Article http://dx.doi.org/10.26855/ijcemr.2023.04.002

Possible Protocol for Deformulation Studies for Pharmaceutical Products


Sharma Jyoti, Gupta Sunil*, Sharma Nitin

ISF College of Pharmacy, Moga, Punjab, India.

*Corresponding author: Gupta Sunil

Published: May 17,2023


The word formulation describes the formation of the product using various methods. While deformulation being the reverse of the formulation describes the deformulating the various components using different methods. One of the main and basic priority in the individual’s life is money. So, to get and save money is one of the motives of every person even in the case of medicine. Here, lies a basic problem. Due to certain circumstances medicine acts as a toolkit in one’s life. So, to save money and get the medicine at an affordable price is one of the basic demands of the society and many industries work on it forming the basis of generic drug production from the reference listed product. To prepare the generic product requires lot of efforts so with the advancement of technology a study named as deformulation also referred to as reverse engineering is a basic requirement for the preparation of generic product from reference listed drug.  As India is known as the pharmacy of the world, in manufacturing of the generic products. So, there is an increasing demand of reverse engineering or deformulation studies. To carry out these studies there is no possible protocol available till date. So, this review will focus on the required protocol to carry out deformulation studies.


[1] Ahmed, Z.Z., Khan, F.N. and Shaikh, D.A. (2018). Reverse engineering and formulation by QBD of olopatadine hydrochloride ophthalmic solution. Journal of Pharmaceutical Investigation, 48(3), pp. 279-293.

[2] Bansal, A. and Koradia, V. (2005). The role of reverse engineering in the development of generic formulations.

[3] Berkowitz, S.A., Engen, J.R., Mazzeo, J.R. and Jones, G.B. (2012). Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nature Reviews Drug Discovery, 11(7), pp.527-540.

[4] Paliwal, R., Mamgain, A., Kenwat, R. and Paliwal, S.R. (2021). Reverse Engineering in Pharmaceutical Product Development. In Micro-and Nanotechnologies-Based Product Development (pp. 235-242). CRC Press.

[5] Chen, K., Park, J., Li, F., Patil, S.M. and Keire, D.A. (2018). Chemometric methods to quantify 1D and 2D NMR spectral differences among similar protein therapeutics. AAPS PharmSciTech, 19(3), pp.1011-1019.

[6] Clément, Y., Gaubert, A., Bonhommé, A., Marote, P., Mungroo, A., Paillard, M., Lantéri, P. and Morell, C. (2019). Raman spectroscopy combined with advanced chemometric methods: A new approach for detergent deformulation. Talanta, 195, pp.441-446.

[7] Cotte, J.F., Sonnery, S., Martial, F., Dubayle, J., Dalençon, F., Haensler, J. and Adam, O. (2012). Characterization of surfactants in an oil-in-water emulsion-based vaccine adjuvant using MS and HPLC–MS: Structural analysis and quantification. International journal of pharmaceutics, 436(1-2), pp.233-239.

[8] Duraipandi, S. and Selvakumar, V. (2020). Reinventing nano drug delivery systems for hydrophilic active ingredients in Ayurvedic lipid based formulations containing poly herbal decoction. Journal of Ayurveda and integrative medicine, 11(3), pp.224-227.

[9] Duraipandi, S., Selvakumar, V. and Er, N.Y. (2015). Reverse engineering of Ayurvedic lipid based formulation, ghrita by combined column chromatography, normal and reverse phase HPTLC analysis. BMC complementary and alternative medicine, 15(1), pp.1-6.

[10] Gohel, M.C., Sarvaiya, K.G., Shah, A.R. and Brahmbhatt, B.K. (2009). Mathematical approach for the assessment of similarity factor using a new scheme for calculating weight. Indian Journal of Pharmaceutical Sciences, 71(2), p.142.

[11] Gokhale, M.Y. and Mantri, R.V. (2017). API Solid-Form Screening and Selection. In Developing Solid Oral Dosage Forms (pp. 85-112). Academic Press.

[12] Koradia, V.S., Chawla, G. and Bansal, A.K. (2005). Comprehensive characterisation of the innovator product: targeting bioequivalent generics. Journal of Generic Medicines, 2(4), pp.335-346.

[13] Law, D. and Zhou, D. (2017). Solid-state characterization and techniques. In Developing Solid Oral Dosage Forms (pp. 59-84). Academic Press.

[14] Matsui, K., Takeuchi, S., Haruna, Y., Yamane, M., Shimizu, T., Hatsuma, Y., Shimono, N., Sunada, M., Hayakawa, M., Nishida, T. and Ito, S. (2020). Transverse comparison of mannitol content in marketed drug products: Implication for no-effect dose of sugar alcohols on oral drug absorption. Journal of Drug Delivery Science and Technology, 57, p.101728.

[15] Nie, H., Mo, H. and Byrn, S.R. (2018). Investigating the physicochemical stability of highly purified darunavir ethanolate extracted from prezista® tablets. AAPS PharmSciTech, 19(5), pp.2407-2417.

[16] Zahid, Z., Furquan, N., Sarfaraz, K., Moizul, H., Obaid, S. and Raheel, K. (2016). Reverse engineering and development of generic Orlistat formulation. JIPBS, 3(4), pp.17-25.

[17] Munjal, Bhushan et al. (2015). “Role of Innovator Product Characterization in Generic Product Development.”

How to cite this paper

Possible Protocol for Deformulation Studies for Pharmaceutical Products

How to cite this paper: Sharma Jyoti, Gupta Sunil, Sharma Nitin. (2023) Possible Protocol for Deformulation Studies for Pharmaceutical Products. International Journal of Clinical and Experimental Medicine Research7(2), 111-116.

DOI: http://dx.doi.org/10.26855/ijcemr.2023.04.002