scholarly journals Eye Drops, Prolonged-Release Solution in Single-dose Container

2020 ◽  
Author(s):  
Keyword(s):  
Single Dose ◽  
Prolonged Release ◽  
Eye Drops

scholarly journals Bio-Distribution and Pharmacokinetics of Topically Administered γ-Cyclodextrin Based Eye Drops in Rabbits

2021 ◽  
Vol 14 (5) ◽  
pp. 480
Author(s):  
Martin Kallab ◽  
Kornelia Schuetzenberger ◽  
Nikolaus Hommer ◽  
Bhavapriya Jasmin Schäfer ◽  
Doreen Schmidl ◽  
...  
Keyword(s):  
Single Dose ◽  
Drug Concentration ◽  
Vitreous Humor ◽  
Controlled Study ◽  
Eye Drops ◽  
Corneal Tissue ◽  
Single Administration ◽  
Local Tolerability ◽  
Dose Administration ◽  
Retinal Tissue

The purpose of this study was to evaluate the ocular pharmacokinetics, bio-distribution and local tolerability of γ-cyclodextrin (γCD) based irbesartan 1.5% eye drops and candesartan 0.15% eye drops after single and multiple topical administration in rabbit eyes. In this randomized, controlled study, a total number of 59 New Zealand White albino rabbits were consecutively assigned to two study groups. Group 1 (n = 31) received irbesartan 1.5% and group 2 (n = 28) candesartan 0.15% eye drops. In both groups, single dose and multiple administration pharmacokinetic studies were performed. Rabbits were euthanized at five predefined time points after single-dose administration, whereas multiple-dose animals were dosed for 5 days twice-daily and then euthanized 1 h after the last dose administration. Drug concentration was measured by using liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the retinal tissue, vitreous humor, aqueous humor, corneal tissue and in venous blood samples. Pharmacokinetic parameters including maximal drug concentration (Cmax), time of maximal drug concentration (Tmax), half-life and AUC were calculated. To assess local tolerability, six additional rabbits received 1.5% irbesartan eye drops twice daily in one eye for 28 days. Tolerability was assessed using a modified Draize test and corneal sensibility by Cochet Bonnet esthesiometry. Both γCD based eye drops were rapidly absorbed and distributed in the anterior and posterior ocular tissues. Within 0.5 h after single administration, the Cmax of irbesartan and candesartan in retinal tissue was 251 ± 142 ng/g and 63 ± 39 ng/g, respectively. In the vitreous humor, a Cmax of 14 ± 16 ng/g for irbesartan was reached 0.5 h after instillation while Cmax was below 2 ng/g for candesartan. For multiple dosing, the observed Cmean in retinal tissue was 338 ± 124 ng/g for irbesartan and 36 ± 10 ng/g for candesartan, whereas mean vitreous humor concentrations were 13 ± 5 ng/g and <2 ng/g, respectively. The highest plasma concentrations of both irbesartan (Cmax 5.64 ± 4.08 ng/mL) and candesartan (Cmax 4.32 ± 1.04 ng/mL) were reached 0.5 h (Tmax) after single administration. Local tolerability was favorable with no remarkable differences between the treated and the control eyes. These results indicate that irbesartan and candesartan in γCD based nanoparticle eye drops can be delivered to the retinal tissue of the rabbit’s eye in pharmacologically relevant concentrations. Moreover, safety and tolerability profiles appear to be favorable in the rabbit animal model.

scholarly journals Contact Lenses as Ophthalmic Drug Delivery Systems: A Review

Polymers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1102
Author(s):  
Paola Franco ◽  
Iolanda De Marco
Keyword(s):  
Contact Lenses ◽  
Pharmacological Action ◽  
Active Principle ◽  
Prolonged Release ◽  
Eye Drops ◽  
Polymeric Support ◽  
Physiological Factors ◽  
Ophthalmic Drugs ◽  
Innovative Methods ◽  
Ophthalmic Drug

Ophthalmic drugs used for the treatment of various ocular diseases are commonly administered by eye drops. However, due to anatomical and physiological factors, there is a low bioavailability of the active principle. In order to increase the drug residence time on the cornea to adequate levels, therapeutic contact lenses have recently been proposed. The polymeric support that constitutes the contact lens is loaded with the drug; in this way, there is a direct and effective pharmacological action on the target organ, promoting a prolonged release of the active principle. The incorporation of ophthalmic drugs into contact lenses can be performed by different techniques; nowadays, the soaking method is mainly employed. To improve the therapeutic performance of drug-loaded contact lenses, innovative methods have recently been proposed, including the impregnation with supercritical carbon dioxide. This updated review of therapeutic contact lenses production and application provides useful information on the most effective preparation methodologies, recent achievements and future perspectives.

Treatment of persistent epithelial defects with single-dose autologous serum eye drops

2021 ◽  
pp. 112067212110483
Author(s):  
Selma Özbek-Uzman ◽  
Züleyha Yalnız-Akkaya ◽  
Evin Şingar Özdemir ◽  
Ayşe Burcu
Keyword(s):  
Single Dose ◽  
Healing Time ◽  
Autologous Serum ◽  
Eye Drops ◽  
Artificial Tears ◽  
Duration Of Treatment ◽  
The Mean ◽  
Preservative Free ◽  
Serum Eye Drops

Purpose: We aimed to investigate the efficacy and safety of single-dose autologous serum eye drops (ASEDs) for treatment of persistent corneal epithelial defects (PEDs). Methods: About 34 eyes of 26 patients treated from March 2016 to May 2020 with a single dose of ASEDs for PEDs that did not respond to conventional treatment were retrospectively evaluated. Patient demographics, predisposing factors, size, and duration of the PED, duration of treatment, and dosage of ASEDs, PED healing time, success rate of the ASED treatment, and follow-up time after the onset of ASED treatment were recorded. Autologous serum eye drops (20%) were prepared by diluting the serum with preservative-free artificial tears in single-dose vials. Vials were stored at −20°C and used daily after dissolving. Results: The mean patient age was 47.0 ± 18.5 years, and 13 (50%) of the patients were male. The most common indication for ASEDs was PED after keratoplasty. The mean duration of ASED treatment was 8.5 ± 6.3 months, and mean follow-up time was 22.8 ± 12.2 months. Autologous serum eye drop treatment was effective in 25 (73.5%) eyes and partially effective in 5 (14.7%) eyes. None of the eyes displayed complications related to the treatment. Conclusion: In patients with PED for whom conservative treatment is insufficient, ASEDs prepared by dilution with preservative-free artificial tears in single-dose vials and administered based on the daily use principle appear to be effective and safe.

scholarly journals Amino Acid Plasma Profiles from a Prolonged-Release Protein Substitute for Phenylketonuria: A Randomized, Single-Dose, Four-Way Crossover Trial in Healthy Volunteers

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1653 ◽  
Author(s):  
Mika Scheinin ◽  
Anna Barassi ◽  
Jouni Junnila ◽  
Zsófia Lovró ◽  
Giorgio Reiner ◽  
...  
Keyword(s):  
Single Dose ◽  
Amino Acid ◽  
Healthy Volunteers ◽  
Crossover Trial ◽  
Peak Plasma ◽  
Plasma Concentrations ◽  
Prolonged Release ◽  
Metabolic Markers ◽  
Primary Endpoints ◽  
Secondary Endpoints

Several disorders of amino acid (AA) metabolism are treated with a protein-restricted diet supplemented with specific AA mixtures. Delivery kinetics impacts AA absorption and plasma concentration profiles. We assessed plasma profiles after ingestion of an AA mixture engineered to prolong AA absorption with Physiomimic TechnologyTM (Test) in a randomized, single-dose, four-way crossover trial in healthy volunteers (Trial Registration: ISRCTN11016729). In a two-step hypothesis, the primary endpoints were (i) significant reduction in peak plasma concentrations (Cmax) of essential amino acids (EAAs) while (ii) maintaining EAA bioavailability (AUC0-300 min) compared to a free AA mixture (Reference). Secondary endpoints included effects on plasma profiles of other AA groups and effects on several metabolic markers. Thirty subjects completed the study. Both co-primary endpoints were met: Cmax for EAAs was 27% lower with the Test product compared to the Reference product (ratio, 0.726, p < 0.0001); overall plasma EAA levels from the two AA mixtures was within the pre-specified bioequivalence range (AUC0-300min ratio, 0.890 (95% CI: 0.865, 0.915)). These findings were supported by the results of secondary endpoints. Prolongation of AA absorption was associated with modulation of several metabolic markers. It will be important to understand whether this can improve the long-term management of disorders of AA metabolism.

Pharmacokinetics of a single dose of fulvestrant prolonged-release intramuscular injection in postmenopausal women awaiting surgery for primary breast cancer

2003 ◽  
Vol 25 (5) ◽  
pp. 1440-1452 ◽  
Author(s):  
John F.R. Robertson ◽  
William Odling-Smee ◽  
Chris Holcombe ◽  
Stanley R. Kohlhardt ◽  
Mike P. Harrison
Keyword(s):  
Breast Cancer ◽  
Single Dose ◽  
Postmenopausal Women ◽  
Primary Breast Cancer ◽  
Intramuscular Injection ◽  
Prolonged Release

Comparison among adjuvant treatments for primary pterygium: a network meta-analysis

2017 ◽  
Vol 102 (6) ◽  
pp. 748-756 ◽  
Author(s):  
Ellen Carrara Fonseca ◽  
Eduardo Melani Rocha ◽  
Gustavo Viani Arruda
Keyword(s):  
Single Dose ◽  
Latin American ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
Amniotic Membrane Transplantation ◽  
Surgical Removal ◽  
Eye Drops ◽  
Conjunctival Autograft ◽  
Pterygium Surgery ◽  
Primary Pterygium

PurposePterygium is a frequent ocular disease, where the major challenge is the high level of recurrence after its surgical removal. We performed a network meta-analysis to identify, among several adjuvant treatments for primary pterygium, which is the best to prevent recurrence.MethodsA search was conducted using PubMed, Scientific Electronic Library Online, Latin American and Caribbean Centre on Health Sciences and Cochrane Eyes and Vision Group Trials Register between 1993 and 2015 for randomisedclinical trials (RCTs) comparing adjuvant treatments following primary pterygium surgery.Results24 RCTs that studied 1815 eyes of 1668 patients were included and allowed direct and indirect comparison among 14 interventions through network meta-analysis. The rank from the best to worse treatment to prevent recurrence is: conjunctival autograft + ciclosporin 0.05% eye drops, bare sclera + intraoperativemitomycin C (MMC) <0.02%, bare sclera + beta therapy (2500 cGy single dose), conjunctival autograft + beta therapy (1000 cGy single dose), bare sclera + MMC 0.02% eye drops, conjunctival autograft, bare sclera + intraoperative MMC >0.02%, bare sclera + ciclosporin 0.05% eye drops, bare sclera + intraoperative 5-fluorouracil 5%, amniotic membrane transplantation, bare sclera + intraoperative MMC 0.02%, conjunctival autograft + bevacizumab 0.05% eye drops, bare sclera + bevacizumab 0.05% eye drops and bare sclera alone.ConclusionThe best adjuvant treatment to prevent recurrence after primary pterygium surgery is the association of conjunctival autograft and ciclosporin 0.05% eye drops. Bare sclera technique alone should be discontinued since it is associated with high recurrence rates.

Prospective Cohort Trial of Euphrasia Single-Dose Eye Drops in Conjunctivitis

2000 ◽  
Vol 6 (6) ◽  
pp. 499-508 ◽  
Author(s):  
Matthias Stoss ◽  
Christoph Michels ◽  
Ellen Peter ◽  
Ramona Beutke ◽  
Robert William Gorter
Keyword(s):  
Single Dose ◽  
Prospective Cohort ◽  
Eye Drops

scholarly journals Gel-Based Materials for Ophthalmic Drug Delivery

Gels ◽  
2021 ◽  
Vol 7 (3) ◽  
pp. 130
Author(s):  
Roberta Cassano ◽  
Maria Luisa Di Gioia ◽  
Sonia Trombino
Keyword(s):  
Drug Delivery ◽  
Side Effects ◽  
Contact Lenses ◽  
Prolonged Release ◽  
Eye Drops ◽  
Non Invasive ◽  
Ophthalmic Drug Delivery ◽  
Ophthalmic Drug ◽  
In Situ Gelling

The most common route of administration of ophthalmic drugs is the topical route because it is convenient, non-invasive, and accessible to all patients. Unfortunately, drugs administered topically are not able to reach effective concentrations. Moreover, their bioavailability must be improved to decrease the frequency of administrations and their side effects, and to increase their therapeutic efficiency. For this purpose, in recent decades, particular attention has been given to the possibility of developing prolonged-release forms that are able to increase the precorneal residence time and decrease the loss of the drug due to tearing. Among these forms, gel-based materials have been studied as an ideal delivery system because they are an extremely versatile class with numerous prospective applications in ophthalmology. These materials are used in gel eye drops, in situ gelling formulations, intravitreal injections, and therapeutic contact lenses. This review is intended to describe gel-based materials and their main applications in ophthalmology.

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