FORMULATION AND EVALUATION OF FLUVOXAMINE CONTROLLED RELEASE TABLETS
A controlled drug delivery system is usually designed to deliver the drug at the particular rate. The performance of a drug presented as a controlled-release system depends upon its release from the formulation. Movement within the body during its passage to the site of action. The former depends upon the fabrication of the formulation and the physicochemical properties of the drug while the latter element is dependent upon pharmacokinetics of drug. In comparison to conventional dosage form where the rate-limiting step in drug availability is usually absorption through the biomembrane, the rate-determining step in the availability of a drug from controlled delivery system is the rate of release of drug from the dosage form which is much smaller than the intrinsic absorption rate for the drug. The objective of the development programme was to formulate a robust, stable formulation of Fluvoxamine controlled release tablets 100mg comparable to the reference product Fluvoxin CR 100mg(Luvox) in terms of in-vitro dissolution profile. Matrix tablets were compressed without any problem and do not require any change in ratio of excipients in formulation. Results of the present study demonstrated that hydrophilic polymers could be successfully employed for formulating controlled-release matrix tablet of fluvoxamine. Formulations containing polymer percentage 15% controlled the drug release for 12 h. The combination of drug Fluvoxamine, lubricant [SSF] and glidant[Aerosil] was showed high drug release profile. Wet granulation method was found to be better choice to extend the drug release for 12 h. Film coating of tablet is beneficial for protecting the drug.Keywords: Controlled release tablet, Orally controlled drugs, Rate determining step, Controlled drug delivery systems, Fluvoxamine.
2. Agarwal SP, Vasudha S, Anitha P. Spectrophotometric determination of atenolol and timolol dosage forms via charge-transfer complexation. Indian J Pharm Sci 1998;(2)53-5.
3. Amelia A, Vikram K. Design and evaluation of matrix-based controlled release tablets of diclofenac sodium and chondriotin sulphate. Am Assoc Pharm Sci 2007;8(4):88-97.
4. Anna ViridÃ©n, Bengt Wittgren, Anette Larsson. Investigation of critical polymer properties for polymer release and swelling of HPMC matrix tablets. Eur J Pharm Sci 2009;36:297â€“309.
5. Atul K, Ashok KT, Narendra KJ, Subheet J. Formulation and in vitro in vivo evaluation of extended-release matrix tablet of zidovudine: Influence of combination of hydrophilic and hydrophobic matrix formers. Am Assoc Pharm Sci 2006;7:1-10.
6. Basak SC, Jayakumar Reddy BM, Lucas Mani KP. Formulation and release behaviour of sustained release ambroxol hydrochloride HPMC matrix tablet. Indian J Pharm Sci 2006;6:594-7.
7. Bhalla HL, Handa AK. Development and evaluation of controlled release tablets of carbamazepine. Indian Drugs 1999(2):100-5.
8. Bolton S, Bon C. Pharmaceutical Statistics: Practical and Clinical Applications. Marcel Dekker, New York; 2004. p. 23-6.
9. Bourne DW. Pharmacokinetics. In: Banker GS, Rhodes CT. eds. Modern Pharmaceutics. 4th ed. Marcel Dekker, New York, NY; 2002;4:67-92.
10. Bramhanker DM, Jaiswal SB. Controlled release medications. In: Biopharmaceutics and Pharmacokinetics a treatise. Vallabh Prakashan 1995;6:335-75.
11. Carmen AL, Haruviki H, Jose GA, Ramon MP, Consuelo S, Angel C. Soft contact lenses capable of sustained delivery of timolol. J Pharm Sci 2002;91(10):2182-92.
12. Chetoni P, Mariotti Bianchi L, Giannaccini B, Saettone MF, Conte U, Sangalli ME. Ocular mini-tablets for controlled release of timolol: evaluation in rabbits. J Ocul Pharmacol Ther 1996;3:245-52.
13. Chien YW. Controlled and modulated-release drug delivery systems. In: Swarbrick J, Balyan JC. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker; 1990;2:281-313.
14. Chien YW. Novel drug delivery systems. 2nd ed. New York: Marcel Dekker, Inc; 1992;2:303-39.
15. Colombo P, Bettini R, Catellani PL. Drug volume fraction profile in the gel phase and drug release kinetics in hydroxypropylmethylcellulose matrices containing a soluble drug. Eur J Pharm Sci 1999;(9):33-40.
16. Colombo P, Bettini R, Massimo G. Drug diffusion front movement is important in drug release control from swellable matrix tablets. J Pharm Sci 1995;(8):991-7.
17. Colombo P, Bettini R, Santi P, Peppas NA. Swellable matrices for controlled drug delivery: gel-layer behaviour, mechanisms and optimal performance. Pharm Sci Technol Today 2000;3:198-204.