Patent ID: 9468604
Filing Date: 2016-10-18
CPC Classification: A61K

Claim Text:
1. A method of making a solid amorphous dispersion pharmaceutical composition, the method comprising: (i) providing a drug to be in the pharmaceutical composition, the drug having a solubility in aqueous solution of up to about 1 to 2 mg/ml at any pH from 1 to 8; (ii) determining whether the drug is acid sensitive by determining whether, when said drug is administered to an acidic aqueous solution having a pH from 1-4, the concentration of said drug decreases by at least 1 wt % within 24 hours after administration; (iii) combining the drug, if determined to be acid sensitive, with a solvent, a neutral concentration-enhancing dispersion polymer selected from the group consisting of hydroxypropyl methylcellulose (HPMC) and hydroxypropyl methylcellulose acetate (HPMCA) and with an excipient selected from the group consisting of a base and a basic buffer, to form a solution; and (iv) spray drying the solution to form a substantially homogeneous solid amorphous dispersion that provides improved chemical stability relative to a first control composition comprised of either an equivalent quantity of a dispersion of said drug and an acidic polymer or of an equivalent quantity of a dispersion of said drug and said neutral polymer but free from said base and said buffer.