Dr. Sonali Bharate

Qualification : M. Pharm., Ph.D.Specialization : Pharmaceutics

E-mail : sonali.bharate@nmims.edu

Phone : 022-42332000 (Extn- 2027)

Experience : 12 years (Post-PhD)

(Research and Development: 7.5 years, Academics: 4.5 years)

Dr. Sonali S. Bharate has a strong background in drug discovery, with specific training and expertise in preformulation studies and formulation development of small molecules and phytopharmaceuticals. Her primary research focuses on resolving the physicochemical barriers associated with drugs/ NCEs/ botanicals via formulation-driven fine-tuning. In the past 10 years, she actively contributed in preformulation studies for early drug discovery and formulationdevelopment of NCEs and phytopharmaceuticals. The formulations developedfrom her research on preclinical candidates reached the human clinical trials (IIIM-290 solid dispersions in phase I/II clinical trial).Two oral formulations developed by her group are part of IND applications. Furthermore, the sustained-release formulations of two botanical leads have been out-licensed to the industries for launching in the market.She also led the IIIM-Innoveda joint project on thepreclinical development of an anti-diabetic formulation that has ultimately reached the market (DIABE-250® by Nirogstreet).

Dr. Sonali S. Bharate earnedPh.D. in the Faculty of Technology (Subject: Pharmaceutics) from SNDT Women’s University, Mumbai, in 2010. In August 2020,she joined NMIMSas an Associate Professor. Before joiningNMIMS, she hadworked in CSIR-IIIM as a formulation scientist.

Google scholar profile/ Scopus/ Research gate: https://scholar.google.co.in/citations?user=fWNJy6UAAAAJ&hl=en https://pubmed.ncbi.nlm.nih.gov/?term=Bharate+SS https://orcid.org/0000-0001-7267-5080 https://www.researchgate.net/profile/Sonali-Bharate

Research areas:

• Utilizing formulation approaches for addressing the physicochemical barriers associated with drugs/ NCEs/ natural products/ nutraceuticals, and phytopharmaceuticals.
• Preformulation (early drugdiscovery) studies for drugs/ naturalproducts/ NCEs

Projects completed/ ongoing: 4

• Development of salts/cocrystals of natural product-derived anticancer leads with favorablebiopharmaceutical properties. (DBT,Govt of India;2017-2020).
• Oral delivery of anticancer flavopiridol: Development and biological characterization of nanoparticles (ICMR, Govt.of India; 2014-2017).
• Development of formulations of niclosamide, a COVID-19 clinicalcandidate, to improve its patientcompliance (NMIMS Seed Grant; 2021-2022).
• Development of topical ointment formulations of a natural product and its enriched extract (Industry sponsored; 2021-2022).

Academic activities

Ph.D. guidance: Guided 1 Ph.D. student

M. Pharm. research projects: Guiding 5 M. Pharm. for the thesis work

Awards

·2021: CSIR Technology Award2021 (Team memberfor the development of Saffron-based nutraceuticaltechnology)

·2017: Award of prestigious DBT-BioCaRe Women Scientist grant

·2014-2017: Award of Research Associate fellowship from ICMR

·2010: Two ‘Innocentive’ awards from Innocentive Inc. USA

·2005-2007: Award of a research fellowship from LupinPharma, Mumbai, duringPh.D.

·2002, 2004: Received first class withdistinction, both in B. Pharm.and M. Pharm.

·2002: Qualified GATE-2002 in Pharmaceutical Scienceswith 94 Percentile.

·2002-2004: Award of a researchfellowship from UGCduring M. Pharm.

·2000-2001: Winner of Science QuizCompetition during B. Pharm.

·2001-2002: Winner of Extempore Competition in National PharmacyWeek

·1998-2002: Topper (Rank1) in the college throughout four years of B. Pharm.

·1998-99: Winner of ‘Best Disciplined Student’ of the College

Professional Memberships

·Maharashtra State PharmacyCouncil (Life member)

·American Chemical Society(2019-2022; honorary)

Publications & patents

·Publications: >55(International – 55, National - 0), Totalimpact factor: Morethan 225, h- Index: 23, Citations: >1700

·Book Chapters- 01

·Patents- 09 filed and 05 granted

·Presentations- 15 (International - 07, National- 08)

·Conferences/Workshops/Seminars attended- 16

Recent Publications, 2021-22 [Total publications= 56; citations > 1700].

1.Gupta DS, Bharate SS*. Techniques for analytical estimation of COVID-19 clinicalcandidate, niclosamide in pharmaceutical and biomedical samples.Separation Science Plus.Accepted

2.Bhanushali JS, Dhiman S, Nandi U, Bharate SS*. Molecular interactions of niclosamide with hydroxyethyl cellulose in binary and ternary amorphous solid dispersions for synergisticenhancement of water solubility and oral pharmacokinetics in rats. International Journal of Pharmaceutics. 2022, doi:10.1016/j.ijpharm.2022.122144 (Impact factor= 6.51)

3.Shah RP, Bharate SS*. Analytical methods for furanochromone natural product, khellin and its inspired drug candidates, amiodarone and sodium cromoglycate. Critical Reviews in Analytical Chemistry. 2022, DOI: 10.1080/10408347.2022.2094198 (Impact factor = 5.686)

4.Fulmali A, Bharate SS*. Phosphate moiety in FDA-approved pharmaceutical salts and prodrugs. Drug Development Research, 2022, 83, 1059-1074. (Impact factor= 5.004)

5.Shah RP, Bharate SS*. Thermodynamic solubility determination of khellinin eight mono- solvents at the range of 298.15to 323.15 K. Journal of Molecular Liquids,2022, 351, 118637 (Impact factor = 6.165)

6.Devadiga SJ, Bharate SS*. Recent developments in the management of Huntington's disease. Bioorganic Chemistry, 2022, 120,105642 (Impact factor= 5.275)

7.Kantak MN, Bharate SS*. Analysis of clinical trialson biomaterial and therapeuticapplications of chitosan:A review. Carbohydrate Polymers, 2022, 278, 118999 (Impact factor = 9.381)

8.Bharate SS*. Criticalanalysis of drug product recallsdue to nitrosamine impurities. Journal of Medicinal Chemistry, 2021, 64,2923- 2936 (Impactfactor = 7.446)

9.Bharate SS*. Recentdevelopments in pharmaceutical salts: FDA approvals from 2015 to 2019. DrugDiscovery Today, 2021,26, 384-398 (Impactfactor = 7.851)

10.Bharate SS*. Modulation of biopharmaceutical properties of acidic drugsusing cationic counterions: A critical analysis of FDA-approved pharmaceutical salts. International Journal ofPharmaceutics, 2021, 607,120993 (Impact factor= 5.875)

11.Bharate SS*. Carboxylic acid counterions in FDA-approved pharmaceutical salts. Pharmaceutical Research, 2021, 38, 1307–1326 (Impact factor= 4.2)

12.Bharate SS*. Modulation of biopharmaceutical properties of drugs usingsulfonate counterions: A critical analysisof FDA-approved pharmaceutical salts. Journal of DrugDelivery Science andTechnology, 2021, 66, 102913 (Impactfactor = 3.981)

13.Bharate SS*. Enhancing biopharmaceutical attributes of khellin by amorphous binary solid dispersions. AAPS PharmSciTech, 2021,22, 260 (Impactfactor = 3.246)

14.Wani A, Al RihaniSB, Sharma A, Weadick B, Govindarajan R, Khan SU,Sharma PR, DograA, Nandi U, ReddyCN, Bharate SS, Singh G, Bharate SB, Vishwakarma RA, Kaddoumi A, Kumar

A. Crocetin promotes clearance of amyloid-β by inducing autophagy via the STK11/LKB1- mediated AMPKpathway. Autophagy, 2021, 17, 3813-3832 (Impact factor = 16.016)