Abstract: An antisense compound for use in treating myotonic dystrophy DM1 or DM2, a method of enhancing antisense targeting to heart and quadricep muscles, and a method for treating DM1 or DM2 in a mammalian subject are disclosed. The oligonucleotide has 8-30 bases, with at least 8 contiguous bases being complementary to the polyCUG or polyCCUG repeats in the 3?UTR region of dystrophia myotonica protein kinase (DMPK) mRNA in DM1 or DM2, respectively. Conjugated to the oligonucleotide is a cell-penetrating peptide having the sequence (RXRR(B/X)R)2XB, where R is arginine; B is ?-alanine; and each X is —C(O)—(CH2)n—NH—, where n is 4-6. The antisense compound is effective to selectively block the sequestration of muscleblind-like 1 protein (MBNL1) and/or CUGBP, in heart and quadricep muscle in a myotonic dystrophy animal model.

Abstract: The present invention is related to crystalline forms of 2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethyl-N-(6-(4-methylpiperazin-1-yl)-4-(o-tolyl)pyridin-3-yl)propanamide which is an NK-1 antagonist useful in the treatment of induced vomiting and other disorders.

Abstract: The present invention relates, in various embodiments, to formulations comprising hydrocortisone and silicon dioxide. In additional embodiments, the invention relates to suppositories comprising hydrocortisone and silicon dioxide. The formulations of the present invention are useful for administration to patients who have gastrointestinal diseases and disorders such as, for example, inflammatory bowel disease.

Abstract: Disclosed are compounds having the formula (I): wherein R1, R2, and R3 are as defined herein, and methods of making and using the same.

Abstract: A medicament container carrier comprising a proximal section having a first diameter, a distal section having a second diameter less than the first diameter, and at least one resilient beam arranged in the proximal section and having a beam head protruding radially to form a third diameter. The at least one beam has a non-deflected position in which the third diameter is less than the first diameter and a deflected position in which the third diameter is substantially equal to the first diameter.

Abstract: An antimicrobial therapeutic hydrogel composition comprises a pharmaceutical and/or medical grade silver salt, and an Aloe vera gel or extract. The composition could also include stabilizing agents, a non-ionic surfactant, polyol, and hydrophilic hygroscopic polymers. The resulting product has potent antimicrobial activity against bacteria, protozoa, fungi and viruses. The antimicrobial therapeutic composition can serve as a treatment for burns and as a wound/lesion dressing that either donates or receives moisture to provide a physiologic environment for accelerated wound healing and the relief of pain.

Abstract: The present disclosure relates to acid resistant banding solutions for two piece hard capsules endowed with acid resistant properties, and methods of making and using acid resistant banding solutions. The present disclosure also relates, in part, to methods for banding such acid resistant capsules which provides an acid resistant seal between the capsule parts and achieves increased acid resistance in vitro.

Abstract: Methods for treating fecal incontinence by administering to a subject in need thereof compositions including oxymetazoline as an active ingredient. Kits including compositions of oxymetazoline suitable for topical application, for the treatment of fecal incontinence.

Abstract: The invention concerns a pH-dependent gradual sustained release composition for increasing the pH in the upper part of the small intestines. Particles of the composition are provided with a multilayer polymer coating of specific structure which ensures the gradual release of the active agent in the range of pH 4.5 to 5.5. A process for preparing said composition is also claimed.

Abstract: Suppository, hot melt and ophthalmic formulations containing amino esters of the formulae (I), (II) and (III), where R1, R2 and R3 are residues of amino acids such as, but not limited to, valine, sarcosine, leucine, glutamine, tryptophan, tyrosine, alanine and 4(4-aminophenyl)butyric acid or combination thereof, and salts thereof.

Abstract: The present invention relates to low dose estradiol solutions for oromucosal administration suitable in replacement therapy or suppletion of low estradiol levels and also for preventing, alleviating or treating symptoms associated with low endogenous levels of estradiol in female subjects.

Abstract: An apparatus for cleansing wounds in which irrigant fluid from a reservoir connected to a conformable wound dressing and wound exudate from the dressing are recirculated by a device for moving fluid through a flow path which passes through the dressing and a means for fluid cleansing and back to the dressing. The cleansing means (which may be a single-phase, e.g. microfiltration, system or a two-phase, e.g. dialytic system) removes materials deleterious to wound healing, and the cleansed fluid, still containing mate rials that are beneficial in promoting wound healing, is returned to the wound bed. The dressing and a method of treatment using the apparatus.

Abstract: A tampon applicator that is water-sensitive (e.g., water-soluble, water-dispersible, etc.) in that it loses its integrity over time in the presence of water is provided. The tampon applicator can be discreetly disposed of in a toilet without the risk of clogging sewer pipes. The tampon applicator includes a molded thermoplastic composition containing a cellulose derivative, a synthetic water-soluble polymer, and a plasticizer. The desired water-sensitive characteristics of the tampon applicator may be achieved in the present invention by selectively controlling a variety of aspects of the thermoplastic composition from which the applicator is formed, such as the nature of the components employed, the relative amount of each component, the manner in which the composition is formed, and so forth.

Abstract: The present invention relates to a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cave and the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cmax of the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such dosage forms to a patient, as well as to kits comprising such dosage forms and instructions for administration of the dosage forms to a patient. The inventors believe that the dosage forms and methods of the present invention will lead to improved safety and patient acceptance.

Abstract: There is disclosed herein a composition for treating extracellular parasitic infections, the composition comprising one or more of the following combinations: at least one quinolone or fluoroquinolone together with at least one tetracycline, iodoquinol, an azole or imidazole; or at least two agents selected from the group consisting of iodoquinol, thiazolidones, tetracycline, nitroimidazoles, cotrimoxazole and diloxanide furoate.

Abstract: Compositions containing polymetal complexes are useful in treating anorectal disorders.

Abstract: Single-core and multi-core microcapsules are provided, having multiple shells, at least one of which is formed of a complex coacervate of two components of shell materials. The complex coacervate may be the same or different for each shell. Also provided are methods for making the microcapsules.

Abstract: A hemorrhoid-treating composition comprising gentian violet and a lubricant or suppository base. A method of treating hemorrhoids by topically applying a composition comprising gentian violet and a lubricant or suppository base.

Abstract: Methods and products are provided for treating a wound or infection in a mammal or disinfecting a surface with a hypochlorous acid solution that has been activated by a catalyst. Additionally provided is a process for preparing an antimicrobial product that produces an activated hypochlorous acid solution for use as an antimicrobial.

Abstract: A rectally insertable device for localized drug delivery to the anal sphincter of a subject, a method of using the device and the use of the device is disclosed. The device comprises a shell for containing an active pharmaceutical ingredient, the shell being substantially impermeable to the active pharmaceutical ingredient wherein a lower portion of the shell is configured to release the active pharmaceutical ingredient from the shell and wherein when the device is inserted into the rectum of the subject, the lower portion of the shell is proximal to the anal sphincter, such that the active pharmaceutical ingredient is released proximal to the anal sphincter.

Abstract: Controlled release melatonin formulations are useful for imparting avoidance of mood depression which may be associated with administration of melatonin in conventional form comprising. Particular embodiments of methods use formulations designed to release melatonin according to a profile that simulates a normal endogenous melatonin nocturnal profile. The methods also include co-administration with additional medicaments.

Abstract: The present invention relates to the use of R(+)-alpha-lipoic acid ((R)-5-(1,2-dithiolan-3-yl)valeric acid) and/or of a physiologically acceptable derivative of this compound for cryptogenic neuropathy.

Abstract: A device for drug delivery to an orifice of a subject, comprising a shell which is elastically stressed by an active pharmaceutical ingredient, said shell containing and being substantially impermeable to said active pharmaceutical ingredient, wherein said shell has at least one hole sized for in-vivo release of said active pharmaceutical ingredient as a result of elastic stressing.

Abstract: The present invention relates to a method for forming a temporary obstruction of the intestine of a mammal, using a solidifiable composition, said composition being flowable and solidifiable to form a solid plug at a desired site within the intestine, the structure of said plug being changeable in order to allow for the subsequent, at least partial removal of the obstruction.

Abstract: A device for treating fecal incontinence in a subject is provided. The device includes a plug configured for positioning mostly within an anal canal of the subject.

Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.

Abstract: A method utilizing a dissolvable device for the internal delivery of medication and more particularly to the use of fibers or non-woven fabrics made of a safe polymer material incorporating a medication that is released by dissolution of the fibers or non-woven fabrics over time, and more particularly a treatment method for controlling or regulating the pH in the vagina by stabilizing and adjusting the pH in the vagina by minimizing the impact of the vaginal flora.

Abstract: A controlled release pharmaceutical composition for oral use comprising carvedilol. The composition releases carvedilol after oral administration to a mammal, including a human, in such a manner that a prolonged residence of carvedilol is obtained in the circulatory system compared with the known compositions of carvedilol. Furthermore, a composition according to the present invention makes available to the body a suitable plasma concentration of one or both of the enantiomeric species, namely R(+) and/or S(?) carvedilol for obtaining the desired therapeutic effect.

Abstract: Provided herein are methods of treating neuropsychiatric disorders or improving the symptoms associated therewith administering a medical food, such as L-methylfolate, to a subject having the disorder. The neuropsychiatric disorder may be an autism spectrum disorder or attention deficit disorder with or without hyperactivity (ADD/ADHD). The L-methylfolate may be administered as an adjunct to other therapeutic agents effective to treat the disorder. The subject preferably may be a child and also may have a single nucleotide polymorphism in the MTHFR gene associated with reduced expression of MTHFR enzyme. Also provided is a method of increasing the de novo synthesis of neurotransmitters in vivo by transporting a methyl-donating compound across the blood-brain barrier in a subject.

Abstract: The invention relates to fatty acid stimulation of rectal mucosa initiating the process of defecation, acting as a laxative. Furthermore, the invention relates to the usage of free fatty acids, fatty acid mixtures and fatty acid extracts from marine lipids in pharmaceutical formulations such as suppositories, ointments, tablets and gelatin capsules for treatment and prevention of multiple disorders like constipation, hemorrhoids, bacterial infections (e.g. helicobacter pylori), viral infections (e.g. herpes simplex virus infections) and inflammations, as well as against fissura ani and pruritus ani.

Abstract: The present invention relates to a novel foam-forming composition suitable for rectal administration of locally-acting pharmaceutically active ingredients, and the product adapted to administer said foam-forming composition. Also, the present invention relates to a method for its preparation. According to the present invention a foam-forming composition is provided which exhibits a high expansion ratio and at the same time conferring optimal appearance of the formed foam to allow sufficient contact time of the active to the target site in the intestine in order to obtain optimal local effect. The composition according to the present inventions provides superior properties for the treatment of rectal diseases.

Abstract: A preparation for vaginal and rectal use comprising hyaluronic acid, with an average particle size comprised between about 50 micrometers and about 200 micrometers and a molecular weight comprised between about 1,000,000 Da and about 1,800,000 Da.

Abstract: The invention relates to a pharmaceutical composition in the form of rectal capsules, comprising a combination, effective against malaria parasites, of artemisinine or a derivative of artemisinine, particularly artesunate, with piperaquine or a pharmaceutically acceptable salt thereof, particularly piperaquine tetraphosphate, and having high activity against Plasmodium such as, for example, Plasmodium falciparum.

Abstract: A container suitable for the preparation, storage and dispensing of compounded suppositories is provided. Methods of preparing, storing and dispensing compounded suppositories utilizing such a container and related kits are also provided.

Abstract: This invention provides novel nanofiber enhanced surface area substrates and structures comprising such substrates for use in various medical devices, as well as methods and uses for such substrates and medical devices. In one particular embodiment, a method of administering a composition to a patient is disclosed which comprises providing a composition-eluting device, said composition-eluting device comprising at least a first surface and a plurality of nanostructures attached to the first surface, and introducing the composition-eluting device into the body of the patient.

Abstract: The present invention relates to the supply of coenzyme Q which is highly useful in maintaining human health, and provides a method and preparations whereby coenzyme Q can be efficiently supplied to patients having difficulties in oral administration, aged having swallowing difficulties and patients with diseases caused by topical disorders. It is found that the coenzyme Q concentration in the blood or topical mucosae can be elevated by using a composition for transmucosal administration containing oxidized coenzyme Q and/or reduced coenzyme Q as the active ingredient, wherein the total content of the oxidized coenzyme Q and the reduced coenzyme Q amounts to 0.0001 to 99% by weight of the whole composition.

Abstract: Described herein is a transmucosal delivery device and their use for delivering bioactive agents across a mucosal membrane. The delivery devices contain a pharmaceutically acceptable oxidizing and agents that facilitates the delivery of the blood stream across the mucosal membrane.

Abstract: A polymeric antimicrobial comprising a derivative of poly(2-propenal, 2-propenoic acid) formed by reaction between a poly(2-propenal, 2-propenoic acid) and an alcohol or phenol to form protected carbonyl groups. The invention also relates to antiseptic compositions and compositions for treating gastrointestinal disease containing the polymeric antimicrobial.

Abstract: The Human Immunodeficiency Virus poses a significant threat to the world's population. Current strategies to treat infectious agents have not been adequate to eradicate such deadly viral infections. HIV seeks out its host, a T-Helper cell, by utilizing glycoprotein 120 probes to engage a CD4 cell-surface receptor located on the surface of a T-Helper cell. Developing devices to offer HIV virions' probes the opportunity to engage the cell-surface receptors they are seeking offers a means of neutralizing the infectious threat of HIV. A device in the form of a solution containing a filter medium comprised of sheets or strips or spheres of lipid bilayer or virus-like structures or hypoallergenic surfaces to carry cell-surface receptors, each type of medium having affixed to its surface cell-surface receptors intended to engage and neutralize the infectious nature of HIV virions provides an effective strategy to avert AIDS.

Abstract: The present invention is directed to attaching drugs and other functional groups to surfaces of nano-sized diamonds (NDs) to enhance the efficacy of drugs and other substances. The method involved enhancing the efficacy of a drug having an active site by acquiring a plurality of nanodiamond (ND) particles having a plurality of carbon chain surface molecules on its surface. Intermediate amine entities are covalently attached to the surface molecules of the ND particles. These are then replaces with said drug molecules such that the active sites of said drug molecules point away from the ND particle exposing them for enhanced activity and enhanced drug efficacy. The efficacy of antimicrobial drugs are enhanced, however, this may be used with many different types of drugs.

Abstract: A tablet for oral administration comprises a lipid phase, comprised to 80% by weight or more by a mixture of (a) triglyceride, (b) mono- or/and diglyceride, and (c) cell membrane lipid; (d) one or more pharmacologically active agents dissolved or dispersed in the lipid phase; (e) water and/or ethanol; and (f) an absorption controlling amount of particulate pharmaceutical excipient. Also disclosed are granules, a suppository for rectal administration, and a capsule filled with the granules. Methods for preparing the tablet, the suppository and the granules are also disclosed as well as uses of the granules and a method for coating them.

Abstract: A rectally insertable device for localized drug delivery to the anal sphincter of a subject, a method of using the device and the use of the device is disclosed. The device comprises a shell for containing an active pharmaceutical ingredient, the shell being substantially impermeable to the active pharmaceutical ingredient wherein a lower portion of the shell is configured to release the active pharmaceutical ingredient from the shell and wherein when the device is inserted into the rectum of the subject, the lower portion of the shell is proximal to the anal sphincter, such that the active pharmaceutical ingredient is released proximal to the anal sphincter.

Abstract: This invention is a probiotic composition using the delivery mode of a rectal suppository for the treatment and relief of symptoms of urogenital infections including prostatitis. This invention is unique in both mode of delivery and in enabling the treatment of such urogenital infections as prostatitis. The present invention discloses compositions, methodologies, and delivery mode for the utilization of probiotic organisms in therapeutic compositions for treatment and relief from the symptoms of urogenital infections by maintaining and restoring normal flora in humans. The composition includes one or more bacteria selected from the genus Lactobacillus. More specifically, the invention relates to the utilization of one or more species or strains of Lactobacillus producing bacteria for the control of urinary tract bacteria and pathogens, including antibiotic-resistant urinary tract pathogens, and their associated diseases by both a reduction in the rate of colonization of the infection and pathogens.

Abstract: A preparation containing active and/or auxiliary substance(s) for the time- and/or dose-controllable release of said substances, comprising at least two layers (1, 2) in rolled or folded shape, is characterized in that a) the first layer contains at least one active or auxiliary substance, is continuous at least in sections thereof, that at least one of the parameters thickness, width and concentration of the active and/or auxiliary substance of this layer is not constant, and b) in that the second layer is continuous and possesses a lower moisture permeability than the first layer.

Abstract: Methods of treating conditions using metal-containing materials are disclosed. Exemplary conditions include bacterial conditions, biofilm conditions, microbial conditions, inflammatory conditions, fungal conditions, viral conditions, autoimmune conditions, idiopathic conditions, hyperproliferative conditions, noncancerous growths, cancerous conditions and combinations of such conditions. In certain embodiments, the metal-containing material is an atomically disordered, nanocrystalline silver-containing material.

Abstract: The invention relates to a pharmaceutically active composition or pharmaceutical form of administering that contains at least one of the active ingredients indomethacin or acemetacin and optionally other adjuvants, the composition containing the active ingredient, or a mixture of the active ingredients, in micronized form, preferably mixed with at least one flavonoid derivative or a polypeptide or with a mixture of such compounds.

Abstract: A pharmaceutical composition in the form of a solution, cream, lotion, spray, ointment, gel, aerosol, tablet, suppository or patch device for transdermal or transmucosal administration of alprazolam to a subject, which includes as a permeation enhancing mixture a fatty component in an amount of 0.1% to 20% by weight which is one of (a) a saturated fatty alcohol of formula CH3—(CH2)n—CH2OH, a saturated fatty acid of formula CH3—(CH2)n—CH2COOH, (b) an unsaturated fatty alcohol of formula CH3(CnH2(n?1))—OH, or (c) a fatty acid of formula CH3(CnH2(n?1))—COOH, wherein n is an integer of between 8 and 22; and a vehicle that includes a C1-C4 alkanol, a polyalcohol, and water.

Abstract: One embodiment provides an insert, which includes a non-degradable hydrogel matrix and clindamycin hydrochloride in contact with the matrix, wherein the insert is suitable for mammalian intravaginal, buccal, or intrarectal use. Methods of using and making the insert are also provided.

Abstract: Optimum compounding composition of a local injection preparation for treating rectal submucous lesioned abnormal tissue with local anesthetic is decided to provide a medical composition kit. In a composition kit for the treatment where respective containers are unsealed upon being used and respective contents are mixed to obtain a preparation for injection, a medical composition kit which is characterized in that respective single doses of a therapeutic preparation and local anesthetic are fractionally charged in containers, the said therapeutic preparation contains 1˜10% of a water-soluble aluminum compound and 0.01˜2% of tannic acid and the said local anesthetic contains 0.1˜1% of lidocaine hydrochloride or 0.5˜5% of procaine hydrochloride.

Abstract: A tampon adapted to deliver a therapeutic agent, the tampon including a tampon body that is manufactured at a first manufacturing facility; and a dosage form coupled to the body, wherein the dosage form includes a formulation including a therapeutic agent, and wherein the dosage form is manufactured at a second manufacturing facility. Also, a method for producing a medicated tampon including manufacturing a tampon body at a first manufacturing facility; manufacturing a dosage form at a second manufacturing facility, wherein the dosage form includes a formulation including a therapeutic agent; and coupling the dosage form to the tampon body.