Ph.D. Pharmaceutics and Industrial Pharmacy, Massachusetts College of Pharmacy 1991

M.S. Pharmaceutics and Industrial Pharmacy, Massachusetts College of Pharmacy 1986

B.S. Pharmacy, Massachusetts College of Pharmacy 1989

B.S. Pharmacy, University of Bombay, Bombay 1983

Research Areas: Formulation development, pharmaceutical dosage forms, clinical supplies, CMC, regulatory submissions, transfer technology, patents

Opportunities for Collaboration:  Research and development projects requiring: drug delivery, nanotechnology, controlled release, abuse deterrent opioid formulations, GMP/GLP Training, Pharmaceutical/Biotechnology Manufacturing and Analytical Laboratory Student Training

USP, Member Expert Committee on Chemical Medicines Monograph (2015 – present)

Developing and revising USP standards, monographs and lead other expert committee projects impacting global public health

United States Pharmacopeia (USP)  Voting Delegate – 2014

UGA College of Pharmacy representative, Critical governance responsibilities, Voting delegate of the USP Convention – resolutions, bylaws, election-Officers & Trustees (BoT) and Council of Experts (CoE)

Fellow, American Association of Pharmaceutical Scientists (AAPS) 2011

“As a distinguished contributor and acknowledged leader in the advancement of the pharmaceutical sciences”  

Distinguished Scientist, American Association of Indian Pharmaceutical Scientists (AAiPS) 2011

“Dedicated contribution to the field of pharmaceutical sciences, leadership role in AAPS and active support to AAiPS”

Pharmaceutical Technology, Editorial Advisory Board Member

American Association of Pharmaceutical Scientists (AAPS), Member

American Pharmacists Association (APhA) Member

Controlled Release Society (CRS) Member

Nanotechnology – absorption of low solubility / permeability drugs

Immediate and controlled-release dosage forms

Topical and Transdermal Dosage Forms

In vitro in vivo correlation (IVIVC)

Chemistry Manufacturing Controls (CMC), Technology transfer

Regulatory Submissions

Patent – Development (US, EP), Interference, Litigation, Expert

BOOK CHAPTERS

Gurvinder Singh Rekhi and Richard Sidwell “Sizing of Granulation”, in Handbook of Pharmaceutical Granulation Technology, Dilip M. Parikh, ed. (Informa Healthcare Inc., NY, 2010) Third Edition 2010.

Gurvinder Singh Rekhi and Leon Shargel, “Drug Product Development in Pharmaceutical Industry”, in Comprehensive Pharmacy Review, Leon Shargel, Alan Mutnick, Paul Souney and Larry Swanson eds.  (Lippincott Williams & Wilkins, MD, 2012) Eighth Edition 2012.

Gurvinder Singh Rekhi, Sarwar Beg, Rajneet Kaur Khurana, and Bhupinder Singh, “Recent Paradigms in Nano-Based Solid Oral Drug Delivery Technologies” in Volume 2: Nanopharmaceuticals, Kamalinder K Singh and Gurvinder Singh Rekhi, eds.(Studium Press, LLC, TX, 2015).

BOOK EDITOR

Kamalinder K Singh and Gurvinder Singh Rekhi, eds. Volume 2: NanoPharmaceuticals of six volume book series: NanoBioMedicine (6 Volume Set), (Studium Press, LLC, TX, 2015).

PATENTS

Multiparticulate Modified Release Composition PCT / US99 / 25632 and 32 several EU countries International Publication Number WO 00 / 25752, May 11 2000.

The countries are Argentina, Australia, Brazil, Canada, Chile, China, China (divisional), Columbia, Czech Republic, Ecuador, Hong Kong, Hungry, Indonesia, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Russian Federation, Singapore, Slovak Republic, Taiwan, Taiwan (divisional), Turkey, Venezuela, Vietnam.

Multiparticulate Modified Release Composition US Patent 6,228,398 B1, May 8, 2001.

Contributed as co-inventor on this patent and is one of the critical patents used a platform technology for development of pulsed / bimodal release dosage forms.  Ritalin LA and Focalin XR Capsules has been formulated using this technology and marketed in US and approximately 26 countries.  Responsible for the formulation, analytical development, transfer and regulatory filing of this product for the US and rest of the world. 

Alcohol Resistant Enteric Pharmaceutical Compositions US Patent Application Publication: 2014/ 0248341 A1, WO2011/112709, PCT /US2011027736, September 15, 2011, EP 2544667 A4

Contributed as co-inventor on this patent and is one of the critical patents used a platform technology for development of alcohol-resistant enteric dosage forms. 

Nanoparticulate and Controlled Release Compositions comprising of Cefditoren US Patent 8,119,163 B2, February 21, 2012.

Contributed as co-inventor on this patent and is one of the critical patents used a platform technology for development of nanocrystal oral controlled release dosage forms.

Controlled Release Combinations Comprising a Combination of Isosorbide Dinitrate and Hydralazine Hydrochloride US Patent 8,992,973 B2, March 31, 2015.

Controlled Release Combinations Comprising a Combination of Isosorbide Dinitrate and Hydralazine Hydrochloride US Patent 9,308,177 B2, April 12, 2016.

Controlled Release Combinations Comprising a Combination of Isosorbide Dinitrate and Hydralazine Hydrochloride US Patent  9,463,166 B2,  October 11, 2016

Contributed as co-inventor on this patent and is one of the critical patents used a platform technology for development of pulsed / bimodal release dosage forms.  This combination of drugs BiDil has been shown to treat heart failure.

Abuse Resistant Pharmaceutical Compositions US Patent 9,132,096 B1 September 15, 2015.

Abuse Resistant Pharmaceutical Compositions US Patent 9,452,163 B2 September 27, 2016.

Abuse Resistant Pharmaceutical Compositions US Patent 9,486,451 B2 November 8, 2016.

WO2016/038584A1

Contributed as co-inventor on this patent and is one of the critical patents used a platform technology for development of abuse-resistant controlled release dosage forms.

Participated in several successful US/EP patent oral depositions and proceedings to defend patent challenges from brand/generic manufacturers.

PUBLICATIONS

Gurvinder S. Rekhi and Sunil S. Jambhekar, “Bioavailability and In Vitro In Vivo Correlation for Propranolol Hydrochloride Beads Prepared Using Aqueous Polymeric Dispersions”.  J.Pharm. Pharmacol.  48, 1276 – 1284 (1996).

Gurvinder S. Rekhi, Ralph Caricofe, Dilip M. Parikh and Larry L. Augsburger, “A New Approach to Scale-up of a High-shear Granulation Process”.  Pharm. Tech., Tableting and Granulation Yearbook, 20 (10), 58 – 66 (1996).

Gurvinder S. Rekhi, Ranjani V. Nellore, Lloyd G. Tillman and Larry L. Augsburger, “Identification of Critical Formulation and Processing Variables for Metoprolol Tartrate Extended-release Tablets”.  J. Controlled Release 59 (3), 327 – 342 (1999).

1. Mahayni, G. S. Rekhi, R. S. Uppoor, P. Marroum, A. S. Hussain, L. L. Augsburger, N. D. Eddington, “Evaluation of External Predictability of an in vitro–in vivoCorrelation for an Extended-release formulation Containing Metoprolol Tartrate”, J. Pharm. Sci. 89 (10), 1354 – 1361 (2000).

Yanfeng Wang, Lucy Lee, Russell Somma, Glen Thompson, Ray Bakhtiar, James Lee, Gurvinder S. Rekhi, Henry Lau, Greg Sedak and Mohammad Hossain, “In vitroDissolution and In vivo Oral Absorption of Methylphenidate from a Bimodal Release Formulation in Healthy Volunteers.  Biopharm. Drug Dispos.  25 (2):  91 – 98 (2004).

Gurvinder Singh Rekhi, “Advances in Drug Delivery”, in Oral Drug Delivery and Advanced Excipients, www.ondelivery.com, May 2010.