Effective methods and compositions to deter abuse of pharmaceutical products (e.g., orally administered pharmaceutical products) including but not limited to immediate release, sustained or extended release and delayed release formulations for drugs subject to abuse.

The present disclosure provides programmable osmotic-controlled oral compositions providing delayed extended release of a therapeutically acceptable amount of methylphenidate hydrochloride. 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 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 that matches the circadian rhythm of an individual being treated to optimize therapeutic outcome and minimize side effects.

The use of powder-form, crosslinked, water-insoluble, low-swelling polyacrylates as disintegrants for solid pharmaceutical dosage forms.

The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

The invention is directed to pharmaceutical compositions such as tablets that exhibit delayed release properties when administered as either whole or half tablets. The invention is also directed to delayed release tablets comprising deferiprone for oral administration, for which twice daily administration is bioequivalent to the same daily dose of an immediate release tablet administered thrice daily. The invention is also directed to methods of making and using the same.

The present disclosure is directed to chemical compounds and to the use of such compounds in the treatment of diseases associated with a serotonin 5-HT.sub.2 receptor.

An oral dosage form of ticagrelor includes a core and a semi-permeable membrane coating the core. The core comprises a first drug layer and a push layer. The first drug layer contains ticagrelor that is sufficient to deliver an effective amount of the drug over an intended delivery time. The push layer comprises a swelling agent and an osmogen agent. The semi-permeable membrane has at least one passageway formed therethrough, positionally configured to face the first drug layer, but not to face the push layer, of the core, and functionally configured to allow the ticagrelor to realize an extended release out of the core upon contacting an aqueous environment. The dosage form optionally further includes a second ticagrelor-containing drug layer coating the semi-permeable membrane, thereby providing a starting effective dose upon administration. The dosage form can realize once-a-day administration of ticagrelor of patients in need thereof.

The present invention relates to water dispersible mini-tablets of Enalapril or a pharmaceutically acceptable salt thereof for use in the treatment of hypertension in a pediatric population. The pediatric population is defined as 0 to 18 years of age. The water dispersible mini-tablets of Enalapril further include a disintegrant, a diluent, a lubricant and a glidant. The active ingredient is distributed evenly in the mini-tablet and the disintegrant comprises Crospovidone. The mini-tablet has a diameter of 3 mm and disintegrates in less than 15 seconds in water.

The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API):

##STR00001##

wherein “R.sup.a” is independently —H or —F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released.

Pharmaceutical compositions comprising nitroxoline lysinate, a preparation method therefor and a use thereof. The pharmaceutical compositions comprise a first layer and a second layer. The first layer comprises, based on the total weight of the first layer, 40%-70% of active pharmaceutical ingredient, 10%-30% of filler, 5%-12% of disintegrant, 0.5%-2% of lubricant, 0.1%-1.5% of glidant and 10%-20% of alkaline substance. The second layer comprises, based on the total weight of the second layer, 40%-70% of active pharmaceutical ingredient, 10%-30% of filler, 10%-35% of sustained-release material, 0.1%-2% of lubricant and 0.1%-2% of glidant. The active pharmaceutical ingredient is selected from one or more of nitroxoline lysinate, nitroxoline lysinate crystalline form and nitroxoline lysinate solvate. The pharmaceutical compositions can achieve the purpose of burst release at an early stage and sustained and slow release at a later stage.