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Pharmaceutics
Special Issues
Drug Formulation and Controlled Release Systems for the Gastrointestinal Tract
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Drug Formulation and Controlled Release Systems for the Gastrointestinal Tract

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: 20 August 2025 | Viewed by 3710

Special Issue Editors

Dr. Borislav S. Tzankov

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Guest Editor
Faculty of Pharmacy, Department Pharmaceutical Technology and Biopharmacy, Medical University—Sofia, 1000 Sofia, Bulgaria
Interests: inorganic, polymer and hybrid nanosystems; controlled release of active substances; biopharmaceutical control
Dr. Christina Voycheva

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Guest Editor
Department of Pharmaceutical Technology, Faculty of Pharmacy, Medical University of Sofia, 1000 Sofia, Bulgaria
Interests: polymer nanoparticles; drug delivery; dermal and transdermal drug delivery
Dr. Teodora Popova

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Guest Editor
Faculty of Pharmacy, Department Pharmaceutical Technology and Biopharmacy, Medical University—Sofia, 1000 Sofia, Bulgaria
Interests: multiparticulate drug delivery systems; modified release dosage forms; chronopharmaceutical systems

Special Issue Information

Dear Colleagues,

This Special Issue aims to provide an update on the current and recent progress in different drug formulation and controlled release systems (modified release tablets, nanoparticles, microneedle injectors or other devices) that can unlock options for drug and protein delivery to the gastrointestinal tract. They may possess suitable bioadhesion, pH-sensitive or microenvironment-triggered release properties, and active targeting. The possibility for oral or parenteral application would further improve the opportunities for therapy and diagnosis of diseases affecting the stomach, intestines, colon,  liver or biliary tract. Such systems must offer advantages over traditional methods of drug delivery, including the tailoring of drug release rates, stability protection of drugs, and increased patient comfort and compliance.

We welcome researchers to contribute original research articles and reviews, with topics addressing, but not limited to, the key findings on and contributions to drug and protein delivery to the gastrointestinal tract and related structures via different delivery routes or strategies.

We look forward to receiving your contributions.

Dr. Borislav S. Tzankov
Dr. Christina Voycheva
Dr. Teodora Popova
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • gastrointestinal diseases
  • gastrointestinal tract
  • gastrointestinal cancer
  • colorectal cancer
  • rectal cancer
  • nanomedicine
  • drug formulation
  • drug delivery systems
  • nanocarriers
  • targeted drug delivery
  • nanotechnology
  • pharmaceutical science
  • nano-bioengineering

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Published Papers (3 papers)

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Research

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24 pages, 23251 KiB  
Article
In Vitro Evaluation of the Safety and Antineoplastic Effects in Gastrointestinal Tumors of Nanostructured Lipid Carriers Loaded with Berberine
by Denitsa Stefanova, Yordan Yordanov, Radostina Bogdanova, Christina Voycheva, Borislav Tzankov, Teodora Popova, Magdalena Kondeva-Burdina, Virginia Tzankova, Natalia Toncheva-Moncheva, Diana Tzankova and Marta Slavkova
Pharmaceutics 2025, 17(3), 331; https://doi.org/10.3390/pharmaceutics17030331 - 4 Mar 2025
Viewed by 565
Abstract
Background/Objectives: Natural substances have been a widely studied source of both pharmaceutical excipients and drugs. Berberine (BRB) is a benzylisoquinoline alkaloid isolated from different plant sources. It possesses various pharmacological properties including antibacterial, antitumor, antidiabetic, neuroprotective, hepatoprotective, anti-inflammatory, antioxidant, etc. However, the [...] Read more.
Background/Objectives: Natural substances have been a widely studied source of both pharmaceutical excipients and drugs. Berberine (BRB) is a benzylisoquinoline alkaloid isolated from different plant sources. It possesses various pharmacological properties including antibacterial, antitumor, antidiabetic, neuroprotective, hepatoprotective, anti-inflammatory, antioxidant, etc. However, the limited aqueous solubility hinders its application. Nanosized drug delivery systems are an innovative approach for addressing various challenges regarding drug delivery via different routes of administration. Their utilization could improve the solubility of active constituents. Methods: A melt-emulsification and ultrasonication technique was applied for the preparation of nanostructured lipid carriers (NLCs). They were thoroughly physicochemically characterized by the means of Dynamic Light Scattering, TEM, FTIR, DSC, TGA, and In Vitro release. The In Vitro efficacy and safety were evaluated on cholangiocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, lymphoma, fibroblast, and cardioblast cells, as well as rat liver microsomes by means of cytotoxicity assays and the comet assay. Results: The obtained nanoparticles had a spherical shape and size around 158.2 ± 1.8 nm with negative zeta potential. They revealed successful drug loading and improved dissolution of berberine in physiological conditions. The In Vitro safety studies showed that loading BRB in NLCs resulted in improved or retained cytotoxicity to tumor cell lines and reduced cytotoxicity to normal cell lines and liver microsomes. The NLC itself increased microsomal malondialdehyde (MDA) and comet formation. Conclusions: A successful preparation of NLCs with berberine is presented. The nanocarriers show favorable physicochemical and biopharmaceutical properties. The cellular experiments show that the NLC loading of berberine could improve its anticancer efficacy and safety. These findings highlight the potential applicability of berberine in gastrointestinal neoplasms and build the foundation for future practical translation. Full article
(This article belongs to the Special Issue Drug Formulation and Controlled Release Systems for the Gastrointestinal Tract)
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17 pages, 3480 KiB  
Article
Self-Microemulsifying Drug Delivery System to Enhance Oral Bioavailability of Berberine Hydrochloride in Rats
by Xiaolan Chen, Haifeng Yang, Longyu Shi, Yujuan Mao, Lin Niu, Jing Wang, Haifeng Chen, Jiping Jia, Jingxuan Wang, Jiajie Xue, Yan Shen, Chunli Zheng, Yu Tian and Yi Zheng
Pharmaceutics 2024, 16(9), 1116; https://doi.org/10.3390/pharmaceutics16091116 - 24 Aug 2024
Cited by 1 | Viewed by 1503
Abstract
Berberine hydrochloride (BH) is a versatile bioactive compound derived from the plants of the Berberis genus, known for its various pharmacological effects. However, its oral bioavailability is low due to its high hydrophilicity and limited permeability. To enhance its clinical efficacy and oral [...] Read more.
Berberine hydrochloride (BH) is a versatile bioactive compound derived from the plants of the Berberis genus, known for its various pharmacological effects. However, its oral bioavailability is low due to its high hydrophilicity and limited permeability. To enhance its clinical efficacy and oral bioavailability, this study designed and prepared a BH-loaded self-microemulsifying drug delivery system (BH-SMEDDS), and characterized its in vitro and in vivo properties. Firstly, the optimal formulation of BH-SMEDDS was selected using solubility evaluations, pseudo-ternary phase diagrams, and particle size analysis. The formulation containing 55% Capmul MCM, 22.5% Kolliphor RH 40, and 22.5% 1,2-propanediol was developed. BH-SMEDDS exhibited stable physicochemical properties, with an average particle size of 47.2 ± 0.10 nm and a self-emulsification time of 26.02 ± 0.24 s. Moreover, in vitro dissolution studies showed significant improvements in BH release in simulated intestinal fluid, achieving 93.1 ± 2.3% release within 300 min. Meanwhile, BH-SMEDDS did not exhibit cytotoxic effects on the Caco-2 cells. Additionally, BH-SMEDDS achieved a 1.63-fold increase in oral bioavailability compared to commercial BH tablets. Therefore, SMEDDS presents a promising strategy for delivering BH with enhanced oral bioavailability, demonstrating significant potential for clinical application. Full article
(This article belongs to the Special Issue Drug Formulation and Controlled Release Systems for the Gastrointestinal Tract)
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Review

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26 pages, 1185 KiB  
Review
pH-Dependent Drug Delivery Systems for Ulcerative Colitis Treatment
by Yana Gvozdeva and Radiana Staynova
Pharmaceutics 2025, 17(2), 226; https://doi.org/10.3390/pharmaceutics17020226 - 10 Feb 2025
Cited by 2 | Viewed by 1064
Abstract
Inflammatory bowel diseases (IBDs), such as ulcerative colitis (UC) or Crohn’s disease, are becoming a growing global problem due to the limitations of current treatments, which fail to address the needs of patients effectively. UC is characterized by the widespread inflammation of the [...] Read more.
Inflammatory bowel diseases (IBDs), such as ulcerative colitis (UC) or Crohn’s disease, are becoming a growing global problem due to the limitations of current treatments, which fail to address the needs of patients effectively. UC is characterized by the widespread inflammation of the mucosal lining, affecting both the rectum and the entire length of the colon. Over the past forty years, traditional treatments for IBDs have primarily relied on anti-inflammatory drugs and immunosuppressive medications. Treatment could be more effective if drugs could be specifically targeted to act directly on the colon. Conventional drug delivery systems for IBDs encounter numerous challenges on their way to the colon, such as physiological barriers and disease severity. To address these issues, pH-dependent carriers have emerged as a promising advancement, offering a more effective and tolerable treatment for UC. These carriers enable localized, targeted action, reducing side effects and preventing the premature clearance of drugs from inflamed colon tissues. pH-responsive systems are a leading approach for targeted drug release in colitis treatment as they take advantage of the varying pH levels throughout the gastrointestinal tract (GIT). By incorporating pH-sensitive polymers, they ensure drug protection and controlled release in the lower GIT. This review will discuss the advantages and limitations of pH-dependent drug delivery systems for colon-targeted drug delivery. Full article
(This article belongs to the Special Issue Drug Formulation and Controlled Release Systems for the Gastrointestinal Tract)
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