Polymers in Medicine
2020, vol. 50, nr 1, January-June, p. 33–40
doi: 10.17219/pim/128473
Publication type: original article
Language: English
License: Creative Commons Attribution 3.0 Unported (CC BY 3.0)
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Evaluation of starch-clay composites as a pharmaceutical excipient in tramadol tablet formulations
1 Department of Pharmaceutics and Industrial Pharmacy, University of Ibadan, Nigeria
2 Chitkara College of Pharmacy, Chitkara University, Patiala, India
Abstract
Background. Co-processing starch with clay nanocomposite has been shown to yield a new class of materials, potentially with better properties than pristine starch, that could be used as directly compressible excipients in tablet formulations.
Objectives. In this study, starches from 3 botanical sources, i.e., millet starch from Pennistum glaucum (L) RBr grains, sorghum starch from Sorghum bicolor L. Moench grains and cocoyam starch from Colocasia esculenta L. Schott tubers, were co-processed with montmorillonite clay (MMT) and evaluated as a directly compressible excipient in tramadol tablet formulations. The effects of different starch-to-clay ratios on the material and drug release properties of the resulting tablets were evaluated.
Material and Methods. The starch-clay composites were prepared by heating a dispersion of the starch in distilled water, then precipitating the dispersion with an equal volume of 95% ethanol. The starch-clay composites were characterized and used as direct compression excipients for the preparation of tramadol tablets. The mechanical and drug release properties of the tablets were evaluated.
Results. Co-processing MMT with the starches yielded starch-clay composites with different material and tablet properties than the pristine starches. The co-processed starch-MMT biocomposites exhibited improved flowability and compressibility over the pristine starches. The mechanical and drug release properties of tramadol tablets containing starch-clay composites were significantly better than those containing only pristine starches. The properties of the starch-clay composites were not related to the botanical source of the starches.
Conclusion. The study showed that starch-clay biocomposites could be used in the controlled release of tramadol.
Key words
starch, tablets, excipients, biocomposite, dissolution test
References (29)
- Bagdi K, Muller P, Pukanszky B. Thermoplastic starch/layered silicate composites: Structure, intercalation, properties. Comp Interf. 2006;13(1):1–17.
- Chiou BS, Yee E, Wood D, Shey J, Glenn G, Orts W. Effects of processing conditions on nanoclay dispersion in starch-clay nanocomposites. Cereal Chem. 2006;83(3):300–305.
- Chung YL, Ansari S, Estevez L, Hayrapetyan S, Giannelis EP, Lai HM. Preparation and properties of biodegradable starch-clay nanocomposites. Carbohyd Polym. 2010;79:391–396.
- Madhumitha G, Fowsiya J, Mohana RS, Thakur VK. Recent advances in starch-clay nanocomposites. Inter J Polym Analy Charac. 2018;23(4):331–345.
- Zhao R, Torley P, Halley PJ. Emerging biodegradable materials: Starch and protein-based bio-nanocomposites. J Mater Sci. 2008;43:3058–3071.
- Odeku OA, Picker-Freyer KM. Analysis of the material and tablet formation properties of four Dioscorea starches. Starch/Stärke. 2007;59(9):430–444.
- Odeku OA. Potentials of tropical starches as pharmaceutical excipients: A review. Starch/Stärke. 2013;65(1–2):89–106.
- Tang X, Alavi S, Herald TJ. Barrier and mechanical properties of starch-clay nanocomposite films. Cereal Chem. 2008;85(3):433–439.
- Thakur G, Singh A, Singh I. Formulation and evaluation of transdermal composite films of chitosan-montmorillonite for the delivery of curcumin. Int J Pharm Investig. 2016;6(1):23–31.
- Giannelis EP. Polymer layered silicate nanocomposites. Advan Mat. 1996;8(1):29–35.
- Paul DR, Robeson LM. Polymer nanotechnology: Nanocomposites. Polymer. 2008;49(15):3187–3204.
- Pavlidou S, Papaspyrides CD. A review on polymer-layered silicate nanocomposites. Prog Polym Sci. 2008;33(12):1119–1198.
- Raquez JM, Narayan R, Dubois P. Recent advances in reactive extrusion processing of biodegradable polymer-based compositions. Macromol Mat Eng. 2008;293:447–470.
- Ray SS, Okamoto M. Polymer/layered silicate nanocomposites: A review from preparation to processing. Prog Poly Sci. 2003;28(11):1539–1641.
- Barton CD, Karathanasis AD. Clay minerals. In: Encyclopedia of Soil Science. New York, NY: Marcel Dekker Inc. US; 2007:187–190.
- Yang H, Wang W, Zhang J, Wang A. Preparation, characterization, and drug-release behaviors of a pH-sensitive composite hydrogel bead based on guar gum, attapulgite, and sodium alginate. Int J Polym Mater Polym Biomater. 2012;62(7):369–376.
- Odeku OA, Awe OO, Popoola B, Odeniyi MA, Itiola OA. Compression and mechanical properties of tablet formulations containing corn, sweet potato, and cocoyam starches as binders. Pharm Tech. 2005;29(4):82.
- Dare K, Akin-Ajani DO, Odeku OA, Odusote OM, Itiola OA. Effects of pigeon pea and plantain starches on the compressional, mechanical and disintegration properties of paracetamol tablets. Drug Dev Ind Pharm. 2006;32(3):357–365.
- Alabi CO, Singh I, Odeku OA. Evaluation of natural and pregelatinized forms of three tropical starches as excipients in tramadol tablet formulation. J Pharm Investig. 2018;48(3):333–340.
- Kizilbash A, Ngô-Minh C. Review of extended-release formulations of tramadol for the management of chronic non-cancer pain: Focus on marketed formulations. J Pain Res. 2014;7:149–161.
- Young AH, In: Whistler RL, BeMiller JN, Pashall EF, eds. Starch Chemistry and Technology. London, UK: Academic Press; 1984:183–184,249–283.
- Goel H, Kaur G, Tiwary A. K, Rana A. Formulation development of stronger and quick disintegrating tablets: A crucial effect of chitin. Yakugaku Zasshi. 2010;130(5):729–735.
- European Pharmacopoeia: Directorate for the Quality of Medicines of the Council of Europe. 5th ed. Strasbourg, France. 2007.
- Carr RL. Evaluating flow properties of solids. Chem Eng. 1965;72:163–168.
- Müller CMO, Laurindo JB, Yamashita F. Composites of thermoplastic starch and nanoclays produced by extrusion and thermopressing. Carbohyd Polym. 2012;89(2):504–510.
- Weiss J, Takhistov P, McClements J. Functional materials in food nanotechnology. J Food Sci. 2006;71(9):R107–R116.
- Odeku OA, Schmid W, Picker-Freyer KM. Material and tablet properties of pregelatinized (thermally modified) Dioscorea starches. Eur J Pharm Biopharm. 2008;70(1):357–371.
- Manek RV, Builders PF, Kolling WM, Emeje M, Kunle OO. Physicochemical and binder properties of starch obtained from Cyperus esculentus. AAPS PharmSciTech. 2012;13(2):379–388.
- Odeku OA, Itiola OA. Evaluation of the effects of khaya gum on the mechanical and release properties of paracetamol tablets. Drug Dev Ind Pharm. 2003;29(3):311–320.