Development Project

PUNIT SHAH (M. Pharm., Ph. D)

**** *** ***** ********* **, Tallahassee, FL 32301

Cell : +1-505-***-****, E-mail: **********@*****.***,

http://drpunitshah.weebly.com/

SUMMARY

. New product identification, patent search and infringement analysis

for development of ANDAs (Para III and IV)

. Generation of innovative ideas for development of new formulations and

existing drug for the product life cycle management

. Patent drafting to prevent infringement for generics (ANDAs)

. Preformulation (Solubility, Log P) and compatibility studies (FT-IR,

DSC and X-RPD)

. Solublization and stabilization of new chemical entity (NCE) along

with novel peptide

. Development of tablets and capsules including pellets, liquid orals,

suspensions, ophthalmics, topical and transdermal formulations

. Process optimization, scale-up, technology transfer to process

validation/commercial batches and stability studies

. Handling trouble shooting during technology transfer

. Analytical method development and validation (HPLC, UV-

spectrophotometer, spectrofluorometer)

. Documentation - preparation of exhibit batch summary reports, product

development reports, cleaning verification reports, Batch

Manufacturing Records (BMR), sampling protocol, validation protocol

and other relevant document for execution of exhibit and validation

batches

. Managed a team of undergraduate and graduate students for their

research projects

. Competent to work well on own initiative and demonstrate the high

levels of motivation required to meet the deadlines.

PROFESSIONAL EXPERIENCE

Florida A&M University, USA, Research Associate (Feb 2010 - present)

. Develop transdermal formulations and HPLC method for a novel anti-

cancer peptide, obtained from marine source (Industry sponsored)

. Develop in vivo model for allergic contact dermatitis and psoriasis

(Industry sponsored)

. Develop and character surface modified multi-layered nanostructures

for the dermal delivery of more than 2 drugs

. Investigation of 3D Epiderm Full Thickness (EFT-300) cultures for

chemical and burn wound healing process (Industry sponsored)

. Purchasing and inventory management of raw materials, laboratory

supplies and drug supplies

. Calibration, maintenance and establishing SOPs for new equipments

. Tracking project status and co-ordination with collaborators

. Co-supervision and training of undergraduate/graduate students for the

research projects

University of New Mexico, USA, Post-Doctoral Research Associate (Oct 2008 -

Jan 2010)

. Preformulation, solubility enhancement, physicochemical

characterization and biological activity of novel titanium based anti-

cancer drug (NCE)

. Development of deuterated glucose formulation for anti-counterfeiting

in commercial formulations

. Drug coating and skin permeation study of microneedles for Transdermal

Drug Delivery

. Development and evaluation of Imatinib mesylate topical formulation

. Hands on use of confocal fluorescence microscope

. Plasma analysis of Sildenafil using HPLC

. Co-supervision and training of undergraduate/graduate students for

their research projects

Lupin Ltd., India, Research Associate (Feb 2008 to Sep 2008)

. New product identification (supported by business and medical group)

. Patent evaluation for identified products

. Generation of innovative ideas for development of new formulations and

existing drug for the product life cycle management

. Patent drafting for innovative formulations

. Patent search and Infringement analysis for development of ANDAs (Para

III and IV)

. Patent drafting to prevent infringement for generics (ANDAs)

. Project status tracking and co-ordination with other departments

Evonik (Degussa) India Pvt. Ltd., India, Scientist (May 2005 to Aug 2005)

. Preparation of pellets using spheronisation technique

. Pellet coating using Glatt fluidized bed coater and then curing

. Preparation and execution of stability protocols as per ICH norms for

developed batches

. Documentation of the research data viz. preparation of product

development reports

Ajanta Pharma Ltd., India, Scientist - FD (May 2003 to May 2005)

. Literature Survey and Patent evaluation

. API Sourcing, Vendor validation and setting up the specification for

API

. Preformulation and Compatibility studies (FT-IR, DSC)

. Formulation development of Tablets (Immediate and Extended release),

Capsules, Liquid Orals, Suspensions and Ophthalmics

. Hands on use of powder blending, tray dryer, fluidized bed dryer, high

shear granulator, rotary compression machines and tablet coater etc.

. Process improvement/process optimization, scale-up and transfer of

technology to process validation/commercial batches

. Trouble shooting during technology transfer

. Documentation of the research data viz. preparation of exhibit batch

summary reports, product development reports and cleaning verification

reports

. Preparation & execution of Batch Manufacturing Records (BMR), sampling

protocol, validation protocol and other relevant document for

execution of exhibit and validation batches

. Preparation and execution of stability protocols as per ICH guidelines

for exhibit and developmental batches

. Calibration, maintenance and establishing SOPs for equipments

. Project status tracking and co-ordination with analytical department

. Scaled up 2 ophthalmic dosage forms FIRST TIME in India

. Training of new resources for formulation development and technology

transfer process

EDUCATIONAL QUALIFICATION

Doctor of Philosophy in Pharmacy 2005 - 2008

TIFAC Center of Relevance and Excellence

in New Drug Delivery Systems,

The M. S. University of Baroda, India

Dissertation Title: Development and evaluation of some taste masked

formulations

Summary of Dissertation:

. Primaquine phosphate (freely soluble), Mefloquine hydrochloride

(slightly soluble) and Artemether (insoluble) selected, based on their

solubility characteristics

. Solid dispersion, CD complexation and microencapsulation techniques

used for bitterness masking of antimalarials

. Solid dispersion and CD complexation techniques showed significant

improvement in drug release at gastric and salivary pH along with

complete bitterness masking while microencapsulation showed

significant improvement in drug release at gastric pH along with

complete bitterness masking

. Synthesis of a novel graft of Eudragit E with ?-cyclodextrin using

Microwave and Microwave assisted ultrasound

. Characterization of taste masked drug by FT-IR, DSC, XRPD and SEM

. Analytical method development including HPLC, UV-spectrophotometer,

spectrofluorometer

. Statistical approaches used for optimization of microparticles

. Development of rapid disintegrating tablets and oral reconstitutable

dry suspensions for taste masked drugs

. Development of an in vitro model, Mini-column, to avoid bias of human

volunteers in taste evaluation

Master of Pharmacy (with First class) 2001 - 2003

Principle K M Kundnani College of Pharmacy

Mumbai University, India

Dissertation Title: Development and evaluation of anti-fungal formulations

prepared from herbal extract

Bachelor of Pharmacy (with First class) 1997 - 2001

Pune University, India

ACHIEVEMENTS

. Invited presentation on "Taste Masking of Bitter Anti-malarials" at

University of New Mexico, Albuquerque, NM

. Visiting Research Scholar at University of Turin, Italy

. Outstanding Team of the Year 2003 - 04, Ajanta Pharma Ltd., 2004 -

Awarded for outstanding achievement of a performance objective,

department and company goal.

. Qualified GATE (Graduate Aptitude Test in Engineering) - 2001,

conducted by Indian Institute of Technology (IIT), Kanpur

PATENT

. Filed provisional US patent application entitled "Surface modified

multi-layered nanostructures for dermal delivery" in Nov 2010.

COMPUTER SKILLS

Scientific Applications: Design of Expert (DOE, Stat-Ease Inc), JMP

(SAS institute Inc), Sigma-Stat, Sigma Plot, End

note, ChemOffice, Prism

Technical Drawings: Adobe Photoshop, Corel draw

Office Applications: Microsoft power point, Word, Excel, Lotus

Notes

PROFESSIONAL AFFILIATION

. Indian Pharmaceutical Association (IPA)

. American Association of Pharmaceutical Scientists (AAPS)

REVIEWER FOR SCIENTIFIC JOURNALS & MEETINGS

. Journal of Pharmaceutical Sciences

. Journal of Pharmacy and Pharmaceutical Sciences

. AAPS PharmSciTech

. Drug Development and Industrial Pharmacy

. PDA Journal of Pharmaceutical Sciences & Technology

. Asian Journal of Pharmaceutics

. Paper presentations at the 2009 & 2010 AAPS Annual Meeting and

Exposition

SELECTED PUBLICATIONS (Total - 17)

1. Felton LA, Shah PP, Sharp Z, Atudorei V, Timmins GS. Stable isotope-

labeled excipients for drug product identification and counterfeit

detection. Drug Development and Industrial Pharmacy, 2011, 37(1): 88-

92.

2. Punit P Shah, Rajashree C Mashru. "Palatable reconstitutable dry

suspension of artemether for flexible pediatric dosing using

cyclodextrin inclusion complexation". Pharmaceutical Development and

Technology, 2010, 15(3): 276-285.

3. Punit P Shah, Rajashree C Mashru. "Influence of chitosan cross linking

on bitterness of mefloquine hydrochloride microparticles using central

composite design". Journal of Pharmaceutical Sciences, 2009, 98(2):

690-703.

4. Punit P Shah, Rajashree C Mashru. "Development and evaluation of

primaquine phosphate taste masked rapid disintegrating tablet. Journal

of Pharmacy and Pharmacology, 2008; 60(10): 1279-85.

5. Punit P Shah, Rajashree C Mashru. "Formulation and evaluation of taste

masked oral reconstitutable suspension of primaquine phosphate". AAPS

PharmSciTech, 2008; 9(3): 1025-30.

6. Punit P Shah, Rajashree C Mashru. "Development and evaluation of

artemether palatable rapid disintegrating tablet with improved

dissolution" AAPS PharmSciTech, 2008; 9(2): 494-500.

7. Punit P Shah, Rajashree C Mashru, Yogesh M Rane, Arti R Thakkar.

"Design and optimization of mefloquine hydrochloride microparticles

for bitter taste masking". AAPS PharmSciTech, 2008; 9(2): 377-89.

SELECTED PRESENTATIONS (TOTAL - 19)

1. M Singh, P.P. Shah, U.S. Desai, R.R. Patlolla, M.Klausner, P. Hayden.

Use of Epiderm Full Thickness (EFT) Skin Cultures as an in vitro model

for wound healing. SOT 50th Annual Meeting, 6th-10th March, 2011.

2. Punit P. Shah, P. R. Desai, R.R. Patlolla, K. Belay and M. Singh. In

vivo studies of cell penetrating peptide coated lipid nanocarriers for

skin-targeted drug delivery. 2010 Biomedical Nanoscience Initiative of

University of Miami ("BioNIUM"), 9th and 10th December 2010. 2nd prize

winner

3. Felton LA, Shah PP, Sharp Z, Atudorei V, Timmins GS. Stable isotope-

labeled excipients for drug product identification and counterfeit

detection. AAPS Annual Meeting & Exposition, New Orleans, 14th - 19th

November, 2010.

4. Desai, P. R., R. R. Patlolla, P. P. Shah, K. Belay, M. Sachdeva.

Translocation and quantification of surface modified lipid

nanocarriers across rat skin using confocal microscopy and

microdialysis. AAPS meeting in New Orleans, 2010.

5. Desai, P.R., Patolla, R.R., Shah, P.P., and Singh, M. In vivo

permeation of cell penetrating peptide modified lipid Nanoparticles

formulations in rat skin. Third Annual Joint Student Research Forum

and FAMU Graduate Feeder Conference, Florida A&M University, September

30th, 2010, Tallahassee, FL. 3rd prize winner

6. P. P. Shah, R. C. Mashru. "Influence of sodium saccharin on the

stability and in vitro drug release of artemether in rapid

disintegrating tablets". AAPS Annual Meeting & Exposition, Los

Angeles, California, 8th - 12th November, 2009.

7. P. P. Shah, J. Farrington, R. Raymond, T. Boyle, R. Hromas, L. A.

Felton. "Effect of cyclodextrin complexation on the solubility and in

vitro activity of a novel anticancer agent". AAPS Annual Meeting &

Exposition, Los Angeles, California, 8th - 12th November, 2009.

REFERENCES

References will be available on request.

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