Alleviated Side Effects and Improved Efficiency of Omeprazole Using Oral Thin Film: In Vitro Evaluation

Won Kyung Kim; Hun Hwi Cho; Gi Won Lee; Yong Woon Jeong; Jin Su Kim; Alessio Bucciarelli; Jeong Eun Song; Gilson Khang

Macromolecular Research, Vol.28, No.5, 417-424, May, 2020

DOI10.1007/s13233-020-8060-x Export Citation

Alleviated Side Effects and Improved Efficiency of Omeprazole Using Oral Thin Film: In Vitro Evaluation

Won Kyung Kim, Hun Hwi Cho, Gi Won Lee, Yong Woon Jeong, Jin Su Kim, Alessio Bucciarelli¹, Jeong Eun Song , and Gilson Khang^†

Department of BIN Convergence Technology, Department of PolymerNano Science &Technology and Polymer BIN Research Center, Chonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54896 Korea
¹Department of Industrial Engineering, University of Trento, via Sommarive 9, Trento, Italy, and BIOTech Research Center, European Institute of Excellence on Tissue Engineering and Regenerative Medicine, University of Trento, via delle Regole 101, Trento, Italy

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Omeprazole (OM), typically used for patients with gastric problems, is a proton pump inhibitor, which reduces the amount of stomach acid production effectively by regulating the proton pump. However, the main side effect of OM is the calcium indigestion, which may cause the calcium deficiency in the long term. Seaweeds are abundant in calcium (approximately 560?1200 mg per 100 g) and nutrients such as vitamins (approximately 150?400 mg per 1 kg) and minerals. In particular, high level of magnesium in the seaweed can assist the absorption of calcium. Accordingly, seaweeds can be a good source of nutrients to support OM therapy. Herein, we produced a solid dispersion (SD) which is composed of OM and seaweed calcium (SC) and can be suitable for the oral treatment, via the ultra-multiple crystal method. We also optimized the film formulation so that the SD could be absorbed quickly and efficiently by the oral cavity. Due to many advantages of using the oral thin film (OTF), we chose to fabricate OTF with our optimized dispersion method. OTF allows for both the rapid and efficient dissolution within the oral cavity and the protection of the active ingredient (i.e., OM) from rapid degradation under acidic conditions. The prepared SD samples were characterized by scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FT-IR), and X-ray diffraction (XRD). Thermal analysis of SD was conducted by differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA). Hydrophobicity of SD was evaluated by the contact angle. Furthermore, the dissolution test and the HPLC analysis of SD were performed.

Keywords:omeprazole;calcium;solid dispersion;immediate absorption;oral thin film

[References]

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[1] Hveem K, Hausken T, Svebak S, Berstad A, Scand J Gastroentero, 31, 452 (1995)

[2] Mayer EA, Gut, 47, 861 (2000)

[3] Ming CH, in Physiology Question-Based Learning: Neurophysiology, Gastrintestinal and Endocrine Systems, Springer, Singapore, pp.137-148 2016.

[4] Cederberg C, Andersson T, Skanberg I, Scand J Gastroentero., 24, 33 (1989)

[5] Hassall E, Isreal D, Shepherd R, Radke M, Dalvag A, Skold B, Junghard O, Lundborg P, J. Pediatr., 137, 800 (2010)

[6] Lind T, Cederberg C, Ekenved G, Haglund U, Olbe L, Gut., 24, 270 (1983)

[7] McTravish D, Buckley MM, Hell RC, Drugs, 42, 138 (1991)

[8] Li W, Zeng S, Yu L, Zhou Q, Ther. Clin. Risk Manag., 9, 259 (2013)

[9] Khatib MA, Rahim O, Kania R, Molloy P, Dig. Dis. Sci., 47, 2596 (2002)

[10] Sugiyama T, Int. J. Epidemiol., 47, 669 (2018)

[11] Cashman KD, Br. J. Nutr., 87, S169 (2002)

[12] Tai V, Leung W, Grey A, Reid IR, Bolland MJ, BMJ., 351, h4183 (2015)

[13] Wlodarek D, Glabska D, Kolota A, Adamczyk P, Czekajlo A, Grzeszczk W, Drozdzowska B, Pluskiewicz W, Public Health Nutr., 17, 383 (2014)

[14] Bae YJ, Bu SY, Kim JY, Yeon JY, Sohn EW, Jang KH, Lee JC, Kim MH, Biol. Trace Elem. Res., 144, 992 (2011)

[15] Brown EM, Allsopp PJ, Magee PJ, Gill CIR, Nitecki S, Strain CR, McSorley EM, Nutr. Rev., 72, 205 (2014)

[16] Kong XF, Wu GY, Liao YP, Hou ZP, Liu HJ, Yin G, Li TJ, et al., Livest. Sci., 108, 272 (2007)

[17] Arya A, Chandra A, Sharma C, Pathak K, Int. J. Chemtech. Res., 2, 576 (2010)

[18] Keshari A, Sharma PK, Parvez N, Int. J. Chemtech. Res., 5, 92 (2014)

[19] Patil P, Shrivastava SK, Int. J. Sci. Res., 3, 2088 (2014)

[20] Kucerova K, Reiska V, Svec F, Krcmova LK, Matysova L, RSC Adv., 11, 517 (2019)

[21] Ning YL, Ruyue T, Jianqing L, Wu QW, Int. J. Pharm., 465, 25 (2014)

[22] Mishra R, Amin A, Pharmaceutical Technol., 35, 70 (2011)