Characterization and safety assessment of Hydroxypropyl Musa paradisiaca starch for pharmaceutical applications

Samyuktha Metta Suvendu Kumar Sahoo   

Open Access   

Published:  May 09, 2024

DOI: 10.7324/JAPS.2024.174568

The aim of the current investigation was to produce native banana starch (NBS) and hydroxypropyl banana starch (HPBS) , assess physicochemical properties, and evaluate toxicity. NBS was modified to its propyl form with a propylene oxide solution and characterized. The physicochemical properties of NBS and HPBS met the required specifications. The amylose content of NBS was found to be 25.41% ± 0.08%. The degree of substitution and hydroxyl propyl group % were found to be 0.028 and 2.894, respectively, which were within the Food and Drug Administration’s (FDA’s) acceptable limits of 0.2% and 7%, respectively. The NBS possesses superior swelling power (26.68 ± 1.06) compared to the HPBS swelling power (15.66 ± 0.61). In terms of soluble starch content (%), HPBS displayed a higher soluble starch content percentage (69.21 ± 2.04) compared to the NBS (17.01 ± 1.06). The HPBS yielded high viscosity relative to the NBS in all the concentrations of starch solutions. The increase in the soluble starch content and viscosity of propyl starch may be attributed to the increased number of hydroxy propyl group substitutions in the HPBS. For up to 14 days of the experimental period in the acute toxicity studies, the rats showed no symptoms of toxicity or fatalities. According to the findings of the subacute toxicity studies, neither the hematological nor the biochemical analyses showed any apparent abnormalities. The study’s overall results show that HPBS were safe up to doses of 1,000 mg/kg body weight, which may be regarded as a safe dosage. The modified starch’s enhanced physicochemical properties make it suitable for industrial use, and it meets FDA-approved limits, affirming its safety as a pharmaceutical excipient.

Keyword:     Native banana starch hydroxypropyl banana starch degree of substitution acute toxicity subacute toxicity


Metta S, Sahoo SK. Characterization and safety assessment of Hydroxypropyl Musa paradisiaca starch for pharmaceutical applications. J Appl Pharm Sci. 2024. Online First.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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1. Wang X, Huang L, Zhang C, Deng Y, Xie P, Liu L, et al. Research advances in chemical modifications of starch for hydrophobicity and its applications: a review. Carbohydr Polym. 2020;240:116292. doi:

2. Builders PF, Arhewoh MI. Pharmaceutical applications of native starch in conventional drug delivery. Starch. 2016;68:864–73. doi:

3. Lawal MV. Modified starches as direct compression excipients—effect of physical and chemical modifications on tablet properties: a review. Starch. 2018;71:1800040. doi:

4. Masina N, Choonara YE, Kumar P, du Toit LC, Govender M, Indermun S, et al. A review of the chemical modification techniques of starch. Carbohydr Polym. 2017;157:1226–36. doi:

5. Lemos PVF, Marcelino HR, Cardoso LG, de Souza CO, Druzian JI. Starch chemical modifications applied to drug delivery systems: from fundamentals to FDA-approved raw materials. Int J Biol Macromol. 2021;184:218–34. doi:

6. Kunle OO. Review: pharmaceutical grade starch and some of its potential sources in Nigeria. J Phytomed Ther. 2002;7(1 & 2):1–17.

7. Benyerbah N, Ispas-Szabo P, Sakeer K, Chapdelaine D, Mateescu MA. Ampholytic and polyelectrolytic starch as matrices for controlled drug delivery. Pharmaceutics. 2019;11:253. doi:

8. Lemos PVF, Opretzka LCF, Almeida LS, Cardoso LG, da Silva JBA, de Souza CO, et al. Preparation and characterization of C-phycocyanin coated with STMP/STPP cross-linked starches from different botanical sources. Int J Biol Macromol. 2020;159:739–50. doi:

9. Mora CP, Martinez-Alejo JM, Roman L, Martinez MM, Carvajal T, Pinal R, et al. Molecular and physical characterization of octenyl succinic anhydride-modified starches with potential applications in pharmaceutics. Int J Pharm. 2020;579:119163. doi:

10. Bertoft E. Understanding starch structure: recent progress. Agronomy. 2017;7(3):56–67. doi:

11. Quadrado RFN, Fajardo AR. Microparticles based on carboxymethyl starch/chitosan polyelectrolyte complex as vehicles for drug delivery systems. Arab J Chem. 2020;13(1):2183–94. doi:

12. Bhatt P, Kumar V, Goel R, Sharma SK, Kaushik S, Sharma S, et al. Structural modifications and strategies for native starch for applications in advanced drug delivery. Biomed Res Int. 2022;2022:1–14. doi:

13. Heslop-Harrison JS, Schwarzacher T. Domestication, genomics and the future for banana. Ann Bot. 2007;100(5):1073–84.

14. Jyothi AN, Sajeev MS, Sreekumar JN. Hydrothermal modifications of tropical tuber starches. 1. Effect of heat-moisture treatment on the physicochemical, rheological and gelatinization characteristics. Starch Stärke. 2010;62:28–40. doi:

15. Bello-Pérez LA, Romero-Manilla R, Paredes-López O. Preparation and properties of physically modified banana starch prepared by alcoholic-alkaline treatment. Starch Stärke. 2000;52(5):154–9. doi:<154::aid-star154>;2-#

16. Hadisoewignyo L, Foe K, Tjandrawinata RR. Isolation and characterization of Agung Musa paradisiaca starch from East Java Indonesia. Int Food Res J. 2017;24(3):1324–30.

17. Puri AV, Khandagale PD, Tiwari AU, Chaudhary RH, Kartan SB. Synthesis and physicochemical characterization of banana starch tartrate and its application as disintegrant in Telmisartan tablets. J Drug Deliv Ther. 2020;10(3):65–72. doi:

18. Avaro MR, Pan Z, Yoshida T, Wada Y. Two alternative methods to predict amylose content of rice grain by using tristimulus CIE lab values and developing a specific color board of starch-iodine complex solution. Plant Prod Sci. 2011;14(2):164–8. doi:

19. Dolas K, Ranveer R, Tapre A, Nandane A, Sahoo A. Effect of starch modification on physico-chemical, functional and structural characterization of cassava starch (Manihot esculenta Crantz). Food Res. 2020;4(4):1265–71. doi:

20. Brhane Y, Gebre-Mariam T, Belete A. Synthesis, characterization, and in vivo safety evaluation of propyl Dioscorea abyssinica starch. PLoS One. 2022;17(11):1–15. doi:

21. Awolu O, Odoro JW, Adeloye JB, Lawal OM. Physicochemical evaluation and Fourier transform infrared spectroscopy characterization of quality protein maize starch subjected to different modifications. J Food Sci. 2020;85(10):3052–60. doi:

22. Biliaderis CG, Maurice TJ, Vose JR. Starch gelatinization phenomena studied by differential scanning calorimetry. J Food Sci. 1980;45(6):1669–74. doi:

23. Schmitz S, Dona AC, Castignolles P, Gilbert RG, Gaborieau M. Quantification of the extent of starch dissolution in dimethylsulfoxide by 1 H NMR spectroscopy. Macromol Biosci. 2009;9:506–14.

24. Kaur M, Oberoi DP, Sogi DS, Gill BS. Physicochemical, morphological and pasting properties of acid treated starches from different botanical sources. J Food Sci Technol. 2010;48(4):460–5. doi:

25. Lipnick RL, Cotruvo JA, Hill RN, Bruce RD, Stitzel KA, Walker AP, et al. Comparison of the up-and down, conventional LD50, and fixed dose acute toxicity procedures. Food Chem Toxicol. 1995;33:223–31.

26. Sutrisni N, Soewandhi S, Adnyana I, Sasongko L. Acute and subchronic (28-day) oral toxicity studies on the film formulation of K-Carrageenan and konjac glucomannan for soft capsule application. Sci Pharm. 2019;87(2):1–9. doi:

27. Brígido HP, Varela EL, Gomes AR, Bastos ML, De Oliveira Feitosa A, Do RosárioMarinho AM, et al. Evaluation of acute and subacute toxicity of ethanolic extract and fraction of alkaloids from bark of Aspido spermanitidum in mice. Sci Rep. 2021;11(1):97637–41. doi:

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