FORMULATION DEVELOPMENT OF MOUTH DISSOLVING PRINTED FILM OF KETOROLAC AND IN VITRO EVALUATION

FARHEEN BANO KHAN; VAISHALI KILOR; NIDHI SAPKAL; PRIYA DULE

doi:10.22159/ijap.2022v14i5.45350

Authors

FARHEEN BANO KHAN Zim Laboratories, B-21/22, MIDC Area, Kalmeshwar 441501, Dist. Nagpur, India https://orcid.org/0000-0002-7620-7927
VAISHALI KILOR Gurunanak College of Pharmacy, 81/1, Nari, Kamgar Nagar, Kamptee Road, Nagpur 440026, Maharashtra, India
NIDHI SAPKAL Gurunanak College of Pharmacy, 81/1, Nari, Kamgar Nagar, Kamptee Road, Nagpur 440026, Maharashtra, India https://orcid.org/0000-0002-8999-6961
PRIYA DULE Gurunanak College of Pharmacy, 81/1, Nari, Kamgar Nagar, Kamptee Road, Nagpur 440026, Maharashtra, India

DOI:

https://doi.org/10.22159/ijap.2022v14i5.45350

Keywords:

Ketorolac printed OTF, 2D printing, HPMC ink, Pneumatic-based printer

Abstract

Objective: The present research work was carried out to prepare Ketorolac printed Oral Thin Films using a pneumatic pressure printer. In this research, we attempted to prepare a non-contact printing system by using pneumatic pressure-based printer that incorporates printing of active pharmaceutical ingredients onto a medical-grade Orodispersible film for developing personalized medication.

Methods: In the present work Ketorolac Trometamol was used as a model drug. Placebo substrate was developed by using cellulosic polymers like HPMC, MCC, Neusilin, and starch to impart paper-like properties that are desirable for printing. It was evaluated for various physicochemical properties like disintegration time, mechanical strength, folding endurance, surface properties, etc. Polymers and plasticizers were evaluated for the development of drug loaded Printing ink. The drug-printed films were characterized for physicochemical properties and in vitro drug dissolution.

Results: Various film-forming polymers were evaluated for the development of printing substrates. The F3 substrate had desired mechanical properties i.e. the thickness of 0.157±0.003, the tensile strength of 0.331±0.016, disintegration within 60 seconds, and this substrate also maintained its integrity after the printing of the drug ink. The HPMC-based ink (I4) with polyethylene glycol for modulating flow properties of ink in the concentration of 1.40%w/v was selected among various ink formulations. The drug release from the printed films was 98±1.94% in 1 h.

Conclusion: Through this new drug printing technology the limitation of low drug dose loading associated with ink-jet and flexographic printing can be solved by increasing the drug loading ranges from micrograms to milligrams by a single pass of the print head.

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References

Planchette C, Pichler H, Wimmer Teubenbacher M, Gruber M, Gruber Woelfler H, Mohr S. Printing medicines as orodispersible dosage forms: effect of substrate on the printed micro-structure. Int J Pharm. 2016 Jul 25;509(1-2):518-27. doi: 10.1016/j.ijpharm.2015.10.054. PMID 26541301.

Ahmed MG, Adinarayana S. Formulation design of hydrocortisone films for the treatment of aphthous ulcers. Turk J Pharm Sci. 2019 Sep;16(3):348-55. doi: 10.4274/ tjps.galenos.2018.75046. PMID 32454734.

Janssen EM, Schliephacke R, Breitenbach A, Breitkreutz J. Drug-printing by flexographic printing technology-A new manufacturing process for orodispersible films. Int J Pharm. 2013 Dec;441(1-2):818-25. doi: 10.1016/j.ijpharm.2012.12.023, PMID 23266759.

Buanz AB, Saunders MH, Basit AW, Gaisford S. Preparation of personalized-dose salbutamol sulphate oral films with thermal ink-jet printing. Pharm Res. 2011 Oct;28(10):2386-92. doi: 10.1007/s11095-011-0450-5. PMID 21544688.

Eleftheriadis GK, Monou PK, Bouropoulos N, Fatouros DG. In vitro evaluation of 2D-printed edible films for the buccal delivery of diclofenac sodium. Materials (Basel). 2018 May 22;11(5):864. doi: 10.3390/ma11050864, PMID 29789468.

Thabet Y, Lunter D, Breitkreutz J. Continuous inkjet printing of enalapril maleate onto orodispersible film formulations. Int J Pharm. 2018 Jul 30;546(1-2):180-7. doi: 10.1016/j.ijpharm.2018.04.064. PMID 29753906.

Genina N, Janßen EM, Breitenbach A, Breitkreutz J, Sandler N. Evaluation of different substrates for inkjet printing of rasagiline mesylate. Eur J Pharm Biopharm. 2013;85(3 Pt B):1075-83. doi: 10.1016/j.ejpb.2013.03.017. PMID 23563101.

Palo M, Kolakovic R, Laaksonen T, Maattanen A, Genina N, Salonen J. Fabrication of drug-loaded edible carrier substrates from nanosuspensions by flexographic printing. Int J Pharm. 2015 Oct 30;494(2):603-10. doi: 10.1016/j.ijpharm.2015.01.027. PMID 25601198.

Genina N, Fors D, Palo M, Peltonen J, Sandler N. Behavior of printable formulations of loperamide and caffeine on different substrates-effect of print density in inkjet printing. Int J Pharm. 2013 Sep 10;453(2):488-97. doi: 10.1016/j.ijpharm.2013.06.003. PMID 23769992.

Sulthana N, Mohammed S. Formulation and in vitro evaluation of oral disintegrating films of lovastatin. IJPRHS. 2019 Jul;7(6):3084-9. doi: 10.21276/ijprhs.2019.06.03.

Oblom H, Cornett C, Bøtker J, Frokjaer S, Hansen H, Rades T. Data-enriched edible pharmaceuticals (DEEP) of medical cannabis by inkjet printing. Int J Pharm. 2020 Nov 15;589:119866. doi: 10.1016/j.ijpharm.2020.119866. PMID 32919002.

Priyanka NVS, Neeraja P, Mangilal T, Kumar MR. Formulation and evaluation of gel loaded with microspheres of apremilast for transdermal delivery system. Asian J Pharm Clin Res 2019;12:411-7. doi: 10.22159/ajpcr.2019.v12i2.29374.

Prabhu P, Malli R, Koland M, Vijaynarayana K, D’Souza U, Harish N. Formulation and evaluation of fast dissolving films of levocitirizine di hydrochloride. Int J Pharm Investig. 2011 Apr;1(2):99-104. doi: 10.4103/2230-973X.82417, PMID 23071928.

Alhnan MA, Okwuosa TC, Sadia M, Wan KW, Ahmed W, Arafat B. Emergence of 3D printed dosage forms: opportunities and challenges. Pharm Res. 2016 Aug;33(8):1817-32. doi: 10.1007/s11095-016-1933-1. PMID 27194002.

Alomari M, Mohamed FH, Basit AW, Gaisford S. Personalised dosing: printing a dose of one’s own medicine. Int J Pharm. 2015 Oct 30;494(2):568-77. doi: 10.1016/j.ijpharm. 2014.12.006. PMID 25498157.

Iftimi LD, Edinger M, Bar Shalom D, Rantanen J, Genina N. Edible solid foams as porous substrates for inkjet-printable pharmaceuticals. Eur J Pharm Biopharm. 2019 Mar;136:38-47. doi: 10.1016/j.ejpb.2019.01.004. PMID 30630061.

Huanbutta K, Sriamornsak P, Singh I, Sangnim T. Manufacture of 2D-printed precision drug-loaded orodispersible film prepared from tamarind seed gum substrate. Applied. 2021 Jun;11(13):5852. doi: 10.3390/app11135852.

Udofia EN, Zhou W. A guiding framework for microextrusion additive manufacturing. J Manuf Sci Eng. 2019;141(5):050801. doi: 10.1115/1.4042607.

Lewis JA. Direct ink writing of 3D functional materials. Adv Funct Mater. 2006;16(17):2193-204. doi: 10.1002/ adfm.200600434.

Mohammed AA, Algahtani MS, Ahmad MZ, Ahmad J, Kotta S. 3D Printing in medicine: technology overview and drug delivery applications. Annals of 3D Printed Medicine. 2021 Nov 16;4:100037. doi: 10.1016/j.stlm.2021.100037.

Raijada D, Genina N, Fors D, Wisaeus E, Peltonen J, Rantanen J. A step toward development of printable dosage forms for poorly soluble drugs. J Pharm Sci. 2013 Oct;102(10):3694-704. doi: 10.1002/jps.23678. PMID 23904182.