Abstract: A lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof, is provided. An aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition is provided. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures.

Abstract: The present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day. The present invention also provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives.

Abstract: The present invention relates to a lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof. The present invention also relates to an aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures.

Abstract: The present invention provides a method for preventing or treating Alzheimer’s disease and symptoms thereof comprising administering to a subject in need thereof a therapeutically effective amount of N?-(2-chloro-6-methylbenzoyl)-4-methyl-3-[2-(3-quinolyl)ethynyl]-benzohydrazide or a its pharmaceutically acceptable salts, wherein the prevention and/or treatment of said disease and symptoms thereof is achieved by inhibition of amyloid-beta (A?) plaque aggregation, tau hyperphosphorylation, c-Abl kinase or a combination thereof. Also disclosed is the use of a therapeutically effective amount of N?-(2-chloro-6-methylbenzoyl)-4-methyl-3-[2-(3-quinolyl)ethynyl]-benzohydrazide or its pharmaceutically acceptable salts to inhibit amyloid-beta (A?) plaque aggregation, tau hyperphosphorylation, c-Abl kinase or a combination thereof.

Abstract: The present invention relates to a lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof. The present invention also relates to an aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures.

Abstract: The present invention relates to nano-resin particles that are suitable for pharmaceutical use and their use in the pharmaceutical field. The present invention provides nano-sized resin particles having a particle size distribution characterized in that D90 value is between 200 nanometers to 900 nanometer and D10 value is not less than 50 nanometers, wherein the nano-resin particles are in pure form and safe for pharmaceutical use. The present invention further relates to pharmaceutical compositions comprising these purified nano-resin particles and their use in the treatment of diseases.

Abstract: An abuse deterrent oral solid dosage form comprising: an inner portion comprising a drug susceptible to abuse and a pH dependent polymer soluble in acidic medium an outer portion, wherein the portion is devoid of drug susceptible to abuse and comprises an immediate release form of alkalizer and a sustained release form of alkalizer, the sustained release form of alkalizer comprising an alkalizer and a rate controlling excipient.

Abstract: A method of treating or preventing synucleinopathies in a human subject comprising administering a therapeutically effective amount of a compound of Formula 1, or its pharmaceutically acceptable salt.

Abstract: A compound of Formula I or a pharmaceutically acceptable salt thereof (wherein X, Y, Z and n are defined herein). These compounds are useful in the treatment of diseases mediated by topoisomerase I enzyme such as cancers. Also provided are processes for the preparation of compounds of Formula I. The compounds are more water soluble, stable in buffer solution at various pH, and exhibit better anti-tumor activity and rapid release of SN-38 in tumor microenvironments.

Abstract: An oral solid dosage form comprising a mixture of compound of formula I and a fusible polymeric carrier; and optionally pharmaceutically acceptable excipients, wherein the mixture is an amorphous dispersion.

Abstract: An oral, solid dosage form comprising a mixture of compound of formula I and a fusible polymeric carrier; and optionally pharmaceutically acceptable excipients, wherein the mixture is an amorphous dispersion.

Abstract: An oral solid dosage form comprising a mixture of compound of formula I and a fusible polymeric carrier; and optionally pharmaceutically acceptable excipients, wherein the mixture is an amorphous dispersion.

Abstract: The present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day. The present invention also provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives.

Abstract: The present invention relates to an injection device for subcutaneous or intramuscular injection of a pharmaceutical formulation characterized by a yield value, said device comprising, a longitudinally continuous hollow element forming a reservoir for the pharmaceutical formulation, said longitudinally continuous hollow element having a first cylindrical hollow element having an internal diameter (d1), in continuum with a second tapering element that tapers from the internal diameter (d1) to an opening with a diameter (d2) over a length (l), wherein d1 ranges from 2.6 mm to 3.0 mm, d2 ranges from 0.71 mm to 1.01 mm and l ranges from 0.91 mm to 1.41 mm; a needle adapted to be attached to the opening of said second tapering element; and a plunger rod for insertion in the said cylindrical hollow element having a thumb rest at one end and a stopper at the other end.

Abstract: A selective estrogen receptor degrader (SERD), a compound 3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, and its S enantiomer, (2S)-3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, or pharmaceutically acceptable salts thereof. Also provided are processes for their preparation. Also provided for is the use of these compounds for the treatment of diseases which are related to modulation of estrogen receptors, such as ER-positive breast cancer.

Abstract: The present invention relates to a method of increasing the bioavailability and/or prolonging ophthalmic action of a drug, the method comprising instilling into the eye an aqueous suspension comprising reversible clusters of drug loaded nano-resin particles, said clusters having a D50 value of at least 2 micrometer and said drug loaded nano-resin particles have a particle size distribution characterized in that the D90 value is 70 nanometer to 900 nanometer. The present invention further relates to an aqueous suspension comprising reversible clusters of drug loaded nano-resin particles, said clusters have a D50 value of at least 2 micrometers and said drug loaded nano-resin particles have a particle size distribution characterized in that the D90 value is 70 nanometers to 900 nanometers.

Abstract: A selective estrogen receptor degrader (SERD), a compound 3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, and its S enantiomer, (2S)-3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, or pharmaceutically acceptable salts thereof. Also provided are processes for their preparation. Also provided for is the use of these compounds for the treatment of diseases which are related to modulation of estrogen receptors, such as ER-positive breast cancer.

Abstract: The present invention provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives. Also, the present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day.

Abstract: The present invention provides novel heterocyclic compounds as anticancer agents, especially as estrogen receptor (ER) antagonists/degraders and process for their preparation.

Abstract: A selective estrogen receptor degrader (SERD), a compound 3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, and its S enantiomer, (2S)-3-(3,5-difluorophenyl)-2-[4-[(E)-3-[3-(fluoromethyl)azetidin-1-yl]prop-1-enyl]phenyl]-4-methyl-2H-chromen-7-ol, or pharmaceutically acceptable salts thereof. Also provided are processes for their preparation. Also provided for is the use of these compounds for the treatment of diseases which are related to modulation of estrogen receptors, such as ER-positive breast cancer.