Author(s):
Deepak Joshi, Naveen K Choudhary
Email(s):
eduexplorer23@gmail.com
DOI:
10.52711/0974-360X.2025.00038 
Address:
Deepak Joshi1, Naveen K Choudhary2
1B R Nahata College of Pharmacy (Faculty of Pharmacy), Mandsaur University, M.P., India.
2B R Nahata College of Pharmacy (Professor), Mandsaur University, M.P., India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 1,
Year - 2025
ABSTRACT:
Sublingual antihypertensive medications provide a rapid and efficient approach to managing high blood pressure by directly absorbing through the mucous membranes under the tongue, thus bypassing the liver's first-pass metabolism. This route significantly improves the bioavailability and speed of action, making it ideal for urgent hypertensive conditions. Utilizing a Quality by Design (QbD) methodology, these formulations are developed to ensure quick disintegration, effective absorption, and minimal side effects, while maintaining patient compliance through taste-masking and ease of use. The development of sublingual Valsartan exemplifies how these medications offer a faster, reliable, and user-friendly alternative for blood pressure control.
Cite this article:
Deepak Joshi, Naveen K Choudhary. Implementation of QbD and Preformulation Characteristics of Sublingual antihypertensive drug. Research Journal of Pharmacy and Technology. 2025;18(1):245-0. doi: 10.52711/0974-360X.2025.00038
Cite(Electronic):
Deepak Joshi, Naveen K Choudhary. Implementation of QbD and Preformulation Characteristics of Sublingual antihypertensive drug. Research Journal of Pharmacy and Technology. 2025;18(1):245-0. doi: 10.52711/0974-360X.2025.00038 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-1-38
REFERENCE:
1. Singh SK, Sameer AA. Development and characterization of sublingual tablet of lisinopril. Asian Pac J Trop Biomed. 2012; S1711-S1719.
2. Vyas AS, Patel KM, Patel HM, Soni SJ, Patel DB. Formulation, development and evaluation of ramipril sublingual tablets. Int J Pharm Res Biosci. 2013; 2(2): 191-202.
3. Sramika NR, Debnath S, Niranjan Babu M. Formulation and evaluation of sublingual tablets of nimodipine. Indian Am J Pharm Res. 2013; 3(12): 1256-1261.
4. Joshi D, Choudhary NK. Enhancing sublingual tablet quality through QbD: Current trends and insights. Precis Nanomed. 2023; 6(3): 1099-1108.
5. Parmar TB, Prajapati TK, Patel CN. Formulation and evaluation of sublingual tablet of valsartan. Int J Pharm Res Biosci. 2014; 3(2): 969-989.
6. Patel RJ, Patel BN, Patel DM, Patel CN. Formulation and evaluation of felodipine sublingual tablet. World J Pharm Pharm Sci. 2014; 3(6): 850-864.
7. Chaudhari KP, Jadhao UT, Chaudhari CD, Thakare VM, Tekade BW, Chaudhari CS. Formulation and evaluation of fast dissolving sublingual tablets of amlodipine besylate. Drug Des Dev Ther. 2014; 5(4): 1-9.
8. Chinchore MV, Kothawade PD, Surwase RK, Maru AD. Formulation, optimization and evaluation of amlodipine besylate sublingual films. Res J Pharm Technol. 2014; 7(8): 840-844.
9. Verma H, Pal P, Joshi D. Formulation, development and evaluation of invasomes loaded gel for fungal treatment. Sch Acad J Pharm. 2022; 7: 105-108.
10. Srilatha G, Potnuri NR, Shivabindu K. Design and characterization of fast release sublingual tablets of atenolol. Indian J Pharm Sci Rev Res. 2014; 27(2): 231-235.
11. Patel RJ, Patel BN, Patel DM, Patel CN. Formulation and evaluation of felodipine sublingual tablet. World J Pharm Pharm Sci. 2014; 3(6): 850-864.
12. Gaikwad SS, Jadhav SS, Chavan MK, Salikhe KS, Ramteke KH, Chaudhari SR. Design and in vitro evaluation of sublingual tablet of timolol maleate. Appl Clin Res Clin Trials RegulAff. 2016; 3(1): 56-63.
13. Dandia PC, Kulkarni SK. Introduction to Pharmacology. New Delhi: Vallabh Prakashan; 2012.
14. Dave V, Haware R, Sangave N, Sayles M, Popielarczyk M. Drug-excipient compatibility studies in formulation development: Current trends and techniques. AAPS FDD Sect Newsl. 2015; Jan.
15. Desai D, Wang J, Wen H, Li XH, Timmins P. Formulation design, challenges, and development considerations for fixed dose combination (FDC) of oral solid dosage forms. Pharm Dev Technol. 2013; 18: 1265-1276. https://doi.org/10.3109/10837450.2012.660699.
16. Destro F, Barolo M. A review on the modernization of pharmaceutical development and manufacturing – Trends, perspectives, and the role of mathematical modeling. Int J Pharm. 2022; 620: 121715. https://doi.org/10.1016/j.ijpharm.2022.121715.
17. Dey S, Mahanti B, Khila S, Mazumder B, Gupta SD. Formulation development and optimization of bilayer tablets of aceclofenac. Expert Opin Drug Deliv. 2012; 9: 1041-1050. https://doi.org/10.1517/17425247.2012.707187.
18. Dholariya YN, Bansod YB, Vora RM, Mittal SS, Shirsat AE. Design and optimization of bilayered tablet of hydrochlorothiazide using the Quality-by-Design approach. Int J Pharm Investig. 2014; 4: 93-101. https://doi.org/10.4103/2230-973x.133058.
19. Ishikawa D, Genkawa T, Murayama K, Komiyama M, Ozaki Y. Feasibility study of diffuse reflectance and transmittance near infrared spectroscopy for rapid analysis of ascorbic acid concentration in bilayer tablets using a high-speed polychromator-type spectrometer. J Near Infrared Spectrosc. 2014; 22: 189-197. https://doi.org/10.1255/jnirs.1116.
20. Hagen E, Løding FS, Mattsson S, Tho I. Use of interactive mixtures to obtain mini-tablets with high dose homogeneity for paediatric drug delivery. J Drug Deliv Sci Technol. 2016; 34: 51-59. https://doi.org/10.1016/j.jddst.2016.03.006.
21. Lopes CM, Lobo JM, Pinto JF, Costa PC. Compressed matrix core tablet as a quick/slow dual-component delivery system containing ibuprofen. AAPS PharmSciTech. 2007; 8 https://doi.org/10.1208/pt0803076.
22. Van der Merwe SM, Verhoef JC, Kotze AF, Junginger HE. N-trimethyl chitosan chloride as an absorption enhancer in oral peptide drug delivery. Development and characterization of minitablet and granule formulations. Eur J Pharm Biopharm. 2004; 57: 85-91. https://doi.org/10.1016/S0939-6411(03)00152-8.
23. Bowles A, Keane J, Ernest T, Clapham D, Tuleu C. Specific aspects of gastrointestinal transit in children for drug delivery design. Int J Pharm. 2010; 395: 37-43. https://doi.org/10.1016/j.ijpharm.2010.04.048.
24. Shukla D, Chakraborty S, Singh S. Mouth dissolving tablets I: An overview of formulation technology. Sci Pharm. 2009; 77: 309-326. https://doi.org/10.3797/scipharm.0811-09-01.
25. Ritschel WA, Bauer-Brandl A. Die Tablette: Handbuch Der Entwicklung, Herstellung Und Qualitätssicherung. ECV-Editio Cantor Verlag; 2002. Retrieved from http://www.ecv.de.
26. Bauer H. Herstellung und Charakterisierung von KombinationenausMannit und SorbitdurchSprühtrocknung und Co-granulation. Doctoral dissertation, Verlag nichtermittelbar; 2000. Retrieved from https://d-nb.info/963170031/34.
27. Saha S, Shahiwala AF. Multifunctional coprocessed excipients for improved tabletting performance. Expert Opin Drug Deliv. 2009; 6: 197-208. https://doi.org/10.1517/17425240802708978.
28. Bolhuis GK, Rexwinkel EG, Zuurman K. Polyols as filler-binders for disintegrating tablets prepared by direct compaction. Drug Dev Ind Pharm. 2009; 35: 671-677. https://doi.org/10.1080/03639040802587799.
29. Charoo NA, Shamsher AA, Zidan AS, Rahman Z. Quality by design approach for formulation development: A case study of dispersible tablets. Int J Pharm. 2012; 423: 167-178. https://doi.org/10.1016/j.ijpharm.2011.12.024.
30. Sugimoto M, Matsubara K, Koida Y, Kobayashi M. The preparation of rapidly disintegrating tablets in the mouth. Pharm Dev Technol. 2001; 6: 487-493. https://doi.org/10.1081/PDT-100108065.
31. Aslan N, Cebeci Y. Application of Box–Behnken design and response surface methodology for modeling of some Turkish coals. Fuel. 2007; 86: 90-97. https://doi.org/10.1016/j.fuel.2006.06.010.
32. Beg S, Sandhu PS, Batra RS, Khurana RK, Singh B. QbD-based systematic development of novel optimized solid self-nanoemulsifying drug delivery systems (SNEDDS) of lovastatin with enhanced biopharmaceutical performance. Drug Deliv. 2015; 22(6): 765-784. https://doi.org/10.3109/10717544.2014.900154.
33. Beg S, Jain A, Kaur R, Panda SS, Katare OP, Singh B. QbD-driven development and validation of an efficient bioanalytical UPLC method for the estimation of olmesartanmedoxomil. J LiqChromatogrRelat Technol. 2016. https://doi.org/10.1080/10826076.2016.1206023.
34. Iancu V, Roncea F, Cazacincu RG, Lupuleasa D. Preparation and evaluation of diclofenac sodium orally disintegrating tablets. Ovidius Univ Ann Chem. 2016; 27: 58-61. Available from: http://anale-chimie.univ-ovidius.ro/anale-chimie/ahead-of-print2016/Article_4_v2.pdf.
35. Comoglu T, Ozyilmaz ED. Orally disintegrating tablets and orally disintegrating mini tablets – novel dosage forms for pediatric use. Pharm Dev Technol. 2019; 24: 902-914. https://doi.org/10.1080/10837450.2019.1615090.
36. Joshi D, Choudhary NK. Implementation of Quality by Design of Sublingual Antihypertensive Drugs. J Pharm Innov. 2024; 19: 20. https://doi.org/10.1007/s12247-024-09832-y.