Irina Nikolaevna Kadiyala
Vertex Pharmaceuticals
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Publication
Featured researches published by Irina Nikolaevna Kadiyala.
Journal of Pharmaceutical Sciences | 2015
Kathy Stavropoulos; Steven C. Johnston; Yuegang Zhang; Bhisetti Govinda Rao; Michael Hurrey; Patricia Hurter; Elizabeth M. Topp; Irina Nikolaevna Kadiyala
A combination of coformer screening and modeling, followed by characterization using calorimetry, structure elucidation, and solubility led to the identification of novel crystalline forms of the hepatitis C protease inhibitor, telaprevir. The lead crystalline form, a cocrystalline solid of telaprevir with 4-aminosalycilic acid, was identified among the list of possible cocrystals via modeling and confirmed by initial screening. It displayed the most significant aqueous solubility improvement over the neat crystalline form. Enhancement of in vivo performance was further demonstrated: a 10-fold increase in bioavailability was achieved for the cocrystal in comparison to the neat nanocrystalline telaprevir and it was found to be not statistically different from the lead amorphous spray-dried formulation.
Pharmaceutical Development and Technology | 2013
Irina Nikolaevna Kadiyala; Elijah Tan
This paper provides an overview of current formulation approaches to mitigate toxicity of orally administrated drugs. The formulation approaches are characterized by their intended impact on a drug’s pharmacokinetic parameters, pharmacological properties or metabolic pathways. Regulatory opportunities and constraints with focus on U.S. regulations in optimizing a drug’s safety or efficacy profile are reviewed. The following formulation approaches are described: (i) pharmacokinetic-modulating and (ii) pharmacodynamic-modulating. In the pharmacokinetic-modulating approach, the pharmacokinetic profile of drug release is modified by, for example, a reduction in peak drug plasma concentration while preserving or improving AUC, thereby potentially reducing toxic effects that may be related to Cmax. In the pharmacodynamic-modulating approach, the drug is co-dosed with pharmacologically active or nonpharmacologically active agent or agents intended for mitigation of the drug’s toxicity. The pharmacodynamic-modulating approach requires information on the specificity of drug interactions with other compounds and also on metabolic pathways. Examples demonstrating successful formulation work in reducing drug toxicity are provided. The in-depth knowledge of the drug’s PK and PD properties combined with a greater understanding of the biology of diseases are necessary for successful drug product formulation leading to optimized in vivo exposure and minimized toxicity.
Archive | 2011
Goor Fredrick F. Van; Rossitza Gueorguieva Alargova; Tim Edward Alcacio; Sneha G. Arekar; Steven C. Johnston; Irina Nikolaevna Kadiyala; Ali Keshavarz-Shokri; Mariusz Krawiec; Elaine Chungmin Lee; Ales Medek; Praveen Mudunuri; Mark Jeffrey Sullivan; Noreen Tasneem Zaman; Beili Zhang; Yuegang Zhang; Gregor Zlokarnik
Archive | 2011
Marinus Jacobus Verwijs; Rossitza Gueorguieva Alargova; Ritu Rohit Kaushik; Irina Nikolaevna Kadiyala; Christopher Ryan Young
Archive | 2011
Rossitza Gueorguieva Alargova; Irina Nikolaevna Kadiyala; Noreen Tasneem Zaman
Archive | 2011
Rossitza Gueorguieva Alargova; Craig A. Dunbar; Irina Nikolaevna Kadiyala
Archive | 2014
Marinus Jacobus Verwijs; Rossitza Gueorguieva Alargova; Ritu Rohit Kaushik; Irina Nikolaevna Kadiyala; Christopher Ryan Young
Archive | 2003
Irina Nikolaevna Kadiyala; Riccardo Panicucci
Archive | 2014
Irina Nikolaevna Kadiyala; Shahla Jamzad; Thomas Hoock; Lori Kell Taylor; Kathryn Lea Sewell
Archive | 2008
Rossitza Gueorguieva Alargova; Irina Nikolaevna Kadiyala; Tiran Arnaud Le; Yuegang Zhang