Implementing Quality by Design for Development and Optimization of Sublingual Tablet of Valsartan

Abouhussein DM, El Nabarawi MA, Shalaby SH, El-Bary AA. Sertraline-cyclodextrin complex orodispersible sublingual tablet: optimization, stability, and pharmacokinetics. J Pharm Innov. 2021 Mar;16:53-66. https://doi.org/10.1007/s12247-019-09416-1

Aghera NJ, Shah SD, Vadalia KR. Formulation and evaluation of sublingual tablets of losartan potassium. Asian Pac J Tropic Dis. 2012;2:S130-5. https://doi.org/10.1016/S2222-1808(12)60138-8.

Article  CAS  Google Scholar 

AlAli AS, Aldawsari MF, Alalaiwe A, Almutairy BK, Al-Shdefat R, Walbi IA, Fayed MH. Exploitation of design-of-experiment approach for design and optimization of fast-disintegrating tablets for sublingual delivery of sildenafil citrate with enhanced bioavailability using fluid-bed granulation technique. Pharmaceutics. 2021;13(6):870. https://doi.org/10.3390/pharmaceutics13060870.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ali R, Mehta P, KyriakiMonou P, Arshad MS, Panteris E, Rasekh M, Singh N, Qutachi O, Wilson P, Tzetzis D, Chang MW, Fatouros DG, Ahmad Z. Electrospinning/electrospraying coatings for metal microneedles: A design of experiments (DOE) and quality by design (QbD) approach. Eur J Pharm Biopharm. 2020;156:20–39. https://doi.org/10.1016/J.EJPB.2020.08.023.

Article  CAS  PubMed  Google Scholar 

Alyami HS, Ibrahim MA, Alyami MH, Dahmash EZ, Almeanazel OT, Algahtani TS, Alanazi F, Alshora DH. Formulation of sublingual promethazine hydrochloride tablets for rapid relief of motion sickness. Saudi Pharmaceut J. 2021;29(5):478–86. https://doi.org/10.1016/j.jsps.2021.04.011.

Article  CAS  Google Scholar 

Ardiana F, Indrayanto G. Valsartan. Profiles of drug substances, excipients and related methodology. 2015 Jan 1;40:431-93.https://doi.org/10.1016/bs.podrm.2015.01.004

Mahajan A, Jayendra P, Patel P, Koradiya S, Mehta F. Formulation, Evaluation and Optimization of Sublingual Tablet of Clonidine Hcl.(2020). Int. J. Life Sci. Pharma Res 10(2):1-8.https://doi.org/10.22376/ijpbs/lpr.2020.10.2.p1-8

Atia NN, Tawfeek HM, Rageh AH, El-Zahry MR, Abdelfattah A, Younis MA. Novel sublingual tablets of Atorvastatin calcium/Trimetazidine hydrochloride combination; HPTLC quantification, in vitro formulation and characterization. Saudi Pharmaceut J. 2019;27(4):540–9. https://doi.org/10.1016/j.jsps.2019.02.001.

Article  Google Scholar 

Bolourchian N, Hadidi N, Foroutan S, Shafaghi B. Development and optimization of a sublingual tablet formulation for physostigmine salicylate. Acta Pharmaceutica. 2009;59(3):301–12. https://doi.org/10.2478/v10007-009-0028-5.

Article  CAS  PubMed  Google Scholar 

Charankumar K, Bagasariya D, Jain N, Famta P, Shah S, Vambhurkar G, Fernandes V, Khatri DK, Singh SB, Srivastava S. Quality by design (QbD) abetted development of pioglitazone incorporated liposomes-loaded hyaluronic acid-based in situ hydrogel for the management of melanoma. J Drug Deliv Sci Technol. 2023;84:104453. https://doi.org/10.1016/J.JDDST.2023.104453.

Article  CAS  Google Scholar 

Chordiya M, Gangurde H, Sancheti V. Quality by design: A Roadmap for quality pharmaceutical products. J Rep Pharmaceut Sci. 2019;8(2):289. https://doi.org/10.4103/jrptps.JRPTPS_2_18.

Article  Google Scholar 

Costa CP, Cunha S, Moreira JN, Silva R, Gil-Martins E, Silva V, Azevedo L, Peixoto AF, Sousa Lobo JM, Silva AC. Quality by design (QbD) optimization of diazepam-loaded nanostructured lipid carriers (NLC) for nose-to-brain delivery: Toxicological effect of surface charge on human neuronal cells. Int J Pharm. 2021;607:120933. https://doi.org/10.1016/J.IJPHARM.2021.120933.

Article  CAS  PubMed  Google Scholar 

Cunha S, Costa CP, Moreira JN, Lobo JM, Silva AC. Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: A review. Nanomedicine: Nanotechnol Biol Med. 2020;28:102206.. https://doi.org/10.1016/J.NANO.2020.102206

Dhawan S, Nanda S. Implementation of Quality by Design (QbD) concept for the development of emulsion based nanotailored gel for improved antiphotoageing potential of Silymarin. J Drug Deliv Sci Technol. 2023;81:104201. https://doi.org/10.1016/J.JDDST.2023.104201.

Article  CAS  Google Scholar 

Genedy S, Khames A, Hussein A, Sarhan H. Hydralazine HCl rapidly disintegrating sublingual tablets: Simple dosage form of higher bioavailability and enhanced clinical efficacy for potential rapid control on hypertensive preeclampsia. Drug design, Develop Therap. 2018:3753-66. https://doi.org/10.2147/DDDT.S173326

Hasnain MS, Ahmed SA, Khatoon A, Afzal M, Ansari MT, Khatoon S, Tabish M, Al-Marshad FM, Nayak AK. Pharmaceutical product development: A quality by design (QbD) approach. InAdv Chall Pharmaceut Technol 2021 (pp. 131-146). Academic Press. https://doi.org/10.1016/B978-0-12-820043-8.00017-7

Ibrahim HK, El-Setouhy DA. Valsartan Orodispersible Tablets: Formulation, In vitro/In vivo Characterization. AAPS PharmSciTech. 2010;11(1):189. https://doi.org/10.1208/S12249-009-9354-7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Joshi D, & Choudhary NK (2023). Enhancing Sublingual Tablet Quality through QbD: Current Trends and Insights". Precision Nanomed 6(3). https://doi.org/10.33218/001c.88223

Joshi D, Choudhary NK. Implementation of Quality by Design of Sublingual Antihypertensive Drugs. J Pharm Innov. 2024;19(3):20. https://doi.org/10.1007/s12247-024-09832-y.

Article  Google Scholar 

Karaman M, Balta S, AY SA, Cakar M, Naharci I, Demirkol S, Celik T, Arslan Z, Kurt O, Kocak N, Sarlak H. The comparative effects of valsartan and amlodipine on vWf levels and N/L ratio in patients with newly diagnosed hypertension. Clinic Exp Hyperten. 2013 Nov 1;35(7):516-22. https://doi.org/10.3109/10641963.2012.758734

Khan AB, Kingsley T, Caroline P (2017) Sublingual Tablets and the Benefits of the Sublingual Route of Administration. J Pharmaceut Res 16(3):273. https://doi.org/10.18579/jpcrkc/2017/16/3/118766

Mann DL, Givertz MM, Vader JM, Starling RC, Shah P, McNulty SE, Anstrom KJ, Margulies KB, Kiernan MS, Mahr C, Gupta D, Redfield MM, Lala A, Lewis GD, DeVore A D, Desvigne-Nickens P, Hernandez AF, Braunwald E, Mohammed SF, … Gagliardi A (2022) Effect of Treatment With Sacubitril/Valsartan in Patients With Advanced Heart Failure and Reduced Ejection Fraction. JAMA Cardiology, 7(1), 17. https://doi.org/10.1001/jamacardio.2021.4567

Mayet-Cruz L, Rodríguez JM, Jung-Cook H (2021). Development of a dissolution test for melatonin sublingual tablets using a factorial experimental design. Farmacia, 69(1):169-173. https://doi.org/10.31925/farmacia.2021.1.23

Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System vs. Intravenous Patient-Controlled Analgesia with Morphine for Postoperative Pain Control: A Randomized Active-Comparator Trial. Pain Pract. 2014;14(8):679–88. https://doi.org/10.1111/papr.12238.

Article  PubMed  PubMed Central  Google Scholar 

Mishra V, Thakur S, Patil A, Shukla A. Quality by design (QbD) approaches in current pharmaceutical set-up. Expert Opin Drug Deliv. 2018;15(8):737–58. https://doi.org/10.1080/17425247.2018.1504768.

Article  CAS  PubMed  Google Scholar 

Mujtaba A, Kohli K, Ali J, Baboota S. Formulation and Evaluation of Sublingual Drug Delivery of Ondansetron Hydrochloride Tablets. Adv Sci Eng Med. 2013;5(4):349–54. https://doi.org/10.1166/asem.2013.1263.

Article  CAS  Google Scholar 

Nikam RS, Borkar SPD, Jadhav PD, Yadav V, Jadhav AV (2020). Sublingual Tablets : An Overview. Int J Sci Res Sci Technol https://doi.org/10.32628/ijsrst207357

Pallagi E, Ambrus R, Szabó-Révész P, Csóka I. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation. Int J Pharm. 2015;491(1–2):384–92. https://doi.org/10.1016/j.ijpharm.2015.06.018.

Article  CAS  PubMed  Google Scholar 

Pathak K. (2021). Effective formulation strategies for poorly water soluble drugs. Advances and Challenges in Pharmaceutical Technology: Materials, Process Development and Drug Delivery Strategies, 181–228. https://doi.org/10.1016/B978-0-12-820043-8.00004-9

Prajapati S, Patel M, Patel C. Preparation and evaluation of sublingual tablets of zolmitriptan. Int J Pharmaceutic Investig. 2014;4(1):27. https://doi.org/10.4103/2230-973X.127737.

Article  CAS  Google Scholar 

Pramod K, Tahir Ma, Charoo N, Ansari S, Ali J. Pharmaceutical product development: A quality by design approach. Int J Pharmaceutic Investig. 2016;6(3):129. https://doi.org/10.4103/2230-973X.187350.

Article  Google Scholar 

Raut MB, & Gedam P (2020) Overview on Sublingual Tablets. Int J Res Pharm Pharmaceutic Sci 1(1).

Rawas-Qalaji M, Rachid O, Mendez BA, Losada A, Simons FER, Simons KJ. Adrenaline (epinephrine) microcrystal sublingual tablet formulation: Enhanced absorption in a preclinical model. J Pharm Pharmacol. 2015;67(1):20–5. https://doi.org/10.1111/jphp.12312.

Article  CAS  PubMed  Google Scholar 

Reardon CE, Kane-Gill SL, Smithburger PL, Dasta JF. Sufentanil Sublingual Tablet: A New Option for Acute Pain Management. Annals Pharmacother. 2019;53(12):1220–6. https://doi.org/10.1177/1060028019863144.

Article  CAS  Google Scholar 

Rizwan M, Aqil M, Ahad A, Sultana Y, Ali MM. Transdermal delivery of valsartan: I Effect of various terpenes. Drug Develop Indust Pharm. 2008;34(6):618–26. https://doi.org/10.1080/03639040701833740.

Article  CAS  Google Scholar 

Shelke V, & Mutha S (2020). Formulation and evaluation of lansoprazole sublingual tablet. J Res Pharma 24(2):618-626. https://doi.org/10.35333/jrp.2020.143

Simão J, Chaudhary SA, Ribeiro AJ. Implementation of Quality by Design (QbD) for development of bilayer tablets. Eur J Pharm Sci. 2023;184:106412. https://doi.org/10.1016/J.EJPS.2023.106412.

Article  PubMed  Google Scholar 

Singh MK, Mazumder R, Padhi S, Singh DK. Formulation Development and Optimization of Bioenhanced Sublingual Tablets of Rizatriptan Benzoate to Combat Migraine. Indian J Pharmaceut Educ Res. 2022;56(2):s200–15. https://doi.org/10.5530/ijper.56.2s.91.

Article  CAS  Google Scholar 

Sivadasan, D., Sultan, M. H., Alqahtani, S. S., & Javed, S. (2023). Cubosomes in Drug Delivery—A Comprehensive Review on Its Structural Components, Preparation Techniques and Therapeutic Applications. Biomedicines, 11(4). https://doi.org/10.3390/BIOMEDICINES11041114

Than YM, Titapiwatanakun V. Tailoring immediate release FDM 3D printed tablets using a quality by design (QbD) approach. Int J Pharm. 2021;599:120402. https://doi.org/10.1016/J.IJPHARM.2021.120402.

Article  CAS  PubMed  Google Scholar 

Thiirmann PA. Valsartan: A novel angiotensin Type 1 receptor antagonist. Expert Opin Pharmacother. 2000;1(2):337–50. https://doi.org/10.1517/14656566.1.2.337.

Article  Google Scholar 

Tilekar, K., Khade, P., Kakade, S., & Kotwal, S. (n.d.). International journal of pharmaceutical, chemical and biological sciences cubosomes-a drug delivery system. IJPCBS, 2014(4), 812–824. Retrieved October 7, 2023, from

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