The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. In certain embodiments, the programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The programmable osmotic-controlled oral compositions of the disclosure comprise a multilayer core comprising a drug for controlled release, wherein the core is coated with a semipermeable membrane comprising an orifice and, optionally, an immediate release coating, comprising a drug for immediate release, over the semipermeable membrane. The multilayered core comprises a pull layer containing the drug and a push layer. The pull layer comprises at least two layers: a placebo layer for providing a desired lag time for the drug release; and an active layer containing the drug and providing a delayed controlled release of the drug. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

A single tablet comprising Compound I. Methods of treating cystic fibrosis comprising administering one or more of such single tablets to a patient.

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The present invention relates to an antimicrobial composition comprising a product of co-treatment of polyphenol and polysaccharide, and to a method for preparing this composition and an antiviral agent.

Provided is a composition comprising delamanid particles for which the formation of secondary particles is suppressed. Specifically, provided is a composition comprising (A) delamanid particles and (B) a surface stabilizer.

Pharmaceutical compositions comprising an antidiabetic agent as an active agent are provided. The present invention relates to pharmaceutical compositions comprising linagliptin or a pharmaceutically acceptable salt thereof as an active agent. The present invention also relates to process of preparation of pharmaceutical compositions comprising linagliptin or a pharmaceutically acceptable salt thereof. The present invention also relates to method of administering the compositions comprising linagliptin to a subject in need thereof.

The present invention relates to multiple unit extended release pharmaceutical compositions comprising plurality of modified release units wherein each unit comprises of an active agent core comprising at least one pharmaceutically active agent and at least one pharmaceutically acceptable excipient substantially coated with at least one release-controlling agent. The present invention also relates to a process for the preparation of these multiple unit extended release pharmaceutical compositions.

The present invention relates to a solid colonic purgative for oral application, containing anhydrous magnesium sulfate, potassium sulfate, anhydrous sodium sulfate, and, additionally, simethicone. The present invention is more satisfactory in the colon cleansing effect even with the doses reduced by up to about 20 percent compared to those of a conventional colonic purgative consisting of anhydrous magnesium sulfate, potassium sulfate and anhydrous sodium sulfate. Besides, the present invention, due to the reduced doses, has less unpleasant taste or odor caused by the main ingredients and requires a less intake of the preparation and water, improving drug compliance significantly. Further, unlike the conventional solid colonic purgative, the present invention can be prepared into tablets without using a water-soluble lubricant. In other words, the present invention can be formulated into a solid preparation for oral application by using a water-soluble lubricant, or even without using any water-soluble lubricant.

Extended-release formulations can be prepared that comprise a core and an optional coating layer formed over the core. The core comprises a therapeutically effective amount an active pharmaceutical ingredient (API), a non-swelling matrix forming agent comprising a water-soluble agent and a water-insoluble polymer; one or more extended-release agents; an optional, wicking agent; and one or more optional excipients. Such formulations may be useful for preparing extended-release formulations of pregabalin that are suitable for once-daily dosing for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN).

An object of the present invention is to provide a tablet containing a succinate salt of (S,E)-N-(1-((5-(2-((4-cyanophenyl)amino)-4-(propylamino)pyrimidin-5-yl)-pent-4-yn-1-yl)amino)-1-oxopropan-2-yl)-4-(dimethylamino) -N-methylbut-2-enamide (Compound A) which is rapidly dissolved in a weakly acidic solution in order to prevent a decrease in bioavailability. According to the present invention, there is provided a tablet containing a succinate salt of (S,E)-N-(1-((5-(2-((4-cyanophenyl)amino)-4-(propylamino)pyrimidin-5-yl)-pent-4-yn-1-yl)amino)-1-oxopropan-2-yl)-4-(dimethylamino) -N-methylbut-2-enamide (Compound A), at least one or more kinds selected from the group consisting of sugars and sugar alcohol, and crospovidone.

Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.