Material and Tableting Properties of Theophylline Solid Dispersions
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Abstract
This study was carried out to evaluate the material and tableting properties of theophylline solid dispersions (SDs) prepared by the solvent evaporation technique using Eudragit polymers (RS 100 & RSPO) as carriers. The dispersions were directly compressed into tablets using microcrystalline cellulose (MCC) as filler/binder. Compatibility studies of the prepared dispersions were conducted using FTIR, DSC and TLC while physicotechnical properties of the tablets were evaluated. Results of compatibility studies revealed no chemical interaction between theophylline and the selected polymers. All the tablet properties evaluated were in conformity with the USP specifications. In vitro drug release was observed to be prolonged for about 24 h and the mechanism of drug release was principally by diffusion. Stability studies showed that drug content of all the tablets remained within the official specifications after three months. Overall, the material properties of the SDs were consistent with good tableting properties as confirmed by the tablets produced.
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References
Aiman AO (2013). Modulation of the micro-environmental pH and its influence on the gel layer behavior and release of theophylline from hydrophilic matrices. Int J Pharma Bio Sciences 4(2):794 – 802
Allen LV, Popovich NG, Ansel HC (2005). Ansel?s pharmaceutical dosage forms and drug delivery systems. Lippincott Williams and Wilkins, Philadelphia
Apu AS, Pathan AH, Kibria G, Jalil R (2009). In vitro release kinetic study of theophylline from Eudragit RS PO and Eudragit RL PO matrix tablets. Dhaka Univ J Pharm Sci 8(1): 1-6
Apurba SA, Atiqul HP, Golam K, Reza U J (2009). In vitro release kinetic study of theophylline from Eudragit RSPO and Eudragit RLPO matrix tablets. Dhaka Univ J Pharm Sci 8(1): 1 – 6
Balami A (1991). Evaluation of Cissus populnea bark mucilage as a tablet binder, emulsifying agent and suspending agent. Dissertation, Ahmadu Bello University, Zaria
Chau Le-Ngoc V, Chulhun P, Beom-Jin L, Vo CL-N, Park C, Lee B-J (2013). Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm 85:799-813
Chowhan ZT (1998). Tablet ingredients.http://www.fmcbiopolymer.com/Portals/Pharm/Content/Docs/PS/04 TabletIngredients.pdf. Accessed 22 December 2012
Chris Brougha RO, Williams III (2013). Amorphous solid dispersions and nano-crystal technologies for poor water-soluble drug delivery. Int J Pharm 453:157-166
Fassihi RA, Ritschel NA (1993). Multiple layer, direct compression controlled release system: in vitro and in vivo evaluation. J Pharm Sci 82:750 – 754
Gohel MC, Jogani PD (2005). A review of co-processed directly compressible excipients. J Pharmacy Pharm Sci 8(1):76-93
Itishree J, Hamansu B, Suddhasaltya D (2011). Enhancement of dissolution rate of piroxicam using solid dispersion with PEG 600 and Eudragit RL 100. J Pharmacy Res 4(5): 1473 – 1479
Kamlesh JW, Rajendra BK, Milind JU (2012). Formulation and evaluation of sustained release tablets of metformin hydrochloride by solid dispersion technique using pH dependent and pH independent Eudragit polymers. Ars Pharm 53(1): 28-36
Kibbe AH (2000). Handbook of pharmaceutical excipients. American Pharmaceutical Association, Washington DC
Korhonen O, Pohja S, Peltonen S, Suikho E, Mika V, Paronen P, Ketolainen J (2002). Physical properties of starch acetate powders on tableting. AAPS PharmSciTech 3(4): 1 – 9
Kulkami P, Dixit M, Panur S, Achin J. (2012). Improvement of solubility and dissolution rate of piroxicam by solid dispersion in PEG 4000. Int Res J Pharmacy 3(4): 231 – 235
Kumar K, Bhowmik D, Srivastara S (2012). Sustained release drug delivery system potential. The Pharma Innov 1(2):48 – 60
Marwa HA, Omaina AS, Hanaa AE, Hanan ME, Waleed B (2012). Development and characterization of controlled release ketoprofen microspheres. J Appl Pharm Sci 2(3): 60 – 67
Nayak A, Jain A (2011). In-vitro and in-vivo study of poly ethylene glycol conjugated ibuprofen to extend the duration of action. Sci Pharm 79: 359 – 363
Odeku OA, Itiola OA (2003). Effects of interacting variables on the tensile strength and release properties of paracetamol tablets. Trop J Pharm Res 2(1):147 – 153
Orugun OA, Oyi A, Olowosulu A, Apeji Y, Olayemi O (2016). Effect of Eudragit on the release behaviour of theophylline solid dispersions. ?es slov Farm 65: 226–231
Patel S, Kou X, Hou HH, Huang YB, Strong JC, Zhang GGZ, Sun CC (2017). Mechanical properties and tableting behavior of amorphous solid dispersions. J Pharm Sci 106(1):217-223
Poovi G, Umamahaswari M, Sharmila S, Kumar S, Rajalakshimi N (2013). Development of domperidone solid dispersions powders using sodium alginate as carrier. Eur J Appl Sci 5(2): 36 – 42
Siepmann J, Peppas NA (2001). Modelling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC). Adv Drug Del Rev 48(2):139-57
Shivkumar HN, Desai BG, Deshmukh G (2008). Design and optimization of diclofenac sodium controlled release solid dispersion by response surface methodology. Indian J Pharm Sci 70: 22 – 30
Suvakanta D, Padala N, Lilakanta N, Prasanta C (2010). Kinetic modeling of drug release from controlled drug delivery systems. Acta Poloniae Phamaceutica – Drug Research 67: 217 – 223
Tiekink ER, Vittal J, Zaworotko M (Eds.) (2010). Organic crystal engineering: Frontiers in crystal engineering. John Wiley & Sons.
Uhumwangho MU, Ramana MK (2011). In-vitro characterization of optimized multi – unit dosage forms of theophylline and its solid state characterization. J Applied Sci Env Mgmt 15(4): 649 - 655.
United States Pharmacopeia (2011) Published by the United States Pharmacopoeia convention
Verma S, Rudraraju VS (2015). Disintegration mediated controlled release supersaturating solid dispersion formulation of an insoluble drug: design, development, optimization, and in vitro evaluation. AAPS PharmSciTech 16(1): 85-97.
www.chem.zenkyo.h.kyoto – u.ac.jp/operation.