Author(s): Joe Chou, Roger Lai, Jason Chou, Shelly Fu, Hsin-Ai Tung

Email(s): a0968288562@gmail.com

DOI: 10.52711/0975-4377.2023.00019   

Address: Joe Chou1*, Roger Lai2, Jason Chou1, Shelly Fu2, and Hsin-Ai Tung1
1YQ Biotech Ltd., Taiwan.
2Isuzu Optics Ltd., Taiwan.
*Corresponding Author

Published In:   Volume - 15,      Issue - 2,     Year - 2023


ABSTRACT:
Traditionally, the pilot bioequivalence study is a generalpractice for generic drug development. However, due to its difficulty in differentiating the variation between subject and drug formulation for bioequivalence results. A new instrument called PAMPA Dissolution is proposed in this study to improve the correlation between in vitro and in vivo absorption forbioequivalence study. PAMPA Dissolution allows for the simultaneous measurement of drug dissolution (Cb) and permeation (Pe), two key parameters in oral drug absorption according to the validated equation F (drug absorbed) = Cb*Pe*Area. The use of Parallel Artificial Membrane Permeability Assay (PAMPA) eliminates the concern of subject variation. Biorelevant media further allows this device to simulate in vivo conditions closely. Brand and generic formulations of 40 mg telmisartan tablets were used in various studies to demonstrate the potential of PAMPA Dissolution in generic drug development. Bioequivalence predictions between brand and generic telmisartan from PAMPA Dissolution produced avalue(test/reference)for Cmax of 86.3% and a value for AUC of 91.4%, indicating that PAMPA Dissolution predictions conform with bioequivalence requirements. Other parameters such as stirring at different speeds and phospholipids concentrations for PAMPA are also included for optimal performance of the system. Based on these data, the PAMPA Dissolution system is reproducible, precise, and can therefore be applied in predicting bioequivalence study.


Cite this article:
Joe Chou, Roger Lai, Jason Chou, Shelly Fu, Hsin-Ai Tung. Enhancing Bioequivalence Predictions with PAMPA Dissolution Using Formulations of Telmisartan. Research Journal of Pharmaceutical Dosage Forms and Technology.2023; 15(2):109-4. doi: 10.52711/0975-4377.2023.00019

Cite(Electronic):
Joe Chou, Roger Lai, Jason Chou, Shelly Fu, Hsin-Ai Tung. Enhancing Bioequivalence Predictions with PAMPA Dissolution Using Formulations of Telmisartan. Research Journal of Pharmaceutical Dosage Forms and Technology.2023; 15(2):109-4. doi: 10.52711/0975-4377.2023.00019   Available on: https://rjpdft.com/AbstractView.aspx?PID=2023-15-2-7


REFERENCES:
1.    Roudier B, Davit BM, Beyssac E, Cardot JM. In vitro- in vivo correlation's dissolution limits setting. Pharm Res. 2014; 31(9): 2529-38. doi: 10.1007/s11095-014-1349-8. Epub 2014 Mar 28. PMID: 24676770.
2.    Sinko, Patrick and Leesman, Glen and Amidon, Gordon. (1991). Predicting Fraction Dose Absorbed in Humans Using a Macroscopic Mass Balance Approach. Pharmaceutical Research. 8. 10.1023/A:1015892621261.
3.    Sugano K, Hamada H, Machida M, Ushio H, Saitoh K, Terada K. Optimized conditions of bio-mimetic artificial membrane permeation assay. Int J Pharm. 2001; 228(1-2): 181-8. doi: 10.1016/s0378-5173(01)00845-6. PMID: 11576780.
4.    Jantratid E, Janssen N, Reppas C, Dressman JB. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm Res. 2008; 25(7): 1663-76. doi: 10.1007/s11095-008-9569-4. Epub 2008 Apr 11. PMID: 18404251.
5.    Mann J, Dressman J, Rosenblatt K, Ashworth L, Muenster U, Frank K, Hutchins P, Williams J, Klumpp L, Wielockx K, Berben P, Augustijns P, Holm R, Hofmann M, Patel S, Beato S, Ojala K, Tomaszewska I, Bruel JL, Butler J. Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study. Mol Pharm. 2017; 14(12): 4192-4201. doi: 10.1021/ acs.molpharmaceut.7b00198. Epub 2017 Aug 23. PMID: 28737403.
6.    Nielsen PE, Avdeef A. PAMPA--a drug absorption in vitro model 8. Apparent filter porosity and the unstirred water layer. Eur J Pharm Sci. 2004; 22(1): 33-41. doi: 10.1016/j.ejps.2004.02.003. PMID: 15113581.
7.    Avdeef A, Artursson P, Neuhoff S, Lazorova L, Gråsjö J, Tavelin S. Caco-2 permeability of weakly basic drugs predicted with the double-sink PAMPA pKa(flux) method. Eur J Pharm Sci. 2005; 24(4): 333-49. doi: 10.1016/j.ejps.2004.11.011. Epub 2005 Jan 20. PMID: 15734300.
8.    Bermejo M, Avdeef A, Ruiz A, Nalda R, Ruell JA, Tsinman O, González I, Fernández C, Sánchez G, Garrigues TM, Merino V. PAMPA--a drug absorption in vitro model 7. Comparing rat in situ, Caco-2, and PAMPA permeability of fluoroquinolones. Eur J Pharm Sci. 2004; 21(4): 429-41. doi: 10.1016/j.ejps.2003.10.009. PMID: 14998573.
9.    Kakuta H, Kurosaki E, Niimi T, Gato K, Kawasaki Y, Suwa A, Honbou K, Yamaguchi T, Okumura H, Sanagi M, Tomura Y, Orita M, Yonemoto T, Masuzaki H. Distinct properties of telmisartan on agonistic activities for peroxisome proliferator-activated receptor γ among clinically used angiotensin II receptor blockers: drug-target interaction analyses. J Pharmacol Exp Ther. 2014; 349(1): 10-20. doi: 10.1124/jpet.113.211722. Epub 2014 Jan 14. PMID: 24424487.
10.    Dahan A, Miller JM. The solubility-permeability interplay and its implications in formulation design and development for poorly soluble drugs. AAPS J. 2012; 14(2): 244-51.
11.    R. K. Verma. Generic Medicines: Core Issues and Legal Mechanism. Int. J. Rev. and Res. Social Sci. 2019; 7(2): 405-414. doi: 10.5958/2454-2687.2019.00033.9
12.    Swati Saxena, Sarang Jain. A Review on Biopharmaceutical Classification System. Asian J. Pharm. Tech. 2019; 9(4): 267-270. doi: 10.5958/2231-5713.2019.00044.8
13.    Priyanka M. Salve, Shital V. Sonawane, Mayuri B. Patil, Rajendra K. Surawase. Dissolution and Dissolution Test Apparatus: A Review. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3): 229-6. doi: 10.52711/2231-5659.2021.00037
14.    Kuchake VG, Patil PH, Mahajan HS, Ingle PV, Surana SJ, Thakare MM, S Sudharshini. Determination of Bioequivalence of Two Oral Formulations of Gatifloxacin Tablets in Healthy Male Volunteers Using Urinary Excretion Data. Research J. Pharmacology and Pharmacodynamics. 2009; 1(2): 73-78.
15.    Sharad Desai, Nilesh Patel. Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers. Research Journal of Pharmacology and Pharmacodynamics. 2021; 13(4): 131-2. doi: 10.52711/2321-5836.2021.00026
16.    SR Shinde, S I Bhoir, NS Pawar, AM Bhagwat. Quantitation of Valsartan in Human Plasma by High Performance Liquid Chromatography with Fluorescence Detection and its Application to Bioequivalence Study. Research J. Pharm. and Tech. July-Sept. 2009; 2(3): 487-490.
17.    Amol K Choulwar, Ashish A. Mungantiwar, Meena Chintamaneni. A comparative, Bioequivalence study to evaluate the safety and pharmacokinetic profile of single dose Ivabradine 7.5mg Tablets in healthy, adult, human subjects under fasting condition. Research J. Pharm. and Tech. May 2012; 5(5): 658-666.
18.    D B Doshi, P A Bhatt. Development and Validation of UV Spectrophotometric Methods for the Estimation of Pravastatin Sodium in Bulk and Tablet Dosage Form. Research J. Pharm. and Tech. July-Sept. 2010; 3(3): 869-871.
19.    YK Naidu, Raghunadha Reddy S, Koteswara Rao Divi, MP Kalyan Reddy, I Sarath Chandiran, KN Jayaveera. Quantification of Levetiracetam in Human Plasma with Precipitation Extraction by Using Fully Validated LC-MS/MS and Its Application to a Bioequivalence Study. Research J. Pharm. and Tech. July-Sept. 2010; 3(3): 847-853.
20.    Anuradha D. Mahapatra, Krishna R. Gupta. Validated Spectrophotometric Determination of Prulifloxacin in Tablet Dosage Form. Research J. Pharm. and Tech. Oct.-Dec. 2010; 3(4): 1114-1117.

Recomonded Articles:

Author(s): Domendra Sahu, Shekhar Verma , Ravindra D. Dubey

DOI:         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): 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): 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): Rakesh P. Patel, Grishma Patel, Hitesh Patel , Ashok Baria

DOI:         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): Doppalapudi Sandeep, A. P. Pratyusha, G. Sudheshna, K. Lakshmi prasanna, P. Sreekanth

DOI:         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): Omprasad Nayakal, Prajakta Patil, Mangesh Bhutkar, Dheeraj Randive, Somnath Bhinge

DOI: 10.5958/0975-4377.2018.00032.0         Access: Open Access Read More

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

DOI: 10.5958/0975-4377.2016.00014.8         Access: Open Access Read More

Author(s): Malti Sao, Khomendra Kumar Sarwa, Amrendra Pratap Yadav, Seema Tandon, Moham Lal Kori

DOI: 10.5958/0975-4377.2019.00043.0         Access: Open Access Read More

Author(s): Sayad Basha.K, Sheema Nafees. S, Nethravani. G, Thirumalesh Naik S.B

DOI: 10.5958/0975-4377.2016.00015.X         Access: Open Access Read More

Author(s): B. Siddartha, I. Sudheer Babu, C. Parthiban, C. Madhavi

DOI:         Access: Open Access Read More

Author(s): V Ganesan, Nilesh P Tekade, Nitin S Bhajipale, Durgesh R Dewade, Raju R Thenge

DOI:         Access: Open Access Read More

Author(s): Kiran Khapake, Smrutidevi H. Sonavane, Shrikrishna B. Baokar, Vinod S. Pawar, Mahesh S. Rode

DOI:         Access: Open Access Read More

Author(s): B. Soujanya, G. Pavani Priya, T.E.G.K.Murthy

DOI: 10.5958/0975-4377.2015.00005.1         Access: Open Access Read More

Author(s): V. Saikishore, G. Srikanth, Ch. Pooja, Y. Mrudula, R. Pavani, Ch. Jyosthna , C. Mayuren

DOI:         Access: Open Access Read More

Author(s): Rutuja R. Shah, Abhijeet Jadhav, Rohan R. Vakhariya

DOI: 10.5958/0975-4377.2017.00027.1         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




Tags