Abstract: In a powder formulation for use in a dry powder inhaler, a pharmaceutical acts as its own carrier, so that use of lactose or other excipients are not needed. The dry powder formulation has a single active pharmaceutical compound having two major populations in particle size distribution: microfine particles of the active pharmaceutical, of 1-10 microns in diameter, and larger carrier particles, also of the active pharmaceutical compound. The carrier particles provide a long acting, delayed onset, and optionally therapeutic effect via the GI tract, while the microfine particles provide a fast onset effect via the lung.

Abstract: The present invention relates to formulations comprising particulate products which may be prepared by methods and apparatus using supercritical fluids. More particularly, the invention relates to formulations comprising certain crystalline forms of 4-hydroxy-&agr;1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol (salmeterol) 1-hydroxy-2-naphthalenecarboxylate (xinafoate). Accordingly, the present invention provides an aerosol pharmaceutical formulation comprising salmeterol xinafoate with a controlled particle size, shape and morphology, and a fluorocarbon, hydrogen-containing fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.

Abstract: A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.

Abstract: A medicinal aerosol steroid solution formulation product with enhanced chemical stability. The steroid is a 20-ketosteroid having an OH group at the C-17 or C-21 position and the aerosol container has a non-metal interior surface which has been found to reduce chemical degradation of such steroids.

Abstract: A medicinal formulation is disclosed comprising pioglitazone or a derivative thereof. The formulation additionally comprises a fluid carrier and a stabilizer.

Abstract: A polymeric construct is disclosed. The construct comprises a polymer selected from silica gel, fumed silica gel, silicic acid, disilicic acid, trisilicic acid, metasilicic acid, and orthosilicic acid in their free or salt forms; silicon dioxide in either of its amporphous, crystalline, or precipitated forms such as Purified Siliceous Earth; diatomacous earth; Fuller's earth, Kieselhurh, Celite; talc; attapulgite; micas; montmorilonite, kaolin, aluminum oxide (Hydrargilite), bentonite, pumice; silanes and siloxanes and any mixture of the foregoing having a selected medicament associated therewith. The medicament thus present is provided in a slow release form.

Abstract: Disclosed are solid dose nanoparticulate compositions comprising a poorly soluble active agent, at least one polymeric surface stabilizer, and dioctyl sodium sulfosuccinate (DOSS). The solid dose compositions exhibit superior redispersibility of the nanoparticulate composition upon administration to a mammal, such as a human or animal. The invention also describes methods of making and using such compositions.

Abstract: A method and composition are disclosed utilizing the pure (R,R) isomer of formoterol, which is a potent bronchodilator with reduced adverse effects, having a low incidence of the development of tolerance and having increased duration of action.

Abstract: A pressure-liquefied propellant mixture for aerosols, comprising dinitrogen monoxide and a hydrofluoroalkane having 1 to 3 carbon atoms, in particular 1,1,1,2-tetrafluoroethane and/or 1,1,1,2,3,3,3-heptafluoropropane, makes possible an improvement in the wetting properties of pharmaceutically active compounds, whereby the formulation problems existing with hydrofluoroalkanes can be overcome with respect to suspension and solution aerosols and thus improved medicinal aerosol formulations can be obtained. With the aid of dinitrogen monoxide, it is also possible to influence the pressure and thus the particle size distribution specifically and, by displacement of oxygen from the hydrofluoroalkanes, to improve the storage stability of oxidation-sensitive active compounds. If desired, the propellant mixture can additionally contain carbon dioxide.

Abstract: The present invention provides highly dispersible spray-dried powder compositions, and in particular, inhaleable dry powder compositions for aerosolized delivery to the lungs. The powders of the invention are produced by spray drying a 4 &agr;-helix bundle protein under conditions which both (i) protect the protein from aggregation and (ii) provide particles suitable for inhalation (i.e., demonstrating superior aerosol performance).

Abstract: An aqueous-based sprayable composition comprises a therapeutic or palliative agent, water and a mixture of microcrystalline cellulose and alkali metal carboxyalkylcellulose. In one embodiment, the composition is a non-Newtonian nasal spray exhibiting a very rapid viscosity recovery upon removal of shear forces.

Abstract: Spray drying methods for forming powder compositions for pharmaceutical applications are disclosed. According to one aspect of the invention, the spray drying feed stock comprises a bioactive agent, surfactant, and a blowing agent. Another aspect of the invention is directed to spray drying a feed stock comprising a phospholipid and calcium chloride.

Abstract: Soft gelatin capsules having a capsule shell comprising gelatin, plasticizers and, if desired or required, further auxiliary agents, and a capsule filling containing a solvent including a migrateable solvent such as 1,2-propyleneglycol as a solvent in the capsule filling and in the capsule shell. The manufacture of said capsules is improved, if in the process for making the soft gelatin capsules the gelatin bands are cooled with a liquid, and preferably with water.

Abstract: A modulated release aerosol formulation is disclosed. The formulation comprises a polysaccharide polymer having a selected medicament associated therewith, a fluid carrier for carrying and delivering the construct and a stabilizer.

Abstract: A modulated release aerosol formulation is disclosed. The formulation comprises a polymer, e.g. silica gel, fumed silica gel, having a selected medicament associated therewith, a fluid carrier for carrying and delivering the construct and a stabilizer.

Abstract: A medicament containing, separately or together, (A) formoterol or a pharmaceutically acceptable salt thereof or a solvate of formoterol or said salt and (B) a tiotropium salt of a pharmaceutically acceptable acid, for simultaneous, sequential or separate administration in the treatment of an inflammatory or obstructive airways disease.

Abstract: The invention relates to hair conditioner compositions that are non-irritating to the eye and which comprise: a) a C20-C24 quaternary ammonium compound, which has ethosulfate or methosulfate as an anion; b) a second C20-C24 quaternary ammonium compound, which has chloride or bromide as an anion; c) a compound which is solid at room temperature and which is selected from the group consisting of a fatty alcohol, an ester, an amine, an amide, an acid, and a water-soluble polymer; d) optionally a compound, which is liquid at room temperature, selected from the group consisting of a water insoluble emollient, a water insoluble lubricating agent, and a water insoluble conditioning compound; and wherein a) and b) are present in a weight ratio of about 1:10 to about 10:1; are described.

Abstract: The present application relates to a composition in the form of an oil-in-water emulsion comprising an oily phase dispersed in an aqueous phase, characterized in that the composition is free of surfactant and in that it contains cellulose fibrils which have a length of greater than 1 micron and a length/diameter ratio of greater than 30. The invention also relates to the use of the composition, especially for the care, the treatment, the makeup or the cleansing of the skin, lips, eyelashes and/or hair, as well as for the care of sensitive or dry skin.

Abstract: Pharmaceutical composition comprising at least one active ingredient and hydroxypropylmethylcellulose, highly substituted hydroxypropylcellulose, and/or ethylcellulose as disintegrants, in quantities less than 15% by weight of the composition and in a form providing a disintegrant effect while avoiding the formation of a continuous matrix.

Abstract: The present invention provides a non-invasive method for administering polypeptides across epithelial membranes. The formulations in the present invention comprise solid polypeptide particles mixed with a permeation enhancer and excipients which are dispersed in a media for oral or intranasal administration. Also provided in the present invention is a process to prepare the formulations.