Development Mechanical

SEJAL PRAVINKUMAR SHAH

**** ****** ****, ***-***, Email:*********@*****.*** Cell: 312-***-****.

University Heights, Cleveland OH

44118.

Summary: Strong background in drug product and analytical development with 6 years of research experience

in development of varied dosage forms. Aims to secure a position in solid/liquid oral formulation development

wherein I get to utilize my fine industrial pharmaceutics skills and experience and the opportunity for continuous

learning and career advancement.

EDUCATION

• 2009

PhD Pharmaceutics (Technology), Institute of Chemical Technology University of Mumbai, India

2004

• MS Pharmaceutical Sciences, Institute of Chemical Technology, University of Mumbai, India

2002

• BS Pharmaceutical Sciences, SNDT University, Mumbai, India

Formulation Experience and Interests:

• Design and Development of Solid Oral Dosage Forms: Immediate and Sustained Release Tablets,

Pellets, Melt Extruded dosage forms, Effervescent Powders/Tablets, Gastro-retentive Tablets, Taste-

Masked delivery systems (wet extruded and melt extruded pellets and tablet dosage forms).

• Melt Extrusion based advanced techniques: Face-Cut Pelletized orally disintegrating pellets,

Foamed extrusion, Novel Solubilization Systems (Amorphous and Crystalline Solid Dispersion), Scale-

up utilizing specific mechanical energy inputs, and mean residence time distribution, taste-masking

approaches. Application of QbD based approaches for process and product optimization using DOE.

• Preformulation Studies (Re-crystallization Kinetics – predictive and real time), characterization of

API and selection of excipients and dosage form.

• Development, Characterization, and Functional evaluation of Directly Compressible (DC) grades of

polymeric excipients: HPMC and Carbopol (Patent pending).

Industrial Experience:

Research Scientist, Analytical and Formulations Division R & D, Biocon Ltd. Bangalore, INDIA (2004 – 2006)

Job Description:

• Development of oral insulin (IN-105) tablet formulations and parenteral formulations of insulin.

• Preformulation studies of oral insulin tablet formulation, Optimization, and evaluation of tablet formulation for oral

insulin.

• Developmental studies on liquid parenteral formulations of fast acting and long acting insulin injections.

• Studying effect of various processing parameters on the stability of insulin formulations.

• Testing storage stability of insulin parenteral formulations as per ICH guidelines.

Academic Research and Teaching Experience:

Post-doctoral Research Scholar: The University of Mississippi at Oxford (Oct 2010 –March 2013)

Research subject: Application of Hot-melt extrusion technology for developing pharmaceutical products

Job Profile:

A. Successfully executed short-term result oriented industrial sponsored projects –focused on solubility enhancement

using solid dispersion and monitoring re-crystallization of Low Tg drugs in polymer matrix

B. Solid dispersion matrix characterization- PXRD, DSC, Hot Stage Microscopy, TGA, FTIR.

C. Orientation of incumbent researchers (Graduate students) to lab, while acting as senior member of a diverse team

including members from five different nationalities.

D. Spearheaded and supervised the research projects of graduate students, including two whose work has been

published in peer-reviewed journals. Mentoring and trouble shooting of research projects of graduate students, planning,

organizing experimental design, and interpretation of results.

E. Managed timely submission of quarterly project status updates (technical reports) to funding agencies and engaging in

technical discussions with the industrial sponsors. Co-ordination of journal club/graduate student group discussions and

meetings. Handling communications (manuscripts) on behalf of research group.

F. Lead author on two high impact review articles and textbook chapters addressing the central concept of melt extrusion,

providing a critical assessment of technology and analytical characterizing tools with the latest information available and

thereby advance the overall knowledge on the subject.

G. Lectured on “Capsules and Tablets” in the following courses in Pharm. D. program: Pharmaceutics 3 32, Dosage Forms

and Drug Delivery Systems Spring 2013 and Spring 2011.

Voluntary Research Associate, Institute for Tuberculosis Research, University of Illinois at Chicago, College of Pharmacy,

(December. 2009 – June. 2010). Research Subject: Targeted lipid based drug delivery system for tuberculosis

Textbook Chapters:

1. Hot Melt Extrusion in drug delivery: three decades of progress”, Shah, S. P., Repka, M. A., Melt Extrusion: Materials,

Technology and Drug Product Design, Series: AAPS Advances in the Pharmaceutical Sciences Series, Vol. 9; Repka, M. A.;

Langley, N; DiNunzio, J. (Eds.) Springer 2013.

Melt Extrusion: A Commercial Perception to Practicality”, Shah, S. P ., Jorg Breitenbach, Melt Extrusion: Materials,

2.

Technology and Drug Product Design, Series: AAPS Advances in the Pharmaceutical Sciences Series, Vol. 9; Repka, M. A.;

Langley, N; DiNunzio, J. (Eds.) Springer 2013.

Publications:

1.Shah S., Maddineni S., Lu. J., Repka M. A., Melt extrusion for poorly soluble drug, International journal of

Pharmaceutics. 2012 Nov 20. doi: 10.1016/j.ijpharm.2012.11.001. [Epub ahead of print]

2.Abhilasha Singh, Soumyajit Majumdar,Weibin Deng, Noorullah Naqvi Mohammed, Amar G. Chittiboyina,

Vijaysankar Raman, Sejal Shah, Michael A. Repka, Development and characterization of taste masked Efavirenz

pellets utilizing hot melt extrusion J. DRUG DEL. SCI. TECH., 23 (2-157-***-****.

3.Deng W, Majumdar S, Singh A, Shah S, Mohammed NN, Jo S, Pinto E, Tewari D, Durig T, Repka MA.

Stabilization of fenofibrate in low molecular weight hydroxypropylcellulose matrices produced by hot-melt

extrusion. Drug Dev Ind Pharm. 2012 Apr 23. [Epub ahead of print]

4. Repka M. A., Shah S., Lu J., Maddineni S., Morott J., Patwardhan K. and Mohammed NN. Melt

extrusion: process to product. Expert Opinion in Drug Delivery, 2012 Jan;9(1):105-25.

5. S. P. Jain, S. P. Shah, N. S. Rajadhyaksha, Pirthi Pal Singh P.S. and P. D. Amin. In Situ Ophthalmic Gel of

Ciprofloxacin Hydrochloride for Once A Day Sustained Delivery. Drug Development and Industrial Pharmacy, 2008, 34 (4),

445-452.

6. S. P. Jain, N. D. Desai, S. P. Shah, P.S. Pirthi Pal Singh, P. D. Amin. A simple and Rapid Stability Indicating LC

determination of Ciprofloxacin Hydrochloride as a Bulk drug and from Formulations. Chromatographia, 2009, 69 (11/12),

1489-1491.

7. Pirthi Pal Singh P.S., Satishkumar Jain, Sejal Shah, Namita Rajadhyaksha, Umangi Soni, Ketkee Deshmukh,

Development of Mathematical Model for Predicting Formulation of Sustained Release Products. Proceedings of the 34th

Annual Meeting of the Controlled Release Society, California, USA, July 2007, 677.

8. Satishkumar Jain, Kiran Sawant, Pirthi Pal Singh, Sejal Shah, Purnima Amin. Novel User-Friendly Dosage Forms of

Choline. Proceedings of the 34th Annual Meeting of the Controlled Release Society, California, USA, July 2007, 726.

9. S. P. Jain, Sejal Shah, Namita Rajadhyaksha, P. P. Singh and Purnima Amin, Twice a Day Ocular Inserts of Acyclovir

by Melt Extrusion Technique, Indian Journal of Pharmaceutical Sciences, 2007, 69 (4), 562 – 567.

10. Satishkumar P. Jain, Dharmini Mehta, Sejal Shah, Pirthi Pal Singh and Purnima Amin, Melt in mouth pellets of

fexofenadine hydrochloride using crospovidone as an extrusion – spheronization aid, AAPS Pharm. Sci. Tech, 2010, 11 (2),

917-923.

Education

PhD (Tech) Pharmaceutics 2009, Institute of Chemical Technology (ICT), University of Mumbai. INDIA

Dissertation Research: Development and Evaluation of New Drug Delivery Technologies

• Development of novel granulation process of Carbopol® and Hydroxypropyl methylcellulose, to trounce its limitations

without affecting its performance characteristics resulted in two patents.

• Development of sustained release formulation of Verapamil hydrochloride, Felodipine and Metformin hydrochloride for

generic market.

• To evaluate and compare the permeation enhancing properties of saturated medium chain fatty acid class of

compounds with chain length varying from C6-C12 through biological membrane.

Masters in Pharmaceutics 2004 Institute of Chemical Technology, University of Mumbai. INDIA

Dissertation Research: Novel Oral Drug Delivery systems

• Formulation of gastro retentive drug delivery system of Verapamil hydrochloride and Metformin hydrochloride to increase

bioavailability of drug.

• Evaluation of new dissolution techniques for gastro retentive tablets.

Bachelor of Pharmaceutical Sciences 2002 SNDT University, Mumbai. INDIA

Professional Qualifications: Post Graduate Diploma in Patent Basics, Patent Law and Patent Litigation, 2008.

Instrumentation Skills

Analytical Instruments: Development of chromatography based assays for recombinant proteins (rDNA Human insulin).

Impurity characterization and process optimization. Hands on Chromatography experience on Agilent 1100, 1200 and Waters

Alliance systems. Electrolab / Veego/ Hanson dissolution tester, Differential Scanning Calorimeter, Infrared spectroscopy, Ultra

violet spectroscopy, Thermo gravimetric Analyzer, X-Ray diffractometer. Malvern (Mastersizer and Zetasizer)

Pharmaceutical processing equipment expertise: Prism 16mm Eurolab and 11mm process (ThermoFisher Scientific) twin-

screw extruder, conical twin screw compounder (MiniLab II HAAKE Rheomex CTW5, ThermoFisher Scientific), Freeze drying,

single screw hot melt extruder, single screw extruder, fluid bed dryer/coater, multi mill, multi-station tablet compression

machine, High shear rapid mixer granulator, planetary mixer (Hobart mixer).

Patents:

1. Directly compressible pre-granulated cellulose ether polymer and process for preparing the same. International

publication No. WO 2010/106555 A2 dated September 23rd, 2010.

2. Free flowing polyacrylic acid granules and process of preparing the same. 29th April 2008, 942/MUM/2008.

3. Granular assemblies of hydroxy propyl methyl cellulose and process of preparing the same. 17th March 2009,

572/MUM/2009.

4. Ion exchange resin based extended release gastro-retentive dosage forms. 03rd August 2006, 1230/MUM/2006.

5. Sustained release extrudates using melt extrusion technology. 07th September 2006, 1439/MUM/2006.

Presentations:

1 E. Ashour, B. Almutairy, V. Kulkarni, A. Alshetaili, S. Shah, S. Majumdar, R. Bosworth, Z. Lian, E. Pinto, V.

Bi, T. Durig, M. Repka. Formulation Development and Characterization of Tablets Manufactured from Hot

Melt Extrudates with Supercritical Carbon Dioxide Processing. AAPS Annual Meeting and Exposition,

October 2013, San Antonio TX.

2 E. Ashour, B. Almutairy, V. Kulkarni, S. Alshehri, S. Shah, S. Majumdar, R. Bosworth, Z. Lian, E. Pinto, V.

Bi, T. Durig, M. Repka. Influence of Supercritical Carbon Dioxide on Ketoprofen-Incorporated Hot-Melt

Extruded Low Molecular Weight Hydroxypropylcellulose Matrices. AAPS Annual Meeting and Exposition,

October 2013, San Antonio TX.

3 S. Alshahrani, B. Alsulays, S. Alshehri, S. Shah, V. Kulkarni, J. Park, S. Murthy, S. Stodghill, M. Repka

Effect of Polymer Molecular Weight on Hot Melt Extrusion Processing and Dissolution of Clotrimazole.

AAPS Annual Meeting and Exposition, October 2013, San Antonio TX.

4 M A Repka, E A Ashour, S Shah, S Majumdar, R Bosworth, M Keshtmand, V Bi, T Durig. Effect of

Supercritical Carbon Dioxide on Hot Melt Extruded Cellulose Polymers, Controlled Release Society Annual

meeting and exposition, May 2013, Honolulu Hawai.

5 M. A. Repka, J. Lu, S. Shah, S. Jo, S. Majumdar, K. Kolter, N. A. Langley, H. Jun, D. Zhang. Solid State

Characterization of Felodipine-Soluplus® Solid Dispersions, Controlled Release Society Annual meeting

and exposition, May 2013, Honolulu Hawai.

6 M. A. Repka, S. M. Alshehri, S. Shah, S. M. Alshahrani, B. K. Almutairy, J. Morott, S. N. Murthy, S.

Majumdar. Solubility enhancement of mefenamic acid with Eudragit® EPO using melt extrusion

techniques, Controlled Release Society Annual meeting and exposition, May 2013, Honolulu Hawai.

7 Sejal P. Shah, Jiannan Lu, Xin Feng, Xinyou Ye, S.N. Murthy, Michael A. Repka. Scale-up of the Melt

Extrusion Process from Bench Scale to Pilot Scale Extruder by Equalizing Specific Mechanical Energy

Inputs. AAPS Annual Meeting and Exposition, October 2012, Chicago.

8 Sejal P. Shah, Jiannan Lu, Xin Feng, Xinyou Ye, S.N. Murthy, Michael A. Repka. Scale-up of the Melt

Extrusion Process from Bench Scale to Pilot Scale Extruder by Equalizing Specific Mechanical Energy

Inputs. AAPS Annual Meeting and Exposition, October 2012, Chicago.

9 Sejal Shah, Xing Feng, Xingyou Ye, M. A. Repka. Recrystallization Rate Prediction of Melt Extruded

Polymeric Amorphous Solid Dispersions. AAPS Annual Meeting and Exposition, October 2012, Chicago.

10 J. T. Morott, S. Shah, S. Majumdar, M. Rahman, Z. J. Lian, D. Tewari, V. Bi, T. Durig, M. A. Repka.

Development and characterization of taste masked hot-melt extruded formulations containing sildenafil

citrate. AAPS Annual Meeting and Exposition, October 2012, Chicago.

11 Abdullah S. Alshetaili, Eman. A. Ashour, Bjad. Almutairy, S. Shah, S. Majumdar, M. A. Repka. Evaluation of

the Physico-mechanical Characteristics of Pellets of Different Polymers Prepared by Melt Extrusion/ Face-

cut Pelletization. AAPS Annual Meeting and Exposition, October 2012, Chicago.

12 Abdullah S. Alshetaili, Eman. A. Ashour, Bjad. Almutairy, S. Shah, S. Majumdar, M. A. Repka. Formulation

and Evaluation of Taste Masked Ketoprofen Pellets Prepared by Melt Extrusion/ Face-cut Pelletization.

AAPS Annual Meeting and Exposition, October 2012, Chicago.

13 B. K. Almutairy, A. S. Alshetaili, S. M. Alshehri, S. Shah, S. Majumdar, M. A. Repka. Development and

Characterization of Taste Masked Acetaminophen with Ethyl Cellulose EC-N7 and Klucel™ polymers

Utilizing Hot Melt Extrusion. AAPS Annual Meeting and Exposition, October 2012, Chicago.

14 B. B. Alsulays, S. M. Alshahrani, M. B. pimparade, S. Shah, S. Majumdar, K. Kolter, N. Langley, M. A.

Repka. Characterization of Molecular Interactions of Carbamazepine, Clotrimazole and Fenofibrate with

Kollidon® VA 64 using Hot Melt Extrusion. AAPS Annual Meeting and Exposition, October 2012, Chicago.

15 S. M. Alshahrani, B.B. Alsulays, S. M. Alshehri, S. Shah, S. Majumdar, K. Kolter, N. Langley, M. A.

Repka. Improving the solubility and physical stability of carbamazepine using hot melt extrusion. AAPS

Annual Meeting and Exposition, October 2012, Chicago.

16 S. M. Alshahrani, B.B. Alsulays, M.B. Pimparade, S. Shah, S. Majumdar, K. Kolter, N. Langley, M. A.

Repka. Characterization of Polymer-Drug Interactions during melt extrusion processes. AAPS Annual

Meeting and Exposition, October 2012, Chicago.

17 S. M. Alshehri, S. M. Alshahrani, B. K. Almutairy, S. Shah, S. Majumdar, M. A. Repka. Development and

Evaluation of Taste-Masked Formulations of Mefenamic Acid using Hot Melt Extrusion Techniques. AAPS

Annual Meeting and Exposition, October 2012, Chicago.

18 X. Feng, S. Shah, M. Rahman, Z. Y. John Lian, T. Durig,D. Tewari, V. Bi, S. Majumdar, M. A. Repka.

Remodeled recrystallization kinetics to predict the physical stability of polymeric amorphous solid

dispersions. AAPS Annual Meeting and Exposition, October 2012, Chicago.

19 M. B. Pimparade, S. M. Alshahrani, B. B. Alsulays, S. Shah, S. Majumdar, K. Kolter, N. A. Langley, M. A.

Repka. Compatibility and Intermolecular Interactions of Melt Extruded APIs with Polymeric Blends. AAPS

Annual Meeting and Exposition, October 2012, Chicago.

20 M. B. Pimparade, J. Lu, S. Shah, Soumyajit Majumdar, M. Rahman, Z. John Lian, V. Bi, D. Tewari, T. Durig,

Michael A. Repka. Development of pediatric and geriatric taste-masked formulations by hot-melt extrusion

techniques. AAPS Annual Meeting and Exposition, October 2012, Chicago.

21 Eman A. Ashour, Abdullah S. Alshetaili, Xin Feng, Sejal Shah, Michael A. Repka. Influence of cooling

temperatures on the stability of Fenofibrate solid dispersions produced by melt extrusion. AAPS Annual

Meeting and Exposition, October 2012, Chicago.

22 Eman A. Ashour, Sejal Shah, Soumyajit Majumdar, M. Rahman, Z. John Lian, V. Bi, D. Tewari, T. Durig,

Michael A. Repka. Effect of supercritical carbon dioxide on hot-melt extruded cellulose polymers,

hydroxypropylcellulose and ethyl cellulose. AAPS Annual Meeting and Exposition, October 2012, Chicago.

23 Jiannan Lu, Sejal Shah, Soumyajit Majumdar, Karl Kolter, Nigel A. Langley, Michael A. Repka. Solid

Dispersion of Carbamazepine with Lutrol® F127 Using Hot Melt Extrusion, AAPS Annual Meeting and

Exposition, October 2012, Chicago.

24 Jiannan Lu, Sejal Shah, Soumyajit Majumdar, Karl Kolter, Nigel A. Langley, Michael A. Repka. Dissolution

behavior of Soluplus®-felodipine solid dispersions. AAPS Annual Meeting and Exposition, October 2012,

Chicago.

25 Jiannan Lu, Sejal Shah, Abhilasha Singh, Soumyajit Majumdar, Karl Kolter, Nigel A. Langley, Michael A.

Repka. Thermal analysis of the miscibility of Soluplus®-Felodipine Solid Dispersions. AAPS Annual

Meeting and Exposition, October 2012, Chicago.

26 K. Patwardhan, S. Shah, S. Majumdar, K. Kolter, N. Langley, M. A. Repka. Comparative drug-polymer

miscibility of Ketoconazole in different grades of PVP polymers. AAPS Annual Meeting and Exposition,

October 2011, Washington, D.C.

27 K. Patwardhan, S. Alshahrani, S. Shah, E. Pinto, D. Tewari, T. Durig, S. Majumdar, M. A. Repka. Taste

Masking Performance of Two Grades of Hydroxypropylcellulose Melt Extruded Pellets. AAPS Annual

Meeting and Exposition, October 2011, Washington, D.C.

28 S. Shah, S. Jain, K. Sawant, S. Sathaye, R. Patole, P. Amin, M. A. Repka. Characterization and Functional

Evaluation of Novel Granular Grades of Carbomers. AAPS Annual Meeting and Exposition, October 2011,

Washington, D.C.

29 Abhilasha Singh, W. Deng, N. N Mohammed, S. Shah, S. Majumdar, M. A. Repka. Preparation and

characterization of solid dispersion tablets of Efavirenz with Benecel™ E5 PH. AAPS Annual Meeting and

Exposition, October 2011, Washington, D.C.

30 Abhilasha Singh, W. Deng, N. N Mohammed, S. Shah, S. Majumdar, M. A. Repka. Characterization of hot

melt extruded immediate release solid dosage forms with cellulose ether polymers for a poorly soluble

drug. AAPS Annual Meeting and Exposition, October 2011, Washington, D.C.

31 Abhilasha Singh, W. Deng, N. N Mohammed, S. Shah, S. Majumdar, M. A. Repka. Development of taste

masked tablets with Eudragit® E PO utilizing melt extrusion. AAPS Annual Meeting and Exposition,

October 2011, Washington, D.C.

32 Solubility Enhancement and Precipitation Inhibition of Paclitaxel Using Hot Melt Extrusion Technology.

Jiannan Lu, Sejal Shah, Seongbong Jo, Michael A. Repka. American Association of Pharmaceutical

Scientists Annual Meeting,October 23-27, 2011, Washington Convention Center, Washington DC.

33 Influence of Formulation Factors and Processing Parameters on Chemical Properties of Ketoconazole-

Soluplus® Melt Extrudates Using Response Surface Methodology. Jiannan Lu, Abdullah S. Alshetaili, Sejal

Shah, Soumyajit Majumdar, Karl Kolter, Nigel A. Langley, Michael A. Repka. American Association of

Pharmaceutical Scientists Annual Meeting,October 23-27, 2011, Washington Convention Center,

Washington DC

34 Weibin Deng, Abhilasha Singh, Sejal Shah, Seongbong Jo, Soumyajit Majumdar, Elanor Pinto, Divya

Tewari, Thomas Durig, Michael A. Repka, In vitro evaluation of hydroxypropylcellulose immediate-release

tablets produced by melt extrusion technology, AAPS Annual Meeting and Exposition, Washington DC,

October, 2011

35 Directly compressible grade of hydroxyl propyl methyl cellulose using high shear spray granulation”

presented at Controlled Release Society student chapter at University of Illinois at Chicago, 17th May

2010.

36 Use of Novel Hydrodynamic diffusion enhancer and Avicel for sustained release felodipine pellets,

presented at 60th Indian Pharmaceutical Congress, held at New Delhi, 12th -14th December 2008.

37 Cost effective sustained Release tablet of Metformin Hydrochloride, presented at 60th Indian

Pharmaceutical Congress, held at New Delhi, 12th -14th December 2008.

38 Novel User – Friendly Dosage Forms of Choline, Presented at 34th Annual Meeting of the Controlled

Release Society, Los Angeles, California, USA, July 2007.

39 Development of Mathematical Model for Predicting Formulation of Sustained Release Products, Presented

at 34th Annual Meeting of the Controlled Release Society, Los Angeles, California, USA, July 2007.

40 Ion Exchange Resin Based Extended Release Gastro – Retentive Dosage Forms, presented at 7th

International Symposium on Advances in Technology & Business Potential of New Drug Delivery Systems,

held at Mumbai, 13th to 14th February, 2007.

41 Characterization of Calcium Citrate Malate, presented at 3rd Nutraceutical Summit, held at Mumbai, 15th

to 17th November 2006.

42 Gastroretentive Dosage Form of Metformin, presented at International Symposium on Recent Advances in

Drug Design & Drug Delivery Systems, held at BITS Pilani, 26th & 27th February 2005.

43 Gastroretentive Dosage Form of Verapamil Hydrochloride, presented at 5th International Symposium on

Advances in Technology & Business Potential of New Drug Delivery Systems, held at Mumbai, February

2004.

Professional Memberships:

Member of American Association of Pharmaceutical Scientist (AAPS) (2010- present)

Life Member Indian Pharmaceutical Association Maharashtra State Branch. (IPA MSB)

Academic Awards/ Workshops:

Junior Research Fellowship (Masters) awarded by University Grants Commission (UGC) INDIA

Sir Ratan Tata Scholarship for academic excellence 2002.

Attendee of APV Experts' Workshop on Hot Melt Extrusion and its use in the Manufacturing of Pharmaceutical Dosage Forms,

April 12–13, 2011, Tarrytown, NY

.

Certificate course “Practical and Theoretical applications of Twin-Screw Extrusion Technology”, Akron Polymer

Training Center, Akron University, OH, Sept 2013

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