Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Formulation and Evaluation of Vilazodone Sublingual Tablets by using Lyophilization Technique


Affiliations
1 JNTUA, Ananthapuramu, Andhra Pradesh, India
2 Anwarul Uloom College of Pharmacy, New Mallepally, Hyderabad, Telangana., India
3 Adept Pharma and Bioscience Excellence, Balanagar, RR Dist., Telangana, India
4 VEMU Institute of Technology, P. Kothakota, Chittoor, Andhra Pradesh, India
     

   Subscribe/Renew Journal


Vilazodone is approved for treatment of acute episodes of major depression (Major Depressive Disorder (MDD). It is a BCS Class - II drug, offer challenges in developing a drug product with adequate bioavailability. The aim of present investigation was to formulate and evaluate vilazodone sublingual tablets using poloxamer 407 as a carrier by lyophilized solid dispersion technique.The lyophilized solid dispersion of vilazodone prepared by poloxamer 407 (1:5) showed more than 85% drug release within 5 min, so it was used for the development of sublingual tablets by direct compression technique. The physicochemical, solid-state properties, dissolution behaviour of lyophilized solid dispersion as well as sublingual tablets were evaluated. Finally, the bioavailability studies of the prepared tablets were performed by sublingual administration to rabbits. The sublingual tablets showed a higher in vitrodis solution rate and bioavailability compared with the commercial tablets. It is evident from the results herein that the developed sublingual tablets provide a promising drug delivery system in drug development, owing to their excellent performance of a rapid onset of action and improved bioavailability.

Keywords

Vilazodone, Lyophilization, Sublingual, Dissolution.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Narang N, Sharma J. Sublingual mucosa as a route for systemic drug delivery. Int J Pharma Sci. 3(1); 2011:18–22.

  • Shojaie AH. Buccal mucosa as a route for systemic drug delivery: A review. J Pharm Pharm Sci. 1(1); 1998: 15–30

  • "VIIBRYD (vilazodone hydrochloride) tablet VIIBRYD (vilazodone hydrochloride) kit [Forest Laboratories, Inc.]". Daily Med. Forest Laboratories, Inc. December 2012.

  • "Clinical Data's Vilazodone Patient Enrolment Over One Third Complete". Business Wire. Berkshire Hathaway. 17 August 2006.

  • "FDA approves Clinical Data Inc's antidepressant". January 22, 2011.

  • "FDA approves Clinical Data Inc's antidepressant". Reuters. January 22, 2011.

  • "Clinical Data, Inc. - Clinical Data, Inc. Submits New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder". April2014.

  • Rothschild, Anthony J. The Evidence-based Guide to Antidepressant Medications. American Psychiatric; 2012.

  • Laughren TP, Gobburu J, Temple RJ, Unger EF, Bhattaram A, Dinh PV, Fossom L, Hung HM, Klimek V, Lee JE, Levin RL, Lindberg CY, Mathis M, Rosloff BN, Wang SJ, Wang Y, Yang P, Yu B, Zhang H, Zhang L, Zineh I. "Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant". The Journal of Clinical Psychiatry. 72(9); 2011: 1166–73.

  • Amidon GL. A theoretical basis for a biopharmaceutical drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 12(1); 1995:413-420.

  • Dhirendra K, Lewis S, Udupa N, Atin K. Solid Dispersions, A Review. Pak J Pharm Sci. 22(2); 2009: 234-246

  • Raymond CR, Paul JS, Sion CO. In: Hand book of pharmaceutical excipients, 5th Edition, Pharmaceutical press, Great Britain, 2006.

  • Chen Y, Zhang G, Neilly J, Marsh K, Mawhinney D, Sanzgiri Y. Enhancing the bioavailability of ABT‐963 using solid dispersion containing Pluronic F‐68. Int J Pharm. 286(1); 2004: 69‐80.

  • Higuchi T, Connors KA. Phase solubility Techniques. Adv Anal ChemInstrum. 4; 1965: 117‐212.

  • Tsinontides SC, Rajniak P, Hunke WA, Placek J, Reynolds SD. Freeze drying‐principles and practice for successful scale‐up to manufacturing. Int J Pharm. 280(1); 2004: 1‐16.

  • Bandry MB, Fathy M. Enhancement of the dissolution and permeation rates of meloxicam by formation of its freeze‐dried solid dispersions in polyvinylpyrrolidone K‐30. Drug DevInd Pharm. 32(2); 2006: 141‐150.

  • Fathy M, Sheha M. In vitro and in vivo evaluation of an amylobarbitone/hydroxypropyl‐betacyclodextrin complex prepared by a freeze‐drying method. Pharmazie. 55(7); 2000: 513‐ 517.

  • Betageri GV, Makarla KR. Enhancement of dissolution of glyburide by solid dispersion and lyophillisation techniques. Int J Pharm. 126(2); 1995: 155–160.

  • Vijayalakshmi P, Kusum V, Kshama D, Benson MK, Srinagesh S. Formulation Development and in vivo Characterization of Solubility Enhanced Gliclazide Tablets. Current Trends in Biotechnology and Pharmacy. 2 (3); 2008: 456‐461.

  • Rote H, Thakare VM, Tekade BW, Zope RP, Chaudhari RY, Patil VR. Solubility Enhancement of Glipizide Using Solid Dispersion Technique. World Journal of Pharmaceutical research. 4(1); 2012:1096-1115.

  • Rao AB, Shivalingam MR, Reddy K, Rao S, Rajesh K, Sunitha N. Formulation and Evaluation of Aceclofenac Solid Dispersions for Dissolution Rate Enhancement. International Journal of Pharmaceutical Sciences and Drug Research. 2(2); 2010: 146-150.

  • Kumar VR, Sevukarajan M, Vulava J, Pavankumar AG, Deepthi Y, Manjunath M, Anand A. Improvement of Dissolution Characteristics and Bioavailability of Tadalafil by Solid Dispersion Technique Using Water-Soluble Polymers. International Journal of Advanced Pharmaceutics. 2(2); 2012: 56- 63.

  • Nikunj J. Aghera, Suresh D. Shah, Kantilal R. Vadalia. Formulation and evaluation of sublingual tablets of losartan potassium. Asian Pacific Journal of Tropical Disease. 2 (1); 2012: 130- 135.


Abstract Views: 276

PDF Views: 0




  • Formulation and Evaluation of Vilazodone Sublingual Tablets by using Lyophilization Technique

Abstract Views: 276  |  PDF Views: 0

Authors

K. C. Panda
JNTUA, Ananthapuramu, Andhra Pradesh, India
A. V. Reddy
Anwarul Uloom College of Pharmacy, New Mallepally, Hyderabad, Telangana., India
N. Panda
Anwarul Uloom College of Pharmacy, New Mallepally, Hyderabad, Telangana., India
M. D. Shamim
Anwarul Uloom College of Pharmacy, New Mallepally, Hyderabad, Telangana., India
M. Habibuddin
Adept Pharma and Bioscience Excellence, Balanagar, RR Dist., Telangana, India
K. N. Jayaveera
VEMU Institute of Technology, P. Kothakota, Chittoor, Andhra Pradesh, India

Abstract


Vilazodone is approved for treatment of acute episodes of major depression (Major Depressive Disorder (MDD). It is a BCS Class - II drug, offer challenges in developing a drug product with adequate bioavailability. The aim of present investigation was to formulate and evaluate vilazodone sublingual tablets using poloxamer 407 as a carrier by lyophilized solid dispersion technique.The lyophilized solid dispersion of vilazodone prepared by poloxamer 407 (1:5) showed more than 85% drug release within 5 min, so it was used for the development of sublingual tablets by direct compression technique. The physicochemical, solid-state properties, dissolution behaviour of lyophilized solid dispersion as well as sublingual tablets were evaluated. Finally, the bioavailability studies of the prepared tablets were performed by sublingual administration to rabbits. The sublingual tablets showed a higher in vitrodis solution rate and bioavailability compared with the commercial tablets. It is evident from the results herein that the developed sublingual tablets provide a promising drug delivery system in drug development, owing to their excellent performance of a rapid onset of action and improved bioavailability.

Keywords


Vilazodone, Lyophilization, Sublingual, Dissolution.

References