Design, formulation and evaluation of sustained release bilayer tablets of ciprofloxacin hydrochloride
The present research work involve the development of a bilayer tablet of ciprofloxacin hydrochloride using a superdisintegranting agent (sodium starch glycolate) for the fast releasing layer and hydrophobic polymers like ethyl cellulose, acrycoat L100 and acrycoat S100 for the delayed releasing layer. Ciprofloxacin was used as a model drug. Tablets were prepared by wet granulation method. The prepared bilayer tablets were evaluated for angle of repose, bulk density, tapped density, Carr’s index, Hausner’s ratio at the precompression stage and thickness variation, weight variation, hardness, friability, drug content, disintegration time, in vitro drug release study at the post compression stage.. In vitro dissolution studies were carried out in a USP 24 apparatus I. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. FT-IR studies revealed that there was no interaction between the drug and polymers. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 12 h from optimized formulations was observed. Present research work involves the development of a bilayer tablet of ciprofloxacin hydrochloride using a superdisintegrant for the fast releasing layer and hydrophobic polymers for the delayed releasing layer. There was the initial burst effect from the formulations to provide the loading dose of the drug, followed by sustained release to provide maintenance dose of the drug.
Keywords: Superdisintegrants, Burst release, Wet granulation, non-Fickian, Sustained release
2. Rahman Z, Ali M and Khar R K. Design and evaluation of bilayer floating tablets of captopril. Acta Pharmaceutica, 2006; 56:49–57.
3. Libermann H.A, Lachman L, Kanig J.L. The Theory and Practice of Industrial Pharmacy, Indian 3rd Ed., Bombay; Varghese Publishing house: 1987.
4. Foster, Rachel H, Keam, Susan J. Prolonged Release Ciprofloxacin. American Journal of Drug Delivery, 2006; 4:113-20.
5. Upadrashta S.M, Katikaneni P.R, Hileman G.A and Keshary P.R. Direct compression controlled release tablets using ethyl cellulose matrices. Drug Development and Industrial Pharmacy, 1993; 19:449– 60.
6. Chinam N.P, Arethi B.K, Hemant K.P, Satya P.S, Medhuri V.D., Design and evaluation of Sustained release bilayer tablets of Propanolol Hydrochloride. Acta Pharmaceutica, 2007; 57:479-89.
7. Indurwade N.H, Rajyagures T.H, Halith S.M, Pillai K.K, Balasubhramaniyam P, Nakhat PD. Formulation and evaluation of bilayer tablets of amlodipine besilate and metprolol succinate. Indian Drug, 2002; 39(8):405-09.
8. Guyot M, Fawaz F. Nifedipine loaded polymeric microspheres: preparation and physical characteristics. International Journal of Pharmaceutics, 1998; 175:61-74.
9. Remya P.N, Damodharan N, Sulakshan K.C.V. Formulation and Evaluation of bilayered tablets of Ibuprofen and Methocarbamol. International Journal of Pharm Tech Research, 2010; 2(2):1250 - 55.
10. Patel H.P, Patel N.J. Formulation and Evaluation of Biphasic Drug Delivery System of Diclofenac Sodium using Compressed Mini Tablet. International Journal of Pharma. Research & Development, 2009; 3:76-82.
11. Shirse P. Formulation and Evaluation of Bilayer Tablets of Diclofenec Sodium with Ranitidine HCL for Susteained and Immediate Release. Journal of Applied Pharmaceutical Sciences, 2012; 02(5):136-41.
12. Statistical Analysis 8: Two Way Analysis of Variance (ANOVA), Compliation prepared by Center for Excellence, Sigma, http://www.statstutor.ac.uk/resources/uploaded/coventrytwowayanova.pdf.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (SeeÂ The Effect of Open Access).