Author(s): Sirisha. S


DOI: 10.5958/0975-4377.2020.00034.8   

Address: Sirisha. S
Sree Venkatsewara University of Pharmaceutical Sciences, Tirupathi, Chitoor (Dis).
*Corresponding Author

Published In:   Volume - 12,      Issue - 3,     Year - 2020

Rapidity in Drug development can be achieved by researchers on finding a mathematical link between bioavailability and dissolution testing which leads to the concept of in vitro - in vivo correlation (IVIVC). This review article aimed to assess papers published in the last two decades regarding the use of the IVIVC in the development of oral formulations. A systematic search was done to retrieve articles reporting the use of the IVIVC in the oral formulation development in the period from 2000 to2020. The qualified studies were abstracted regarding the Biopharmaceutical Classification System (BCS)that explains the suitability of IVIVC, drug name, dosage form number of formulations, presence of the validation and predictability. The discussion was supported by these data, which allowed to address broadly strengths and weaknesses in thisarea. Moreover, a large database has been described in this article containing different IVIVC models, with different substances, providing support to scientists interested in this area.

Cite this article:
Sirisha. S. A Review on IVIVC in The Development of Oral Drug Formulation: Data Obtained from Past Two Decades. Res. J. Pharma. Dosage Forms and Tech.2020; 12(3):198-204. doi: 10.5958/0975-4377.2020.00034.8

1. Yu, L. X. y otros, 2014. Understanding Pharmaceutical Quality by Design. TheAAPS Journal, 7, 16(4), pp. 771-783.
2. Pramod, K. y otros, 2016. Pharmaceutical Product Development: A quality by design approach. International Journal of Pharmaceutical Investigation, 6(3), pp. 129-138.
3. N. Politis, S., Colombo, P., Colombo, G. and M. Rekkas, D., 2017. Design of experiments (DoE) in Pharmaceutical Development. Drug Development and Industrial Pharmacy, 3 6, 43(6), pp. 889-901.
4. Kaur, P., Jiang, X., Duan, J. and Stier, E., 2015. Applications of In Vitro–In VivoCorrelations in Generic Drug Development: Case Studies. The AAPS Journal,17(4), pp. 1035-1039.
5. Yousefi, N., Mehralian, G., Rasekh, H. R. and Yousefi, M., 2017. New Product Development in the Pharmaceutical Industry: Evidence from a generic market. Iranian Journal of Pharmaceutical Research: IJPR, 16(2), pp. 834-846.
6. González-García, I., Mangas-Sanjuán, V., Merino-Sanjuán, M. and Bermejo, M., 2015. 
7. FDA, 1997. US Food and Drug Administration/Center for Drug Evaluation and Research - Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. [En línea] Available at: [Último acceso: 13 October 2019].
8. Cardot, J., Garrait, G. and Beyssac, E., 2011. Use of IVIVC to Optimize Generic Development. Dissolution Technologies, May.
9. Li, Z.-q.y otros, 2018. In Vitro-In Vivo Predictive Dissolution-Permeation-Absorption Dynamics of Highly Permeable Drug Extended-Release Tablets via Drug Dissolution/Absorption Simulating System and pH Alteration. AAPS PharmSciTech, 19(4) May, pp. 1882-1893.
10. Li Zi-qiang and Tian, S. G. H. W. Z.-g. N. M. F. G. H. X., 2018. In Vitro-In Vivo Predictive Dissolution-Permeation-Absorption Dynamics of Highly Permeable Drug Extended-Release Tablets via Drug Dissolution/Absorption Simulating System and pH Alteration. AAPS PharmSciTech, 5, 19(4), pp. 1882-1893.
11. Kulkarni, R. y otros, 2012. Comparative Pharmacokinetics Studies of Immediateand Modified-Release Formulations of Glipizide in Pigs and Dogs. Journal of Pharmaceutical Sciences, 101(11), pp. 4327-4336.
12. Petrovic, A. A. y otros, 2013. Preliminary evaluation of the in vitro release and invivo absorption in rabbits of the modified-release dosage forms. Drug Development and Industrial Pharmacy, 39(6), pp. 889-900.
13. Nishimura, H. y otros, 2007. Application of the Correlation of <i>in Vitro</i> Dissolution Behavior and <i>in Vivo</i> Plasma Concentration Profile (IVIVC) for Soft-Gel Capsules and mdash;a Pointless Pursuit?. Biological and Pharmaceutical Bulletin, 30(11), pp. 2221-2225.
14. Emara, L. H., El-Menshawi, B. S. and Estefan, M. Y., 2000. In Vitro-In VivoCorrelation and Comparative Bioavailablity of Vincamine in Prolonged-ReleasePreparations. Drug Development and Industrial Pharmacy, 1 1, 26(3), pp. 243-251.
15. Viswanathan, P., Muralidaran, Y. and Ragavan, G., 2017. Chapter 7 – Challenges in oral drug delivery: a nano-based strategy to overcome. En: E. Andronescu andA. M. Grumezescu, edits. Nanostructures for Oral Medicine. s.l.: Elsevier, pp. 173-201.
16. Shargel, L., Wu-Pong, S. and Yu, A. B. C., 2012. Chapter 17. Modified-Release Drug Products. En: Applied Biopharmaceutics andamp; Pharmacokinetics, 6e. New York, NY: The McGraw-Hill Companies.
17. Amidon, G. L., Lennernäs, H., Shah, V. P. and Crison, J. R., 1995. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability.. Pharmaceutical Research, 12(3), pp. 413-420.
18. Qiu, Y. and Duan, J. Z., 2017. Chapter 16 - In Vitro/In Vivo Correlations: Fundamentals, Development Considerations, and Applications. En: Y. Qiu, yotros edits. Developing Solid Oral Dosage Forms (Second Edition). Boston: Academic Press, pp. 415-452.
19. Tsume, Y. y otros, 2014. The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC. European Journal of Pharmaceutical Sciences, Volumen 57, pp. 152-163.
20. Cardot, J.-M. and Davit, B. M., 2012. In vitro–In Vivo Correlations: Tricks and Traps. The AAPS Journal, 14(3), pp. 491-499.
21. Abrahamsson, B. y otros, 2004. Food effects on tablet disintegration. European Journal of Pharmaceutical Sciences, 22(2), pp. 165-172.
22. Dressman, J. B., Vertzoni, M., Goumas, K. and Reppas, C., 2007. Estimating drug solubility in the gastrointestinal tract. Advanced Drug Delivery Reviews, 59(7), pp.591-602.
23. Nicolaides, E., Symillides, M., Dressman, J. B. and Reppas, C., 2001. Biorelevant Dissolution Testing to Predict the Plasma Profile of Lipophilic Drugs After Oral Administration. Pharmaceutical Research, 18(3), pp. 380-388.
24. Pezzini, B. R., Issa, M. G., Duque, M. D. and Ferraz, H. G., 2015. Applications of USP apparatus3 in assessing the in vitro release of solid oral dosage forms. Brazilian Journal of Pharmaceutical Sciences, Volumen 51, pp. 265-272.
25. Chevalier, E. y otros, 2009. Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems. AAPS PharmSciTech, 10(2), pp. 597-605.
26. Gao, Z., 2009. In vitro dissolution testing with flow-through method: a technical note. AAPS PharmSciTech, 10(4), pp. 1401-1405.
27. Bhattachar, S. N. y otros, 2002. Dissolution testing of a poorly soluble compound using the flow-through cell dissolution apparatus. International Journal of Pharmaceutics, 236(1), pp. 135-143.
28. Andreas, C. J. y otros, 2015. In vitro biorelevant models for evaluating modified release mesalamine products to forecast the effect of formulation and meal intake on drug release. European Journal of Pharmaceutics and Biopharmaceutics, Volumen 97, pp. 39-50.
29. Minekus, M., 2015. The TNO Gastro-Intestinal Model (TIM). En: K. Verhoeckx, yotros edits. The Impact of Food Bioactives on Health: in vitro and ex vivo models. Cham: Springer International Publishing, pp. 37-46.
30. Costa, P. and Sousa Lobo, J. M., 2001. Modeling and comparison of dissolution profiles. European Journal of Pharmaceutical Sciences, 13(2), pp. 123-133.
31. Siepmann, J. and Siepmann, F., 2013. Mathematical modeling of drug dissolution. International Journal of Pharmaceutics, 453(1), pp. 12-24. 24
32. Derendorf, H. and Meibohm, B., 1999. Modeling of Pharmacokinetic/Pharmacodynamic (PK/PD) Relationships: Concepts and Perspectives. Pharmaceutical Research, 16(2), pp. 176-185.
33. Nishant, T., Sathish Kumar, D., Kumar, A. and Phaneendra, M., 2011. Role of Pharmacokinetic Studies in Drug Discovery. J Bioequiv Availab, 3, pp. 263-267
34. Atkinson, A. J., 2007. Chapter 2 - Clinical Pharmacokinetics. En: A. J. Atkinson, y otros edits. Principles of Clinical Pharmacology (Second Edition). Burlington: Academic Press, pp. 11-23.
35. Langenbucher, F., 2003. Handling of computational in vitro/in vivo correlation problems by Microsoft Excel: III. Convolution and deconvolution. European Journal of Pharmaceutics and Biopharmaceutics, 56(3), pp. 429-437.
36. Margolskee, A. y otros, 2016. Deconvolution and IVIVC: Exploring the Role of Rate-Limiting Conditions. The AAPS Journal, 18(2), pp. 321-332.
37. EMEA, 1999. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit - Note for guidance on quality of modified release products: A: Oral Dosage Forms, B. Transdermal Dosage Forms, Section (Quality). [En línea] Available at: [Último acceso: 19 Aug 2019].

Recomonded Articles:

Author(s): Vinod K.R., Sandhya S

DOI:         Access: Open Access Read More

Author(s): Gopal Rao M., M. A. Amutha Gnana Arasi, S. Jayaprakash, M. Arun Kumar, P. Kavitha

DOI:         Access: Open Access Read More

Author(s): Dipti G. Phadtare, Amol R. Pawar, R.B. Saudagar, Govind K.Patil

DOI: 10.5958/0975-4377.2017.00002.7         Access: Open Access Read More

Author(s): Yamunappa, Ravi Kumar, Pooja Shetty, Prathibha Suvarna, Narayana Swamy VB

DOI: 10.5958/0975-4377.2016.00012.4         Access: Open Access Read More

Author(s): Swapnil T. Deshpande, P. S. Vishwe, Rohit D. Shah, Swati S. Korabu, Bhakti R. Chorghe, DG Baheti

DOI:         Access: Open Access Read More

Author(s): Debarupa Dutta, Prithviraj Chakraborty

DOI:         Access: Open Access Read More

Author(s): Simila Madathil, RaviKumar, Anju Govind, Mercy Mathew, Narayana Swamy VB

DOI: 10.5958/0975-4377.2016.00013.6         Access: Open Access Read More

Author(s): Dilip M. Kumbhar, Kailas K. Mali, Remeth J. Dias, Vijay D. Havaldar, Vishwajeet S. Ghorpade, Nitin H. Salunkhe.

DOI: 10.5958/0975-4377.2016.00036.7         Access: Open Access Read More

Author(s): Patil Namrata D., Gondkar S.B., Saudagar R.B.

DOI: 10.5958/0975-4377.2016.00033.1         Access: Open Access Read More

Author(s): Chirag A. Patel, Priyal R. Patel, Dhrubo Jyoti Sen,Jayvadan K. Patel

DOI:         Access: Open Access Read More

Author(s): Hardik B. Rana, Kajol Patel, Mansi Dholakia, Vaishali T. Thakkar, Mukesh C. Gohel, Tejal R. Gandhi

DOI: 10.5958/0975-4377.2017.00006.4         Access: Open Access Read More

Author(s): R. K.V. Naga Sudha, V. Sai Kishore, CH. Venu Babu, E. Jitendranath

DOI: 10.5958/0975-4377.2015.00016.6         Access: Open Access Read More

Author(s): Debjit Bhowmik, Rishab Bhanot, Darsh Gautam, Parshuram Rai, K.P. Sampath Kumar

DOI: 10.5958/0975-4377.2017.00022.2         Access: Open Access Read More

Author(s): Debjit Bhowmik, Amrendra Singh , Praveen Khirwadkar, Nishi Shukla, Vikas Kumar Chaudhari

DOI: 10.5958/0975-4377.2016.00027.6         Access: Open Access Read More

Author(s): Saikumar Y., Saikishore V., Pavani K., Sairam D.T., Sindhura A.

DOI:         Access: Open Access Read More

Author(s): Masheer Ahmed Khan

DOI:         Access: Open Access Read More

Research Journal of Pharmaceutical Dosage Forms and Technology (RJPDFT) is an international, peer-reviewed journal, devoted to pharmaceutical sciences. ...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/0975-4377 

Recent Articles