Abstract: The present invention discloses a composition for dermatological infections by the use of a lytic enzyme in a carrier suitable for topical application to dermal tissues. The method for the treatment of dermatological infections comprises administering a composition comprising effective amount of a therapeutic agent, with the therapeutic agent comprising a lytic enzyme produced by infecting a bacteria with phage specific for that bacteria.

Abstract: The present invention describes a polyoxaester copolymer and blends thereof that may be used to produce hydrogels, surgical devices such as sutures, sutures with attached needles, molded devices, drug matrices, adhesives, sealants and the like. The invention also contemplates a process for producing these polyesters. The polyoxaester copolymers of the present invention are formed from a first divalent repeating unit of formula IA: [—O—C(O)—R30—C(O)—]  IA a second divalent repeating unit of the formula IB: [O—C(O)—C(R1)(R2)—O—R3—O—C(R′1)(R′2)—C(O)—]  IB and a third repeating unit selected from the group of formulas consisting of: [—O—R4—]A,  II [—O—R5—C(O)—]B,  III ([—O—R5—C(O)]P—O—)LG  XI and combinations thereof.

Abstract: A composition and method for the treatment of the conditions vulvar vestibulitis, interstitial cystitis, vulvar vaginitis or vaginitis dynea wherein a composition containing cromolyn sodium in effective amount is applied to the vaginal vestibule area, with the application repeated as necessary to effectively address the symptoms and conditions. Preferably, the cromolyn sodium is present in an amount of about 2 to 10 percent in a carrier ointment or cream, with the carrier composition preferably comprising a mixture of pluronic gel and lecithin organogel.

Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.

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: 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: A solution or gel composition containing activated stabilized chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for destroying HIV. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.4, at which pH stabilized chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms. Using a lubricant as a vehicle for the chlorine dioxide/phosphate composition; development of vaginal itching due to Candida Albicans will be stopped.

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 delivery system is disclosed for delivering a beneficial agent to an animal. The delivery system comprises a wall that surrounds a lumen, said wall comprising a composition that limits the passage of fluid into the system and a composition that permits the passage of fluid into the system. The lumen comprises a beneficial agent and an expandable member. The delivery system comprises an exit means for delivering the beneficial agent.

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 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: A method for delivering a biologically active substance including the steps of: (a) combining said biologically active substance with a macromer; (b) forming a mixture of the combination formed in step (a); (c) polymerizing said mixture to form articles; and (d) administering said articles, or a portion thereof, to a mammal, where step (c) takes place in the absence of a polymerizable monovinyl monomer, is disclosed.

Abstract: The present invention relates to the use of angiotensin II or an analogue thereof, for the manufacture of a medicament for stimulating cilia, such as fallopian tube cilia or bronchial epithelial cell cilia. Such a medicament may be used for promoting ovarian transport thus benefitting conception, or alternatively for treating such respiratory conditions as asthma.

Abstract: The inventor provides suppositories comprising as the active ingredient 6-amino-5-chloro-1-isopropyl-2-(4-methyl-1-piperazinyl) benzimidazole (I). These suppositories are expected to exert drug effects based on serotonin.sub.3 antagonistic activity when administered rectally. More particularly, these suppositories are useful as antiemetic agents for vomiting accompanying chemotherapy for cancer or remedies for irritable bowel syndrome based on the serotonin.sub.3 antagonistic activity. These suppositories provide also excellent storage stability of benzimidazole derivative (I).

Abstract: A sustained-release microcapsule contains an amorphous water-soluble pharmaceutical agent having a particle size of from 1 nm-10 .mu.m and a polymer. The microcapsule is produced by dispersing, in an aqueous phase, a dispersion of from 0.001-90% (w/w) of an amorphous water-soluble pharmaceutical agent in a solution of a polymer having a wt. avg. molecular weight of 2,000-800,000 in an organic solvent to prepare an s/o/w emulsion and subjecting the emulsion to in-water drying.

Abstract: Disclosed are methods for the sterilization of a male mammal wherein a composition comprising a biocompatible polymer, a biocompatible solvent, and a contrast agent is delivered to the vas deferens of the male mammal.

Abstract: An intravaginal drug delivery device comprising at least one active agent dispersed in a polymer matrix, wherein the concentration of active agent at the outer surface of the device at the time of use is not substantially higher than the concentration of the active agent in the remainder of the device, a method of treatment therewith and a process for its preparation.

Abstract: A method of decreasing atherosclerosis and its complications including but not limited to myocardial infarction, stroke and peripheral vascular disease comprising administering to a human or animal an amount of Leuprolide acetate is sufficient to decrease atherosclerosis and its complications.

Abstract: This invention is directed to a suppository-based vaccine delivery system for immunizing against urogenital infectious disease in humans and a method for treating same. More particularly, this invention is directed to a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections. The suppository-based vaccine delivery system is comprised of a vaccine comprised of inactivated bacteria which originate from cultures of 8 to 14 uropathogenic bacteria strains of the species: Escherichia coli, Klebsiella pnieumoniae, Proteus mirabilis, Proteus morganii, and Streptococcus faecalis; and polyethylene glycol suppository base; wherein the suppository is adapted to be inserted into a bodily orifice of a human so as to allow the suppository to be in contact with tissue of the bodily orifice to facilitate transfer of suppository material therethrough.

Abstract: The present invention describes a polyoxaester copolymers containing amines and/or amido groups and blends thereof with other polymers that may be used to produce surgical devices such as sutures, sutures with attached needles, molded devices, and the like. The polyoxaesters copolymer of the present invention is formed from a first divalent repeating unit of formula IA:[--C(O)--R.sub.30 --C(O)--] IAa second divalent repeating unit of the formula IB:[O--C(O)--C(R.sub.1)(R.sub.2)--O--(R.sub.3)--O--C(R.sub.1)(R.sub.2)--C(O)-- ]Iand a third repeating unit of the formula:[--O--R.sub.12 --].sub.U, XVIand optionally a fourth repeating unit with a formula selected from the group consisting of:[--O--R.sub.4 --].sub.A, II[--O--R.sub.5 --C(O)--].sub.B, III([--O--R.sub.5 --C(O)].sub.P --O--).sub.L G XIand combinations thereof wherein R.sub.12 contains an internal amine or internal amide group.

Abstract: This invention relates to formulations comprising film-forming components capable of forming per se a physical barrier to pathogens. Thermoreversible gels such as poloxamers are particularly preferred for that use. The film-forming formulations may further comprise microbicides, spermicides or any other drug, which choice is guided by the pathogen, organism or the disease to be inactivated or treated. The formulations are therefore efficient as a physical, and optionally, as a chemical or pharmacological barrier as well as usable as a sustained drug-release system at the locus of administration. A part of the drug may also be entrapped in liposomes or other drug carriers. These formulations are intended for use in the prevention of sexually transmitted diseases, as well as in the treatment of infections, cancer, inflammation or any disease or state which requires a pharmacological treatment. Formulations are applicable to mucosae, skin and eye, for example.

Abstract: A biocompatible cell device having an internal foam scaffold to provide a growth surface for encapsulated cells which produce a biologically active molecule.

Abstract: The invention provides an intravaginal drug delivery system having a first intravaginal part comprising at least one active agent in a polymer matrix, said first part being provided in association with a second part comprising a removable polymer membrane arranged to absorb excess active agent. Use of a polymer membrane in this way serves to substantially reduce the initial high burst of active from the intravaginal part following administration. It also reduces the levels of release of active during the first few weeks of use. Also provided is an intravaginal drug delivery device comprising at least one active agent dispersed in a polymer matrix, wherein the concentration of active agent at the outer surface of the device at the time of use is not substantially higher than the concentration of the active agent in the remainder of the device.

Abstract: This invention relates to coating formulations for coating sustained-release drug implants. The coating formulations are capable of formulations are capable of forming a porous film coat over a biologically active agent to provide a release of the active agent at a constant rate over a prolonged period of time. The pore forming agent is used in the formulation of the invention in the amount effective to regulate the release of a biologically active compound at a desired rate. Preferably, the effective amount of the pore forming agent provides long term delivery of the active agent. The invention also provides an improved implant for the sustained administration of a biologically active compound suitable for subcutaneous implantation. The invention also relates to methods for making and using the formulation and the implant of the invention.

Abstract: Described is the use of vitamin E in topically applied compositions for the purpose of enhancing the penetration of therapeutically effective (cosmetically or pharmaceutically-active) drug or cosmetic ingredients. The topical compositions containing the penetration-enhancing concentration of vitamin E may be provided in a variety of forms including semi-solid (gel, paste, cream, lotion, ointment, etc.), liquid, suspension, film or laminate.

Abstract: A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an alkali metal lauryl 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 permeation of a therapeutic agent through the epithelium by topical administration is enhanced by the further topical administration of a stearylamine, transvaccenic acid or a combination of a stearylamine and transvaccenic acid.

Abstract: The present invention relates to an improved intravaginal preparation containing a physiologically active peptide, which comprises a physiologically active peptide, a sucrose fatty acid ester and an organic acid with a pharmaceutically acceptable carrier or diluent, by which the physiologically active peptide can be absorbed safely and efficiently.

Abstract: Crosslinked compositions formed from a water-insoluble copolymer are disclosed. These compositions are copolymers having a bioresorbable region, a hydrophilic region and at least two crosslinkable functional groups per polymer chain. These compositions are able to form hydrogels in aqueous environments when crosslinked. These hydrogels are good sealants for implantable prostheses when in contact with an aqueous environment. In addition, such hydrogels can be used as delivery vehicles for therapeutic agents.

Abstract: A method of treatment of osteo-articular disease which includes administering an effective amount of a pharmaceutical composition containing a compound of specified formula and an excipient to a patient in need of such treatment. The compounds of specified formula have a phosphonate group on one end and a silanol or silanol precursor on the opposite end, and can inhibit serine proteases.

Abstract: Formulations which have been developed for topical or local delivery intrapelvically, intraperitoneally or directly on reproductive organs of interest administration to a region such as the female reproductive system, provide for increased comfort, increased bioavailability, rapid and relatively high blood levels in the regions to be treated in the substantial absence of systemic levels of drug which might cause side effects. These formulations consist of drug micro or nanoparticles, which may be formed of drug alone or in combination with an excipient or polymeric carrier. The excipient or polymer may be used to manipulate release rates and to increase adhesion to the affected region. The particulate formulation can be applied as a dried powder, a liquid suspension or dispersion, or as a topical ointment, creme, lotion, foam or suppository.

Abstract: The present invention is dealing with a drug delivery system, preferably in a ring-shaped form suitable for vaginal administration, for the simultaneous release of a progestogenic steroid compound and an estrogenic steroid compound in a fixed physiological ratio over a prolonged period of time. The drug delivery system comprises at least one compartment comprising a thermoplastic polymer core containing the mixture of the progestogenic and estrogenic compounds and a thermoplastic polymer skin, the progestogenic compound being initially dissolved in the polymer core material in a relatively low degree of supersaturation.

Abstract: Bioadhesive/mucoadhesive composition in a suspension or emulsion form that delivers drugs to the target tissue in a sustained manner is formulated. A composition, method of manufacture and its application in treatment of mammalian tissue are disclosed. The composition includes a bioadhesive/mucoadhesive polymer in an emulsion or suspension form along with a treating agent. The treating agent could be as simple as water as in the case of mucoadhesive moisturizing agent. The bioadhesive/mucoadhesive polymer is a water dispersible high molecular weight crosslinked polyacrylic acid copolymer with free carboxylic acid groups further crosslinked with a combination mono, di and polyvalent metal ions, cationic polymers and surfactants. Type of metal ion and their concentration can be adjusted to get the desired bio/mucoadhesive properties along with several physical properties that are important to the formulation of dosage forms.

Abstract: Disclosed are methods for sterilizing a female mammal wherein a composition comprising a biocompatible polymer and a biocompatible solvent is delivered to the fallopian tube of the female mammal.

Abstract: A method for decreasing the frequency of transmission of human immunodeficiency virus or herpesviruses by administering to a human an anti-human immunodeficiency virus amount or an anti-herpesvirus 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 provides a method of treating or reducing ischemia or incidence of cardiovascular events by administering progesterone. Progesterone, unlike synthetic progestins, has been demonstrated to supplement, rather than to decrease, the beneficial effects of estrogen therapy on myocardial ischemia in females.

Abstract: A new pharmaceutical composition is disclosed that comprises clioquinol, vitamin B.sub.12, and, optionally, pharmaceutical acceptable carriers and/or excipients. The use of the pharmaceutical composition removes or alleviates the side effects of clioquinol.

Abstract: This bioactive concentrate is an active substance--aqueous solution or lyophilized powder--consisting of anti-hyaluronidase and antiinflammatory mucopolysaccharide polymers and an addition of restitutive and anti-hyaluronidase chondroitinsulphate, which has a pH=4-6 and antihyaluronidase activity. The bioactive concentrate producing method consists in a two--phased treatment of animal--originated connective cartilaginous tissues such as bovine and sheep trachea, umbilical cord, young animal tendons, bowels, testicles or sea organisms, with phenol solution and the solution resulted is concentrated by vacuum evaporation and then defatted; after filtering, the supernatant obtained is treated for deproteinization, the ion excess is removed by passing through ion exchanger column, the alcohol solution is concentrated to remove alcohol until reaching a volume of 70% as against the aqueous solution subject to proteinzation.

Abstract: The invention is directed to nitric oxide (NO) donor compounds and to pharmaceutical compositions containing such nitric oxide (NO) donor compounds, for delivering NO to the apical surface of a mucosa, where the nitric oxide is released for passage across the epithelial monolayer of the mucous membrane. The NO donor compounds include polyalkyleneamine NO donors as well as tertiary and quaternary amino aliphatic NO donor compounds. The compounds and compositions of the invention are useful in any situation in which it is desirable to deliver NO across a mucosal surface. For example, the compounds and compositions of the invention are particularly useful in treating pulmonary hypertension, male impotence, and several other specific conditions.

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: A formulation and methods for inducing sustained regional local anesthesia in a patient comprising a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release material prolonging the release of the local anesthetic from the substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a pharmaceutically acceptable, i.e., non-toxic, non-glucocorticoid augmenting agent effective to prolong the duration of the local anesthesia for a time period longer than that obtainable from the substrate without the augmenting agent.

Abstract: Two polymorphs of 1-?2,4-dichloro-.beta.-?(7-chloro-benzo?b!thien-3-yl)methoxy!phenetyl!imid azole mononitrate have been identified. A process for the preparation thereof and composition are described.

Abstract: A method is provided for delaying the onset of ejaculation in an individual. The method involves administration of a pharmacologically active agent, particularly an antidepressant, a serotonin agonist or antagonist, an adrenergic agonist or antagonist, an adrenergic neurone blocker, or a derivative or analog thereof, within the context of an effective dosing regimen; administration is preferably local, and most preferably is transurethral. Pharmaceutical formulations and kits are provided as well.

Abstract: There is disclosed a composition and method for reducing or alleviating the discomforting symptoms associate with menstruation, particularly menstrual pain. The composition is administered by topical or local administration to the uterus or vaginal tissues of a women in need thereof, and contains an omega fatty acid in combination with a cyclo-oxygenase inhibitor. Preferred omega fatty acids include docosahexaenoic acid and eicosapentaenoic acid, and preferred cyclo-oxygenase inhibitors include, ibuprophen, acetylsalicylic acid and salicylic acid. The composition may further include pharmaceutically acceptable carriers or diluents, and may be locally applied via intracervical or intrauterine application, or may be topically applied to the skin of the lower abdomen.

Abstract: A method of treatment for impotency is provided. The method involves the administration of nitric oxide by a nitric oxide-releasing agent capable of providing a penile erection-inducing amount of nitric oxide to the corpus cavernosum of the penis of an impotent male animal. Also provided is a nitric oxide delivery means for use in the method.

Abstract: A synthesis method is set forth for forming a physiologically acceptable composition comprising a plurality of physiologically acceptable hydrogel particles which have been swollen in a water solution containing a low molecular weight water soluble organic compound, the solution having the ability to swell the particles. The concentration of the organic compound is such that the resulting particles can be inserted, without use of a carrier liquid utilizing a hand driven hypodermic syringe. The swollen hydrogel particles are substantially insoluble in body fluids. The method comprises contacting not fully swollen hydrogel particles with the organic compound and with water.

Abstract: A method for enhancing penetration of a therapeutic or prophylactic agent in a host in need of the topical administration thereof which comprises applying to the epithelium of the host, an effective amount of one or more penetration enhancing epithelial sterols and the therapeutic or prophylactic agent.

Abstract: The present invention relates to a method of female sterilization including delivery of a macrolide antibiotic or a pharmacologically acceptable salt of a macrolide antibiotic to the uterine cavity or fallopian tube of the female. The present invention also relates to a method of endometrial ablation including delivery of a macrolide antibiotic or a pharmacologically acceptable salt of a macrolide antibiotic to the uterine cavity of a female. The endometrial ablation effected in this manner may be used to treat the conditions of excessive menstrual bleeding or menstrual pain in women. A preferred macrolide antibiotic is erythromycin, or its pharmacologically acceptable salts.

Abstract: A method for preventing, ameliorating, and/or treating memory and other cognitive disorders associated with aging, such as Age-Associated Memory Impairment (also known as Age-Related Cognitive Decline), and other age-related impairments of, and/or changes in, cognitive function. The method comprises administering to a subject a therapeutically effective amount of a lipid-soluble thiamine or a prodrug thereof in an amount averaging from about 0.02 to about 0.5 grams per day per 70 kg body weight over a period of three months or longer.