Evaluation of the sustained release properties of hydroxypropylated cassava and potato starches in diclofenac tablet formulations
Paper Details
Evaluation of the sustained release properties of hydroxypropylated cassava and potato starches in diclofenac tablet formulations
Abstract
Hydroxypropylation of starch enhances its potential applications, especially its use in specialized drug delivery systems. The study aimed at exploring the sustained release property of hydroxypropylated (HP) cassava and potato starches in diclofenac sodium tablet formulations. Native cassava and potato starches were hydroxypropylated and used in the preparation of batches of diclofenac powder blends and granules either as powders (filler) or mucilage (binder). Powder blends/granules flow properties were investigated as well as drug-excipient interaction using Fourier transform infra-red spectroscopy prior to tablet compression. Compressed tablets were evaluated for tablet properties and in vitro drug release was compared with a commercial brand. Drug release kinetics and mechanisms of the tablets were determined from the dissolution profiles. Powder blends and granules containing HP starches exhibited excellent flow properties. Drug-excipient studies showed the absence of any interaction. Formulated tablets had uniform weights with concentration-dependent hardness for those prepared with HP starch mucilage and were stronger than those prepared with HP starch powder via direct compression. Tablets incorporated with HP starch mucilage produced non-friable tablets (≤ 1%) while those prepared with powder blends were highly friable (10.00 and 11.39 %). Drug release from the tablets was sustained ranging from 43.60 – 81.67% within 8 h and comparable with that of the commercial brand (44.38%). Kinetics of drug release followed first-order with Hixson-Crowell mechanism of release while the commercial brand favoured zero-order kinetics. The study showed that hydroxypropylated cassava and potato starches have potential to retard the rate of drug release in tablet formulations.
British Pharmacopoeia. 2003. Vol. I and II. Her Majesty’s Stationery Office, London. The Pharmaceutical Press. pp 249-252.
Chavez-Salazar A, Bello-Perez LA, Agama E, Castellanos-Galeano FJ, AlvarezBarreto CI. 2017. Isolation and partial characterization of starch from banana cultivars grown in Colombia. International Journal of Biological Macromolecules 98, 240-246. https://doi.org/10.1016/j.ijbiomac.2017.01.024.
Choi HW, Kim HS. 2022. Hydroxypropylation and acetylation of rice starch: effects of starch protein content. Food Science and Biotechnology 31(9), 1169-1177. http://dx.doi.org/10.1007/s10068-022-01106-y.
Compart J, Singh A, Fettke J, Apriyanto A. 2023. Customizing starch properties: A review of starch modifications and their applications. Polymers (Basel) 15(16), 3491. https://doi.org/10.3390/polym15163491.
Cornejo-Ramírez YI, Martínez-Cruz O, Del Toro-Sánchez CL, Wong-Corral FJ, Borboa-Flores J, Cinco-Moroyoqui FJ. 2018. The structural characteristics of starches and their functional properties. CyTA – Journal of Food 16(1), 1003-1017. https://doi.org/10.1080/19476337.2018.1518343.
Edavalath S, Shivanand K, Prakasam K, Divakar G. 2011. Formulation development and optimization of controlled porosity osmotic pump tablets of diclofenac sodium. International Journal of Pharmacy and Pharmaceutical Sciences 3, 80-87.
El-Farkhani M, Dadou S, El-Miz Y, Elyoussfi A, El-Miz M, Salhi A, Koudad M, Benchat N. 2024. A review of the chemical modification and applications of starch. BIO Web of Conferences 109, 01020. https://doi.org/10.1051/bioconf/202410901020.
Gałkowska D, Kapuśniak K, Juszczak L. 2023. Chemically modified starches as food additives. Molecules 28(22), 7543. https://doi.org/10.3390/molecules28227543.
Guleria P, Yadav BS. 2022. Effect of chemical treatments on the functional, morphological and rheological properties of starch isolated from pigeon pea (Cajanus cajan). Current Research in Food Science 5, 1750-1759. https://doi.org/10.1016/j.crfs.2022.10.001.
Gunaratne A, Corke H. 2007. Effect of hydroxypropylation and alkaline treatment in hydroxypropylation on some structural and physicochemical properties of heat-moisture treated wheat, potato and waxy maize starches. Carbohydrate Polymer 68(2), 305-313. https://doi.org/10.1016/j.carbpol.2006.12.004.
He R, Li S, Zhao G, Zhai L, Qin P, Yang L. 2023. Starch modification with molecular transformation, physicochemical characteristics and industrial usability: A state-of-the-art review. Polymers (Basel). 15(13), 2935. https://doi.org/10.3390/polym15132935.
Iftikhar SA, Chakraborty S, Dutta H. 2022. Effect of acetylation, hydroxypropylation and dual acetylation-hydroxypropylation on physicochemical and digestive properties of rice starches with different amylose content. Bio-interface Research in Applied Chemistry 12(5), 6788-6803. https://doi.org/10.33263/briac125.67886803.
Karim AA, Nadiha MZ, Chen FK, Phuah YP, Chui YM, Fazilah A. 2008. Pasting and retrogradation properties of alkali-treated sago (Metroxylon sagu) starch. Food Hydrocolloids 22(6), 1044-1053. https://doi.org/10.1016/j.foodhyd.2007.05.011.
Korma SA, Alahmad K, Niazi S, Ammar AF, Zaaboul F, Zhang T. 2016. Chemically modified starch and utilization in food stuffs. International Journal of Nutrition and Food Sciences 5(4), 264-272. https://doi.org/10.11648/j.ijnfs.20160504.15.
Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. 1983. Mechanisms of solute release from porous hydrophilic polymers. International Journal of Pharmacy 15, 25-35. https://doi.org/10.1016/0378-5173(83)90064-9.
Koster C, Kleinebudde P. 2024. Evaluation of binders in twin-screw wet granulation– Optimization of tabletability. International Journal of Pharmaceutics 659, 1-10. https://doi.org/10.1016/j.ijpharm.2024.124290.
Mohamed IO. 2021. Effects of processing and additives on starch physicochemical and digestibility properties. Carbohydrate Polymer Technologies and Applications 2, 100039. https://doi.org/10.1016/j.carpta.2021.100039.
Mudiaga-Ojemu BO, Eraga SO, Iwuagwu MA. 2023. Characterization of hydroxypropylated cassava and potato starches: Functional and physicotechnical properties. Journal of Science and Practice of Pharmacy 10(1), 489-498. https://doi.org/10.47227/jsppharm.v10i1.1.
Odeku O, Picker-Freyer KM. 2009. Evaluation of the material and tablet formation properties of modified forms of Dioscorea starches. Drug Development and Industrial Pharmacy 35(11), 1389-406. https://doi.org/10.3109/03639040902960185.
Odeku OA, Itiola OA. 2003. Effects of interacting variables on the tensile strength and the release properties of paracetamol tablets. Tropical Journal of Pharmaceutical Research 2(1), 147-153.
Okunlola A, Alade OO, Odeku OA. 2017. Formulation of metronidazole tablets using hydroxypropylated white yam (Dioscorea rotundata) starch as the binding agent. Journal of Excipients and Food Chemistry 8(1), 2017-2027.
Olayinka FS, Olayinka OO, Olu-Owolabi BI, Adebowale KO. 2015. Effect of chemical modifications on thermal, rheological and morphological properties of yellow sorghum starch. Journal of Food Science and Technology 52(12), 8364-8370. https://doi.org/10.1007/s13197-015-1891-3.
Paramasivam SK, Subramaniyan P, Thayumanavan S, Shiva KN, Narayanan S, Raman P, Subbaraya U. 2023. Influence of chemical modifications on dynamic rheological behaviour, thermal techno-functionalities, morpho-structural characteristics and prebiotic activity of banana starches. International Journal of Biological Macromolecules 249, 126125. https://doi.org/10.1016/j.ijbiomac.2023.126125.
Rashwan AK, Younis HA, Abdelshafy AM, Osman AI, Eletmany MR, Hafouda MA, Chen W. 2024. Plant starch extraction, modification, and green applications: A review. Environmental Chemistry Letters 22, 2483-2530. https://doi.org/10.1007/s10311-024-01753-z.
Senanayake SA, Gunaratne A, Ranaweera KKDS, Bamunuarachchi A. 2014. Effect of hydroxypropylation on functional properties of different cultivars of sweet potato starch in Sri Lanka. International Journal of Food Science 2014, 148982. https://doi.org/10.1155/2014/148982.
Shen Y, Yao Y, Wang Z, Wu H. 2021. Hydroxypropylation reduces gelatinization temperature of corn starch for textile sizing. Cellulose 28, 5123-5134. https://doi.org/10.1007/s10570-021-03852-4.
Shivakumar HN, Desai BG, Deshmukh G. 2008. Design and optimization of diclofenac sodium-controlled release solid dispersions by response surface methodology. Indian Journal of Pharmaceutical Sciences 70, 22-30. https://doi.org/10.4103/0250-474X.40327.
Singh J, Kaur L, McCarthy OJ. 2007. Factors influencing the physicochemical, morphological, thermal and rheological properties of some chemically modified starches for food applications-A review. Food Hydrocolloids 21, 1-22. https://doi.org/10.1016/j.foodhyd.2006.02.006.
Turner S, Federici C, Hite M, Fassihi R. 2004. Formulation development and human in-vitro/in-vivo correlation fora novel, monolithic controlled-release matrix system of high load and highly water-soluble drug niacin. Drug Development and Industrial Pharmacy 30(8), 797-807. https://doi.org/10.1081/ddc-200026747.
Zhu J, Han L, Wang M, Yang J, Fang Y, Zheng Q, Zhang X, Cao J, Hu B. 2024. Formation, influencing factors, and applications of internal channels in starch: A review. Food Chemistry: X 21, 101196. https://doi.org/10.1016/j.fochx.2024.101196.
Sylvester O. Eraga, Bibiana O. Mudiaga-Ojemu, Hikmat I. Ishaq, Olubunmi J. Olayemi, Magnus A. Iwuagwu, 2025. Evaluation of the sustained release properties of hydroxypropylated cassava and potato starches in diclofenac tablet formulations. Int. J. Biomol. Biomed., 21(1), 1-11.
Copyright © 2025 by the Authors. This article is an open access article and distributed under the terms and conditions of the Creative Commons Attribution 4.0 (CC BY 4.0) license.