Albert Science International Organization

ARTICLE DESCRIPTION: 

Manas Jyoti Kapil*, Dr. Parthajyoti Gogoi, Dipankar Das, Neelakshi Sharma & Bornali Hazarika, Development of an Optimized, Sustained Release Ofloxacin Tablet for Vaginal Delivery, ASIO Journal of Drug Delivery, 2018, 3(1): 01-12.

ARTICLE TYPE: RESEARCH

Dids Link :  http://doi-ds.org/doilink/02.2018-47499584/

ABSTRACT:

Objective: The aim of the study was to formulate a sustained release Ofloxacin tablet to reduce dosing frequency and prolonged action on the site of administration.

Method: Central composite design for 2 factors at 3 levels each was employed. This gave an optimized drug release profile in a systematic way. Different quantity of HPMC K 15M and Carbopol were selected as the independent variables. Whereas time to 50% drug release (t_50%) and drug release at 12hrs (T12) were selected as dependent variables.

Result: The response surface analysis clearly indicated the effect of both polymers on t₅₀ and T12. The two formulations composition with HPMC concentration of 5.02 % w/w and 7.88 % w/w, the amount of Carbopol was 4.01% w/w and 4.16% w/w respectively, fulfilled maximum requirements of an optimum formulation, desirability 1 and 0.957 respectively.

Conclusion: Study concluded that HPMC K15M and Carbopol can be used as release regulators for formulating Ofloxacin vaginal tablets.                                           

KEYWORDS: Polymers, vaginal drug delivery system, sustain release, central composite design, U.V spectrophotometer.

*Corresponding author: Manas Jyoti Kapil, Regional Drugs Testing Laboratory, Guwahati, Assam, India, e mail ID: Manas.kapil@gmail.com

1. Chinmaya Keshari Sahoo , Prakash Kumar Nayak , Deepak Kumar Sarangi , Tanmaya Keshari Sahoo, Intra Vaginal Drug Delivery System: An Overview, American Journal of Advanced Drug Delivery, 1[1][2013]043-055.
2. Valenta C. The use of mucoadhesive polymers in vaginal delivery. Adv DrugDeliv Rev 2005; 57: 1692-1712.
3. Knuth K, Amiji M, Robinson JR. Hydrogel delivery systems for vaginal and oral applications. Formulation and biological considerations. Adv Drug Deliv Rev 1993; 11: 137-167.
4. Robinson JR, Bologna WJ. Vaginal and reproductive system treatments using a bioadhesive polymer. J Control Release 1994; 28: 87-94.
5. Shah SU, Shah KU, Jan SU, Ahmad K, Rehman UA,Hussain A.Formulation and development of Ofloxacin-Ethocel controlled release matrix tablet, Pak J Pharm Sci. 2011 Jul;24(3):255-61.
6. Mandal U, Gowda V, Ghosh A, Selvan S, Solomon S, Pal KT. Formulation and optimization of sustained release matrix tablet of metformin HCl 500mg using Response Surface Methodology, Yakugaku Zasshi 127 (8) 1281-1290 (2007).
7. Bodea, A, Leucuta, SE. Optimization of propranolol hydrochloride sustained release pellets using box-behnken design and desirability function. Drug Dev. Ind. Pharm. 1998, 24, 145-155.
8. Kramar A, Turk S,Vrecer F.Statistical optimisation of diclofenac sustained release pellets coated with polymethacrylic films, Int. J. Pharm.2003, 256, 43-52.
9. Mandal U, Gowda V, Ghosh A, Selvan S, Solomon S, Pal KT. Formulation and optimization of sustained release matrix tablet of metformin HCl 500mg using Response Surface Methodology, Bioequivalence study, JadavpurUniversity 2007.
10. K. Edsman, J. Carlfors, R. Peterson. Rheological evaluation of Poloxamer as in-situ gel forophthalmic use, Eur. J. Pharm. Sci. 6 (1998) 105–112; DOI: 10.1016/S0928-0987(97)00075-4.
11. Patil P, RaoSB, Kulkarni SV, Basavaraj, SurpurC,Ammanage A. Formulation and Evaluation of Floating Matrix Tablets of Ofloxacin; Department of pharmaceutics, 2011, 17-22.
12. www.drugs.com/Ofloxacin.html  Accessed at 13 December 2013.
13. G. Ashok, V. Uma Maheswara Rao, K. Mahalakshmi, Ch. Sapnil, B. Ajay Kumar, Formulation and evaluation of sustained release tablets of Itopride HCL, 2013, 4 (10).
14. Patil P, Rao SB, Kulkarni SV, Basavaraj, Surpur C, Ammanage A. Formulation and Evaluation of Floating Matrix Tablets of Ofloxacin; Department of pharmaceutics. 2011, 2231-5691.
15. Shah SU, Shah KU, Jan SU, Ahmad K, Rehman UA,Hussain A.Formulation and development of Ofloxacin-Ethocel controlled release matrix tablet, Pak J Pharm Sci. 2011 Jul;24(3):255-61.
16. Padmavathy J, SaravananD, RajeshD. Formulation and evaluation of ofloxacin floating tablets using HPMC, Ratnam institute of pharmacy, Tamil Nadu, 2010, Vol 3, Issue 1, 2011.
17. Arora G., Malik  K, Singh. Formulation and evaluation of mucoadhesive matrix tablet of taro gum: optimization using response surface methodology. Pol Medy,2011, 41 (2), 23-34.
18. Cooper J, Gunn G. Powder flow and compaction et al; In: Tutorial pharmacy (carter SJ; Eds.) New Delhi. India. CBS Publishers and distributers; 1986 p. 211-233.
19. Shah DY, Rampadhan M.Development and evaluation of controlled release diltiazem hydrochloride microparticles using cross-linked polymer (vinyl alcohol). Drug Dev. Ind. Pharm.1997. 23 (6): L 567-574.
20. Aulton ME, Well TI. Pharmaceutics: The Sciences of Dosage form Design, London, England. Churchill Livingstone. 1998, Edition 2, 734.
21. Hadjiioannou TP, Christian GD, koupparisMA. Quantitative calculations in pharmaceutical practices and Research New Dehli, NY: VCH publishers INC; 1993: 345-48.
22. Patil P, Rao SB, Kulkarni SV, Basavaraj, Surpur C, Ammanage A. Formulation and Evaluation of Floating Matrix Tablets of Ofloxacin; Department of pharmaceutics. 2011. 17-22.
23. Bansal K, Pant P, Therdana R, Rao P, Padhee K, Sathapathy P. Development and evaluation of Dienogest Vaginal tablet for treatment of endometrosis, Jagsonpal pharmaceuticals, Uttarakhand, ISSN: 2229-3701.
24. Amish D, Sheth NR, Patel HJ, Shukla TM,Patel HM. Formulation and evaluation once daily mucoadhesive vaginal tablet of clotrimazole using natural and synthetic polymers, Sarashtra university, 2011, VOL-01, ISSUE-04.
25. Kailasam P, Jamunadhevi V, Kaur G. Formulation and evaluation of once daily mucoadhesive vaginal tablet of metronidazole, Delhi institute of pharmaceutical sciences and research, New Delhi, 2010, Vol 1, Issue 3.
26. Patel A, Patel J. Design, Development and In-Vitro evaluation of sertaconazolemucoadhesive vaginal tablet, Nootan Pharmacy college, Gujrat, 2012, 4 (2):418-427.
27. BhatSR, Shivakumar HG; Bioadhesive controlled release clotrimazole vaginal tablets, JSS University, Mysore, 2010, 9 (4): 339-346.
28. Wagner JG. Interpretation of percent dissolved-time plots derived from in vitro testing of conventional tablets and capsules. J Pharm Sci. 58, 1969, 1253-1257.
29. Higuchi T. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 52, 1963, 1145-1149.
30. Katzhendler I, Hoffman A, Goldberger A, Friedman M. Modeling of drug release from erodible tablets. J Pharm Sci. 86, 1997, 110-115.