Changes in drug crystallinity in a commercial tacrolimus amorphous formulation result in variable pharmacokinetics.

Autor: Taylor LS; Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States. Electronic address: lstaylor@purdue.edu., Trasi NS; Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States., Purohit HS; Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States; Small molecule CMC development, R&D, AbbVie Inc, North Chicago, IL 60064, United States., Sun D; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Kinjo M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Ni Z; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Mahjabeen S; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Feng KK; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Sun WJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, United States., Matta MK; Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, MD 20993, United States., Decker B; Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN 46202, United States., Galinsky RE; Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States; Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN 46202, United States.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2025 Jan; Vol. 114 (1), pp. 313-322. Date of Electronic Publication: 2024 Oct 15.

Physical stability and release properties of lumefantrine amorphous solid dispersion granules prepared by a simple solvent evaporation approach.

Autor: Trasi NS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, USA., Bhujbal SV; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, USA., Zemlyanov DY; Birck Nanotechnology Center, Purdue University, West Lafayette, Indiana 47907, USA., Zhou QT; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, USA., Taylor LS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, USA.

Publikováno v: International journal of pharmaceutics: X [Int J Pharm X] 2020 Jul 16; Vol. 2, pp. 100052. Date of Electronic Publication: 2020 Jul 16 (Print Publication: 2020).

Assessing the Impact of Endogenously Derived Crystalline Drug on the in Vivo Performance of Amorphous Formulations.

Autor: Purohit HS; Department of Industrial & Physical Pharmacy, College of Pharmacy , Purdue University , 575 Stadium Mall Drive , Lafayette , Indiana 47907 , United States., Trasi NS; Analytical Development , Celgene Corporation , 556 Morris Avenue , Summit , New Jersey 07901 , United States.; Department of Industrial & Physical Pharmacy, College of Pharmacy , Purdue University , 575 Stadium Mall Drive , Lafayette , Indiana 47907 , United States., Osterling DJ, Stolarik DF, Jenkins GJ, Gao W, Zhang GGZ, Taylor LS; Department of Industrial & Physical Pharmacy, College of Pharmacy , Purdue University , 575 Stadium Mall Drive , Lafayette , Indiana 47907 , United States.

Publikováno v: Molecular pharmaceutics [Mol Pharm] 2019 Aug 05; Vol. 16 (8), pp. 3617-3625. Date of Electronic Publication: 2019 Jul 16.

Surface area normalized dissolution to study differences in itraconazole-copovidone solid dispersions prepared by spray-drying and hot melt extrusion.

Autor: Bhardwaj V; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States., Trasi NS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States., Zemlyanov DY; Birck Nanotechnology Center, Purdue University, West Lafayette, IN 47907, United States., Taylor LS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, IN 47907, United States. Electronic address: lstaylor@purdue.edu.

Publikováno v: International journal of pharmaceutics [Int J Pharm] 2018 Apr 05; Vol. 540 (1-2), pp. 106-119. Date of Electronic Publication: 2018 Feb 07.

Evaluation of the Crystallization Tendency of Commercially Available Amorphous Tacrolimus Formulations Exposed to Different Stress Conditions.

Autor: Trasi NS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA., Purohit HS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA., Taylor LS; Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, Indiana, 47907, USA. lstaylor@purdue.edu.

Publikováno v: Pharmaceutical research [Pharm Res] 2017 Oct; Vol. 34 (10), pp. 2142-2155. Date of Electronic Publication: 2017 Jul 07.