TY  - JOUR
T1  - Formulation optimization and evaluation of oral thin film of bilastine for the treatment of allergic conditions
AU  - Kanugo, Dr. Abhishek
AU  - Gandhi, Yash
PY  - 2025
DA  - June
JF  - Journal of Research in Pharmacy
JO  - J. Res. Pharm.
PB  - Marmara University
WT  - DergiPark
SN  - 2630-6344
SP  - 1214
EP  - 1229
VL  - 26
IS  - 5
LA  - en
AB  - Allergic rhinitis or allergic conditions are associated with the symptoms such as running nose, frequentheadache, sore throat, watering of eye, and sometimes coughing as well as eczema also. The delay in the treatment orignorance may leads to severe health problems like asthma, inability to sleep, severe redness, etc. Bilastine is potent H1antihistaminic agents used in the therapy of allergic conditions and rhinitis without inducing drowsiness. The currentresearch focused on developing oral thin film of Bilastine for all the allergic conditions. The hydroxypropylmethylcellulose (HPMC) was selected as film former and the physical interaction with Bilastine was confirmed withFTIR. The 3 3 Box-Behnken design was applied in the designing of oral thin film which predicted 17 possible runs inDesign of Expert (Version 11). The film former (HPMC E15: X1) plasticizer (PEG 400: X2) and superdisintegrants (CCS:X3) were selected as independent parameters and disintegration time (Y1), folding endurance (Y2) and in-vitrodissolution release (Y3) as dependable parameters in the development of oral thin film. The film was prepared bysolvent casting method and evaluated. The optimized batch F10 tested for weight variation, folding endurance (135),disintegration time (12 sec), percentage of dissolution (98.70%) and found stable during accelerated stability studies.The fast-dissolving oral thin film of Bilastine (F10) was developed which showed prompt relief from the allergicconditions.
KW  - Oral thin film
KW  - bilastine
KW  - allergic rhinitis
KW  - hydroxyl propyl methyl cellulose
KW  - box-behnken design
CR  - [1]. Gómez RM, Croce VH, Zernotti ME, Muiño JC. Active smoking effect in allergic rhinitis. World Allergy Organ J. 2021;14(2):100504. [CrossRef].
CR  - [2]. Rosario Filho NA, Satoris RA, Scala WR. Allergic rhinitis aggravated by air pollutants in Latin America: A systematic review. World Allergy Organ J. 2021;14(8):100574. [CrossRef].
CR  - [3]. Choi S, Jung MA, Hwang YH, Pyun BJ, Lee JY, Jung DH, et al. Anti-allergic effects of Asarum heterotropoides on an ovalbumin-induced allergic rhinitis murine model. Biomed Pharmacother. 2021;141:111944. [CrossRef].
CR  - [4]. Small P, Keith PK, Kim H. Allergic rhinitis. Allergy, Asthma Clin Immunol. 2018;14(2):1–11. [CrossRef].
CR  - [5]. Mengi E, Kara CO, Alptürk U, Topuz B. The effect of face mask usage on the allergic rhinitis symptoms in patients with pollen allergy during the covid-19 pandemic. Am J Otolaryngol. 2022;43(1):103206. [CrossRef].
CR  - [6]. Okubo K, Suzuki T, Tanaka A, Aoki H. Efficacy and safety of rupatadine in Japanese patients with seasonal allergic rhinitis: A double-blind, randomized, multicenter, placebo-controlled clinical trial. Allergol Int. 2019;68(2):207–15. [CrossRef].
CR  - [7]. Wu TF, Shi WY, Chiu YC, Chan YY. Investigation of the molecular mechanism underlying the inhibitory activities of ethanol extract of Bombyx mori pupa-incubated Cordyceps militaris fruiting bodies toward allergic rhinitis. Biomed Pharmacother. 2021;135:111248. [CrossRef].
CR  - [8]. Suryawanshi D, Wavhule P, Shinde U, Kamble M, Amin P. Development, optimization and in-vivo evaluation of cyanocobalamin loaded orodispersible films using hot-melt extrusion technology: A quality by design (QbD)approach. J Drug Deliv Sci Technol. 2021;63:102559. [CrossRef].
CR  - [9]. Elbadawi M, Nikjoo D, Gustafsson T, Gaisford S, Basit AW. Pressure-assisted microsyringe 3D printing of oral films based on pullulan and hydroxypropyl methylcellulose. Int J Pharm. 2021;595:120197. [CrossRef].
CR  - [10]. Bodini RB, Guimarães J das GL, Monaco-Lourenço CA, Aparecida de Carvalho R. Effect of starch and hydroxypropyl methylcellulose polymers on the properties of orally disintegrating films. J Drug Deliv Sci
Technol. 2019;51:403–10. [CrossRef].
CR  - [11]. Alaei S, Omidian H. Mucoadhesion and Mechanical Assessment of Oral Films. Eur J Pharm Sci. 2021;159:105727. [CrossRef].
CR  - [12]. Takeuchi Y, Nishimatsu T, Tahara K, Takeuchi H. Novel use of insoluble particles as disintegration enhancers for orally disintegrating films. J Drug Deliv Sci Technol. 2019;54:101310. [CrossRef].
CR  - [13]. Takeuchi Y, Ikeda N, Tahara K, Takeuchi H. Mechanical characteristics of orally disintegrating films:
Comparison of folding endurance and tensile properties. Int J Pharm. 2020;589:119876. [CrossRef].
CR  - [14]. Wolthers OD. Bilastine: A new nonsedating oral h1 antihistamine for treatment of allergic rhinoconjunctivitis and urticaria. Biomed Res Int. 2013;2013. [CrossRef].
CR  - [15]. Ridolo E, Montagni M, Bonzano L, Incorvaia C, Canonica GW. Bilastine: new insight into antihistamine treatment. Clin Mol Allergy. 2015;13(1). [CrossRef].
CR  - [16]. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):771–83. [CrossRef].
CR  - [17]. Zhang L, Mao S. Application of quality by design in the current drug development. Asian J Pharm Sci. 2017;12(1):1–8. [CrossRef].
CR  - [18]. Pezik E, Gulsun T, Sahin S, Vural İ. Development and characterization of pullulan-based orally disintegrating films containing amlodipine besylate. Eur J Pharm Sci. 2021;156:105597. [CrossRef].
CR  - [19]. Sharma S, Kanugo A, Gaikwad J. Design and development of solid lipid nanoparticles of tazarotene for the treatment of psoriasis and acne: a quality by design approach. Mater. Technol. 2021. [CrossRef]
CR  - [20]. Prajapati VD, Chaudhari AM, Gandhi AK, Maheriya P. Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design. Int J Biol Macromol. 2018;107:2075–85.
[CrossRef].
CR  - [21]. Han X, Yan J, Ren L, Xue M, Yuan Z, Wang T, et al. Preparation and evaluation of orally disintegrating film containing donepezil for Alzheimer disease. J Drug Deliv Sci Technol. 2019;54:101321. [CrossRef].
CR  - [22]. Gupta MS, Kumar TP, Gowda DV, Rosenholm JM. Orodispersible films: Conception to quality by design. Adv Drug Deliv Rev. 2021;178:113983. [CrossRef].
CR  - [23]. Al-Mogherah AI, Ibrahim MA, Hassan MA. Optimization and evaluation of venlafaxine hydrochloride fast dissolving oral films. Saudi Pharm J. 2020;28(11):1374–82. [CrossRef].
CR  - [24]. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. Int J Pharm Investig. 2013;3(2):67.
CR  - [25]. Alhayali A, Vuddanda PR, Velaga S. Silodosin oral films: Development, physico-mechanical properties and in vitro dissolution studies in simulated saliva. J Drug Deliv Sci Technol. 2019;53:101122. [CrossRef].
CR  - [26]. Zaki DY, Safwat EM, Nagi SM, Salem HN, Hamdy TM, Moharam LM, et al. A novel dental re-mineralizing blend of hydroxyethyl-cellulose and cellulose nanofibers oral film loaded with nepheline apatite glass:
Preparation, characterization and in vitro evaluation of re-mineralizing effect. Carbohydr Polym Technol Appl. 2021;2:100035. [CrossRef].
CR  - [27]. Dahmash EZ, Iyire A, Alyami HS. Development of orally dissolving films for pediatric-centric administration of anti-epileptic drug topiramate – A design of experiments (DoE) study. Saudi Pharm J. 2021;29(7):635–47. [CrossRef].
CR  - [28]. Zhao Y, Quan P, Fang L. Preparation of an oral thin film containing meclizine hydrochloride: In vitro and in vivoevaluation. Int J Pharm. 2015;496(2):314–22. [CrossRef].
CR  - [29]. Bharti K, Mittal P, Mishra B. Formulation and characterization of fast dissolving oral films containing buspirone hydrochloride nanoparticles using design of experiment. J Drug Deliv Sci Technol. 2019;49:420–32. [CrossRef].
UR  - https://dergipark.org.tr/en/pub/jrespharm/issue//1690861
L1  - https://dergipark.org.tr/en/download/article-file/4834579
ER  -