Abstract: A composition containing therapeutic agents and/or breath freshening agents for use in the oral cavity is disclosed. The carrier comprises water-soluble polymers in combination with certain ingredients and provides a therapeutic and/or cosmetic effect. The film is coated and dried utilizing existing coating technology and exhibits instant wettability followed by rapid dissolution/disintegration upon administration in the oral cavity.

Abstract: A buccal dosage unit is provided for administering a combination of steroidal active agents to a female individual. The novel buccal drug delivery systems may be used in female hormone replacement therapy, in female contraception, to treat female sexual dysfunction, and to treat or prevent a variety of conditions and disorders which are responsive to the active agents discussed herein. The buccal dosage unit comprises a progestin, an estrogen and optionally an androgenic agent, as well as a polymeric carrier that bioerodes and provides for delivery of the active agents throughout a predetermined drug delivery period.

Abstract: A dietary supplement system having a daytime component and a nighttime component is provided, wherein the daytime component comprises at least one thermogenic substance and the nighttime component comprises at least one adrenal support substance.

Abstract: Physostigmine, 1,2,3,3a,8,8a-hexahydro-1,3a,8-trimethylpyrrolo[2,3-b] indol-5ol methylcarbamate, administered buccally or sublingually in non-sustained release dosage form provides extremely prolonged blood levels. This active agent is physically compounded with materials of some or all of classes of ingredients that function as pH controls, preservative agents, viscosity control agents, absorption enhancers, stabilizing agents, solvents, and carrier vehicles. This compounding will produce a pharmaceutical composition in the form of a liquid, tablet, gel, patch or lozenge for administration of the active agent, Physostigmine, by absorption through the buccal or sublingual mucosa of the patient. This method of delivery of Physostigmine and similar compounds is useful for treatment of cognitive deficiencies and/or neurological function deficits, mood and/or mental disturbances in mammals including human beings.

Abstract: A method of hydrating nasal airway surfaces in a subject in need of such treatment comprises topically applying a sodium channel blocker to a nasal airway surface of the subject in an amount effective to inhibit the reabsorption of water by the surface. The channel blocker may be a pyrazinoylguanidine sodium channel blocker, such as benzamil, phenamil, amiloride, or a pharmaceutically acceptable salts thereof. The method may further comprise the step of topically applying a P2Y2 receptor agonist to a nasal airway surface of the subject in an amount effective to stimulate chloride secretion by the nasal airway surface. In a preferred embodiment, the sodium channel blocker is a covalent conjugate of a pyrazinoylguanidine sodium channel blocker and a non-absorbable carrier moiety (e.g., albumin, polyethylene glycol). Such compounds may also be administered to other mucosal surfaces where it is desired to inhibit the reabsorption of water.

Abstract: The claimed invention pertains to methods for treating a patient who is at risk for a vascular (e.g., cardiovascular, cerebrovascular) event comprising administering to the patient an effective amount of a lipid-modifying drug. The claimed methods are particularly effective in patients having a lipid profile comprising a low Low Density Lipoprotein and a low High Density Lipoprotein.

Abstract: Methods for treating specific patient groups for sexual dysfunction are provided. The methods of the present invention comprise the utilization of flosequinan and pharmaceutical compositions comprising flosequinan in patients who are free of cardiac disease, who have not been treated with a drug that causes hypotensive effects, and/or who have not been given organic nitrites or nitrates. Flosequinan and pharmaceutical compositions of flosequinan are administered to patients intranasally, orally, topically, and/or through respiratory inhalation.

Abstract: Nasopharyngeal congestion, irritation, and inflammation and associated upper respiratory infections such a otitis media, sinusitis are adjunctivly treated and prevented by nasal application of xylitol/xylose in a saline solution.

Abstract: The invention relates to a mixture for use as wound dressing, which comprises:

Abstract: This invention provides esters of propofol (2,6,-diisoprophenol). The propofol esters are soluble in water and metabolize rapidly to propofol in the body. The propofol esters are useful as pro-drugs for the same indications as propofol. This invention also provides methods of treating neurodegenerative diseases by administering as effective amount of propofol.

Abstract: The present invention is directed to the transmucosal, transdermal or oral administration of ketamine, either alone or in combination with other pain medications, to manage and treat pain and to reduce drug dependency in a subject.

Abstract: The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutrionals, cosmeceuticals and diagnostic agents.

Abstract: A tablet for the transmucosal administration of nicotine. The nicotine is in one or more layers upon a non-nicotine containing matrix. The nicotine layers rapidly dissolve in the mouth. The nicotine is then rapidly absorbed by the intra-oral mucosal surfaces. The short, rapid pulse of nicotine is similar to that given by cigarette smoking. The nicotine may be provided in a plurality of layers separated by one or more layers that are essentially free of nicotine to support the nicotine layers.

Abstract: Novel Polygala senega saponin pharmaceutical compositions are disclosed. The P. senega saponins are useful as immunological adjuvants to enhance immune responses to a co-administered antigen.

Abstract: The invention relates to bioadhesive compounds in the form of multilayers and having at least one bioadhesive layer with the total charge of bioadhesive material wherein the bioadhesive layer is directly compressible during the production of the tablet, and also containing at least one layer with the total charge of active principals.

Abstract: The extract of the pericarp of Zanthoxylum bungeanum, prepared by extraction with carbon dioxide in supercritical conditions, has remarkable analgesic activity without exerting the local anesthetic activity characteristic of the extracts obtained by solvent means. The product of the present invention is prepared by extracting the pericarp of Zanthoxylurn bungeanum, finely ground or transformed into pellets, with carbon dioxide under pressure conditions ranging from 150 to 300 bars at temperatures ranging from 35 to 55° C.

Abstract: A cosmetic and/or dermatological composition containing an aqueous phase and a separate oily phase, containing, as a preserving agent, at least one ammonium bromide. Other preserving agents may be included in the composition. The composition is well-tolerated by the eyes and stores entirely satisfactorily, although it is in the form of two phases. It is used in particular for cleansing and/or removing make-up from the skin, mucous membranes and/or the eyes, and, most particularly, for removing make-up from sensitive eyes.

Abstract: The present invention concerns a method for inhibiting HIV replication in a cell by binding Leukemia Inhibitory Factors (“LIF”) LIF to its receptor in a cell to inhibit HIV replication within the cell. In addition, the present invention concerns a method for preventing uninfected individuals from infection with HIV by administering a dosage of LIF to prevent establishment of HIV infection. The present invention also provides a method of treating HIV infected individuals by administering a dosage of LIF to prevent disease progression.

Abstract: The components of this invention are chosen because of their complementarity for the prevention or treatment of diseases caused by the herpes simplex virus. L-Lysine favorably increases the physiologic immunomodulation necessary for defense against this virus. Zinc improves and maintains a normal immune response. 2-Deoxy-2-D-glucose and heparin sodium alter the surface interaction between the herpes virus and the cell, preventing fusion and infectivity. N-Acetyl-L-cysteine increases glutathione levels thereby creating a thiol redox barrier to the virus at the cell membrane. Quercetin reduces intracellular replication of the herpes virus and viral infectivity. Ascorbate, in concert with copper and D-&agr;-tocopherol, provides an antioxidant defense against the herpes virus, which tends to lose latency during period of oxidative, free radical excess. Selenium and quercetin also participate in reducing various oxidative stresses.

Abstract: A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an alkali metal C8 to C22 alkyl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compounds. The absorption enhancing compounds are selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening of primrose oil, trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof. The amount of each absorption enhancing compound is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt. % of the formulation.

Abstract: The present invention relates to a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof. In one embodiment, the present invention includes a method of making morphine gluconate or chemical equivalent thereof by mixing morphine sulfate with sodium gluconate. The present invention also includes a method for eliciting an analgesic or anesthetic response in a mammal which includes administering a therapeutically effective amount of a pharmaceutical composition including morphine gluconate or chemical equivalent thereof.

Abstract: A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an lkali metal C8 to C22 alkyl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compounds. The absorption enhancing compounds are selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening of primrose oil, trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof. The amount of each absorption enhancing compound is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt. % of the formulation.

Abstract: Administration mediums comprising solutions of nitrous oxide in water, alcohols, ethers or oils, and optionally including essential fatty acids or C1-C6 alkyl esters thereof enhance the action of analgesic, anti-inflammatory and anti-pyretic drugs. The drugs may be combined with the medium into a pharmaceutical composition or may be taken orally by swallowing the drug with the aid of the medium.

Abstract: The present invention provides a bilayer structure for encapsulating multiple containment units. These containment units can attach or contain therapeutic or diagnostic agents that can be released through the bilayer structure. A suitable example of such a containment unit is a unilamellar or multilamellar vesicle.

Abstract: A topical spreadable composition comprising 5-aminosalicylic acid (5-ASA) as active and monoolein is provided for treatment ulcers, inflammation and lesions of the oral cavity. The composition is spread over and adheres to the lesion, and is preferably prepared in a water free state. Examples of indications that can be treated are oral Crohn's Disease, apthous ulcers, orofacial granulomatosis, oral ulcers associated with Behet's disease and oral lichen planus.

Abstract: The present disclosure relates to novel dosage forms, drug delivery regimens, methods and pharmaceutical compositions which optimize the therapeutic effects of active therapeutic substances through the application of the concept of uneven dosing.

Abstract: Microspheres, having a size lower than 1&mgr; and comprising a biocompatible polysaccharidic polymer, are prepared with a process comprising the precipitation of polymer induced by means of a supercritical antisolvent (SAS). These microspheres are used as vehicling agents or carriers in the preparation of pharmaceutical compositions administrable by oral, nasal, pulmonary, vaginal or rectal route. These microspheres can also be advantageously used as vehicling agent or carriers in the preparation of pharmaceutical compositions for the treatment of human diseases associated with genic defects, for the preparation of diagnostics and in the agro-alimentary industry.

Abstract: Methods and compositions are provided for enhancing the bioadhesive properties of polymers used in drug delivery systems. The bioadhesive properties of a polymer are enhanced by incorporating an anhydride oligomer into the polymer to enhance the ability of the polymer to adhere to a tissue surface such as a mucosal membrane. Anhydride oligomers which enhance the bioadhesive properties of a polymer include oligomers synthesized from dicarboxylic acid monomers, preferably those found in Krebs glycolysis cycle, especially fumaric acid. The oligomers can be incorporated within a wide range of polymers including proteins, polysaccharides and synthetic biocompatible polymers. In one embodiment, anhydride oligomers can be incorporated within polymers used to form or coat drug delivery systems, such as microspheres, which contain a drug or diagnostic agent. The oligomers can either be solubilized and blended with the polymer before manufacture or else used as a coating with polymers over existing systems.

Abstract: Compositions for suppositories comprising (A) a fatty base, (B) monodecanoyl-glycerol, (C) monolauroyl-glycerol, (D) a powder insoluble in fatty base and (E) a drug for suppositories capable of giving highly useful suppositories which sustain a melting point higher than the body temperature under dry storage conditions and thus remain stable without melting during storage but, when inserted into body cavity, quickly melt or gel.

Abstract: The present invention provides novel compositions and methods for using the S(+) enantiomer of desmethylselegiline (N-methyl-N-(prop-2-ynyl)-2-aminophenylpropane), for the treatment of selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.

Abstract: The present invention relates to a composition for the delivery of a pharmaceutical agent to a patient that comprises polyethylene glycol, an aqueous solution containing polyvinylpyrrolidone, and a pharmaceutical agent. The invention also relates to methods of making a composition for the delivery of a pharmaceutical agent.

Abstract: Immune response modifier compounds—imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, and 1,2-bridged imidazoquinoline amines—are useful for the treatment of TH2 mediated diseases by administering a therapeutically effective amount of such compounds in order to inhibit TH2 immune response, suppress IL-4/IL-5 cytokine induction and eosinophilia, as well as enhance TH1 immune response.

Abstract: A buccal dosage unit is provided for administering a combination of steroidal active agents to a female individual. The novel buccal drug delivery systems may be used in female hormone replacement therapy, in female contraception, to treat female sexual dysfunction, and to treat or prevent a variety of conditions and disorders which are responsive to the active agents discussed herein. The buccal dosage unit comprises a progestin, an estrogen and optionally an androgenic agent, as well as a polymeric carrier that bioerodes and provides for delivery of the active agents throughout a predetermined drug delivery period.

Abstract: A phased-release suppository delivery system is disclosed wherein microscopic polymeric “nanospheres” ladened with one or more active agents are homogeneously incorporated within a pharmaceutically acceptable suppository base. The preparation of the “nanospheres” allows the spheres to be transported, substantially intact, across fenestrated membranes such as the capillary membranes of the rectum. The method of preparation of the “nanospheres” allows for the controlled release of active agent(s) only after a substantial number of the spheres have been transported across the capillary membrane of the rectum or other body cavity and have been taken up into the systemic circulation system.

Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administerable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.

Abstract: This invention provides a method of rapidly and reliably delivering sildenafil, or derivatives thereof, alone or in combination with other compounds, to the systemic circulation by administration via the nasal route so as to produce virtually instantaneous onset of beneficial effects in the treatment of erectile dysfunction. The present invention further provides pharmaceutical compositions comprising sildenafil, or derivatives thereof, and/or pharmaceutically acceptable salts thereof in a variety of unique pharmaceutical dosage forms, with and without apomorphine.

Abstract: Methods, devices, and compositions for treatment of dysmenorrhea comprise an intravaginal drug delivery system containing an appropriate pharmaceutical agent incorporated into a pharmaceutically acceptable carrier whereby the pharmaceutical agent is released into the vagina and absorbed through the vaginal mucosa to provide relief of dysmenorrhea. The drug delivery system can be a tampon device, vaginal ring, pessary, tablet, suppository, vaginal sponge, bioadhesive tablet, bioadhesive microparticle, cream, lotion, foam, ointment, paste, solution or gel. The system delivers a higher concentration to the muscle of the uterus, the primary site for the dyskinetic muscle contraction, which is the pathophysiologic cause of dysmenorrhea.

Abstract: A nasally administrable composition which contains physiologically active compounds such as insulin, calcitonin, prostaglandin (PG) derivatives, monoclonal antibodies or interleukin derivatives (IL), and is enhanced in the in vivo absorbability of the physiologically active compound when administered nasally. The compositions are prepared by mixing fine particulate of the physiologically active compound with fine particulate of carrier having a mean particle size from 15 &mgr;m to 300 &mgr;m, and particle surface area from 0.1 to 0.4 m2/g, a which adhere to the mucous membrane of the nasal cavity, and HPC—H as absorption accelerator.

Abstract: A mixed liposome pharmaceutical formulation with multilamellar vesicles, comprises a proteinic pharmaceutical agent, water, an alkali metal lauryl sulphate in a concentration of from 1 to 10 wt./wt. %, at least one membrane-mimetic amphiphile and at least one phospholipid.

Abstract: A method of treating a mammalian patient suffering from or prone to a condition characterized by late phase allergic reactions, airway hyperresponsiveness or inflammatory reactions, e.g., asthma, allergic rhinitis, allergic dermatitis, allergic conjunctivitis, inflammatory bowel disease or rheumatoid arthritis, comprising the administration to the patient of an oral, parenteral, intrabronchial, topical, intranasal or intraocular pharmaceutical composition containing in each dose about 0.005 to about 1.0 mg per kilogram of patient body weight of ultra-low molecular weight heparins (ULMWH) or other sulfated polysaccharides having average molecular weights of about 1,000-3,000 daltons. Suitable inhalant and other pharmaceutical compositions for use in the novel treatment method are also disclosed.

Abstract: Disclosed herein are buffered flowable nasal sprays having a pH of between 4.0 and 5.0. They are primarily water and a citrate (or citrate/phosphate) buffer. They may also contain sodium chloride, thickeners, and/or preservatives. The preparations are able to maintain the aforesaid pH under conditions simulating a runny nose. Methods of using these preparations to inhibit the spread of rhinovirus and/or diseases caused by rhinovirus are also disclosed.

Abstract: A cell migration agent promotes the healing of wounds by promoting movement of fibroblast cells away from the periphery of the wound. The agents can include Indole-3-Acetic acid and its derivatives such as Indole-3-Acetyl-L-Phenylalanine. Significant increases in the migration of fibroblast cells were observed at five days after treatment initiation. When administered in a dosage of between 0.1 and 250 ppm, these compounds appear to have the ability to move healthy human fibroblast cells into areas void of cells more rapidly than if the agent were not present. This results in the plumping of the skin or healing of wounds. The compounds can be delivered by topical or internal methods of application.

Abstract: The present invention reveals an iodine-containing nasal moisturizing saline solution, a method for the prevention and/or treatment of sinusitis and related conditions associated with nasal congestion, an iodine-containing mouthwash solution and a method for the prevention and/or treatment of sore throats caused by bacteria and viruses. The nasal moisturizing saline solution is made of water, sodium chloride, iodine, buffer and a preservative. The mouthwash solution is made of iodine and a pharmaceutically acceptable carrier.

Abstract: The present invention reveals an iodine-containing nasal moisturizing saline solution, a method for the prevention and/or treatment of sinusitis and related conditions associated with nasal congestion, an iodine-containing mouthwash solution and a method for the prevention and/or treatment of sore throats caused by bacteria and viruses. The nasal moisturizing saline solution is made of water, sodium chloride, iodine, buffer and a preservative. The mouthwash solution is made of iodine and a pharmaceutically acceptable carrier.

Abstract: A pharmaceutical composition, intended for menopausal replacement therapy, comprising a suspension of progesterone in a lipophilic medium solution of a 17-estradiol salt in the lipophilic medium, the weight ratio of progesterone to the base 17-estradiol being 25 to 600.

Abstract: A method for decreasing the frequency of transmission of human immunodeficiency virus or herpesviruses or for preventing the transmission of or treating a sexually transmitted bacterial infection by administering to a human an anti-human immunodeficiency virus amount or an anti-herpesvirus amount or an anti-bacterial amount of cellulose acetate phthalate (CAP) or hydroxypropyl methylcellulose phthalate (HPMCP), such as in micronized form, or a combination thereof, either alone or in combination with a pharmaceutically acceptable carrier or diluent. The CAP and/or HPMCP may be employed as a suspension of micronized particles and may further contain a water miscible, non-solvent for CAP or HPMCP, such as glycerol.

Abstract: The present invention relates to a bioadhesive, prolonged release vaginal gel dosage form comprising a synergistic formulation of carrageenan, acrylic acid containing polymers, agarose and an effective amount of a therapeutic agent, whereby the therapeutic agent is released from this composition initially at a first relatively high rate, to provide a loading dose of the therapeutic agent, followed by a second, lower rate of release that provides a constant, maintenance dose of the therapeutic agent for up to 24 hours. More specifically, the present invention includes compositions within which the agarose is ultra low gelling temperature agarose and the acrylic acid containing polymer may be carbophil, a copolymer of acrylic acid and divinyl alcohol, a copolymer of acrylic acid and C.sub.10 to C.sub.30 alkyl acrylic acid or a polyacrylic acid homopolymer.

Abstract: The present invention relates to water-soluble, bioerodable pharmaceutical delivery device for application to mucosal surfaces. The device comprises an adhesive layer and a non-adhesive backing layer, and the pharmaceutical may be provided in either or both layers. Upon application, the device adheres to the mucosal surface, providing drug delivery and protection to the treatment site.

Abstract: The present invention relates to preparations alleviating the symptoms caused by drying of the mucous membranes of the body. The preparations contain trimethylglycine as an active agent. The invention also relates to the use of trimethylglycine as an agent alleviating the symptoms of dry mucous membranes in different preparations intended for the body care and hygiene, and to a method of alleviating the symptoms, caused by drying, appearing on the mucous membranes of the body.

Abstract: Improved aerodynamically light particles for drug delivery to the pulmonary system, and methods for their synthesis and administration are provided. In a preferred embodiment, the aerodynamically light particles are made of a biodegradable material and have a tap density less than 0.4 g/cm3 and a mass mean diameter between 5 &mgr;m and 30 &mgr;m. The particles may be formed of biodegradable materials such as biodegradable polymers. For example, the particles may be formed of a functionalized polyester graft copolymer consisting of a linear &agr;-hydroxy-acid polyester backbone having at least one amino acid group incorporated therein and at least one poly(amino acid) side chain extending from an amino acid group in the polyester backbone. In one embodiment, aerodynamically light particles having a large mean diameter, for example greater than 5 &mgr;m, can be used for enhanced delivery of a therapeutic agent to the alveolar region of the lung.