, chemical, lubrication, and rheological.

Abstract: A process and a pharmaceutical formulation of a water insoluble drug encapsulated in a soft gelatin capsule. The formulation preferably has loratadine as the active ingredient which is formed into a blend with a vehicle which includes a solubilizer, a emulsifier and optionally a viscosity modifying agent. Preferably, the gel encapsulated blend provides a self emulsifying drug delivery system for oral administration of the pharmaceutical formulation.

Abstract: An oily wax matrix suspension pharmaceutical formulation is prepared for oral administration of an active ingredient, such as ibuprofen, through a soft gelatin capsule drug delivery device. The ibuprofen may be in free acid or a mixture of free acid and ibuprofen alkali salt form. The active pharmaceutical ingredient is embedded in an oily wax matrix which is preferably blended with a surfactant. A preferred surfactant is lecithin, a preferred suspending agent is yellow beeswax, and a preferred suspension medium is soybean oil which are all natural ingredients.

Abstract: A one pot process for the preparation of sterically hindered triaryl phosphite is provided. It is suitable for large scale commercial production with an advantage of having carried out the reaction at 0-5° C. in a shortest time of 1 hr using pyridine as Lewis base to remove HCl formed in the reaction; thus avoiding the usage of scrubber. The triaryl phosphite is of the formula P(OR)3 and is produced by reacting a di alkyl—substituted phenol of formula ROH with phosphorus trihalide in a presence of a Lewis base, wherein R represents an aryl compound of a formula C6H3RaRb, wherein Ra is tertiary alkyl, Rb is lower alkyl or tertiary alkyl. The process preferably comprises of mixing a stoichiometric amount of 2,4-dialkyl phenol with phosphorous trihalide in methylene chloride with different stoichiometric amounts of pyridine such as the molar equivalent, 10 mol %, 20 mol % and 50 mol % more than the amount of 2,4 dialkyl phenol. The reaction is preferably carried out at 0-5° C.

Abstract: The present invention relates to a pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation has Pseudoephedrine HCl as the active pharmaceutical ingredient. The active pharmaceutical ingredient is embedded into an oily matrix, also the formulation comprises viscosity imparting agents, a surfactant; a suspending agent; and a suspension medium. The viscosity-imparting agents are partially hydrogenated vegetable oil and colloidal silicon dioxide, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. In one preferred embodiment, the formulation consists essentially of about 60 mg by weight of Pseudoephedrine HCl, about 15-25 mg by weight of partially hydrogenated vegetable oil, about 10-20 mg by weight of yellow beeswax, about 2-8 mg by weight of lecithin, about 2-8 mg by weight of silicon dioxide; and about 150-250 mg by weight of soybean oil.

Abstract: Disclosed are pharmaceutical formulations for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation, in a preferred embodiment, contains Pseudoephedrine HCl and an expectorant as the active ingredients. The active pharmaceutical ingredient is embedded into an oily matrix. The formulation also includes an expectorant; a surfactant; a suspending agent; and a suspension medium, wherein, in a preferred embodiment, the expectorant is guaifenesin, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. In a preferred embodiment, the formulation consists essentially of about 30.5 mg by weight of Pseudoephedrine HCl, about 200 mg by weight of guaifenesin, about 0.1-5.0 mg by weight of yellow beeswax, about 10-15 mg by weight of lecithin; and about 200-300 mg by weight of soybean oil. Also disclosed is a process for preparing the formulation.

Abstract: Disclosed is a pharmaceutical formulation for oral administration through a soft gelatin capsule drug delivery device, wherein the pharmaceutical formulation includes Ephedrine HCl and an expectorant as active ingredients. Preferred formulations include Ephedrine embedded into an oily matrix, an expectorant; a surfactant; a suspending agent; and a suspension medium, wherein the expectorant is guaifenesin, the surfactant is lecithin, the suspending agent is yellow beeswax, and the suspension medium is soybean oil. A preferred formulation consists essentially of either about 25 mg or about 12.5 mg by weight of Ephedrine HCl, about 200 mg by weight of guaifenesin, about 0.1-5.0 mg by weight of yellow beeswax, about 10-15 mg by weight of lecithin; and about 200-300 mg by weight of soybean oil. Also disclosed is a process for preparing the formulation.

Abstract: A one pot process for the preparation of sterically hindered triaryl phosphite is provided. The triaryl phosphite is of the formula P(OR)3 and is produced by reacting a hydroxyl-substituted aryl compound of formula ROH with phosphorus trihalide in a presence of a Lewis base, wherein R represents an aryl compound of a formula C6H3R1R2, wherein each R1 and R2 is an organic substituent. The process preferably comprises of mixing a substantial stoichiometric amount of 2,4-dialkyl phenol with phosphorous trihalide in methylene chloride with stoichiometric amount of pyridine. The reaction is preferably carried out at 0-5° C. and takes only 1 hr for the completion, followed by a precipitation out of isopropanol.

Abstract: A method and system for treating bronchial constriction. The system includes a liposome composition containing a .beta..sub.2 -adrenoreceptor agonist in a liposome-entrapped form, and a device for aerosolizing a metered quantity of the composition. The drug in liposome aerosol form is substantially more effective in bronchodilation, over a substantially longer time, than the same amount of drug in free-drug aerosol form.

Abstract: A liposome composition for extended release of a therapeutic compound into the bloodstream. The liposomes are composed of vesicle-forming lipids and between 1-20 mole percent of a vesicle-forming lipid derivatized with hydrophilic polymer, have sizes in a selected size range between 0.1 and 0.4 microns, and contain the therapeutic compound in liposome-entrapped form. The dosage form of the composition contains at least about three times the dose of the compound required for intravenous injection in free form. Also disclosed in a method for extending to at least 24 hours the period in which an intravenously administered therapeutic compound is therapeutically active in the bloodstream, and novel liposomes compositions for practicing the method.

Abstract: A method for delivering a therapeutic dosage of corticosteroid drug to the lungs, for treating a lung condition or disease. An aqueous suspension of sized liposomes containing the drug in liposome-entrapped form is aerosolized under conditions which produce aerosol particle sizes favoring particle deposition in a selected region of the respiratory tract, and the aerosol is administered in an amount which delivers the thereapeutic dosage level to the selected lung region.

Abstract: A non-conventional lipid particle formulation for the sustained release and delivery of steroids into deep lung is disclosed. The formulation provides prolonged release of the drug, improved therapeutic ratio, lower toxicity, reduced systemic side effects, and stability for several months. The formulation is in particular suitable for treatment of interstitial lung diseases.

Abstract: This invention relates to a novel, non-conventional liposome formulation for the sustained release and delivery of steroids. The formulation provides prolonged release of the drug, improved therapeutic ratio, lower toxicity, reduced systemic side effects and is stable for up to three months. The formulation is suitable for sustained delivery of steroid via inhalation, parenteral, intrathecal, intraarticular, topical, ophthalmic, and oral administration.

Abstract: This invention relates to a novel, non-conventional liposome formulation for the sustained release and delivery of steroids. The formulation provides prolonged release of the drug, improved therapeutic ratio, lower toxicity, reduced systemic side effects and is stable for several months.

Abstract: A system and method for administering a drug, at a selected dose, via the respiratory tract. Spray-dried liposome particles containing the selected dose of the entrapped drug are released into the air in aerosolized form, either by entrainment in an air or propellant stream, or by release from a pressurized can containing a suspension of the liposomes in a fluorchlorocarbon solvent.

Abstract: A liposome composition designed for enhanced binding to mucosal tissue, The liposomes contain about 10-40 mole percent of an amine-derivatized lipid component in which a charged amine group is spaced from a lipid polar head region by a carbon-containing spacer arm at least 3 atoms in length. The liposomes preferably have a close packed lipid structure produced by inclusion of between 20-50 mole percent of cholesterol or an amine-derivatized cholesterol, and/or phospholipids with predominantly saturated acyl chain moieties. For ophthalmic use, the liposomes may be suspended in an aqueous medium containing a high-viscosity polymer, to enhance further the retention of liposomes on a corneal surface.