PREPARATION AND IN VITRO EVALUATION OF SOLID DISPERSIONS CONTAINING NIFEDIPINE
Abstract
The objective of this study was to develop solid dispersions of Nifedipine which has low aqueous solubility and bioavailability. Preliminary solubility studies were carried out using various hydrophilic polymers. The formulations were then optimized and evaluated by in-vitro dissolution studies, X-ray diffraction, FTIR and SEM. Formulation with 1:4:2 ratios of Nifedipine, Labrosol and SLS was found to be the best as it possessed better drug release properties compared to pure drug and other physical mixtures. The optimized formulation SD12 was found to have better drug release of 98.74 ± 5.19% in 90 minutes. From FTIR studies no interaction was takes place between drug and polymers. XRD peaks indicate the successful transformation of drug from crystalline to amorphous form. The final results indicate that the solid dispersion of Nifedipine remained stable over 90 days.
Keywords:
Nifedipine, Solid dispersions, Hypertension, Labrosol, Solubility.DOI
https://doi.org/10.25004/IJPSDR.2018.100408References
Venkat YB, AdhikraoVY. Enhancement of solubility and dissolution rate of BCS class II pharmaceuticals by non aqueous granulation technique. International Journal of Pharma Research and Development. 2010; 1: 1‐12.
Serajuddin ATM. Solid dispersion of poorly water‐soluble drugs: early promises, subsequent problems, and recent breakthroughs. J. Pharm. Sci. 1999; 88: 1058‐1066.
Christian L, Jennifer D. Improving drug solubility for oral deliveryusing solid dispersions. Eur. J. Pharm. Biopharm. 2000; 50: 47‐ 60.
Rogers JA, Anderson AJ. Physical characteristics and dissolution profiles of ketoprofen‐urea solid dispersions. Pharmaceutica Acta Helvetiae. 1982; 57: 276‐281.
Murali Mohan Babu GV, Prasad CHDS, Ramana Murthy KV. Evaluation of modified gum karaya as carrier for the dissolution enhancement of poorly water soluble drug nimodipine. Int. J. Pharm. 2002; 234:117.
El‐Gazayerly ON. Characterization and evaluation of tenoxicam co precipitates. Drug Dev. Ind. Pharm. 2000; 26: 925‐930.
https://www.drugs.com/dosage/nifedipine.html
Ford JL. The current status of solid dispersions. Pharm Acta Helv. 53: 93‐98 (1986).
Chiou WL, Riegelman S. Pharmaceutical applications of solid dispersion systems. J Pharm Sci. 1971; 60(9): 1281-302.
Butler and Mattew J. Method of producing a solid dispersion of a poorly water-soluble drug. 1999; United State Patent No. 5985326.
Kim EJ, Chun MK, Jang JS, Lee I H, Lee KR, Choi HK. Preparation of a solid dispersion of felodipine using a solvent wetting method. Eur J pharm Biopharm. 2006; 64(2): 200-5.
Higuchi T, Connors K. Phase-solubility techniques. Adv Anal Chem Instrum. 1965; 4:117-212.
Chen S, Zhu J, Ma F, Fang Q, Li Y. Preparation and characterization of solid dispersions of dipyridamole with a carrier "copolyvidonum Plasdone S-630". Drug Dev Ind Pharm. 2007; 33(8): 888-99.
Lakshmi K, Reddy MPK, Kaza R. Dissolution enhancement of telmisartan by surface solid dispersion technology. International Journal of Innovative Pharmaceutical Research. 2012; 3(4): 247-251.
Shingala K, Chauhan CS, Dumaniya D, Patel B. Formulation development and evaluation of immediate release tablet of poorly soluble Candesartan Cilexetil. Journal of Pharmaceutical science and Bioscientific Research. 2013; 3 (2): 77-90.
Valizadeh H, Nokhodchi A, Qarakhani N. Physicochemical characterization of solid dispersions of nifedipine with PEG 6000, Myrj 52, lactose, sorbitol, dextrin, and Eudragit E100. Drug Dev IndPharm. 2004; 30(3):303-17.
Yang M, Wang P, Huang CY. Solid dispersion of acetaminophen and poly (ethylene oxide) prepared by hot-melt mixing. Int J Pharm. 2010; 395(1-2):53-61.
Chaulang G, Patel P, Hardikar S, Kelkar M, Bhosale A, Bhise S. Formulation and Evaluation of Solid Dispersions of Furosemide in Sodium Starch Glycolate. Tropical Journal of Pharmaceutical Research. 2009. 8(1): 43-51.
Shamma RN, Basha M. Soluplus®: A novel polymeric solubilizer for optimization of Carvedilol solid dispersions: Formulation design and effect of method of preparation. Powder Technology. 2013; 237: 406–414.
Breitenbach J. Melt extrusion: From process to drug delivery technology. Eur J Pharm Biopharm. 2002; 54: 107–117.
Dhirendra K, Lewis S, Udupa N, Atin K. Solid Dispersions: A Review. Pak. J. Pharm. Sci. 2009; 22(2):234-246.
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