The invention provides methods for producing high concentration crystalline drug substances of an anti-PD-1 monoclonal antibody (mAb), wherein the mAb is pembrolizumab or a pembrolizumab variant. The invention further relates to pharmaceutical compositions comprising the crystals produced by the methods herein and methods of use thereof.
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
This disclosure provides crystalline forms of a compound of Formula (I), as well as pharmaceutically acceptable compositions thereof, and methods for their preparation and use in methods of treating hypercholesterolemia and other conditions related to PCSK9 activity, e.g., atherosclerosis, atherosclerotic cardiovascular disease, peripheral arterial disease, cerebrovascular disease, coronary heart disease, metabolic syndrome, acute coronary syndrome, or related cardiovascular disease and cardiometabolic conditions.
C07D 417/10 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a carbon chain containing aromatic rings
C07D 279/12 - 1,4-Thiazines; Hydrogenated 1,4-thiazines not condensed with other rings
4.
PROCESS FOR PREPARING AGGLOMERATED CRYSTALLINE MEDIUM-CHAIN FATTY ACID SODIUM SALTS
The process of the present invention is used to prepare agglomerated, crystalline particles of medium chain fatty acid sodium salts, such as sodium caprate. This process comprises the steps of: a) dissolving a medium chain fatty acid in a first solvent to produce a first solution, wherein the first solvent comprises an aprotic polar solvent; b) adding to the first solution (i) a second solvent, wherein the second solvent comprises a medium chain aliphatic hydrocarbon solvent, and (ii) a solution comprising a sodium salt of a short chain alcohol to create a resulting slurry; and c) isolating agglomerated crystals from the resulting slurry. The first solvent may comprise acetonitrile, and the second solvent may comprise heptane. Further provided are products generated by this process, including sodium caprate products having superior flowability and compression properties.
The present invention relates to a process for drying crystalline sugammadex to meet solvent specifications that is independent of API crystallinity or crystalline form generated. It further relates to use of sugammadex in the reversal of neuromuscular blockade induced by recuronium bromide or by vecuronium bromide in adults undergoing surgery.
The disclosure provides crystalline forms for certain synthetic intermediates for making belzutifan, a HIF-2α inhibitor, useful for the treatment of cancer. The disclosure also provides processes for isolating the crystalline forms.
C07D 317/72 - Heterocyclic compounds containing five-membered rings having two oxygen atoms as the only ring hetero atoms having the hetero atoms in positions 1 and 3 spiro-condensed with carbocyclic rings
C07C 317/14 - Sulfones; Sulfoxides having sulfone or sulfoxide groups bound to carbon atoms of six-membered aromatic rings
The present disclosure provides a novel crystalline forms of sugammadex, designated herein as crystalline form Type 7 of sugammadex, crystalline form Type 10 of sugammadex, crystalline form Type 12 of sugammadex, and crystalline form Type 13 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by rocuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present invention relates to a process for drying crystalline sugammadex to meet solvent specifications that is independent of API crystallinity or crystalline form generated. It further relates to use of sugammadex in the reversal of neuromuscular blockade induced by recuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present disclosure provides novel crystalline forms of sugammadex, designated herein as crystalline fonn Type 7 of sugammadex, crystalline form Type 10 of sugammadex, crystalline form Type 12 of sugammadex, and crystalline fonn Type 13 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by rocuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present disclosure provides novel crystalline forms of sugammadex, designated herein as crystalline fonn Type 7 of sugammadex, crystalline form Type 10 of sugammadex, crystalline form Type 12 of sugammadex, and crystalline fonn Type 13 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by rocuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present disclosure provides a novel crystalline forms of sugammadex, designated herein as crystalline form Type 7 of sugammadex, crystalline form Type 10 of sugammadex, crystalline form Type 12 of sugammadex, and crystalline form Type 13 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by rocuronium bromide or by vecuronium bromide in adults undergoing surgery.
G01N 23/20 - Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups , or by using reflection of the radiation by the materials
The present invention relates to a process for drying crystalline sugammadex to meet solvent specifications that is independent of API crystallinity or crystalline form generated. It further relates to use of sugammadex in the reversal of neuromuscular blockade induced by recuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present invention relates to crystalline form Type 5 of sugammadex, to uses thereof, and to related pharmaceutical compositions. The crystalline form may be used, for example, in the preparation of a medicament comprising sugammadex for reversing neuromuscular blockade induced by rocuronium and/or vecuronium in patients (e.g., adults, children) undergoing surgery.
The present disclosure provides novel crystalline forms of sugammadex, designated herein as crystalline fonn Type 7 of sugammadex, crystalline form Type 10 of sugammadex, crystalline form Type 12 of sugammadex, and crystalline fonn Type 13 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by rocuronium bromide or by vecuronium bromide in adults undergoing surgery.
The present invention relates to a process for drying crystalline sugammadex to meet solvent specifications that is independent of API crystallinity or crystalline form generated. It further relates to use of sugammadex in the reversal of neuromuscular blockade induced by recuronium bromide or by vecuronium bromide in adults undergoing surgery.
Disclosed herein is a novel process for preparing Compound A free base, 5-((2,4-diaminopyrimidin-5-yl)oxy)-4-iso-propyl-2-methoxybenzenesulfonamide, and a citrate salt of Compound A with simplified chemistry and a high overall yield: Compound A. In one embodiment, the overall yield from the starting material 2-isopropylphenol to Compound A citrate salt is greater than 50%. In another embodiment, the overall yield is greater than 60%. Also disclosed herein are novel salts and solvates of Compound A.
The present invention provides a novel crystalline forms of sugammadex, designated herein as crystalline form Type 1 of sugammadex, crystalline form Type 2 of sugammadex, crystalline form Type 3 of sugammadex, crystalline form Type 8 of sugammadex, and crystalline form Type 9 of sugammadex, pharmaceutical compositions thereof, and methods for their use in the reversal of neuromuscular blockade induced by recuronium bromide or by vecuronium bromide in adults undergoing surgery.
patents
