Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation

Background/Objectives: Raloxifene (RLF) is a therapeutic option for invasive breast cancer because it blocks estrogen receptors selectively. Low solubility, limited targeting, first-pass action, and poor absorption are some of the challenges that make RLF in oral form less effective. This study aime...

Full description

Saved in:
Bibliographic Details
Main Authors: Hanan O. Farouk, Marwa M. Nagib, Amr Gamal Fouad, Demiana M. Naguib, Sherif Faysal Abdelfattah Khalil, Amany Belal, Samar F. Miski, Nisreen Khalid Aref Albezrah, Shatha Hallal Al-Ziyadi, Gi-Hui Kim, Ahmed H. E. Hassan, Kyung-Tae Lee, Doaa S. Hamad
Format: Article
Language:English
Published: MDPI AG 2024-11-01
Series:Pharmaceuticals
Subjects:
Online Access:https://www.mdpi.com/1424-8247/17/11/1518
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1846152733001777152
author Hanan O. Farouk
Marwa M. Nagib
Amr Gamal Fouad
Demiana M. Naguib
Sherif Faysal Abdelfattah Khalil
Amany Belal
Samar F. Miski
Nisreen Khalid Aref Albezrah
Shatha Hallal Al-Ziyadi
Gi-Hui Kim
Ahmed H. E. Hassan
Kyung-Tae Lee
Doaa S. Hamad
author_facet Hanan O. Farouk
Marwa M. Nagib
Amr Gamal Fouad
Demiana M. Naguib
Sherif Faysal Abdelfattah Khalil
Amany Belal
Samar F. Miski
Nisreen Khalid Aref Albezrah
Shatha Hallal Al-Ziyadi
Gi-Hui Kim
Ahmed H. E. Hassan
Kyung-Tae Lee
Doaa S. Hamad
author_sort Hanan O. Farouk
collection DOAJ
description Background/Objectives: Raloxifene (RLF) is a therapeutic option for invasive breast cancer because it blocks estrogen receptors selectively. Low solubility, limited targeting, first-pass action, and poor absorption are some of the challenges that make RLF in oral form less effective. This study aimed to create an intra-tumoral in situ pH-responsive formulation of RLF–invasome (IPHRLI) for breast cancer treatment, with the goals of sustaining RLF release, minimizing adverse effects, and enhancing solubility, bioavailability, targeting, and effectiveness. Methods: Numerous RLF–invasome formulations were optimized using design expert software (version 12.0.6.0, StatEase Inc., Minneapolis, MN, USA). Integrating an optimal formulation with an amalgam of chitosan and glyceryl monooleate resulted in the IPHRLI formulation. In vivo testing of the IPHRLI formulation was conducted utilizing the Ehrlich cancer model. Results: Requirements for an optimum RLF–invasome formulation were met by a mixture of phospholipids (2.46%), ethanol (2.84%), and cineole (0.5%). The IPHRLI formulation substantially sustained its release by 75.41% after 8 h relative to free RLF. The bioavailability of intra-tumoral IPHRLI was substantially raised by 4.07-fold compared to oral free RLF. Histopathological and tumor volume analyses of intra-tumoral IPHRLI confirmed its efficacy and targeting effect. Conclusions: the intra-tumoral administration of the IPHRLI formulation may provide a potential strategy for breast cancer management.
format Article
id doaj-art-b05e1cbfa67946f3953c02017b5cd4f5
institution Kabale University
issn 1424-8247
language English
publishDate 2024-11-01
publisher MDPI AG
record_format Article
series Pharmaceuticals
spelling doaj-art-b05e1cbfa67946f3953c02017b5cd4f52024-11-26T18:17:28ZengMDPI AGPharmaceuticals1424-82472024-11-011711151810.3390/ph17111518Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo EvaluationHanan O. Farouk0Marwa M. Nagib1Amr Gamal Fouad2Demiana M. Naguib3Sherif Faysal Abdelfattah Khalil4Amany Belal5Samar F. Miski6Nisreen Khalid Aref Albezrah7Shatha Hallal Al-Ziyadi8Gi-Hui Kim9Ahmed H. E. Hassan10Kyung-Tae Lee11Doaa S. Hamad12Department of Pharmaceutics, Faculty of Pharmacy, Nahda University, Beni-Suef 62511, EgyptDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, Misr International University, Cairo 11435, EgyptDepartment of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62511, EgyptDepartment of Pharmaceutics, Faculty of Pharmacy, Nahda University, Beni-Suef 62511, EgyptPharmacology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef 62511, EgyptDepartment of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Taif 21944, Saudi ArabiaPharmacology and Toxicology Department, College of Pharmacy, Taibah University, Medina 42278, Saudi ArabiaDepartment of Obstetric & Gynecology, College of Medicine, Taif University, Taif 21944, Saudi ArabiaDepartment of Obstetric & Gynecology, College of Medicine, Taif University, Taif 21944, Saudi ArabiaDepartment of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of KoreaDepartment of Medicinal Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, EgyptDepartment of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of KoreaDepartment of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Nile Valley University, Fayoum 63518, EgyptBackground/Objectives: Raloxifene (RLF) is a therapeutic option for invasive breast cancer because it blocks estrogen receptors selectively. Low solubility, limited targeting, first-pass action, and poor absorption are some of the challenges that make RLF in oral form less effective. This study aimed to create an intra-tumoral in situ pH-responsive formulation of RLF–invasome (IPHRLI) for breast cancer treatment, with the goals of sustaining RLF release, minimizing adverse effects, and enhancing solubility, bioavailability, targeting, and effectiveness. Methods: Numerous RLF–invasome formulations were optimized using design expert software (version 12.0.6.0, StatEase Inc., Minneapolis, MN, USA). Integrating an optimal formulation with an amalgam of chitosan and glyceryl monooleate resulted in the IPHRLI formulation. In vivo testing of the IPHRLI formulation was conducted utilizing the Ehrlich cancer model. Results: Requirements for an optimum RLF–invasome formulation were met by a mixture of phospholipids (2.46%), ethanol (2.84%), and cineole (0.5%). The IPHRLI formulation substantially sustained its release by 75.41% after 8 h relative to free RLF. The bioavailability of intra-tumoral IPHRLI was substantially raised by 4.07-fold compared to oral free RLF. Histopathological and tumor volume analyses of intra-tumoral IPHRLI confirmed its efficacy and targeting effect. Conclusions: the intra-tumoral administration of the IPHRLI formulation may provide a potential strategy for breast cancer management.https://www.mdpi.com/1424-8247/17/11/1518breast cancerraloxifeneinvasomesbioavailabilitychitosantargeting
spellingShingle Hanan O. Farouk
Marwa M. Nagib
Amr Gamal Fouad
Demiana M. Naguib
Sherif Faysal Abdelfattah Khalil
Amany Belal
Samar F. Miski
Nisreen Khalid Aref Albezrah
Shatha Hallal Al-Ziyadi
Gi-Hui Kim
Ahmed H. E. Hassan
Kyung-Tae Lee
Doaa S. Hamad
Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
Pharmaceuticals
breast cancer
raloxifene
invasomes
bioavailability
chitosan
targeting
title Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
title_full Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
title_fullStr Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
title_full_unstemmed Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
title_short Fabrication of an In Situ pH-Responsive Raloxifene-Loaded Invasome Hydrogel for Breast Cancer Management: In Vitro and In Vivo Evaluation
title_sort fabrication of an in situ ph responsive raloxifene loaded invasome hydrogel for breast cancer management in vitro and in vivo evaluation
topic breast cancer
raloxifene
invasomes
bioavailability
chitosan
targeting
url https://www.mdpi.com/1424-8247/17/11/1518
work_keys_str_mv AT hananofarouk fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT marwamnagib fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT amrgamalfouad fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT demianamnaguib fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT sheriffaysalabdelfattahkhalil fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT amanybelal fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT samarfmiski fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT nisreenkhalidarefalbezrah fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT shathahallalalziyadi fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT gihuikim fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT ahmedhehassan fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT kyungtaelee fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation
AT doaashamad fabricationofaninsituphresponsiveraloxifeneloadedinvasomehydrogelforbreastcancermanagementinvitroandinvivoevaluation