Optimiation of sodium starch glycolate and maltodextrin in chlorpheniramine maleate fast disintegrating tablet (FDT) by factorial design

  • Kezia Liviathi Kirana Budhi Sutristio Faculty of Pharmacy, Sanata Dharma University, Yogyakarta, 55281, Indonesia
  • Agatha Budi Susiana lestari Faculty of Pharmacy, Sanata Dharma University, Yogyakarta, 55281, Indonesia

Abstract

Chlorpheniramine maleate (CTM) is an antihistamine that is widely available on the market in tablet form. It needs to be formulated in the form of Fast Disintegrating Tablets (FDT) to produce a faster therapeutic effect to treat allergy symptoms, which are often irritating. The FDT contains a super disintegrant to regulate the disintegration speed of tablet and a binder to provide the ability to bind between powders. This research was conducted to obtain the effect of Sodium Starch Glycolate (SSG) as a super disintegrant and maltodextrin as a binder, and their interaction in the chlorpheniramine maleate tablet formulation. This research was categorized as true experimental designs with FDT quality parameters such as organoleptic, hardness, friability, disintegration time, wetting time, water absorption ratio, and content uniformity. The optimization method used is factorial design. Data analysis was performed using Analysis of Variance (ANOVA). Based on the data, it conclude that Sodium Starch glycolate (SSG) affects increasing hardness, increasing friability, extending disintegration time, extending wetting time, and reducing the water absorption ratio. Maltodextrin, has the effect of increasing hardness, reducing friability, extending disintegration time, extending wetting time, and reducing the water absorption ratio. The interaction of SSG and maltodextrin has the effect of reducing hardness, increasing friability, shortening disintegration time, shortening wetting time, and increasing the water absorption ratio.

References

[1] Pawankar R, Canonica GW, Holgate ST, Lockey RF. WAO White Book on Allergy. World Allergy Organization (WAO); 2011.

[2] Sandhiutami Brayfield A. Martindale: The Complete Drug Reference 38th ed. Pharmaceutical Press; 2014.

[3] Parikh DM. Handbook of Pharmaceutical Granulation Technology, 3rd ed. Informa Healthcare USA, Inc.; 2016.

[4] Chowdary Y, Soumya M, Madhu Babu M, Aparna K, Himabindu P. A Review on fast dissolving drug delivery systems a pioneering drug delivery technology. Bull. Env.Pharmacol.Life Sci.. 2012; 1(12): 8–20.

[5] Rojas J, Aristizabal J, Henao M. Screening of Several Excipients for Direct Compression of Tablets: A New Perspective Based on Functional Properties. Journal of Basic and Applied Pharmaceutical Sciences. 2013; 34(1): 17–23.

[6] Sheskey PJ, Cook WG, Cable CG. Handbook of Pharmaceutical Excipients, 8th ed. The Pharmaceutical Press; 2017.

[7] Bolton S and Bon C. Pharmaceutical Statistics Practical and Clinical Applications, 5th ed. Informa Healthcare USA, Inc; 2010.

[8] Putranti W, Edityaningrum CA, Prastyaningrum E, Widiyastuti L. Formulasi Fast Disintegrating Tablet Ekstrak Etanol Daun Salam dengan Kombinasi Crospovidone dan Croscarmellose Sodium sebagai Super Disintegrants. J Sains Farm Klin. 2021; 8(3): 285–295. DOI : 10.25077/jsfk.8.3.285-295.2021

[9] Ministry of Health of the Republic of Indonesia. Farmakope Indonesia Edisi VI. Ministry of Health of the Republic of Indonesia; 2020.

[10] Irawan W and Sulaiman TNS. Optimasi Formula Fast Disintegrating Tablet Natrium Diklofenak Terinklusi B-Siklodekstrin dengan Super disintegrant Crospovidone dan Filler Binder Mikrokristalin Selulosa PH 102. Majalah Farmaseutik. 2016; 12(2): 443–452.

[11] Zaki A, Anwa E, Surini S. Formulation of a Fast-Disintegrating Tablet Using Maltodextrin DE 10-15 and Pregelatinizated Cassava Starch as Excipients. Int J App Pharm. 2017; 9(1): 71–73. DOI: https://doi.org/10.22159/ijap.2017.v9s1.40_46

[12] Pabari RM and Ramtoola Z. Effect of a Disintegration Mechanism on Wetting, Water Absorption, and Disintegration Time of Orodispersible Tablets. J Young Pharm.. 2012; 4(3): 157–163. DOI: 10.4103/0975-1483.100021

[13] Bestari AN, Sulaiman TNS, Rohman A. Formulasi Orally Disintegration Tablet (ODT) Meloksikam dengan Variasi Komposisi Ac-Di-Sol dan Kollidon Cl® sebagai Bahan Penghancur. Majalah Farmaseutik. 2016; 12(2): 453–465. DOI : https://doi.org/10.22146/farmaseutik.v12i2.26454

[14] Rohmani S and Rosyanti H. Perbedaan Metode Penambahan Bahan Pengahancur secara Intragranular-Ekstragranular terhadap Sifat Fisik serta Profil Disolusi Tablet Ibuprofen. J Pharm Sci Clin Res. 2019; 2(1): 95-108. DOI: https://doi.org/10.20961/jpscr.v4i2.33622

[15] Balfas RF and Nanda MD. Uji Waktu Alir dan Uji Kompresibilitas Granul Pati Kentang dengan Metode Granulasi Basah. Syntax Idea. 2019; 1(5): 58-63. DOI: https://doi.org/10.46799/syntax-idea.v1i5.45

[16] United States Pharmacopeia Convention. a <1174> Powder Flow. United States Pharmacopeia National Formulary 44 NF-39. U.S. Pharmacopeia Convention, Inc.; 2021 Aug.

[17] Sholikhati A, Rahmawati RP, Kurnia SD. Analisis Mutu Fisik Granul Ekstrak Kulit Manggis dengan Metode Granulasi Basah. Indonesia Jurnal Farmasi. 2022; 7(1):1-9. DOI:10.26751/ijf.v7i1.1421

[18] Zaman NN and Sopyan I. Metode Pembuatan dan Kerusakan Fisik Sediaan Tablet’, Majalah Farmasetika. 2020; 5 (2): 82-93. DOI: https://doi.org/10.24198/mfarmasetika.v5i2.26260

[19] Abouhussein D, Teaima MH, Al-Nuseirat A, Badaray O, El-Nabarawi, MA, El-Monem RA. Formulation and Characterization of ODT Using Different Co-process Containing Daclatsvir: In Vivo Pharmacokinetics Study on Healthy Volunteers for Hepatitis C Treatment. Int J App Pharm, 2022; 14(5): 105-112.

[20] Pandeya A and Puri VM. Feasibility of Relationships between Tablet Physical Quality Parameters and Mechanical Properties of Dry Powder Formulation. KONA Powder and Particle Journal. 2013; 30 (30): 211-220. DOI:10.14356/kona.2013020

[21] Farahiyah D and Sulaiman TS. Pengaruh Kombinasi Super disintegrant Crospovidone dan Croscarmellose Sodium pada sifat fisik dan disolusi Fast Disintegrating Tablet Hidroklorotiazid. Majalah Farmaseutik. 2021; 17(1): 140-148.

[22] United States Pharmacopeia Convention. b <1226> Verification of Compendial Procedures. United States Pharmacopeia National Formulary 44 NF-39. U.S. Pharmacopeia Convention, Inc.; 2021 Aug.

[23] AOAC. Guidelines for Standard Method Performance Requirements. AOAC International; 2016.
Published
2024-04-30
How to Cite
SUTRISTIO, Kezia Liviathi Kirana Budhi; LESTARI, Agatha Budi Susiana. Optimiation of sodium starch glycolate and maltodextrin in chlorpheniramine maleate fast disintegrating tablet (FDT) by factorial design. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 22, n. 1, p. 99-108, apr. 2024. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/1493>. Date accessed: 21 may 2024. doi: https://doi.org/10.35814/jifi.v22i1.1493.