Optimization of Fast Disintegrating Tablets Diphenhydramine HCl using Co-process of Cross-link Yellow Kepok Banana Starch, Crospovidone, and Microcrystalline Cellulose

  • Tias Eka Rahmawati Faculty of Pharmacy, Universitas Muhammadiyah Purwokerto, Banyumas, Central Java, 53182, Indonesia
  • Agus Siswanto Faculty of Pharmacy, Universitas Muhammadiyah Purwokerto, Banyumas, Central Java, 53182, Indonesia
  • Asmiyenti Djaliasrin Djalil Faculty of Pharmacy, Universitas Muhammadiyah Purwokerto, Banyumas, Central Java, 53182, Indonesia

Abstract

Diphenhydramine HCl is an antihistamine drug that is available in conventional tablet form. This study aimed to produce the optimum formula for a diphenhydramine fast disintegrating tablet (FDT) using a modification of starch, crospovidone, and microcrystalline cellulose (MCC) to produce quality tablets that meet the tablet's physical requirements and tablet dissolution. Starch modification was made using a two-step method of starch cross-link, then continued with silica coprecipitation. FDT was prepared by the direct compression method. Optimisation with the simplex lattice design (SLD) model uses three components: co-process starch crosslink-silica, crospovidone, and MCC, which obtained 14 formula designs. The hardness, wetting time, disintegration time, and percent dissolution are optimisation parameters. Equations, contour plots, and desirability values were determined as the optimum formula. Based on the research results, an optimum formula was obtained with the proportion of co-process cross-link starch-silica was 56.185 mg, crospovidone at 6 mg, and MCC at 45.815 mg. The result of hardness was 5 kg, wetting time 51.061 seconds, disintegration time 63.129 seconds, and dissolution was 100.972%. The interaction of the three components reduces hardness and increases disintegration time, wetting time, and percent dissolution.

References

1. Rahmawati TE, Nursoleha E. Formulation of fast disintegrating tablet diphenhydramine HCl using combination of SSG and crospovidone as disintegrant. J Pharm Aisyah. 2022;1(1):1–5.

2. Prajapati BG, Ratnakar N. A review on recent patents on fast dissolving drug delivery system. International Journal of PharmTech Research. 2009;1(3):790-8.

3. Marta H, Cahyana Y, Djali M, Arcot J. A comparative study on the physicochemical and pasting properties of starch and flour from different banana (Musa spp.) cultivars grown in Indonesia. Int J Food Prop. 2019;22(1):1562–75.

4. Dumancela K, Mayorga E, Aguirre JS. Acetylation of starch extracted from rejected fruits of Musa paradi¬siaca L. to obtain a pharmaceutical disintegrant. Pharmacol Pharm. 2020;11(06):118–26.

5. Babalola OC, Odeku OA. Disintegrant properties of banana starch obtained from the unripe fruits of Musa sapientum L. J Appl Pharm Sci. 2014;4(9):83–8.

6. Nsor-Atindana J, Chen M, Goff HD, Zhong F, Sharif HR, Li Y. Functionality and nutritional aspects of microcrystalline cellulose in food. Carbohydrate polymers. 2017;172:159-74.

7. Rahmawati TE, Cahyani IM, Munisih S. Characterization of sucker starch of yellow kepok banana (Musa paradisiaca L.) as pharmaceutical excipient. J Sains dan Kesehat. 2023;5(2):100–8.

8. Heo H, Lee Y-K, Chang YH. Rheological, pasting, and structural properties of potato starch by cross-linking. Int J food Prop. 2017;20(sup2):2138–50.

9. Trisopon K, Kittipongpatana OS. Development of a direct compression excipient from epichlorohydrin‐crosslinked carboxymethyl rice starch with sodium silicate using a coprocessing technique. Starch‐Stärke. 2019;71(5–6):1800220.

10. Jia R, Cui C, Gao L, Qin Y, Ji N, Dai L, Wang Y, Xiong L, Shi R, Sun Q. A review of starch swelling behavior: Its mechanism, determination methods, influencing factors, and influence on food quality. Carbohydrate Polymers. 2023;321:121260.

11. Gautam D, Talwan P. Formulation aspects and manufacturing technology – A review on fast disintegrating tablets. 2023;22(1):1-24

12. Ansari N. Formulation of carbamazepine fast dissolving tablets employing guar gum and croscarmellose sodium as disintegrants. 2021;15(3):2–7.

13. Mangal M, Thakral S, Goswami M, Thakur N. Comparison study between various reported disintegration methods for fast dissolving tablets. African J Basic & Appl Sci. 2012;4(4):106-9.

14. Rahmawati TE, Cahyani IM, Munisih S. Characteriza¬tion of sucker starch of yellow kepok banana (Musa paradisiaca L.) as pharmaceutical excipient. Jurnal Sains dan Kesehatan. 2023;5(2):100-8.

15. Trisopon K, Kittipongpatana OS. Development of a direct compression excipient from epichlorohydrin-crosslinked carboxymethyl rice starch with sodium silicate using a coprocessing technique. Starch/Staerke. 2019;71(5–6):1–8.

16. Tran DT, Majerová D, Veselý M, Kulaviak L, Ruzicka MC, Zámostný P. On the mechanism of colloidal silica action to improve flow properties of pharmaceutical excipients. Int J Pharm. 2019;556:383–94.

17. Dhakal B, Thakur JK, Mahato RK, Rawat I, Rabin DC, Chhetri RR, Shah KP, Adhikari A, Pandey J. Formulation of ebastine fast-disintegrating tablet using coprocessed superdisintegrants and evaluation of quality control parameters. The Scientific World Journal. 2022;2022:1-13

18. Quodbach J, Kleinebudde P. A critical review on tablet disintegration. Pharmaceutical Development and Technology. 2016;21(6):763-74.

19. Chaerunisaa AY, Sriwidodo S, Abdassah M. Microcrystalline cellulose as pharmaceutical excipient. In: Pharmaceutical Formulation Design-Recent Practices. IntechOpen; 2019.

20. Depkes RI. Farmakope Indonesia edisi VI. Departemen Kesehatan Republik Indonesia. 2020.
Published
2023-10-19
How to Cite
RAHMAWATI, Tias Eka; SISWANTO, Agus; DJALIL, Asmiyenti Djaliasrin. Optimization of Fast Disintegrating Tablets Diphenhydramine HCl using Co-process of Cross-link Yellow Kepok Banana Starch, Crospovidone, and Microcrystalline Cellulose. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 21, n. 2, p. 231-238, oct. 2023. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/1406>. Date accessed: 05 nov. 2024. doi: https://doi.org/10.35814/jifi.v21i2.1406.
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Articles