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DOI: 10.1055/s-0043-1777043
Quality by Design Approach for Development and Characterization of Granisetron Hydrochloride-Loaded Orodispersible Films
Autoren
Abstract
Granisetron hydrochloride can be used to prevent and treat nausea and vomiting induced by chemotherapy. Its prolonged half-life and reduced dose requirement improve patient acceptance. However, patients undergoing chemotherapy often suffer from dysphagia and drug spitting due to emesis. Hence, the development of a patient-centered formulation of granisetron hydrochloride with simple medication and high compliance is crucial. The current study employed a polymer combination of polyvinylpyrrolidone/polyvinyl alcohol (PVP/PVA) as film-forming materials and Lycoat® RS 780 as a disintegrant to formulate orodispersible films (ODFs) loaded with granisetron hydrochloride. Guided by the concept of quality by design, the quality target product profile and critical quality attributes (CQAs) for the ODF were defined. Through the quality risk assessment, essential factors that have a significant impact on CQAs were identified. The formulation was screened using the Box–Behnken statistical design with three factors and three levels. Our data suggested that all ODF formulations exhibited a disintegration time of less than 60 seconds and complete dissolution within 5 minutes. Furthermore, the formulation displayed appropriate mechanical properties, water residue, and pH values. Thus, the granisetron hydrochloride-loaded ODF is regarded as a patient-friendly formulation that enhances compliance and consequently aids in therapeutic effectiveness.
# These authors contributed equally to this work.
Publikationsverlauf
Eingereicht: 17. März 2023
Angenommen: 27. Oktober 2023
Artikel online veröffentlicht:
01. Dezember 2023
© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
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Reference
- 1 Nguyen TTL, Duong VA, Maeng HJ, Chi SC. Development of an oil suspension containing granisetron hydrochloride as a sustained-release parenteral formulation for enhancement of pharmacokinetic properties. J Drug Deliv Sci Technol 2019; 51: 643-650
- 2 Guo Z, Chen P, Liu L, Song H. Compatibility and stability of methylprednisolone sodium succinate and granisetron hydrochloride in 0.9% sodium chloride solution. Medicine (Baltimore) 2022; 101 (28) e29674
- 3 Kovac AL. Benefits and risks of newer treatments for chemotherapy-induced and postoperative nausea and vomiting. Drug Saf 2003; 26 (04) 227-259
- 4 Sathanish R, Bengali RV, Kalidass AmuthanS. Comparative study of ondansetron and granisetron for postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia –randomized double blind study. Eur J Mol Clin Med 2022; 9 (04) 2556-2562
- 5 Guan J, Guo Y, Chang P. et al. Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): study protocol for a randomized controlled trial. Medicine (Baltimore) 2019; 98 (39) e17354
- 6 Cabanillas Stanchi KM, Ebinger M, Hartmann U. et al. Efficacy, safety and feasibility of antiemetic prophylaxis with fosaprepitant, granisetron and dexamethasone in pediatric patients with hemato-oncological malignancies. Drug Des Devel Ther 2019; 13: 3439-3451
- 7 Singh H, Sharma R, Joshi M, Garg T, Goyal AK, Rath G. Transmucosal delivery of Docetaxel by mucoadhesive polymeric nanofibers. Artif Cells Nanomed Biotechnol 2015; 43 (04) 263-269
- 8 Singh B, Garg T, Goyal AK, Rath G. Recent advancements in the cardiovascular drug carriers. Artif Cells Nanomed Biotechnol 2016; 44 (01) 216-225
- 9 Gupta MS, Kumar TP, Gowda DV. Orodispersible thin film: a new patient-centered innovation. J Drug Deliv Sci Technol 2020; 59: 101843
- 10 Özcan Bülbül E, Mesut B, Cevher E, Öztaş E, Özsoy Y. Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films using quality by design approach. J Drug Deliv Sci Technol 2019; 54: 101358
- 11 Mazumder S, Pavurala N, Manda P, Xu X, Cruz CN, Krishnaiah YSR. Quality by design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films. Int J Pharm 2017; 527 (1–2): 151-160
- 12 Mishra V, Thakur S, Patil A, Shukla A. Quality by design (QbD) approaches in current pharmaceutical set-up. Expert Opin Drug Deliv 2018; 15 (08) 737-758
- 13 Kovács B, Péterfi O, Kovács-Deák B. et al. Quality-by-design in pharmaceutical development: from current perspectives to practical applications. Acta Pharm 2021; 71 (04) 497-526
- 14 Silva BMA, Vicente S, Cunha S. et al. Retrospective Quality by Design (rQbD) applied to the optimization of orodispersible films. Int J Pharm 2017; 528 (1–2): 655-663
- 15 Londhe V, Shirsat R. Formulation and characterization of fast-dissolving sublingual film of iloperidone using Box-Behnken design for enhancement of oral bioavailability. AAPS PharmSciTech 2018; 19 (03) 1392-1400
- 16 Shen C, Shen B, Xu H. et al. Formulation and optimization of a novel oral fast dissolving film containing drug nanoparticles by Box-Behnken design-response surface methodology. Drug Dev Ind Pharm 2014; 40 (05) 649-656
- 17 <711> Dissolution. In: U.S. Phramacopeia and National Formulary. Rockville, MD: : The United States Pharmacopeial Convention, Inc.; 2021
- 18 Jain SK, Sahu A, Keservani RK. Oral drug delivery system. In: Keservani RK, Kesharwani RK, Sharma AK. eds. Advances in Novel Formulations for Drug Delivery. Beverly, MA: Scrivener Publishing; 2023: 383-400
- 19 Monograph “Granisetron Hydrochloride Tablets.”. In: U.S. Phramacopeia and National Formulary. Rockville, MD: United States Pharmacopeial Convention, Inc.; 2021
- 20 Sohrabi S, Akhlaghian F. Modeling and optimization of phenol degradation over copper-doped titanium dioxide photocatalyst using response surface methodology. Process Saf Environ Prot 2016; 99: 120-128
- 21 Chen A, Miao Y, Pora B. et al. Film-forming compositions for hard capsule shells and hard capsule shells obtained thereof. WIPO Patent WO2018/146165(A1). August, 2018
- 22 EDQM. . Povidone. In: Pharmacopoeia Europea. 10th ed. Strasbourg, France: EDQM Council of Europe
- 23 EDQM. . Poly(vinyl alcohol). In: Pharmacopoeia Europea. 10th ed. Strasbourg, France: EDQM Council of Europe; 2021
- 24 Ali FM, Kershi RM, Sayed MA, AbouDeif YM. Evaluation of structural and optical properties of Ce3+ ions doped (PVA/PVP) composite films for new organic semiconductors. Physica B 2018; 538: 160-166
- 25 Guo X, Cun D, Wan F. et al. Comparative assessment of in vitro/in vivo performances of orodispersible electrospun and casting films containing rizatriptan benzoate. Eur J Pharm Biopharm 2020; 154: 283-289
- 26 Scarpa M, Paudel A, Kloprogge F. et al. Key acceptability attributes of orodispersible films. Eur J Pharm Biopharm 2018; 125: 131-140
- 27 Hoffmann EM, Breitenbach A, Breitkreutz J. Advances in orodispersible films for drug delivery. Expert Opin Drug Deliv 2011; 8 (03) 299-316
- 28 Drašković M, Turković E, Vasiljević I. et al. Comprehensive evaluation of formulation factors affecting critical quality attributes of casted orally disintegrating films. J Drug Deliv Sci Technol 2020; 56: 101614