Abstract: The present approach effectively eradicates senescent cells and cells carrying the hallmarks associated with aging, through inhibiting mitochondrial biogenesis during induced mitochondrial oxidative stress, without inhibiting normal cells. Embodiments may include a therapeutic agent that inhibits mitochondrial biogenesis and targets the large mitochondrial ribosome, a therapeutic agent that inhibits mitochondrial biogenesis and targets the small mitochondrial ribosome, and a therapeutic agent that behaves as a pro-oxidant or induces mitochondrial oxidative stress. Some embodiments include sub-antimicrobial antibiotic concentrations, thereby minimizing antibiotic resistance concerns.

Abstract: A method for making a controlled release material, comprising the steps of: — (a) forming granules comprising one or more wax and one or more disintegrant; (b) spheronisation of the granules and (c) compaction of the spheronised granules of step so as to form the controlled release material. The invention also relates to a tablet and delayed and sustained release material made according to the method.

Abstract: Compositions and methods to avoid the gag reflex to enable swallowing of pills, by applying an edible coating to the pill that generates bubbles, so that the bubbles prevent direct contact of the pill with the back of the mouth, thereby avoiding the gag reflex. Preferably the coating generates bubbles from an acid-base reaction, from compressed bubbles entrapped in hard candy, or from any other manner for creating fizzing, effervescent or popping confectionary or other food products. Optionally the coating can have a strong taste, such as by being sour, to distract away from the gag reflex. Optionally, a time release envelope is provided to delay bubbling or to block atmospheric humidity.

Abstract: The present application relates to a method of orally administering once daily tablet of minocycline to a subject in need thereof, wherein said tablet is substantially free of lactose. The present application also relates to processes for preparing said once daily tablet of minocycline that provides reduced stock keeping units with improved inventory by supplying multiple doses of minocycline in single tablet.

Abstract: The invention is directed to pharmaceutical compositions such as tablets that exhibit delayed release properties when administered as either whole or half tablets. The invention is also directed to delayed release tablets comprising deferiprone for oral administration, for which twice daily administration is bioequivalent to the same daily dose of an immediate release tablet administered thrice daily. The invention is also directed to methods of making and using the same.

Abstract: Provided herein are methods and dose packs for the monitoring of medication adherence. In one aspect, the dose pack comprises comprise a multiplicity of doses of an agent and a multiplicity of doses of a marker and be configured to isolate a pair of at least one of the multiplicity of doses of the agent and at least one of the multiplicity of doses of the marker for co-administration of the pair to the subject according to the dosing schedule. In another aspect, the method comprises obtaining a sample from the subject subsequent to the conclusion of a monitoring window and analyzing the sample for the presence or absence of a marker or a degradation product thereof.

Abstract: Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).

Abstract: Pharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use.

Abstract: Devices for guided tissue regeneration (GTR) include a matrix of chitosan and mutable collagenous tissue (MCT) wherein the chitosan is electrostatically bonded to the MCT to form MCT-chitosan composite material. The MCT can be isolated from invertebrate marine organisms, such as sponges, jellyfish, mollusks and echinoderms. The MCT-chitosan composite material can be formulated as a biofilm, a 3D-sponge, a hydrogel, or as an electrospun nanofiber, or the MCT-chitosan composite material can coat a biomaterial surface. The devices can include wound dressings and tissue sponges, including 3D sponges. Applications include tissue engineering and wound healing, as well as burns and other related guided tissue regeneration applications. MCT and MCT-chitosan composite material, contained in a pharmaceutically acceptable topical carrier, also has cosmeceutical applications, for treating scars, as well as skin discoloration and various pigmentation issues, including melasma/chloasma.

Abstract: Pharmaceutical compositions including an active ingredient and a stabilizer, as well as methods of manufacture of the compositions, and methods of their use.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: A composition and method for preventing or reducing the incidence of a transient ischemic attack in a subject at risk for developing a stroke comprises orally administering to the subject a prophylactically effective amount of a pharmaceutical composition comprising an ASIC1a inhibitor capable of penetrating the blood-brain barrier. Preferred ASIC1a inhibitors for use in the disclosed methods include amiloride and amiloride analogs.

Abstract: The present disclosure relates to compositions that are useful in the delivery of various materials. In particular, the compositions comprise a suspension wherein an internal phase material is surrounded by an external phase material. The internal phase specifically can be a hydrophilic material, and the external phase specifically can be a hydrophobic material. The materials are combined so that the internal phase is substantially encapsulated by the external phase such that release can be controlled in relation to osmotic pressure differentials. The suspension can be combined with a carrier, and various systems and products can be formed with the suspension and optional carrier, such as oral strips, spray delivery systems, smokeless tobacco products, aerosol delivery devices, cigarettes, and packaging.

Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, the drug is modified to increase its lipophilicity by forming a salt between the drug and one or more fatty acids wherein the concentration of the one or more fatty acids is one to 15 times the molar amount of the active agent, preferably two to ten times the molar amount of the active agent. In one embodiment the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and preferably organic solvent insoluble.

Abstract: There is disclosed herein a composition for treating gastrointestinal or neurological disorders, constipation, functional constipation, irritable bowel syndrome, diverticulitis, travelers diarrhoea, chronic idiopathic nausea, IBD-associated constipation and diarrhoea, pseudo-obstruction, diabetic gastroparesis, cyclic vomiting, reflux oesophagitis, autism enteropathy, flatulence, halitosis, chronic fatigue, bloating, proctalgia fugax, Parkinsons disease, MS, Alzheimers Disease, Motor Neurone Disease or autism, the composition comprising: (i) at least two anti-clostridial agents selected from the group consisting of: vancomycin, vancomycin derivatives, a multi-valent polymer of vancomycin, am inoglycosides, nitroimidazoles, ansamysins, nifuroxazide, colchicine, prucalopride, prokinetic agent and 5-aminosalicylic acid; or (ii) at least one anti-clostridial agent selected from the above combined with an opioid blocking agent.

Abstract: The present disclosure relates to aqueous composition comprising hydroxypropyl methyl cellulose acetate succinate (HPMCAS) polymer dispersed in water, wherein the dispersed polymer is partially neutralized with at least one alkaline material. The instant disclosure also relates to compositions for use in methods of making capsule shells endowed with bulk enteric properties. The present disclosure also relates to capsules made according with the compositions and methods of the present disclosure.

Abstract: The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.

Abstract: The invention relates to a drug sustained-release composition, particularly a sustained-release composition comprising metoprolol and preparation method thereof. The invention also relates to a combination product comprising a sustained-release composition comprising metoprolol and a pharmaceutical composition comprising hydrochlorothiazide. The sustained-release composition comprising metoprolol according to the invention eliminates the phenomena of delayed release of such sustained-release compositions in the prior art, has a better drug release curve, and also have the advantages such as simple formula, easy operation, stable quality, strong controllability, and good reproducibility, and therefore have good application prospects.

Abstract: The object of the invention consists of pharmaceutical formulations containing rifaximin in the shape of microgranules made gastroresistant by an insoluble polymer at pH values between 1.5 and 4.0 and soluble at pH values between 5.0 and 7.5, by their preparation and by their use in the manufacture of medicinal preparations useful in the treatment of inflammatory bowel diseases (IBD) and mainly Crohn's disease.

Abstract: Oral formulation of particles made of an agglomeration of a plurality of seed granules or a single seed granule both surrounded by three layers and an outer gel coating. The seed granules are made of calcium carbonate with microscopic fissures. Disposed inside the fissures and in the interstitial spaces of the agglomerate seed granules are microscopic particles of alkali metal salts and other ions. Coating the agglomerate or single seed granules is an alkaline-resistant first layer made of microcrystalline cellulose and croscarmellose sodium that binds and protects the surrounding second layer. Surrounding the first layer is a second layer comprising a mixture of a flavonoid and polysaccharide or polypeptide binder or polymer gel. Surrounding the second layer is a third layer made of alkaline earth metal salt particles holding alkali metal hydroxide ions within a polysaccharide or polymer gel. Surrounding the third layer is at least one outer gel layer.

Abstract: A system and method for determining an optimal combination drug product for a particular patient includes a processor that receives patient information and determines an optimal combination drug product based on the received information. A system which can provide information regarding predicted events or pathologies based on received patient information and guidance on subsequent steps to ameliorate, treat or intervent. A drug production device includes a plurality of drug containers, each of which are coupled to a drug dispensing channel. A controller controls the dispensing of drug through each channel, and a combination drug product is produced from the dispensed drugs. A combination drug product includes a plurality of discrete units of a first drug, and a plurality of discrete units of a second drug. A transdermal patch includes a plurality of drug compartments, each containing a quantity of drug product, and a controller for controlling the release of drugs from each compartment.

Abstract: The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.

Abstract: Oral formulation of particles made of an agglomeration of a plurality of seed granules or a single seed granule both surrounded by three layers and an outer gel coating. The seed granules are made of calcium carbonate with microscopic fissures. Disposed inside the fissures and in the interstitial spaces of the agglomerate seed granules are microscopic particles of alkali metal salts and other ions. Coating the agglomerate or single seed granules is an alkaline-resistant first layer made of microcrystalline cellulose and croscarmellose sodium that binds and protects the surrounding second layer. Surrounding the second layer is a third layer made of alkaline earth metal salt particles holding alkali metal hydroxide ions within a polysaccharide or polymer gel. Surrounding the third layer is at least one outer gel layer. The fourth and third layers dissolve in a low pH environment and release the fat soluble antioxidant and ions in the seed granule fissures.

Abstract: A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drag, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.

Abstract: The present invention relates to a once daily pharmaceutical composition comprising doxycycline and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition exhibits a reduced food effect. The invention further provides a method of treatment of rosacea by administering to a person in need thereof the doxycycline pharmaceutical composition with or without food. A process of preparing such pharmaceutical composition is also provided.

Abstract: The present invention relates to a once daily pharmaceutical composition comprising doxycycline, a controlled-release polymer, and one or more pharmaceutically acceptable excipients. The invention further provides a method of treatment of rosacea by administering such pharmaceutical composition. A process of preparing such pharmaceutical composition is also provided.

Abstract: The disclosure provides controlled release compositions comprising tetracyclines and in some embodiments, doxycycline. The controlled release doxycycline compositions of the invention exhibit a superior dissolution profile and provide reduced side effects such as nausea and irritation.

Abstract: The present invention relates to a once daily tablet comprising doxycycline at sub-antibiotic dose and one or more pharmaceutically acceptable excipients, wherein the tablet exhibits a reduced food effect. The invention further provides a method of treatment of rosacea by administering to a person in need thereof the doxycycline tablet with or without food. A process of preparing the tablet is also provided.

Abstract: The present invention provides a joint product comprising synephrine and topiramate, in which the synephrine or salt thereof is administered in form of rapid-release preparation, preferably rapid-release pellet, having daily dose of 2 mg to 25 mg, preferably 5 mg to 20 mg; the topiramate is administered in form of sustained-release or controlled-release preparation, preferably sustained-release pellet, having daily dose of 20 mg to 100 mg, preferably 23 mg to 92 mg. The composition is used for treatment of obesity or other diseases associated with obesity.

Abstract: Various fenofibrate dosage forms contain a plurality of beads or particles, where the beads or particles include a pharmaceutical composition comprising fenofibrate; from 0.3% to 10% by weight of the beads or particles of a surfactant; and from about 5% to about 15% by weight of the beads or particles of a water soluble or water dispersible cellulosic binder. The mass ratio of the drug to the binder in the dosage form is between about 3.5:1 and 4.5:1; and the dosage form produces a first Cmax in vivo that is between about 10% and about 50% higher than a comparative Cmax produced by a comparative dosage form. The comparative dosage form comprises the drug and the binder in a ratio of between about 5:1 and 15:1.

Abstract: The present invention relates to a pharmaceutical composition comprising (i) 50% to 99% of doxycycline as an immediate-release portion; (ii) 1% to 50% of doxycycline as a controlled-release portion; and (iii) one or more pharmaceutically acceptable excipients; wherein the pharmaceutical composition provides a total daily dosage of 40 mg when administered once daily. It also relates to process for preparation of the pharmaceutical composition and its use for treating rosacea.

Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opiods. In the preferred embodiment, a drug is modified to increase its lipophilicity. In preferred embodiments the modified drug is homogeneously dispersed within microparticles composed of a material that is either slowly soluble or not soluble in water. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is broken down or dissolved gradually within the GI tract by a combination of enzymatic degradation, surfactant action of bile acids, and mechanical erosion.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

Abstract: The present invention provides a pharmaceutical formulation for oral administration comprising an agonist of two or more of the 5-HT1B, 5-HT1D and 5-HT1F receptors, such as a triptan, e.g. zolmitriptan, in a matrix constituent with extended release characteristics, and further comprising a 5-HT1A-R agonist, such as buspirone, in a constituent with immediate-release characteristics. The special formulation is particularly well-suited for use in the treatment of movement disorders by combining the two active ingredients in a manner that achieves synergy from both the combination per se and the special release parameters of the pharmaceutical formulation, allowing for ease of administration and reducing the risk of adverse effects of each of the two active ingredients.

Abstract: The invention relates to a controlled release composition comprising a combination of isosorbide dinitrate and hydralazine, such as hydralazine hydrochloride, that in operation delivers the drug in a pulsed or multi-modal manner for the treatment of angina, ischaemic heart disease, arterial hypertension and related disease conditions. Preferably, the isosorbide dinitrate and hydralazine hydrochloride can be released from the dosage form in an erodable, diffusion and/or osmotic-controlled release profile.

Abstract: A film coating agent for a solid formulation includes a water-soluble cellulose derivative, swelling clay, a cationic surfactant, and a fatty acid, wherein mass ratio of the swelling clay to the water-soluble cellulose derivative is 2:8 to 8:2, and content of the cationic surfactant is not less than 0.5 equivalents and not more than 3.0 equivalents relative to a cation exchange equivalent of the swelling clay.

Abstract: The invention provides an apparatus for producing soft gel capsules having encapsulated therein microparticles, nanoparticles and fluids, said apparatus comprising: (a) two spreader boxes; (b) two casting drums; (c) a pair of rotary dies; (d) a liquid fill system (medicine pump system); (e) a wedge for heating gelatine ribbons and feeding said fill; and (f) one or more microgranule or nanogranule feeders located on each side of the rotary dies, said feeders being synchronized to rotate at the same tangential speed as the rotary dies.

Abstract: The present invention provides pharmaceutical photosensitizer-loaded nanoparticle formulations and their methods of preparation for photodynamic therapy, comprising a hydrophobic or hydrophilic photosensitizer, nanoparticulate calcium phosphate and in certain cases auxiliary reagents such as stabilizers. The calcium phosphate-based nanoparticle formulations of the present invention provide excellent storage stability and therapeutically effective amounts of photosensitizer for intravenous or topical administration. In a preferred embodiment, tetrapyrrole derivatives such as porphyrins, chlorins and bacteriochlorins, are the preferred hydrophobic photosensitizers to be formulated in calcium phosphate nanoparticle formulations for photodynamic tumor therapy. Additionally, 5,10,15,20-tetrakis(4-phosphonooxyphenyl)porphine (pTPPP) is a preferred hydrophilic photosensitizer for photodynamic tumor therapy.

Abstract: Disclosed are a sustained release solid formulation comprising a drug, for example, oxycodone or its pharmaceutically acceptable salt, in a water-insoluble matrix, which comprises a wax type excipient and copovidone, and thus, has increased compressibility and fluidity and reduced adhesiveness, and a method of preparing the same.

Abstract: The present invention relates to pharmaceutical compositions of levodopa and carbidopa. In particular, the invention relates to modified release pharmaceutical compositions of levodopa and carbidopa with at least one organic acidic excipient. The invention also relates to processes for the preparation of such compositions and use thereof for treatment of Parkinson's disease.

Abstract: A method for effecting weight loss by administering a combination of topiramate and phentermine is provided. The phentermine is generally administered in immediate release form, in a daily dose in the range of 2 mg to 8 mg, in combination with a daily dose of topiramate selected to prevent the loss of effectiveness of phentermine alone. Methods for treating obesity, conditions associated with obesity, and other indications are also provided, as are compositions and dosage forms containing low doses of phentermine and topiramate, e.g., 3.75 mg phentermine and 23 mg topiramate.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

Abstract: An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.

Abstract: The present invention provides compositions comprising carisoprodol or pharmaceutically acceptable salts, esters or derivatives thereof. In certain embodiments, the invention provides pharmaceutical compositions comprising the skeletal muscle relaxant carisoprodol and one or more additional active agents, such as one or more nonsteroidal antiinflammatory drugs (NSAIDs). The invention further provides methods of use of such compositions in preventing, alleviating and/or treating musculoskeletal pain, muscle spasms, or other non-malignant painful conditions including methods in which the circulating levels of the active pharmaceutical form of carisoprodol are controlled by use of extended- or controlled-release formulations or by strict control of dosage regimen, so as to reduce the level of somnolence observed with other muscle relaxant compositions.

Abstract: The present invention relates to co-extruded pharmaceutical compositions and dosage forms including an active agent, such as an opioid agonist, and an adverse agent, such as an opioid antagonist. Such compositions and dosage forms are useful for preventing or discouraging tampering, abuse, misuse or diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods of treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient.

Abstract: The present invention deals with extended release pharmaceutical compositions comprising tolterodine, wherein the composition comprises: a) a drug layer comprising tolterodine tartrate, monosaccharide and/or disaccharide on an inert core; or a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide; and b) a polymer layer comprising extended release polymer(s). The invention also provides a process for the preparation of the above mentioned composition.

Abstract: The present invention is directed to implantable compositions comprising substantially spherical bioactive glass particles.

Abstract: The present invention relates to compositions containing at least one cationic peptide active agent, at least one neutral structure forming amphiphile, at least one anionic structure forming amphiphile and optionally at least one solvent wherein the composition is in the form of a non-lamellar phase structure and/or forms a nonlamellar phase structure on exposure to body fluids. The invention also relates to methods for protecting peptides from enzymic degredation in vivo and to compositions in which the peptide active agent is so protected.