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Current Opinion in Ophthalmology May 2017To describe the risk factors, clinical course, and complications related to anterior segment migration of a dexamethasone (DEX) intravitreal implant, and review over... (Review)
Review
PURPOSE OF REVIEW
To describe the risk factors, clinical course, and complications related to anterior segment migration of a dexamethasone (DEX) intravitreal implant, and review over potential management strategies.
RECENT FINDINGS
Recent reports have demonstrated that migration of a DEX implant into the anterior chamber may occur in patients with higher risk ocular characteristics. Although a relatively rare occurrence, DEX implant migration carries the possibility of inducing potentially vision-threatening corneal endothelial decompensation and edema.
SUMMARY
Any combination of previous pars plana vitrectomy, an open/defective lens capsule, and/or iris defects may increase the risk of DEX implant migration into the anterior chamber. In the setting of a DEX implant that has moved into the anterior segment with corneal edema already present, urgent removal of the implant is warranted to reduce the risk of permanent visual compromise.
Topics: Anterior Eye Segment; Device Removal; Dexamethasone; Drug Implants; Foreign-Body Migration; Glucocorticoids; Humans; Risk Factors; Vitrectomy
PubMed: 28376511
DOI: 10.1097/ICU.0000000000000365 -
Transactions of the American Clinical... 2017The Johns Hopkins Hunterian Neurosurgical Laboratory at the Johns Hopkins University School of Medicine was created in 1904 by Harvey Cushing and William Halsted and has... (Review)
Review
The Johns Hopkins Hunterian Neurosurgical Laboratory at the Johns Hopkins University School of Medicine was created in 1904 by Harvey Cushing and William Halsted and has had a long history of fostering surgical training, encouraging basis science research, and facilitating translational application. Over the past 30 years, the laboratory has addressed the paucity of brain tumor therapies. Pre-clinical work from the laboratory led to the development of carmustine wafers with initial US Food and Drug Administration (FDA) approval in 1996. Combining carmustine wafers, radiation, and temozolomide led to a significant increase in the median survival of patients with glioblastoma. The laboratory has also developed microchips and immunotherapy to further extend survival in this heretofore underserved population. These achievements were made possible by the dedication, commitment, and creativity of more than 300 trainees of the Hunterian Neurosurgical Laboratory. The laboratory demonstrates the beneficial influence of research experience as well its substantial impact on the field of biomedical research.
Topics: Antineoplastic Agents; Baltimore; Biomedical Research; Brain Neoplasms; Drug Implants; Education, Medical; History, 20th Century; Humans; Neurosurgery; Schools, Medical; Women
PubMed: 28790487
DOI: No ID Found -
International Journal of Pharmaceutics Aug 2023Pellet coat damage in multi-unit pellet system (MUPS) tablets has previously been studied and addressed with limited success. The effects of lactose filler material...
Pellet coat damage in multi-unit pellet system (MUPS) tablets has previously been studied and addressed with limited success. The effects of lactose filler material attributes on pellet coat damage have been relatively well-studied but a similar understanding of microcrystalline cellulose (MCC) is lacking notwithstanding its high cushioning potential. Hence, the relationships between MCC attributes and pellet coat damage were investigated. Single pellet in minitablets (SPIMs) were used to isolate pellet-filler effects and reveal the under-unexplored impact of risk factors found in MUPS tablets. MUPS tablets and SPIMs were prepared with various grades of MCC and pellets with an ethylcellulose or acrylic coat at various compaction pressures. Subsequently, the extent of pellet coat damage was determined by dissolution test and quantified using two indicators to differentiate the nature of the damage. A multi-faceted analytical approach incorporated linear regression, correlations and a classification and regression tree algorithm and evaluated how MCC attributes, such as flowability, particle size and plastic deformability, exert various influences on the extent of ethylcellulose and acrylic pellet coat damage. This analysis improved the understanding of the different mechanisms by which pellet coat damage to these two polymer types occurs which can help enhance future pellet coat damage mitigation strategies.
Topics: Drug Implants; Excipients; Tablets; Lactose; Particle Size
PubMed: 37467819
DOI: 10.1016/j.ijpharm.2023.123245 -
Contraception Sep 2016This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics... (Review)
Review
OBJECTIVES
This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics identified by the World Health Organization for eligibility for contraceptive use.
STUDY DESIGN
We searched PubMed, WEIPU, CNKI and Wanfang to identify all relevant evidence published in peer-reviewed journals from 1991 through 2014 regarding the safety of SI (II). We considered studies among women with medical conditions or other characteristics, such as age and parity, as direct evidence and studies among healthy women or a general population of women as indirect evidence.
RESULTS
We identified 108 articles of which 9 met our inclusion criteria. Among women with medical conditions, no evidence was identified for the outcomes of interest, including serious adverse events or outcomes related to medical conditions. Among healthy women, evidence regarding efficacy of SI (II) for women weighing ≥70 kg was conflicting; one study showed an increased pregnancy rate and another showed no relationship. Women with menorrhagia did not experience worsened symptoms and may benefit from SI (II) use. Healthy women using SI (II) were no more likely than users of other methods to gain weight, develop elevated blood pressure, have abnormal liver or bone density tests or develop ovarian cysts or uterine myomas.
CONCLUSIONS
Evidence among healthy women suggests SI (II) is safe and had health outcomes similar to those of other levonorgestrel implants. Studies were limited and conflicting regarding efficacy for women ≥70 kg. All included studies were conducted in China, limiting generalizability.
Topics: Bone Density; China; Contraception Behavior; Contraceptive Agents, Female; Drug Implants; Female; Humans; Leiomyoma; Levonorgestrel; Ovarian Cysts; Patient Satisfaction; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 27217053
DOI: 10.1016/j.contraception.2016.05.004 -
European Journal of Ophthalmology Jan 2022The purpose of this report is to describe a successful management of idiopathic neuroretinitis with intravitreal dexamethasone implant.
INTRODUCTION
The purpose of this report is to describe a successful management of idiopathic neuroretinitis with intravitreal dexamethasone implant.
METHOD
Interventional case report.
CLINICAL CASE
A 34-year-old man with an acute painless unilateral vision loss, optic disc swelling, and a macular edema was diagnosed as idiopathic neuroretinitis, and he underwent 0.7 mg dexamethasone intravitreous implant injection. Macular edema responded quickly and visual acuity improved from 20/50 to 20/25 within 2 weeks and to 20/20 within a month. One month after the injection, optic disc edema disappeared. No recurrence occurred and visual acuity was stable at 20/20 during 3 years of follow-up.
CONCLUSION
Idiopathic neuroretinitis can be treated with intravitreal dexamethasone implant.
Topics: Adult; Dexamethasone; Drug Implants; Glucocorticoids; Humans; Intravitreal Injections; Male; Retinitis
PubMed: 32880185
DOI: 10.1177/1120672120953075 -
European Journal of Pharmaceutics and... Feb 2021In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems... (Review)
Review
In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems associated with this type of delivery is that the drug concentration is controlled by first pass metabolism, and therefore may not always remain within the therapeutic window. Implantable drug delivery systems (IDDSs) are an excellent alternative to traditional delivery because they offer the ability to precisely control the drug release, deliver drugs locally to the target tissue, and avoid the toxic side effects often experienced with systemic administration. Since the creation of the first FDA-approved IDDS in 1990, there has been a surge in research devoted to fabricating and testing novel IDDS formulations. The versatility of these systems is evident when looking at the various biomedical applications that utilize IDDSs. This review provides an overview of the history of IDDSs, with examples of the different types of IDDS formulations, as well as looking at current and future biomedical applications for such systems. Though there are still obstacles that need to be overcome, ever-emerging new technologies are making the manufacturing of IDDSs a rewarding therapeutic endeavor with potential for further improvements.
Topics: Delayed-Action Preparations; Drug Approval; Drug Compounding; Drug Implants; Drug-Eluting Stents; History, 20th Century; History, 21st Century; Humans; United States; United States Food and Drug Administration
PubMed: 33338604
DOI: 10.1016/j.ejpb.2020.12.005 -
International Journal of Pharmaceutics Mar 2024Multiple-unit dosage forms prepared by compacting pellets offer important manufacturing and compliance advantages over pellet-filled capsules. However, compaction may...
Multiple-unit dosage forms prepared by compacting pellets offer important manufacturing and compliance advantages over pellet-filled capsules. However, compaction may negatively affect the release control mechanism of pellets, and subunits may not be readily available after intake. Application of a cushioning layer to the starting units is here proposed as a strategy to obtain tablets with satisfactory mechanical strength, rapid disintegration and maintenance of the expected release profile of individual subunits while avoiding the use of mixtures of pellets and excipients to promote compaction and limit the impact of the forces involved. Cushion-coating with PEG1500, a soft and soluble material, was proved feasible provided that the processing temperature was adequately controlled. Cushioned gastro-resistant pellets were shown to consolidate under relatively low compaction pressures, which preserved their inherent release performance after tablet disintegration. Adhesion problems associated with the use of PEG1500 were overcome by applying an outer Kollicoat® IR film. Through design of experiment (DoE), robustness of the proposed approach was demonstrated, and the formulation as well as tableting conditions were optimized. The tableted cushion-coated pellet systems manufactured would allow a relatively high load of modified-release units to be conveyed, thus setting out a versatile and scalable approach to oral administration of multiple-unit dosage forms.
Topics: Excipients; Delayed-Action Preparations; Drug Implants; Tablets; Administration, Oral
PubMed: 38316318
DOI: 10.1016/j.ijpharm.2024.123874 -
Pharmaceutical Development and... Jun 2017The complexity of the brain and the membranous blood-brain barrier (BBB) has proved to be a significant limitation to the systemic delivery of pharmaceuticals to the... (Review)
Review
The complexity of the brain and the membranous blood-brain barrier (BBB) has proved to be a significant limitation to the systemic delivery of pharmaceuticals to the brain rendering them sub-therapeutic and ineffective in the treatment of neurological diseases. Apart from this, lack of innovation in product development to counteract the problem is also a major contributing factor to a poor therapeutic outcome. Various innovative strategies show potential in treating some of the neurological disorders; however, drug delivery remains the most popular. To attain therapeutic drug levels in the central nervous system, large, intolerable systemic doses are generally administered. The major factors responsible for the success maintenance therapy of neurological diseases included controlled and sustained release of neurotherapeutics, reduced frequency of administration, higher bioavailability, and patient compliances. Conventional oral or injectable formulations cannot satisfy all the requirements in many circumstances. This article reviews the therapeutic implantable polymeric and transdermal devices employed in an attempt to effectively achieve therapeutic quantities of drug across the BBB over a prolonged period, to improve patient disease prognosis.
Topics: Administration, Cutaneous; Animals; Blood-Brain Barrier; Central Nervous System; Central Nervous System Agents; Central Nervous System Diseases; Drug Delivery Systems; Drug Implants; Humans; Polymers
PubMed: 27268737
DOI: 10.1080/10837450.2016.1189937 -
The Journal of Experimental Biology Oct 2018In birds, the use of corticosterone (Cort) implants is a frequent tool aimed at simulating systemic elevations of this hormone and studying effects on biological traits...
In birds, the use of corticosterone (Cort) implants is a frequent tool aimed at simulating systemic elevations of this hormone and studying effects on biological traits (e.g. physiology, morphology, behavior). This manipulation may alter adrenocortical function, potentially changing both baseline (Cort) and stress-induced (Cort) plasma Cort levels. However, implant effects on the latter trait are rarely measured, disregarding downstream consequences of potentially altered stress responses. Here, we analyzed the effects of Cort implants on both Cort and Cort in nestling and adult European white storks, In addition, we performed a review of 50 studies using Cort implants in birds during the last two decades to contextualize stork results, assess researchers' patterns of use and infer current study biases. High and low doses of Cort implants resulted in a decrease of both Cort (31-71% below controls) and Cort (63-79% below controls) in storks. Our literature review revealed that Cort generally increases (72% of experiments) whereas Cort decreases (78% of experiments) following implant treatment in birds. Our results challenge and expand the prevailing assumption that Cort implants increase circulating Cort levels because: (i) Cort levels show a quadratic association with implant dose across bird species, and decreased levels may occur at both high and low implant doses, and (ii) Cort implants also decrease Cort levels, thus producing stress-hyporesponsive phenotypes. It is time to work towards a better understanding of the effects of Cort implants on adrenocortical function, before addressing downstream links to variation in other biological traits.
Topics: Animals; Birds; Corticosterone; Dose-Response Relationship, Drug; Drug Implants; Male; Random Allocation; Stress, Physiological
PubMed: 30111557
DOI: 10.1242/jeb.173864 -
Medicine Mar 2019Chronic stable angina (CSA) resulted in a considerable burden for both individuals and the society. In this study we aimed to critically evaluate the effectiveness and... (Comparative Study)
Comparative Study Meta-Analysis
Compound salvia pellet might be more effective and safer for chronic stable angina pectoris compared with nitrates: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Chronic stable angina (CSA) resulted in a considerable burden for both individuals and the society. In this study we aimed to critically evaluate the effectiveness and safety of Compound salvia pellet compared with nitrates in the treatment of Chronic Stable Angina (CSA) pectoris, and to provide more credible evidence for clinical practice.
METHODS
A comprehensive and exhaustive search strategy was formulated to identify potential RCTs of compound salvia pellet for CSA in international and Chinese databases from their inception to July 4th, 2018. We also searched the bibliographies of relevant studies. Two reviewers independently assessed the quality of included trials by using Cochrane Risk of Bias Tool.
RESULTS
The literature search yielded 1849 citations and 51 RCTs (n = 4732) were included for meta-analysis after titles, abstracts and full text selection according to eligibility criteria. The pooled results suggested that compound salvia pellet was much more effective than nitrates in the improvement of angina symptoms (therapy = 4 weeks, RR = 1.23, 95%CI = [1.17, 1.30], P < .001, I = 0%; therapy = 4 weeks, RR = 1.13, 95%CI = [1.08, 1.17], P < .001, I = 45.6%), and ECG test (therapy = 4 weeks, RR = 1.24, 95%CI [1.14, 1.35], P < .001, I = 51.5%; and therapy > 4 weeks, RR = 1.30, 95%CI[1.20, 1.42], P < .001, I = 36.4%) in CSA. Compared with nitrates, the percentage of patients with adverse events significantly decreased when prescribed with compound salvia pellet (3.2% vs 17.0%).
CONCLUSION
Compound salvia pellet might be more effective on the improvement of angina symptoms, ECG test and with few adverse events compared with nitrates. While there are some limitations in this study, which may weaken the results, we believe the findings could provide useful information for stakeholders concerned with outcomes in patients with CSA. More rigorous RCTs with high quality are needed to confirm these findings.
Topics: Angina, Stable; Drug Implants; Drugs, Chinese Herbal; Humans; Nitrates; Phytotherapy; Randomized Controlled Trials as Topic; Salvia; Treatment Outcome
PubMed: 30817582
DOI: 10.1097/MD.0000000000014638