Author(s):
Zainab H. Mahdi, Nidhal K. Maraie, Zahraa Amer Al-Juboori, Aseel S. Najm
Email(s):
zhmpharm@yahoo.com , zhmpharm@uomustansiriyah.edu.iq
DOI:
10.52711/0974-360X.2022.00120
Address:
Zainab H. Mahdi1*, Nidhal K. Maraie1, Zahraa Amer Al-Juboori1, Aseel S. Najm2
1Department of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq.
2Department of Pharmacy, Ashur University College, Baghdad, Iraq.
*Corresponding Author
Published In:
Volume - 15,
Issue - 2,
Year - 2022
ABSTRACT:
For many years oral solid dosage forms were the most preferred dosage form for a wide range of populations due to their safety, efficacy, stability cheapness, and ease of administration. Although, they possess certain drawbacks mainly swallowing difficulties and bioavailability problems. Therefore, oral jellies were developed in an attempt to overcome these restrictions. In this study, six valsartan oral jellies were prepared using three different gelling agents (xanthan gum, sodium alginate, and gelatin) in different concentrations that are designed especially for pediatric patients with swallowing problems. These oral jellies were optimized by the evaluation of the physical appearance, pH, viscosity, and syneresis. In addition to the study of taste masking, content uniformity, and in vitro release profile. Furthermore, FT-IR and stability analyses were performed on the optimum formula. As a result oral jelly (F6) containing 6% gelatin was selected as the optimum formula possessing an acceptable physical property with a pH value of (7.25±0.47) and viscosity of (91200±1.95, 42170 ±2.7) cps at 5 and 10 rpm respectively which showing no syneresis. Moreover, F6 had an acceptable content uniformity of (96.30±1.38) and higher percent drug released in 30 minutes (98.40 ± 1.04) with good taste masking (1.22%±1.18, 4.37%±1.06) after 1 and 2 minutes respectively. Furthermore, the absence of any interactions or instability was assured by the result of the FT-IR and stability analysis. In a conclusion, this study was succeeded to formulate a valsartan oral jelly that can be used as a new easily swallowed form of the antihypertensive drug for the dysphagic population with improved bioavailability.
Cite this article:
Zainab H. Mahdi, Nidhal K. Maraie, Zahraa Amer Al-Juboori, Aseel S. Najm. The Development and Characterization of a New Easily Swallowed Valsartan Oral Jelly. Research Journal of Pharmacy and Technology. 2022; 15(2):723-8. doi: 10.52711/0974-360X.2022.00120
Cite(Electronic):
Zainab H. Mahdi, Nidhal K. Maraie, Zahraa Amer Al-Juboori, Aseel S. Najm. The Development and Characterization of a New Easily Swallowed Valsartan Oral Jelly. Research Journal of Pharmacy and Technology. 2022; 15(2):723-8. doi: 10.52711/0974-360X.2022.00120 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-2-40
REFERENCES:
1. Taranum R, Mittapally S. Soft chewable drug delivery system: oral medicated jelly and soft chew. Journal of Drug Delivery and Therapeutics. 2018;8(4): 65-72.
2. Baghel P, Roy A, Chandrakar S, Bahadur S. Fast dissolving drug delivery systems: a brief review. Research Journal of Pharmacy and Technology. 2013; 6(6): II.
3. Doolaanea AA, Bahari A. Advantages of Jelly over Liquid Formulations for Pediatrics. Journal of Formulation Science & Bioavailability. 2017;1: 102-3.
4. Sarojini S, Anusha K, Maneesha C, Mufaquam MA, Deepika B, Krishna Y. Oral Medicated Jellies–A Review. 2018.
5. Almajidi YQ, Zainab HM, Maraie NK. Preparation and in vitro evaluation of montelukast sodium oral nanoemulsion. Int J Appl Pharm. 2018; 10: 49-53.
6. More S, Ghadge T. Fast disintegrating tablets: An overview. Asian Journal of Research in Pharmaceutical Science. 2013;3(2):47-55.
7. Mahdi ZH, Maraie NK. New easily swallowed tablets with slippery coating for the antihypertensive drug valsartan. UK J Pharm Biosci. 2015; 3:9-19.
8. Shah T. Taste masking, formulation and evaluation of orally disintegrating tablet of anti-histaminic drug. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 6(3): 194-211.
9. Singhvi G, Singh M, Chaturvedi G, Sharma S, Yadav K. Design and Evaluation of Taste Masked Fast Disintegrating Tablet of Racecadotril. Magnesium. 2010; 5: 10.
10. Raja Manali M, Dhiren P. Oral medicated jelly: a recent advancement in formulation. An International Journal of Pharmaceutical Sciences. 2016; 7(2): 13-20.
11. Gade ST. A Review article on Oral Jellies for Pediatrics. Asian Journal of Pharmacy and Technology. 2020; 10(3).
12. Ghanchi SD, Dhawale SC. Taste masking technologies of pharmaceuticals. Research Journal of Pharmacy and Technology. 2011; 4(10): 1513-8.
13. Zaid AN, Cortesi R, Qaddomi A, Khammash S. Formulation and bioequivalence of two valsartan tablets after a single oral administration. Scientia Pharmaceutica. 2011;79(1):123-36.
14. Sweetman SC. Martindale: the complete drug reference: Pharmaceutical Press London; 2009.
15. Salunke T, Mayee R. Formulation and evaluation of medicated jelly of bitter drugs. International Journal Of Pharmaceutical Innovations. 2013;3(5):1-14.
16. Gohel MC, Parikh RK, Nagori SA, Shah SN, Dabhi MR. Preparation and evaluation of soft gellan gum gel containing paracetamol. Indian Journal of Pharmaceutical Sciences. 2009;71(2):120.
17. Jadhav S, Bharkad V, Shinde M, Kadam V, Katkam P. Development and evaluation of oral medicated jelly of ondansetron hydrochloride. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6(9): 1537-49.
18. Prakash K. Formulation development and evaluation of novel oral jellies of carbamazepine using pectin, guar gum, and gellan gum. Asian Journal of Pharmaceutics. 2014; 8(4):241-9.
19. Javed H, Shah S. Formulation and Evaluation of Taste Masked Doxycycline HCl Medicated Jelly. Der Pharmacia Sinica. 2017; 8(2): 33-9.
20. Begum SA, Sree VP, Anusha V, Veronica ZK, Sree PV, Prameela K, et al. Formulation and evaluation of pediatric oral soft jellies of salbutamol sulphate. Research Journal of Pharmacy and Technology. 2018; 11(11): 4939-45.
21. Cardoz MR, Ravikumar P. Design, Development and Evaluation of Novel Oral Medicated Jellies. Indo American Journal of Pharmaceutical Sciences. 2017; 4(6):1746-54.
22. Bhoyar PK, Biyani DM, Shahare HV, Ikhar PK, Borkar VS. Formulation and Evaluation of Taste Masked Sustained Release Dosage Form of Metformin Hydrochloride Using Indion Resin. Research Journal of Pharmaceutical Dosage Forms and Technology. 2009; 1(1): 49-54.
23. Dubey M, Sheth Z. Design and development of oral medicated jelly of Palonosetron hydrochloride. Indian Journal of Research. 2015; 4(6): 253.
24. Mahdi ZH, Maraie NK, Al-Juboori ZA. Application of liquisolid technology to enhance the dissolution of cefixime from its oral capsules. Int. J. Appl. Pharm. 2018; 10: 214-9.
25. Nayak K, Mishra MK, Verma G. Formulation and evaluation of oral soft jelly containing Glibenclamide. Indo American Journal of Pharmaceutical Sciences. 2016; 3(10): 1276-82.
26. Brunchi C-E, Bercea M, Morariu S, Dascalu M. Some properties of xanthan gum in aqueous solutions: effect of temperature and pH. Journal of Polymer Research. 2016; 23(7): 123.
27. Król Ż, Malik M, Marycz K, Jarmoluk A. Characteristic of gelatine, carrageenan and sodium alginate hydrosols treated by direct electric current. Polymers. 2016;8(8):275.
28. Agarwal S, Jhunjhunwala V, Priya G. Fabrication and Morphological Analysis of Gelatin-Alginate Scaffolds. Research Journal of Pharmacy and Technology. 2018; 11(9): 3816-8.
29. Zhong L, Oostrom M, Truex MJ, Vermeul VR, Szecsody JE. Rheological behavior of xanthan gum solution related to shear thinning fluid delivery for subsurface remediation. Journal of Hazardous Materials. 2013; 244: 160-70.
30. Narzary A, Devi N. Release Dynamics of Tetracycline from a Loaded Hydrgel of Gelatin, Sodium Salt of 2-Acrylamido-2-Methyl Propane Sulfonic Acid and Acryl Amide. Asian Journal of Research in Chemistry. 2011; 4(5): 779-85.
31. Vijayanand P, Deepa A, Bhagavan Raju M. Development, characterization and evaluation of soft oral edible gel using gellan gum. Int. J. Appl. Pharm. 2017;9:73-7.
32. Osorio FA, Bilbao E, Bustos R, Alvarez F. Effects of concentration, bloom degree, and pH on gelatin melting and gelling temperatures using small amplitude oscillatory rheology. International Journal of Food Properties. 2007; 10(4): 841-51.
33. Kar R, Mohapatra S, Bhanja S, Das D, Barik B. Formulation and in vitro characterization of xanthan gum-based sustained release matrix tables of isosorbide-5-mononitrate. Iranian Journal of Pharmaceutical Research. 2010; 9(1):13.
34. Lu MF, Woodward L, Borodkin S. Xanthan gum and alginate based controlled release theophylline formulations. Drug Development and Industrial Pharmacy. 1991; 17(14): 1987-2004.
35. Nie S-F, Liu H, Liu Y-L, Pan W-S. Comparison of the characteristics of several polymer materials used in hydrophilic matrix tablets. Yao Xue Xue Bao= Acta Pharmaceutica Sinica. 2011;46(3):338-43.
36. Xu W-J, Xie H-J, Cao Q-R, Shi L-L, Cao Y, Zhu X-Y, et al. Enhanced dissolution and oral bioavailability of valsartan solid dispersions prepared by a freeze-drying technique using hydrophilic polymers. Drug Delivery. 2016; 23(1): 41-8.