Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits

Asma Mahmoudi,1 Bizhan Malaekeh-Nikouei,2,3 Mohammad Yahya Hanafi-Bojd,4,5 Mojtaba Toloei,6 Mehran Hosseini,6 Malihe Nikandish7 1Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; 2Department of Pharmaceutics, School of Pharmacy, M...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Mahmoudi A, Malaekeh-Nikouei B, Hanafi-Bojd MY, Toloei M, Hosseini M, Nikandish M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	tacrolimus hydroxypropyl beta cyclodextrin animal study ocular administration safety Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/bd48730f19004032bd77071a096ff4cc
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:bd48730f19004032bd77071a096ff4cc
record_format	dspace
spelling	oai:doaj.org-article:bd48730f19004032bd77071a096ff4cc2021-12-02T12:08:10ZPreliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits1177-5483https://doaj.org/article/bd48730f19004032bd77071a096ff4cc2020-03-01T00:00:00Zhttps://www.dovepress.com/preliminary-in-vivo-safety-evaluation-of-a-tacrolimus-eye-drop-formula-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Asma Mahmoudi,1 Bizhan Malaekeh-Nikouei,2,3 Mohammad Yahya Hanafi-Bojd,4,5 Mojtaba Toloei,6 Mehran Hosseini,6 Malihe Nikandish7 1Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; 2Department of Pharmaceutics, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; 3Nanotechnology Research Center, Institute of Pharmaceutical Technology, Mashhad University of Medical Sciences, Mashhad, Iran; 4Cellular and Molecular Research Center, Birjand University of Medical Sciences, Birjand, Iran; 5Department of Nanomedicine, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran; 6Cellular and Molecular Research Center, Department of Anatomy, Birjand University of Medical Sciences, Birjand, Iran; 7Ophthalmology Department, Valiasr Hospital, Birjand University of Medical Sciences, Birjand, IranCorrespondence: Malihe NikandishOphthalmology Department, Valiasr Hospital, Birjand University of Medical Sciences, P. O. Box:9717853577, Birjand, IranTel +9856 32395000Fax +9856 32430076Email malihenikandish@yahoo.comAim: Tacrolimus is an immunosuppressive drug with higher potency compared to cyclosporine A (as a useful immunosuppressant). We prepared an ophthalmic solution formulation of Tacrolimus using hydroxypropyl beta cyclodextrin (HP-ßCD). In the present study, safety of this formulation was investigated in rabbits.Materials and Methods: Formulation containing HP-ßCD, Tacrolimus, Polyvinyl alcohol (PVA) and Benzalkonium Chloride in PBS 7.4 was prepared. Tacrolimus concentration in ophthalmic preparation was 0.05% w/v. Ten male New Zealand white rabbits were housed in clean separated cages. One drop of Tacrolimus prepared formulation and a placebo formulation were applied every 12 hrs in the right and left eyes respectively, for 28 days.Results: This new aqueous formulation of Tacrolimus could improve Tacrolimus solubility about 42 times. Clinical examinations on the  1st, 3rd, 7th, 14th and 28th days of study showed transient redness and conjunctivitis in some cases of both control and intervention groups that was not persistent. At the end of the study, there were no statistical differences between the two groups in corneal epithelial defect, redness or pathological evaluations.Conclusion: The results of this study suggest that eye drop formulation of CD-Tacrolimus is safe in preliminary evaluations and can be useful for further studies.Keywords: Tacrolimus, hydroxypropyl beta cyclodextrin (HP-BCD), animal study, ocular administration, safetyMahmoudi AMalaekeh-Nikouei BHanafi-Bojd MYToloei MHosseini MNikandish MDove Medical Pressarticletacrolimushydroxypropyl beta cyclodextrinanimal studyocular administrationsafetyOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 947-953 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	tacrolimus hydroxypropyl beta cyclodextrin animal study ocular administration safety Ophthalmology RE1-994
spellingShingle	tacrolimus hydroxypropyl beta cyclodextrin animal study ocular administration safety Ophthalmology RE1-994 Mahmoudi A Malaekeh-Nikouei B Hanafi-Bojd MY Toloei M Hosseini M Nikandish M Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
description	Asma Mahmoudi,1 Bizhan Malaekeh-Nikouei,2,3 Mohammad Yahya Hanafi-Bojd,4,5 Mojtaba Toloei,6 Mehran Hosseini,6 Malihe Nikandish7 1Department of Pharmaceutical Nanotechnology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; 2Department of Pharmaceutics, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; 3Nanotechnology Research Center, Institute of Pharmaceutical Technology, Mashhad University of Medical Sciences, Mashhad, Iran; 4Cellular and Molecular Research Center, Birjand University of Medical Sciences, Birjand, Iran; 5Department of Nanomedicine, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran; 6Cellular and Molecular Research Center, Department of Anatomy, Birjand University of Medical Sciences, Birjand, Iran; 7Ophthalmology Department, Valiasr Hospital, Birjand University of Medical Sciences, Birjand, IranCorrespondence: Malihe NikandishOphthalmology Department, Valiasr Hospital, Birjand University of Medical Sciences, P. O. Box:9717853577, Birjand, IranTel +9856 32395000Fax +9856 32430076Email malihenikandish@yahoo.comAim: Tacrolimus is an immunosuppressive drug with higher potency compared to cyclosporine A (as a useful immunosuppressant). We prepared an ophthalmic solution formulation of Tacrolimus using hydroxypropyl beta cyclodextrin (HP-ßCD). In the present study, safety of this formulation was investigated in rabbits.Materials and Methods: Formulation containing HP-ßCD, Tacrolimus, Polyvinyl alcohol (PVA) and Benzalkonium Chloride in PBS 7.4 was prepared. Tacrolimus concentration in ophthalmic preparation was 0.05% w/v. Ten male New Zealand white rabbits were housed in clean separated cages. One drop of Tacrolimus prepared formulation and a placebo formulation were applied every 12 hrs in the right and left eyes respectively, for 28 days.Results: This new aqueous formulation of Tacrolimus could improve Tacrolimus solubility about 42 times. Clinical examinations on the  1st, 3rd, 7th, 14th and 28th days of study showed transient redness and conjunctivitis in some cases of both control and intervention groups that was not persistent. At the end of the study, there were no statistical differences between the two groups in corneal epithelial defect, redness or pathological evaluations.Conclusion: The results of this study suggest that eye drop formulation of CD-Tacrolimus is safe in preliminary evaluations and can be useful for further studies.Keywords: Tacrolimus, hydroxypropyl beta cyclodextrin (HP-BCD), animal study, ocular administration, safety
format	article
author	Mahmoudi A Malaekeh-Nikouei B Hanafi-Bojd MY Toloei M Hosseini M Nikandish M
author_facet	Mahmoudi A Malaekeh-Nikouei B Hanafi-Bojd MY Toloei M Hosseini M Nikandish M
author_sort	Mahmoudi A
title	Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
title_short	Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
title_full	Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
title_fullStr	Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
title_full_unstemmed	Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits
title_sort	preliminary in vivo safety evaluation of a tacrolimus eye drop formulation using hydroxypropyl beta cyclodextrin after ocular administration in nzw rabbits
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/bd48730f19004032bd77071a096ff4cc
work_keys_str_mv	AT mahmoudia preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits AT malaekehnikoueib preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits AT hanafibojdmy preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits AT toloeim preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits AT hosseinim preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits AT nikandishm preliminaryinvivosafetyevaluationofatacrolimuseyedropformulationusinghydroxypropylbetacyclodextrinafterocularadministrationinnzwrabbits
_version_	1718394712262443008

Preliminary In Vivo Safety Evaluation of a Tacrolimus Eye Drop Formulation Using Hydroxypropyl Beta Cyclodextrin After Ocular Administration in NZW Rabbits

Ejemplares similares