Abstract: The invention provides methods and pharmaceutical compositions for treating symptoms associated with lactose intolerance and for overall improvement in gastrointestinal health. Described herein are methods and pharmaceutical compositions for improving overall gastrointestinal health or for decreasing symptoms of lactose intolerance by administering to subject in need thereof a pharmaceutical composition comprising a prebiotic, optionally in combination with effective amount of a probiotic microbe or microbes.

Abstract: Described herein are pharmaceutical compositions comprising polyunsaturated fatty acids and methods of manufacturing the same. In particular, described herein are pharmaceutical compositions comprising soft enteric capsules comprising omega-3 polyunsaturated fatty acids. The oral pharmaceutical compositions described herein are useful as nutritional supplements or for the treatment of cardiovascular-related diseases, such as hyper dyslipidemia and high triglyceride levels.

Abstract: Fill materials for hydrophobic drugs, such as progesterone, and methods of making and using thereof are described herein. The fill material contains the hydrophobic drug dissolved in one or more fatty acids. The concentration of the hydrophobic drug is typically from about 7% to about 50% by weight of the fill material. The concentration of the one or more fatty acids is from about 60% to about 95% by weight of the carrier. The formulation also contains an organic acid and one or both of one or more pharmaceutically acceptable alcohols and one or more pharmaceutically acceptable mono-, di-, or triesters of medium or long chain fatty acids. The fill material can be encapsulated in a hard or soft capsule. The formulations described herein have a higher dissolution rate and faster onset of dissolution compared to micronized progesterone suspended in an oil and thus should have increased bioavailability in vivo.

Abstract: A composition for vaginal insertion is in the form of a softgel, a two-part gelatin capsule, a tablet, or a suppository. The composition is designed to promote the growth of native vaginal flora, but does not promote the growth of Gardenerella vaginalis and Candida albicans. The composition includes a prebiotic in a pharmaceutically acceptable excipient and is essentially free of probiotics, lactoferrin, and plant extracts containing isoflavones.

Abstract: The present invention relates to a pharmaceutical or nutraceutical preparation comprising a) a core containing a pharmaceutically or nutraceutically active substance and a substance that acts in a modulatory manner with regard of the release of pharmaceutically or nutraceutically active substances; and b) a controlling layer surrounding the core comprising i) 55 to 92% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate copolymers composed of 80 to 98% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from C1 to C4 alkyl esters of (meth)acrylic acid and 2 to 20% by weight based on the weight of the (meth)acrylic copolymer of structural units derived from (meth)acrylate monomers with a quaternary ammonium group in the alkyl radical; and ii) 8 to 45% by weight based on the total weight of (meth)acrylic copolymers present in the layer of one or a mixture of a plurality of (meth)acrylate co

Abstract: Pharmaceutical compositions in unit dose form comprising a hard or soft capsule containing a fill consisting of one or more inert ingredients, and one or more coatings on the capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient.

Abstract: The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.

Abstract: A pharmaceutical composition in multilayer-coated form including an omega-3 fatty acid or an alkyl ester thereof and a statin-based drug, and more particularly, a pharmaceutical composition for oral administration including: (a) a gelatin capsule core containing an omega-3 fatty acid or an alkyl ester thereof; (b) a first coating layer formed by coating, on the gelatin capsule core, hydroxypropyl methylcellulose and a copolymer of butyl methacrylate, (2-demethylaminoeethyl) methacrylate, and methyl methacrylate at a weight ratio of 1:2:1; and (c) a second coating layer formed by coating, on the first coating layer, a coating solution containing a statin-based drug.

Abstract: Activated fatty acids, nutraceutical compositions including activated fatty acids, methods for using activated fatty acids to treat a variety of diseases, and methods for preparing activated fatty acids are provided herein.

Abstract: The present disclosure relates to food supplement, dietary supplement, nutritional supplement, over-the-counter (OTC) supplement, medical food, or pharmaceutical grade supplement compositions comprising omega-3 fatty acids and vitamin D for use in improving at least one parameter associated with acne and/or eczema (dermatitis).

Abstract: Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.

Abstract: A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

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: A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.

Abstract: The present invention relates to new acid resistant hard pharmaceutical capsules, a process for their manufacture and use of such capsules particularly but not exclusively for oral administration of pharmaceuticals, veterinary products, food and dietary supplements to humans or animals. The capsules of the invention are obtained by aqueous compositions comprising a water soluble film forming polymer and gellan gum in a mutual weight ratio of 4 to 15 weight parts of gellan gum for 100 weight parts of film forming polymer.

Abstract: The present invention describes new and improved dosage forms containing a steroid 5-alpha-reductase inhibitor, in combination with an alpha blocker, for the treatment or prophylaxis of an androgen mediated disease or condition, preferably for the treatment of benign prostatic hyperplasia (HPB).

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: The invention relates to a condensation product obtainable by reaction of a1) at least one bicyclic or polycyclic aromatic or heteroaromatic, where the bicyclic or polycyclic aromatic or heteroaromatic is substituted by at least one carboxyl group (—COOH), and where the carboxyl group can be present in salt form, a2) at least one carbonyl compound, a3) if appropriate at least one sulfonating agent, a4) at least one urea derivative, and a5) if appropriate at least one further aromatic or heteroaromatic, or a physiologically tolerable salt thereof.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: Gastric resistant film-forming compositions are described herein. The composition comprises a gastric resistant natural polymer, a film-forming natural polymer, and optionally a gelling agent. Suitable gastric resistant natural polymers include polysaccharides such as pectin and pectin-like polymers. The film-forming composition can be used to prepare soft or hard shell gelatin capsules which can encapsulate a liquid or semi-solid fill material or a solid tablet (Softlet®) comprising an active agent and one or more pharmaceutically acceptable excipients. Alternatively, the composition can be administered as a liquid with an active agent dissolved or dispersed in the composition. The compositions are not only gastric resistant but may also prevent gastric reflux associated with odor causing liquids, such as fish oil or garlic oil, encapsulated in a unit dosage form and esophageal irritation due to the reflux of irritant drugs delivered orally.

Abstract: Embodiments of liquid-filled hard gel capsule pharmaceutical formulations comprise a non-emulsified mixture, wherein the non-emulsified mixture comprises about 0.1 to about 5% by weight of at least one active pharmaceutical ingredient, about 50 to about 95% by weight long chain triglycerides, and about 5 to about 25% by weight medium chain mono/diglycerides, wherein the long chain triglycerides and medium chain mono/diglycerides are present at a ratio by weight of from about 10:1 to about 5:1.

Abstract: The present invention is directed to compositions and methods of delivery of CoQ-10 solubilized in monoterpenes. Use of monoterpenes as dissolving agents, greatly effects the ability to incorporate greater amounts of bioactive CoQ-10 in formulations, such as soft gel capsules.

Abstract: The present invention is directed to compositions and methods of delivery of CoQ-10 solubilized in monoterpenes. Use of monoterpenes as dissolving agents, greatly effects the ability to incorporate greater amounts of bioactive CoQ-10 in formulations, such as soft gel capsules.

Abstract: Activated fatty acids, nutraceutical compositions including activated fatty acids, methods for using activated fatty acids to treat a variety of diseases, and methods for preparing activated fatty acids are provided herein.

Abstract: The present disclosure relates to delayed release capsules and methods of manufacturing the capsules. The capsules comprise a capsule shell comprising a combination of gelatin and alginate, wherein the capsule shell encapsulates or is filled with at least one agent, and the delayed release capsules are chosen from soft capsules and hard capsules.

Abstract: This invention discloses new krill oil compositions characterized by having high amounts of phospholipids, astaxanthin esters and/or omega-3 contents. The krill oils are obtained from krill meal using supercritical fluid extraction in a two stage process. Stage 1 removes the neutral lipid by extracting with neat supercritical CO2 or CO2 plus approximately 5% of a co-solvent. Stage 2 extracts the actual krill oils by using supercritical CO2 in combination with approximately 20% ethanol. The krill oil materials obtained are compared with commercially available krill oil and found to be more bioeffective in a number of areas such as anti-inflammation, anti-oxidant effects, improving insulin resistances and improving blood lipid profile.

Abstract: DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented. Also provided are methods of treating hypertriglyceridemia (200 mg/dL-500 mg/dL) by adjunctive administration of a statin and the pharmaceutical compositions described herein. Further treatment methods include, inter alia, treatments to increase plasma EPA:AA ratios, treatments to decrease ApoCIII levels, and treatments to reduce or prevent resistance to platelet aggregation inhibitors.

Abstract: There is provided a complex comprising rifaximin and a complexing agent, wherein the complexing agent is a polyvinyl pyrrolidone (PVP) or a cyclodextrin. There is also provided a process for preparing the complex, a pharmaceutical composition including the complex, and therapeutic uses of the complex.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.

Abstract: The present invention provides a pharmaceutical formulation suitable for filling softgel capsules comprising: (a) from about 1% to about 90% by weight of a bisphosphonic acid or a pharmaceutically acceptable salt; (b) from 1% to about 99% by weight of lycopene and (c) from about 40% to about 80% by weight of a liquid carrier comprising 50% to 80% by weight polyethylene glycol; 5% to 15% by weight of glycerin; and 5% to 20% by weight water. The invention also describes a method for preparing alendronate or its pharmaceutical acceptable salts in encapsulated therapeutic dosage form in combination with lycopene.

Abstract: The present invention relates to the field of food and medicines for the treatment or alleviation of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), premenopause, menopause and female hormonal disorders. A first embodiment relates to a composition containing vitamins, minerals and oils. Additionally, the invention comprises a pharmaceutical form, more specifically in the form of soft capsules (also known as gelatin) containing the composition of the invention. In particular, the compositions of the invention contain vitamins and minerals in sources compatible with the association of vegetable oils, preferably borage oil, evening primrose oil, or a mixture of two oils, wherein the soft capsule contains a liquid and oily core.

Abstract: A way to formulate prasterone to both increase its oral bioavailability, and decrease the variability of its oral bioavailability. In contrast to the approach taught by the prior art, the instant approach is amenable to scale-up to commercial scale. Further, the resulting product is amenable to analysis using standard, known quantitative analytical techniques; thus, unlike the prior art approach, the instant approach may be used to manufacture a product in conformity with applicable regulatory standards.

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 capsule for encapsulating a tablet, includes two capsule portions of equal sizes and dimensions, each containing a moisture content of 12 to 16% and having a plurality of ridges projecting inwardly from the inner circumference of the respective capsule portions and extending along the inner circumference of the respective capsule portions in radially spaced apart relationship with one another and defining fluid flow passages between the ridges. The outline defined by the tips of the ridges correspond to the outer surface of the tablet to provide an interference fit between the ridges and the tablet when the capsule portions are push fitted over the tablet from the ends of the tablet in an abutting but not overlapping relationship with each other at ambient conditions.

Abstract: The invention relates to compositions and methods for reducing cross-linking in the gelatin shell of gelatin capsules by incorporation of free amino acid into the capsule shell and by inclusion of an ester of carboxylic acid either into the capsule filling, and/or into the capsule shell and/or into the lubrication agent, or in combinations thereof. Described are soft gelatin capsules characterized by improved stability as compared with gelatin capsules that do not contain amino acid in the shell and carboxylic acid ester in the filling, shell or in the lubrication agent, or in combinations thereof.

Abstract: The invention relates to a pharmaceutical composition and oral dosage forms comprising a bisphosphonate in combination with an enhancer to enhance intestinal delivery of the bisphosphonate to the underlying circulation. Preferably, the enhancer is a medium chain fatty acid or a medium chain fatty acid derivative having a carbon chain length of from 6 to 20 carbon atoms, and the solid oral dosage form is a controlled release dosage form such as a delayed release dosage form.

Abstract: Pharmaceutical formulations comprising at least 30% omega-3-fatty acids, salts or derivatives thereof, and one or more additional components selected from the group consisting of: absorption enhancers and adjuvants These formulations have improved pharmacological features, and can be used for the treatment or prophylaxis of dyslipidemic, cardiovascular, CNS, inflammatory, and other diseases/conditions or risk factors therefore.

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

Abstract: The present invention is directed to compositions and methods of delivery of CoQ-10 solubilized in monoterpenes. Use of monoterpenes as dissolving agents, greatly effects the ability to incorporate greater amounts of bioactive CoQ-10 in formulations, such as soft gel capsules.

Abstract: The present invention provides methods of treating a human or other mammal infected with a parasitic microorganism by administering an effective amount in unit dosage form of a C8-C16-alpha, beta-unsaturated aliphatic aldehyde, such as trans-2-dodecenal, to the human or other mammal. The parasitic microorganisms may include trypanosomes, bacteria, fungi and nematodes.

Abstract: A microparticle comprising a pesticidal agent encapsulated within a polymer coating, the polymer coating comprising an oil-soluble dye wherein the oil-soluble dye and the polymer coating increases the pesticidal agent's ability to withstand UV radiation, a method of manufacturing the microparticle and a method of using the microparticle to control pests

Abstract: The present invention relates to new acid resistant hard pharmaceutical capsules, a process for their manufacture and use of such capsules particularly but not exclusively for oral administration of pharmaceuticals, veterinary products, food and dietary supplements to humans or animals. The capsules of the invention are obtained by aqueous compositions comprising a water soluble film forming polymer and gellan gum in a mutual weight ratio of 4 to 15 weight parts of gellan gum for 100 weight parts of film forming polymer.

Abstract: Use of an orally or nasally available formulation of Tretazicar for poisoning vermin. An orally available or nasally available formulation of Tretazicar, wherein in the orally available formulation the Tretazicar is protected from acid hydrolysis, and provided that the formulation is not solid Tretazicar in a gelatin capsule. A formulation of Tretazicar in which the Tretazicar is protected from acid hydrolysis, wherein the formulation is present in a liquid form. A combination of Tretazicar and bait. A method of poisoning vermin comprising making available to the vermin an orally or nasally available formulation of Tretazicar and allowing the vermin to ingest or inhale the formulation of Tretazicar.

Abstract: The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.

Abstract: A solid oral controlled-release oral dosage form of hydrocodone is disclosed. The dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and a sufficient amount of a controlled release material to render the dosage form suitable for twice-a-day administration to a human patient, the dosage form providing a C12/Cmax ratio of 0.55 to 0.85, said dosage form providing a therapeutic effect for at least about 12 hours.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and a statin and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.