A solid, oral pharmaceutical composition is described. The solid, oral pharmaceutical composition includes methylphenidate or a pharmaceutical salt thereof, wherein an in vivo absorption model of the solid, oral pharmaceutical composition has a function selected from the group consisting of: a single Weibull function, a double Weibull function, and a sigmoid eMax function. A correlation of a plurality of fractions of an in vitro dissolution of the solid, oral pharmaceutical composition with a same plurality of fractions of an in vivo absorption of the solid, oral pharmaceutical composition is non-linear. A method of treating a condition in a subject having a disorder or condition responsive to the administration of methylphenidate is also described. The method includes orally administering to the subject an effective amount of the solid, oral pharmaceutical composition.

The present invention relates to a pirfenidone formulation having improved safety and a method for producing same, wherein the pirfenidone formulation comprises pirfenidone as an active component, has two or more mutually different coatings selected from the group consisting of a coating containing a water-soluble polymer and a coating containing an enteric polymer, thereby specifically releasing pirfenidone in the small intestine, and has unique pharmacokinetic properties to reduce variability when pirfenidone is absorbed through the gastrointestinal tract, and reduce gastrointestinal side effects without affecting bioavailability of the active component, and therefore can remarkably improve low medication compliance.

The present invention relates to extended release composition of Mirabegron and process of manufacture thereof. The extended release composition of mirabegron comprising non-polymeric hydrophobic excipient as release controlling agent along with one or more pharmaceutically acceptable excipient is used in the treatment of symptoms associated with overactive bladder.

The present disclosure provides pharmaceutical compositions of niclosamide that may be administered orally. These compositions may allow the achievement of a therapeutically effective dose of niclosamide while preventing crystallization in the stomach which reduces bioavailability. These compositions may be used to treat one or more diseases or disorders such as a viral infection or cancer.

The present invention relates to an enteric coated pharmaceutical composition comprising a solid dispersion comprising regorafenib and at least one stabilizing agent outside of the solid dispersion, its process of preparation and its use for treating disorders.

The present disclosure is directed to oral tablet of ribociclib including its salt(s). One embodiment of the present disclosure is directed to tablet of ribociclib with high drug load with an immediate release profile. One embodiment of the present disclosure is directed to coated tablet of ribociclib. Another embodiment of the present disclosure is directed to coated tablet of ribociclib where the coating is an advanced moisture barrier coating (e.g., Opadry® amb II coating where the coating is PVA based).

The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.

The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

A food safe, plant based, water soluble, dry powder formulation and an aqueous enteric coating solution made therefrom, that is used for providing an enteric film coating on oral dosage forms including capsules, tablets, and the like; and methods of making the dry powder formulation, making the aqueous coating solution, and coating of oral dosage forms including capsules, tablets, and the like.

The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.