Abstract: Provided are novel Zaleplon crystalline Forms II, III, IV and V, which are useful for the treatment of insomnia. Also provided are processes for making Forms I, II, and V using precipitation methods.

Abstract: Provided are novel Zaleplon crystalline Forms II, III, IV and V, which are useful for the treatment of insomnia.

Abstract: The present invention provides a process for the production of N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide (zaleplon), an active ingredient that is approved for the treatment of insomnia. The process involves reacting N-[3-[3-(dimethylamino)-1-oxo-2-propenyl]phenyl]-N-ethylacetamide or a salt thereof with 3-amino-4-cyanopyrazole or a salt thereof under acidic conditions in a reaction medium comprising a mixture of water and a water-miscible organic compound.

Abstract: The present invention provides a powder composition comprising zaleplon of defined particle size distribution. The zaleplon of defined particle size can be formulated into a wide variety of pharmaceutical compositions and dosage forms.

Abstract: A process for the production of N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide (zaleplon) that involves reacting N-[3-[3-(dimethylamino)-1-oxo-2-propenyl]phenyl]-N-ethylacetamide or a salt thereof with 3-amino-4-cyanopyrazole or a salt thereof under acidic conditions in a reaction medium comprising a mixture of water and a water-miscible organic compound produces zaleplon in high yield and high purity. A regioisomer of zaleplon (N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-5-yl)phenyl]-N-ethylacetamide) is useful as a reference standard for monitoring the composition of production batches of zaleplon.

Abstract: A purification process that is capable of separating zaleplon and a regioisomer of zaleplon that tends to form as a byproduct in the chemical synthesis of zaleplon, resulting in essentially pure zaleplon, is disclosed. In addition, novel crystal forms of zaleplon are accessible with the process.

Abstract: Zaleplon crystalline Forms II, III, IV and V are useful for the treatment of insomnia. These crystalline Forms are described along with processes for making them by crystallization from selected solvents. A regioisomer of zaleplon is useful as a reference standard for monitoring the composition of production batches of zaleplon.

Abstract: Zaleplon can be separated from a regioisomer impurity by crystallization from selected solvents or by adding an anti-solvent to a solution of zaleplon and the regioisomer. Zaleplon crystalline Forms II, III, IV, and V are useful for the treatment of insomnia. These crystalline Forms are described along with processes for making them v crystallization from selected solvents.

Abstract: An amorphous dihydroxy open acid simvastatin calcium and methods for preparing amorphous simvastatin calcium.

Abstract: A purification process that is capable of separating zaleplon and a regioisomer of zaleplon that tends to form as a byproduct in the chemical synthesis of zaleplon, resulting in essentially pure zaleplon, is disclosed. In addition, novel crystal forms of zaleplon are accessible with the process.

Abstract: The present invention provides a process for the production of N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide (zaleplon), an active ingredient that is approved for the treatment of insomnia. The process involves reacting N-[3-[3-(dimethylamino)-1-oxo-2-propenyl]phenyl]-N-ethylacetamide or a salt thereof with 3-amino-4-cyanopyrazole or a salt thereof under acidic conditions in a reaction medium comprising a mixture of water and a water-miscible organic compound.