Volume : 13, Issue : 11, November – 2026
Title:
FORMULATION AND CHARACTERIZATION OF METHOTREXATE CONTROL RELEASE TABLETS
Authors :
Rajani Lagisetty, Dur E Sameen Sameena,Pandiri Joanna Nithya,Yanimalla Kalyani, Kotte Kushma, Pampati Lahari
Abstract :
The present study was aimed at the formulation and evaluation of Methotrexate controlled release matrix tablets using suitable hydrophilic polymers to achieve sustained drug release and improve therapeutic efficacy. Methotrexate is an antimetabolite and antifolate drug widely used in the treatment of various cancers and autoimmune disorders. Controlled release dosage forms can reduce dosing frequency, maintain therapeutic drug concentrations, and enhance patient compliance.Methotrexate matrix tablets were prepared by the direct compression method using Sodium Alginate and Guar Gum as release-retarding polymers. The powder blends exhibited good flow properties suitable for tablet compression.The prepared tablets were evaluated for weight variation, thickness, hardness, friability, and drug content. All formulations showed acceptable physicochemical properties and complied with pharmacopeial specifications. In vitro dissolution studies demonstrated sustained drug release from the matrix tablets over a period of 8 hours. Among the four formulations, F3 exhibited the most desirable performance with satisfactory tablet characteristics, high drug content (98.83%), and maximum cumulative drug release (98.36%).Stability studies of the optimized formulation (F3) carried out under different storage conditions showed no significant changes in physicochemical properties or drug content, indicating good stability of the formulation.The results of the present investigation demonstrate that Methotrexate controlled release matrix tablets can be successfully formulated using suitable polymers, and formulation F3 was found to be the optimized formulation for providing sustained drug release with acceptable stability and tablet characteristics.
Keywords: Methotrexate, FTIR Studies, Polymers, Direct compression technique, In vitro drug release studies
Cite This Article:
Please cite this article in press Rajani Lagisetty et al., Formulation And Characterization Of Methotrexate Control Release Tablets.,. Indo Am. J. P. Sci, 2026; 13(11).
REFERENCES:
1. Diclofenac controlled release tablets employing olibanum resin, IJPSR, 2012; Vol. 3(4): 1090-1095
2. Dwarakanadha Reddy peram, Surya prakash,A, Swarnalatha.D, Usha Sree , Formulation and Evaluation of Ethyl Cellulose Coated Microcapsules of Glibenclamide for Controlled Release, Asian Journal of Chemistry; Vol. 26, No. 3 (2014), 770-772
3. Sujata D. Bansode*, Veena S. Kasture, Sarita S. Pawar, Sanjay B. Kasture, Formulation and evaluation of telmisartan microspheres by emulsion solvent evaporation technique, Journal of Applied Pharmaceutical Science Vol. 2 (10), pp. 113-116, October, 2012.
4. GR. Girish Reddy, Design and Evaluation of Sustained Release Capsule of Telmisartan, international journal of advances in pharmacy, biology and chemistry, Vol. 1(3), Jul- Sep, 2012.
5. Avachat, A., and V., Kotwal, 2007 Design and evaluation of matrix-based controlled release tablets of diclofenac sodium and chondroitin sulphate. AAPS PharmSciTech. 8(4):E88. [PMID: 18181548]
6. Kulkarni G.T, Gowthamarajan K, Suresh B. stability testing of pharmaceutical product: an overview. Indian J Phar Edu. 2004, 38(4): p.no.194-202
7. 71) Kanvide S A, Kulkarni M S, Stability of oral solid dosage form: A global perspective. Pharma Time 2005,37(5):p.no. 9-15
8. 72) Mohrle R. Effervescent tablets in Liberman HA, Lachman L, editor. Pharmaceutical dosage form –Tablet, Marcel Dekker Inc, New York:1980, p.no. -232-246(vol-1)
9. 73) Khan G.M., Zhu J.B, “Studies on drug release kinetics from ibuprofun carbomer hydrophilic matrix tablets” J. Cont. Rel.,1999, 57, p.no.197-203.
10. 74) Hoyashi T, Kanbe H, Okado M. Suzuki M, Sonobe T. “formulation study and drug release mechanism of a new theophylline Sustained Release preparation” Int. J. Pharm, 2005,304, p.no. 91-101.
11. 75) Solinis M.A, Cruz Y. De, Gascon A, Calvo B, Pedraz J. L “Release of Ketoprofen enantiomeres from HPMC K100M matrices –Diffusion studies” Int. J. Pharm., 2002,239, p.no. 61-68.
12. 76)Qiu Y. Chidambaram N, Porter W. Flood K., “Formulation and characterization of new diffusional matrices for Zero – order sustained release” J. Cont. Rel., 1998,52, p.no.149-158.
13. Leon Shargel, Susanna Pong, Andrew B.C., Applied Biopharmaceutics and Pharmacokinetics, Modified-Release Drug Products, Pg 515 Fifth Edition, 2004
14. Chien Y.W., Controlled- and modulated-release drug-delivery systems. Encyclopedia of pharmaceutical technology. New York, Dekker, pgs 281-313, 1992.
15. J. R. Robinson, S. P. Eriksen, Theoretical formulation of sustained-release dosage forms.J Pharm Sci. 1966.
16. Gilbert S. Banker, Christopher T. Rhodes, Modern Pharmaceutics, Sustained – and Controlled -release drug-delivery systems, Pg 505 Fourth Edition, 2002