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Pharmaceutics
Special Issues
Controlled-Release Systems for Ophthalmic Applications
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Controlled-Release Systems for Ophthalmic Applications

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

Deadline for manuscript submissions: closed (30 June 2024) | Viewed by 9595

Special Issue Editors

Dr. Quanying Bao

E-Mail Website
Guest Editor
Alexion, AstraZeneca Rare Disease, 101 College St, New Haven, CT 06510, USA
Interests: ophthalmic; long-acting injectables; intrauterine systems; IVIVCs development; gold nanoparticles; complex drug products; formulation sciences
Dr. Narendar Dudhipala

E-Mail Website
Guest Editor
Thermo Fisher Scientific, 5900 MLK Jr Hwy, Greenville, NC 27834, USA
Interests: ophthalmic delivery: lipid nano particles, nano emulsions, inserts, films, in situ gels; glaucoma; keratitis; small molecules; biologics; oral delivery; drug product development
Dr. Laibin Luo

E-Mail Website
Guest Editor
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield, CT 06877, USA
Interests: intravitreal formulation; long-acting injectables; PBBM modeling; biorelevant dissolution

Special Issue Information

Dear Colleagues,

Ophthalmic dosage forms or ocular drug delivery systems face tremendous challenges ranging from drug delivery strategies, formulation, manufacturing, quality control and bioequivalence evaluation due to the complex anatomy of human eyes. In addition, most of the ophthalmic route of administration is for local drug delivery; therefore, the commonly used pharmacokinetic approach is not sufficient to evaluate the absorption of these formulations. Over the past several decades, efforts have been made to improve the bioavailability of the ophthalmic formulations through controlled or sustained drug delivery strategies such as implants (intraocular or intravitreal), long-acting injectable suspensions, and ophthalmic gels. This Special Issue will focus on the controlled or sustained drug delivery of both small and large molecules for ophthalmic application. Both comprehensive reviews and research manuscripts in this area are welcome.

We look forward to receiving your contributions.

Dr. Quanying Bao
Dr. Narendar Dudhipala
Dr. Laibin Luo
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

  • controlled release
  • ophthalmic
  • drug delivery
  • intravitreal
  • implants
  • gels

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Published Papers (3 papers)

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Research

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13 pages, 1696 KiB  
Article
Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation
by Maxime Le Merdy, Jessica Spires, Ming-Liang Tan, Liang Zhao and Viera Lukacova
Pharmaceutics 2024, 16(7), 914; https://doi.org/10.3390/pharmaceutics16070914 - 9 Jul 2024
Cited by 1 | Viewed by 1309
Abstract
The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs. New methods are needed to facilitate the [...] Read more.
The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs. New methods are needed to facilitate the development of ophthalmic generic drug products. Ocular physiologically based pharmacokinetic (O-PBPK) models can provide insight into drug partitioning in eye tissues that are usually not accessible and/or are challenging to sample in humans. This study aims to demonstrate the utility of an ocular PBPK model to predict human exposure following the administration of ophthalmic suspension. Besifloxacin (Bes) suspension is presented as a case study. The O-PBPK model for Bes ophthalmic suspension (Besivance® 0.6%) accounts for nasolacrimal drainage, suspended particle dissolution in the tears, ocular absorption, and distribution in the rabbit eye. A topical controlled release formulation was used to integrate the effect of Durasite® on Bes ocular retention. The model was subsequently used to predict Bes exposure after its topical administration in humans. Drug-specific parameters were used as validated for rabbits. The physiological parameters were adjusted to match human ocular physiology. Simulated human ocular pharmacokinetic profiles were compared with the observed ocular tissue concentration data to assess the OCAT models’ ability to predict human ocular exposure. The O-PBPK model simulations adequately described the observed concentrations in the eye tissues following the topical administration of Bes suspension in rabbits. After adjustment of physiological parameters to represent the human eye, the extrapolation of clinical ocular exposure following a single ocular administration of Bes suspension was successful. Full article
(This article belongs to the Special Issue Controlled-Release Systems for Ophthalmic Applications)
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Review

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44 pages, 3893 KiB  
Review
Advancements in Ocular Therapy: A Review of Emerging Drug Delivery Approaches and Pharmaceutical Technologies
by Bhupendra Raj Giri, Deeksha Jakka, Michael A. Sandoval, Vineet R. Kulkarni and Quanying Bao
Pharmaceutics 2024, 16(10), 1325; https://doi.org/10.3390/pharmaceutics16101325 - 12 Oct 2024
Cited by 2 | Viewed by 5201
Abstract
Eye disorders affect a substantial portion of the global population, yet the availability of efficacious ophthalmic drug products remains limited. This can be partly ascribed to a number of factors: (1) inadequate understanding of physiological barriers, treatment strategies, drug and polymer properties, and [...] Read more.
Eye disorders affect a substantial portion of the global population, yet the availability of efficacious ophthalmic drug products remains limited. This can be partly ascribed to a number of factors: (1) inadequate understanding of physiological barriers, treatment strategies, drug and polymer properties, and delivery systems; (2) challenges in effectively delivering drugs to the anterior and posterior segments of the eye due to anatomical and physiological constraints; and (3) manufacturing and regulatory hurdles in ocular drug product development. The present review discusses innovative ocular delivery and treatments, encompassing implants, liposomes, nanoparticles, nanomicelles, microparticles, iontophoresis, in situ gels, contact lenses, microneedles, hydrogels, bispecific antibodies, and gene delivery strategies. Furthermore, this review also introduces advanced manufacturing technologies such as 3D printing and hot-melt extrusion (HME), aimed at improving bioavailability, reducing therapeutic dosages and side effects, facilitating the design of personalized ophthalmic dosage forms, as well as enhancing patient compliance. This comprehensive review lastly offers insights into digital healthcare, market trends, and industry and regulatory perspectives pertaining to ocular product development. Full article
(This article belongs to the Special Issue Controlled-Release Systems for Ophthalmic Applications)
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13 pages, 914 KiB  
Review
Ranibizumab Port Delivery System in Neovascular Age-Related Macular Degeneration: Where Do We Stand? Overview of Pharmacokinetics, Clinical Results, and Future Directions
by Matteo Mario Carlà, Maria Cristina Savastano, Francesco Boselli, Federico Giannuzzi and Stanislao Rizzo
Pharmaceutics 2024, 16(3), 314; https://doi.org/10.3390/pharmaceutics16030314 - 23 Feb 2024
Cited by 1 | Viewed by 2295
Abstract
The ranibizumab (RBZ) port delivery system (PDS) is a device designed to continuously deliver RBZ in the vitreous chamber for the treatment of neovascular age-related macular degeneration (nAMD). It is implanted during a surgical procedure and can provide sustained release of the medication [...] Read more.
The ranibizumab (RBZ) port delivery system (PDS) is a device designed to continuously deliver RBZ in the vitreous chamber for the treatment of neovascular age-related macular degeneration (nAMD). It is implanted during a surgical procedure and can provide sustained release of the medication for several months. This review, updated to January 2024, focuses on past clinical studies as well as current and forthcoming trials looking into a PDS with RBZ. In the phase 2 LADDER trial, the mean time to first refill of a PDS with RBZ 100 mg/mL was 15.8 months, with the pharmacokinetic (PK) profile showing a sustained concentration of RBZ in the blood and aqueous humor. More recently, a PDS with RBZ (100 mg/mL) refilled every 24 weeks was shown to be non-inferior to a monthly intravitreal injection (IVI) with RBZ (0.5 mg) over 40 and 92 weeks in the phase 3 ARCHWAY trial. The refill every 24 weeks allowed for a RBZ vitreous exposure within the concentration range of monthly intravitreal injections (IVIs), and the expected half-life (106 days) was comparable with the in vitro results. Nonetheless, vitreous hemorrhage and endophthalmitis were more common side effects in PDS patients. In conclusion, a PDS continuously delivering RBZ has a clinical effectiveness level comparable with IVI treatment. However, a greater frequency of unfavorable occurrences highlights the need for procedure optimization for a wider adoption. Ongoing trials and possible future approaches need to be addressed. Full article
(This article belongs to the Special Issue Controlled-Release Systems for Ophthalmic Applications)
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