You are here:

Pharmaceuticals/freeze thaw study


Dear Sir

I'm looking for reference for doing freeze thaw study. Is there any guidance document as to how this study needs to be performed.



Guidance are at:

you should freeze your samples at appropriate freezer (i.e. -20 or -70C) where you  want to store your samples.

Then after freezing for 12h or 24h, take out samples and let it thaw at room temp for 1-2h. After proper thaw, analyze the sample and keep the solution back in freezer for freezing. Then take out for second cycle and so on...  


All Answers

Answers by Expert:

Ask Experts


Himanshu Gupta, Ph.D


I can answer questions related to pharmaceutical formulation, research and publications.


Experienced Formulation Scientist with doctoral degree in Pharmaceutical Sciences. Significantly contributed for advancement of projects at various stages of drug product development cycle from conceptualization to proof-of-concept studies in animals that resulted in invention disclosures. Efficient and diligent team worker with proven track record of being problem solving and innovative. Areas of expertise include: • Formulation and product development for ocular, transdermal and skin care area. • Preformulation and related analytical techniques. • In vitro drug release, skin/corneal permeation studies, irritation/toxicity studies • In vivo: ocular retention (rabbits), intravitreal injection in rats, blood collection through heart puncture, tumor induction in mice, oral/ocular dosing in rats. • Radiolabeling of drug molecule with Tc99m and taking images using gamma camera. • SOP and report writing as per GLP compliance • Biomaterial i.e. absorbent, contact lens and Intraocular lens • Teaching experience in pharmaceutics and hospital pharmacy • Serving as board member in working of non-profit organization and scientific journals. Specialties: Formulation and product development (ocular, transdermal, skin care), Polymeric nanoparticles, in situ gel, pHEMA gel and emulsion based formulation development, excipient interaction and stability study, In vitro and in vivo evaluation of drug products, ocular/skin irritation studies, radiolabeling of small drug molecules, preclinical drug evaluation in rabbits and rats, Franz diffusion cell for skin/corneal permeation studies, SOP and report writing, documentation for regulatory submissions, analytical techniques such as HPLC, UV-Vis, DSC , viscometer, osmometer, DLS, SEM, ERG (Electro retinography), IR camera. Hands on instrument experience for formulation development i.e. high pressure homogenizer, lyophilizer, ultra sonicator, ultra centrifuge, autoclave, gamma sterilization, cold compression etc.

Organization of Pharmaceutical Unity with BioAllied Sciences (OPUBS) University of Toledo Auburn University University of Colorado Recent Patent DDF Journal of Pharmacy and Bioallied Sciences

Publications & Citations Citations record (>300 citations) 1. Himanshu Gupta, Sanyog Jain, Rashi Mathur, A.K. Mishra, Pushpa Mishra, T.Velpandian, Sustained ocular drug delivery from a temperature and pH triggered in-situ gel system, Drug Delivery 14(8) 2007, 507-515. 2. H. Gupta, R.M. Singh, G.N.Singh, A. Sharma, D. Kaushik, pH induced in-situ gel for periodontal anesthesia, Indian Journal of Pharmaceutical Sciences 70(6) 2008, 776-778. 3. Himanshu Gupta, M. Aqil, R.K. Khar, Asgar Ali, Aseem Bhatnagar, Gaurav Mittal, Sanyog Jain. Development and characterization of Tc-99m timolol maleate for evaluating efficacy of in situ ocular drug delivery system, AAPS Pharm. Sci.10(2) 2009, 540-546. 4. Himanshu Gupta Dheeraj Singh, Preet Tyagi, R.K. Diwan, R.K. Khandal, Vinod Paul, Ramesh Aggarwal, Amita Malik, Performace evaluation of market available diapers: Materials and Properties, Indian Journal of Pediatrics 76(8) 2009, 859-60. 5. Himanshu Gupta, Dinesh Bhandari, Aarti Sharma, Recent Trends in Oral Drug Delivery: A Review, Recent Patents on Drug Delivery & Formulation 3 (2) 2009, 162-173. 6. Himanshu Gupta, Aarti Sharma, Tripti Dixit, Intraocular lens and biocompatibility- A Review, Recent Patents on Biomedical Engeniering 2 (2), 2009, 148-156. 7. Himanshu Gupta, Aarti Sharma, Ion activated bioadhesive in situ gel of clindamycin for vaginal application, International Journal of Drug Delivery 1 (1) 2009, 32-40. 8. Himanshu Gupta, M. Aqil, R.K. Khar, Asgar Ali, A. Sharma, Prakash Chander, Development and Validation of Stability Indicating RP-UPLC method for the Quantitative analysis of Sparfloxacin. Journal of Chromatographic Science 48 (1) 2010, 1-6. 9. Himanshu Gupta, Aqil Malik, R.K. Khar, Asgar Ali, Prakash Chander, A Single RP-UPLC method for quantification of Levofloxacin in aqueous humour and pharmaceutical dosage forms, Journal of chromatographic Science 48, 2010: 484-490. More on link..

Diploma in Pharmacy, Bachelor in Pharmacy, Masters in Pharmacy (Pharmaceutics), Post Graduate Diploma in International Business (PGDIB), Certificate in IPR, PhD (Pharmaceutics), Post Doctorate (Pharmaceutics)

Awards and Honors
- Hamdard Appreciation Award 2011 - Awarded with “Dr. P. D. Sethi Annual Award 2010” - Received International travel grant from DST, Ministry of Science and Technology (Govt. of India) for 37th CRS, USA. - Invited to Moderate “Nanotechnology I” session in 37th Annual Meeting and Exposition of the Control Release Society, Portland, Oregon, USA 10-14 July 2010 - Awarded “Budding Nanotechnologist Award” (Young Scientist Award) in DST (Ministry of Science and Technology, Govt. of India) sponsored 2nd Summer School on Nanotechnology in Advanced Drug Delivery, NIPER, Chandigarh, 2009. - Received SRF fellowship of Central Council of Scientific and Industrial Research (CSIR), Govt. Of India, New Delhi, India. - Awarded SRF fellowship of Indian Council of Medical Research (ICMR), Govt. of India, India. - Conference Grant from Society of Nuclear Medicine (India) - Organized planary lectures and symposium with scientific committee in 60th IPC. - Conference Grant from IOMC

Past/Present Clients
Member Organization of Pharmaceutical Unity with BioAllied Sciences (OPUBS) Public Company; 11-50 employees; Nonprofit Organization Management industry January 2010 – Present (2 years 6 months) Organization of Pharmaceutical Unity with BioAllied Sciences (OPUBS) is an educational society registered under “The Societies Registration Act, 1860” with Govt. of India. We assist scientific communities, students and researchers. We help them with every aspect of education, research and publication to grow and prosper in their respective field. I work for all projects and their working. Post Doc- VRA University of Colorado-Anschutz Medical Campus, Denver, USA Educational Institution; 51-200 employees; Higher Education industry June 2011 – May 2012 (1 year) Aurora, CO, USA Research on novel drug delivery systems Senior Research Fellow Council of Scientific and Industrial Research Government Agency; 10,001+ employees; Research industry April 2009 – June 2011 (2 years 3 months) New Delhi Area, India Working on my PhD project PhD Scholar Faculty of Pharmacy, Jamia Hamdard, New Delhi November 2007 – June 2011 (3 years 8 months) Pursuing my PhD (Pharmaceutics). I am working on novel drug delivery systems i.e. ocular drug delivery. Research Associate Shriram Institute for Industrial research September 2007 – January 2008 (5 months) Biomaterials and nanotechnology Lecturer BIT, UP Technical University May 2006 – September 2007 (1 year 5 months) Teaching B.Pharm students

©2016 All rights reserved.