The present invention aims to provide a preparation expected to improve the bitter taste of an organic acid salt of vonoprazan and permit rapid dissolution of the organic acid salt of vonoprazan after administration. The present invention provides a preparation containing fine granules or granules containing (1) a core granule containing an organic acid salt of vonoprazan, (2) an intermediate layer containing the same organic acid as the organic acid forming the salt of vonoprazan in (1), or a salt thereof, and (3) a coating layer containing a water-insoluble polymer.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

An immediate release, unit doses of GHB or one of the therapeutically acceptable salts thereof administered via oral route. Such unit doses contain between 0.37 and 1.75 g of GHB, when under the form of granules, these granules have the following composition (weight % relative to the total weight of the granule): Active ingredient (sodium oxybate): 50 to 60%; Effervescent agent: 5 to 15%; Diluent: 2 to 18%; Binder: 3 to 10%; Substrate (Solid core of the granule): 15 to 25%; Coating agent/flavouring agent/sweetening agent/lubricant: 3 to 6%. Application for maintaining abstinence from alcohol of patients with mild or moderate alcohol dependence or with severe or very severe alcohol dependence, either suffering or not from liver disease.

Disclosed is a pharmaceutical unit dosage composition including a plurality of enteric coated micro pellets. Each enteric coated micro pellet includes a core bead, an optional first sealing layer, an API layer including a Compound (I) having the following structure or a pharmaceutically acceptable salt thereof, an optional second sealing layer, and an enteric coating layer. Also disclosed is a method for the treatment and prophylaxis of RSV diseases including providing a Compound (I) and administering to a patient in need thereof a therapeutically effective amount of the Compound (I) so that t½ of the Compound (I) is about 6 to 13 hours.

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This invention provides, in part, various compositions and methods for protecting the gastrointestinal microbiome from antibiotic disruption from orally administered antibiotics.

The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

The present invention relates to non-hormonal compositions and methods for inducing a condition of aspermia, azoospermia, or severe oligozoospermia in the male subject such that these compositions and methods for administering the same may be used as male contraception. Embodiments of the present invention may comprise a composition comprising an alpha-1-adrenoreceptor antagonist, such as (R)-silodosin, for daily administration to a male subject. The compositions and related methods may further include pharmaceutically acceptable carriers. The present invention further includes formulations which allow for a delay such that delayed or missed dose(s) do not nullify the contraceptive effect of the treatment regimen. Such compositions and methods may also avoid the side effects associated with typical formulations of alpha-1-adrenoreceptor antagonists.

The present invention includes a compositions and methods comprising: one or more thyroid hormones in or on a micro-multi-particulate having a mean particle size of 150 uM or smaller and a Span (D90−D10)/(D50) of less than 2.0, wherein the total thyroid hormone(s) are less than 10% weight-to-weight (w/w) of the micro-multi-particulate; and a polymer release coating on the micro-multi-particulate that is greater than a 5:1 ratio w/w, on a dry weight basis, to a dry weight of the thyroid hormone(s), wherein a total tablet weight exceeds a micro-multi-particulate weight by a ratio of 5:1 or greater.