Abstract: The invention relates to a drug delivery system for contraception including a steroidal estrogenic compound, a steroidal progestogenic compound or a combination thereof for the purposes of contraception in a subject, and provides for an ultra-low dose delivery of a steroidal estrogenic compound which minimizes or eliminates a burst release effect. The invention also relates to a method of contraception using the drug delivery system and method of manufacturing the drug delivery system.

Abstract: The invention relates to a drug delivery system for contraception including a steroidal estrogenic compound, a steroidal progestogenic compound or a combination thereof for the purposes of contraception in a subject, and provides for an ultra-low dose delivery of a steroidal estrogenic compound which minimizes or eliminates a burst release effect. The invention also relates to a method of contraception using the drug delivery system and method of manufacturing the drug delivery system.

Abstract: The present invention is related to deuterated secnidazole, a prodrug thereof, a metabolite thereof, a hydrate thereof, a solvate thereof, a polymorph thereof, or a pharmaceutically acceptable salt thereof and its use for the treatment of bacterial vaginosis or trichomoniasis in a subject in need thereof. The present invention is also related to pharmaceutical compositions and methods and uses of treating bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, or a combination thereof. The present invention is also related to methods of screening deuterated forms of secnidazole to identify potent and high metabolic lifetime compounds for treating bacterial vaginosis or trichomoniasis.

Abstract: The present invention is related to deuterated secnidazole, a prodrug thereof, a metabolite thereof, a hydrate thereof, a solvate thereof, a polymorph thereof, or a pharmaceutically acceptable salt thereof and its use for the treatment of bacterial vaginosis or trichomoniasis in a subject in need thereof. The present invention is also related to pharmaceutical compositions and methods and uses of treating bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, or a combination thereof. The present invention is also related to methods of screening deuterated forms of secnidazole to identify potent and high metabolic lifetime compounds for treating bacterial vaginosis or trichomoniasis.

Abstract: The invention described herein provides new combination products for the cyclical provision of a methylcobalamin compound and a steroid compound in a dosing regimen wherein the total amount of methylcobalamin administered during any one treatment cycle does not exceed 35 mcg. More specifically, the combination products described in this disclosure promote the prevention or treatment of a vitamin B12 deficiency, support the replenishment and or maintenance of healthy blood cell levels, or both, particularly in those experiencing a periodic physiological challenge which may compromise vitamin B12 status or result in an increased requirement for vitamin B12, such as the monthly blood loss experienced by a reproductively cycling human female.

Abstract: The invention described herein provides new methods and compositions for the cyclical provision of a vitamin B12 compound in a dosing regimen wherein the total amount of vitamin B12 administered during any one treatment cycle does not exceed 35 mcg. More specifically, the invention described in this disclosure promotes the prevention or treatment of a vitamin B12 deficiency, supports the replenishment and or maintenance of healthy blood cell levels, or both, particularly in those experiencing a periodic physiological challenge which may compromise vitamin B12 status or result in an increased requirement for vitamin B12, such as the monthly blood loss experienced by a reproductively cycling human female.

Abstract: The present invention is related to deuterated secnidazole, a prodrug thereof, a hydrate thereof, a solvate thereof, a polymorph thereof, or a pharmaceutically acceptable salt thereof and its use for the treatment of bacterial vaginosis or trichomoniasis in a subject in need thereof. The present invention is also related to pharmaceutical compositions and methods and uses of treating bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, or a combination thereof.

Abstract: New deuterated analogs of elagolix are provided. The novel deuterated elagolix analogs differ from the only previously disclosed deuterated elagolix analogs in structure based on the exclusion of deuterium at certain sites in the compounds and the inclusion of deuterium at other sites. Also provided are new formulations for deuterated elagolix compounds and methods of using such compounds and formulations in the modification of mammalian physiology and especially in the treatment and prevention of a number of diseases and disorders, including endometriosis-associated pain and uterine fibroid conditions.

Abstract: The invention described herein provides new methods and compositions for the cyclical provision of a vitamin B12 compound in a dosing regimen wherein the total amount of vitamin B12 administered during any one treatment cycle does not exceed 35 mcg. More specifically, the invention described in this disclosure promotes the prevention or treatment of a vitamin B12 deficiency, supports the replenishment and or maintenance of healthy blood cell levels, or both, particularly in those experiencing a periodic physiological challenge which may compromise vitamin B12 status or result in an increased requirement for vitamin B12, such as the monthly blood loss experienced by a reproductively cycling human female.

Abstract: A soft gelatin capsule composition for vaginal administration of secnidazole includes a therapeutically effective amount of secnidazole dispersed in a pharmaceutically acceptable carrier. The therapeutically effective amount of secnidazole is in a range of from about 1 mg to about 500 mg, or in a range of from about 1,000 mg to about 1,500 mg. The composition is used for treating diseases, including bacterial vaginosis or trichomoniasis.

Abstract: New deuterated analogs of elagolix are provided. The novel deuterated elagolix analogs differ from the only previously disclosed deuterated elagolix analogs in structure based on the exclusion of deuterium at certain sites in the compounds and the inclusion of deuterium at other sites. Also provided are new formulations for deuterated elagolix compounds and methods of using such compounds and formulations in the modification of mammalian physiology and especially in the treatment and prevention of a number of diseases and disorders, including endometriosis-associated pain and uterine fibroid conditions.

Abstract: The invention relates to a drug delivery system for contraception including a steroidal estrogenic compound, a steroidal progestogenic compound or a combination thereof for the purposes of contraception in a subject, and provides for an ultra-low dose delivery of a steroidal estrogenic compound. The invention also relates to a method of contraception using the drug delivery system and method of manufacturing the drug delivery system.

Abstract: The present invention is related to deuterated secnidazole, a prodrug thereof, a hydrate thereof, a solvate thereof, a polymorph thereof, or a pharmaceutically acceptable salt thereof and its use for the treatment of bacterial vaginosis or trichomoniasis in a subject in need thereof. The present invention is also related to pharmaceutical compositions and methods and uses of treating bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, or a combination thereof.

Abstract: A stable pharmaceutical liquid composition of sodium picosulfate, magnesium oxide, citric acid, comprising one or more stabilizers selected from organic acid or its derivatives thereof selected from maleic acid, sodium gluconate, formic acid, sodium alginate, oxalic acid; ammonium chloride or a combination thereof is provided. The present invention also relates to process of making and using such a composition.

Abstract: The present invention relates to the pharmaceutical compositions of a mixture of dextro- and levo-amphetamines complexed with ion exchange resin and precursor resins. More particularly the invention relates to Attention Deficit Hyperactivity Disorder (ADHD) effective agent dosage forms that both facilitate oral ingestion and provide an effective treatment over a prolonged period oftime. In particular, the invention provides for pharmaceutical compositions having a first and second plurality of particles, where the first plurality of particles comprises drug-resin particles and the second plurality of particles comprises drug-precursor resin particles with or without any extended release coating, where the drug is an ADHD effective agent and the composition achieves an escalating in vivo plasma concentration of the ADHD effective agents selected from amphetamine and methylphenidate.

Abstract: The present invention relates to pharmaceutical compositions of dronabinol and process for preparation thereof. The stable oral solution of dronabinol can be formulated by further reducing the amount of water to less than about 25% w/w of the composition. The solution of the invention was found to be stable at various temperature and humidity conditions for prolonged periods of time. The invention relates to dronabinol compositions administered through oral route in the form of solutions.

Abstract: A long-acting pharmaceutical composition comprising at least one amphetamine salt is provided. The composition comprises an immediate release component, a delayed release component, and a sustained release component comprising one or more amphetamine salts. The sustained release component comprises a sustained release layer and a delayed release layer, such that the delayed release layer is coated onto the sustained release layer. The time (Tmax) to achieve Cmax after administration of said composition is between 7-10 hours.

Abstract: Extended-release oral pharmaceutical compositions of amphetamine, a pharmaceutically acceptable salt, enantiomer, or combination thereof are provided. The compositions comprise drug-cation exchange resin complex particles which comprise extended-release coated amphetamine-cation exchange resin-matrix particles coated with an extended-release coating. Both the matrix and the extended-release coating comprise the same polymer or copolymer, and preferably the composition is devoid of uncoated amphetamine-ion exchange resin complex particles and amphetamine particles which are not complexed with an ion exchange resin.

Abstract: A solid oral pharmaceutical composition of promethazine, hydrocodone and acetaminophen, or a pharmaceutically acceptable salt thereof is provided. The composition comprises promethazine formulated for immediate release, both hydrocodone and acetaminophen formulated for controlled release, and at least one of the hydrocodone and acetaminophen formulated for immediate release.

Abstract: An oral modified release pharmaceutical composition of methylergonovine suitable for oral once daily administration is provided. The composition includes at least about 0.6 mg dose of methylergonovine or a pharmaceutically acceptable salt thereof and is particularly useful for treating migraine or refractory migraine.