Author(s): Bhupinder Bhyan, Dinesh Chandra Bhatt, Sarita Jangra

Email(s): bhyan2021@gmail.com , Email: sarita28787@gmail.com

DOI: 10.52711/0974-360X.2022.00664   

Address: Bhupinder Bhyan1,2*, Dinesh Chandra Bhatt3, Sarita Jangra4
1Ph D Scholar, Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar, Haryana.
2Assistant Professor, Department of Pharmaceutics, Teerthanker Mahaveer College of Pharmacy, TMU, Moradabad, 244001, U.P, India.
3Professor, Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar, Haryana.
4Associate Professor, Department of Pharmacy Practice, Chitakara College of Pharmacy, Chitkara University, Rajpura, Punjab, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 9,     Year - 2022


ABSTRACT:
In the current work, sublingual bilayer thin films (SBTFs) containing piroxicam and zolmitriptan, were prepared by solvent casting technique using HPMC E15, pullulan afterwards evaluated for their physicomechanical properties, disintegration time and in-vitro drug release. A single dose of formulated SBTFs containing piroxicam (10mg) and Zolmitriptan (2.5mg) was administered to healthy volunteers and their blood samples were withdrawn at predefined time interval for in-vivo pharmacokinetic studies. Plasma concentration of drugs were analysed using a validated HPLC-MS/MS method. The pharmacokinetic parameters were obtained and compared with pharmacokinetic data of marketed formulation. The thickness, weight variation, folding endurance and pH of the films was found to be within the acceptable range. The in-vitro disintegration time varied from 27-45 sec and drug content was found to be 96.01- 100.62% for all the formulation. Formulation B3 showed drug release of 92% within 3-4.5 mins. The plasma concentration time curve helped in assessing the pharmacokinetic parameters i.e. AUC0-24, t1/2, Cmax, tmax, and Vd. The plasma concentration time profile of both drugs indicated the increase of AUC, bioavailability, elimination half-life and Vd when compared with the pharmacokinetic parameters of marketed formulation which helped in the rapid onset of action in the management of acute pain. The results suggested that plasma drug concentration of active ingredient started appearing in a significant amount within 30 minutes which indicated that the developed sublingual delivery system had effectively delivered the drug into the systemic circulation.


Cite this article:
Bhupinder Bhyan, Dinesh Chandra Bhatt, Sarita Jangra. Evaluation and Pharmacokinetic Study in healthy human volunteers of developed bilayer thin films containing Piroxicam and Zolmitriptan. Research Journal of Pharmacy and Technology. 2022; 15(9):3962-8. doi: 10.52711/0974-360X.2022.00664

Cite(Electronic):
Bhupinder Bhyan, Dinesh Chandra Bhatt, Sarita Jangra. Evaluation and Pharmacokinetic Study in healthy human volunteers of developed bilayer thin films containing Piroxicam and Zolmitriptan. Research Journal of Pharmacy and Technology. 2022; 15(9):3962-8. doi: 10.52711/0974-360X.2022.00664   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-9-24


REFERENCES:
1.    Cilurzo F. Cupone IE. Minghetti P. Selmin F. Montanari L. et al Fast dissolving films made of maltodextrins. European. Journal of Pharmaceutics and Biopharmaceutics. 2008; 70(3):895-900. doi: 10.1016/j.ejpb.2008.06.032.
2.    Bhagwat R. Vaidhya I. et al. Novel Drug Delivery System: An Overview. International Journal of Pharmaceutical Sciences and Research. 2017; 4(3):970-982.
3.    Patil S. Mhaiskar A. Dharmendra M. et al A Review on Novel Drug Delivery System: A Recent Trend. International Journal of Current Pharmaceutical and Clinical Research. 2016; 6(2):89-93.
4.    Kathpalia H. Gupte A. An Introduction to Fast Dissolving Oral Thin Film Drug Delivery System: A Review. PubMed. 2013; 10(6):667-84. doi: 10.2174/156720181006131125150249.
5.    Bala R. Pawar P. Khanna S. Arora S. Orally dissolving strips: A new approach to oral drug delivery system.  International Journal of Pharmaceutical Investigation. 2013; 3(2):67-76. doi:10.4103/2230-973X.114897.
6.    Fulzele SV. Satturwar PM. Dorle AK. Polymerized rosin: novel film forming polymer for drug delivery. International Journal of Pharmaceutics. 2002; 5:249(1-2):175-84. doi: 10.1016/s0378-5173(02)00529-x.
7.    Mahboob MBH. Riaz T. Jamshaid M. Bashir I. Zulfiqar S.  Oral Films: A Comprehensive Overview. International Current Pharmaceutical Journal. 2016; 5(12):111-117.
8.    Panda BP. Dey NS. Rao MB. et al.  Development of Innovative Orally Fast Disintegrating Film Dosage Forms: A Review. International Journal of Pharmaceutical Sciences and Nanotechnology. 2012; 5(2):1666-1673.
9.    Patel P. Dhave R. Shah D. et al. Development and Evaluation of High Loading Oral Dissolving Film of Aspirin and Acetaminophen. Journal of Pharmaceutical Sciences and Pharmacology. 2014; 10:112-122. doi:10.1166/jpsp.2014.1014
10.    Tuti S. Fudholi A. Ronny M. Sudibyo M. et al. Pharmaceutical nanoparticle technologies: An approach to improve drug solubility and dissolution rate of Piroxicam. Research Journal of Pharmacy and Technology. 2017; 10(4): 968-974. doi: 10.5958/0974-360X.2017.00176.7
11.    Swapnil S. Sonawane J., Siddiqua S. Shaikh H. et al. Design Preparation and Formulation of Piroxicam Solid Dispersion. Asian Journal of Pharmacy and Technology. 2021:11(01): 211-18. doi: 10.5958/2231-5713.2021.00005.2
12.    Bhaskar D. Bhyan B. et al. Surface Solid Dispersion: A Novel Method for improving in-vitro dissolution and in-vivo pharmacokinetics of Meclizine hydrochloride. Research Journal Pharmacy and Technology 2021; 14(2):685-693. doi: 10.5958/0974-360X.2021.00121.92.
13.    Feldene® (piroxicam) CAPSULES 10 mg and 20 mg For Oral Use. 2015[Updated 2015 Feb]. AvailableFrom: https://www.accessdata.fda.gov/ drugsatfda_docs.
14.    Jhadav P. Yadav A. et al. Polymeric Nanosuspension Loaded Oral Thin Films of Flurbiprofen: Design, Development and In Vitro Evaluation. Research Journal Pharmacy and Technology. 2020; 13(4): 1905-1910. doi: 10.5958/0974-360X.2020.00343.1.
15.    Dahl SL. Ward JR. Pharmacology, Clinical efficacy and Adverse effects of Piroxicam, a New Nonsteroidal Anti-inflammatory Agent. Pharmacotherapy. 1982; 2:80-9.http://www.ncbi.nlm.nih.gov/pubmed/6765393.
16.    Ortego D. Cruz M. Largo R. Navarro A. Palacios I. Solans A. Sanchez PO. et al. Studies of Piroxicam Absorption by Oral Mucosa. Arzneimittelforschung. 2002; 52(5): 385-387. doi: 10.1055/s-0031-1299902.
17.    Mayuri K. Mohan K. Chinnala L. Rmayee J. Avirnei K. Kondamalla C. et al. Formulation and Characterization of Nicotine Thin Films for Smoking Cessation through Buccal Delivery. Research Journal of Pharmacy and Technology. 2016; 9(12):2079-2086. doi: 10.5958/0974-360X.2016.00424.8
18.    Swami S. Jangra S. et al.  Formulation and Evaluation of Fast Dissolving Oral Films of Metoprolol Succinate. International Journal of Engineering and Applied Sciences.2015 ;6:11-41.
19.    Kulkarni P. et al. Formulation and Evaluation of Mouth Dissolving Film Containing Rofecoxib. International Research Journal of Pharmacy. 2011; 2(3):273-278.
20.    Alayoubi A. Haynes L. Patil H. Daihom B. et al. Development of a Fast Dissolving Film of Epinephrine Hydrochloride as a Potential Anaphylactic Treatment for Pediatrics. Pharmaceutical Development and Technology. 207; 22(8):1012-1016.
21.    Abdelbary A et al.  Pharmaceutical and Pharmacokinetic Evaluation of a Novel Fast Dissolving Film Formulation of Flupentixol Dihydrochloride. AAPS PharmSciTech. 2014; 15(6):1603-10.
22.    Gowda DV. et al.  Comparative Bioavailability of Two Marketed Piroxicam Formulations in Healthy Human Volunteers. Indian Drugs. 2003; 40:573-576.
23.    Zhou H Xu. Wu G. Wu L. Shentu J. Pan Z. Hu S. Liu Y. et al. Pharmacokinetics and Tolerability of Intravenous Ibuprofen Injection in Healthy Chinese Volunteers: A Randomised Open-Label Single- and Multiple- Dose Study. International Journal of Clinical Pharmacology and Therapeutics. 2016; 54(11):904-913. doi: 10.5414/CP202603
24.    Declaration of Helsinki as amended by the 52nd World Medical Assembly (WMA) Edinburgh, Scotland: World Medical Association. 2000.
25.    Ramandeep S. Upadhayay A. Kale MK. et al. Effect of Liposomes as a carrier on Pharmacokinetics of Cisplatin. Research J. Pharm. and Tech 2018; 11(11): 5073-5077. doi: 10.5958/0974-360X.2018.00925.3.
26.    Sathesh K. Binil A. et al. Pharmacokinetics of Tacrine Loaded MPEG-PCL Polymeric Nanoparticles. Research Journal of Pharmacy and Technology. 2017; 10(1): 135-140. doi: 10.5958/0974-360X.2017.00030.0
27.    Bilal Y. Vedat A. et al. Determination and Pharmacokinetics of Ibuprofen in Rabbit Plasma by GC-MS Method. Research Journal Pharmacy and Technology. 2011; 4 (1): 52-56
28.    Calvo M. Prado T. Dionísio J. Marques P, Brozoski DT. Lanchote L. Faria A. et al. Effective Method for the Detection of Piroxicam in Human Plasma Using HPLC. Brazilian Oral Research. 2016; 30(1):121- 130. doi: 10.1590/1807-3107BOR-2016.vol30.0058.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available