Formulation and evaluation of immediate release tablet of zopiclone using wet granulation method

Authors

  • Rajesh Bhatt School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA
  • Aditya Sharma School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA
  • Prevesh Kumar Pharmacy Academy, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA
  • Sukirti Upadhyay School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA
  • Prashant Upadhyay School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Abstract

Zopiclone, a cyclopyrolone, is a non-benzodiazepine derivative used as a hypnotic agent in the treatment of short term insomnia. The main objective of the present investigation was to formulate a pharmaceutically active stable and bioequivalent immediate release (IR) tablets of zopiclone using wet granulation method. The prepared formulations were evaluated using various physical parameters, equipment, dissolution study and drug release profile.  The basic approach used in development of zopiclone IR tablets was that the use of superdisintegrants as like Corn starch (maize) and Sodium starch glycolate which provide instant disintegration after administration. In-vitro dissolution testing study was carried out for 1 hours using 0.1N HCl in a dissolution apparatus for evaluation of Drug release. On the basis of the dissolution profile, F3 gives a better result and were found 100 % release in just 20 minutes and also found that as the polymer ratio were increases the drug release rate also increased from the formulation.

Keywords: Hypnotic agent, immediate release, Wet granulation Method, Non-benzodiazepine derivative, Superdisintegrants, Zopiclone 

DOI

https://doi.org/10.22270/jddt.v9i2-s.2473

Author Biographies

Rajesh Bhatt, School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Aditya Sharma, School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Prevesh Kumar, Pharmacy Academy, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Pharmacy Academy, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Sukirti Upadhyay, School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

Prashant Upadhyay, School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

School of Pharmaceutical Sciences, IFTM University, Moradabad-244001, Uttar Pradesh, INDIA

References

Aulton M. E: Pharmaceutics the science of dosage form design. Churchill Livingstone Edinburgh, Second Edition 2002.

Augsburger LL, Hahm HA, Brzeczko AW, Shah V. Superdisintegrants: Characterization and function. In: Swarbrick J, Boylan JC, editors. Encyclopedia of pharmaceutical technology. 2nd ed. New York: Marcel dekker Inc; 2002. pp. 2623–38.

Atram SC: Formulation and evaluation of immediate release tablet using response surface methodology. Asian J Pharm 2011; 5:46-51.

Hyder AS, Hasan S, Sharma S: Formulation and optimization of immediate release tablet of rupatidine fumarate, International journal of pharma professionals research 2011; 2(3):345- 350

Bhardwaj V, Bansal M and Sharma PK: Formulation and Evaluation of Fast Dissolving Tablets of Amlodipine Besylate Using DifferentSuper Disintegrants and Camphor as Sublimating Agent, American-Eurasian Journal of Scientific Research 2010; 5(4):264-269.

Sakore S, Choudhari S, Chakraborty B: Biowaiver Monograph For Immediate Release Solid Oral Dosage Forms: Ofloxacin, International Journal of Pharmacy and Pharmaceutical Sciences 2010; 2(4):156-161.

Gowtham.M, Vasanti.S, Rohan.RD, Ashwath.N, Paridhavi.M: Formulation and evaluation of immediate release folic acid tablets, Der Pharmacia Lettre 2011; 3(6):157-162.

Gibson Mark: Pharmaceutical preformulation and formulation- A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. CRC Press 2004

U.S. FDA/CDER: Guidance for Industry, “Dissolution testing of immediate release solid oral dosage forms” 1997

Zhang H, Yu L: Dissolution Testing for Solid Oral Drug Products: Theoretical Considerations, American Pharmaceutical Review 2004; 7(5):26-31.

Wang Q, Fotaki N, Mao Y: Biorelevant Dissolution: Methodology and Application in Drug Development, Dissolution Technologies 2009; 6-12.

U.S. FDA/CDER: Guidance for Industry: Immediate release solid oral dosage forms, “Scale-up and post approval changes: chemistry, manufacturing, and controls, in-vitro dissolution testing and in-vivo bioequivalence documentation” 1995

Martindale: The complete Drug Reference. Pharmaceutical Press 2002; 33rd Edition 921‐922.

Bauer K, Vadagnini M. New developments in wet granulation. Pharm Tech Eur 1997; 9(3):27–34.9

Chirkot T, Propost C. Low-shear granulation. In: Parikh D, Handbook of Pharmaceutical Granulation Technology. Boca Raton, FL: Taylor & Francis, 2006: 230.

Parmar J, Rane M.,Sashi S. Pandeya: Tablet formulation design and manufacture: Oral immediate release application. Pharma Times 2009; 41(4):21‐29.

Lieberman H A, Lachman L, Joseph B. Schwartz: Pharmaceutical dosage forms- -tablets I ., MARCEL DEKKER, INC. NEW YORK, 2nd edition, revised and expanded; 1989; 1:77-158

Published

15-04-2019
Statistics
Abstract Display: 1930
PDF Downloads: 1757

How to Cite

1.
Bhatt R, Sharma A, Kumar P, Upadhyay S, Upadhyay P. Formulation and evaluation of immediate release tablet of zopiclone using wet granulation method. J. Drug Delivery Ther. [Internet]. 2019 Apr. 15 [cited 2025 Mar. 17];9(2-s):132-7. Available from: https://jddtonline.info/index.php/jddt/article/view/2473

How to Cite

1.
Bhatt R, Sharma A, Kumar P, Upadhyay S, Upadhyay P. Formulation and evaluation of immediate release tablet of zopiclone using wet granulation method. J. Drug Delivery Ther. [Internet]. 2019 Apr. 15 [cited 2025 Mar. 17];9(2-s):132-7. Available from: https://jddtonline.info/index.php/jddt/article/view/2473

Most read articles by the same author(s)