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Women's Health (London, England) Mar 2015
Topics: Contraception; Contraceptive Agents, Female; Desogestrel; Drug Implants; Female; Humans; Intrauterine Devices; Postpartum Period; Women's Health
PubMed: 25776281
DOI: 10.2217/whe.14.78 -
The Journal of Sexual Medicine Jul 2017Implantation of testosterone doses of at least 150 to 450 mg (ie, two to six pellets) is common clinical practice despite a lack of prospective data. (Clinical Trial)
Clinical Trial
Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency.
BACKGROUND
Implantation of testosterone doses of at least 150 to 450 mg (ie, two to six pellets) is common clinical practice despite a lack of prospective data.
AIM
To evaluate pharmacokinetics, clinical efficacy, safety, and patient-reported outcomes in men with androgen deficiency who received implantation of testosterone pellets (900 mg) in an open-label study.
METHODS
Men with androgen deficiency (serum testosterone < 300 ng/dL [10.4 nmol/L]) were screened and received 12 testosterone pellets (900 mg). Serum hormone measurements (total and free testosterone, dihydrotestosterone, and estradiol) were obtained on days 1, 5, 8, 15, 29, 57, 85, and 113. All hormones were assayed using validated liquid chromatography and tandem mass spectrometry.
OUTCOMES
Pharmacokinetics of selected hormones was determined. The patient-reported International Index of Erectile Function (IIEF), Center for Epidemiologic Studies Depression (CES-D), and Androgen Deficiency in the Aging Male (qADAM) questionnaires also were performed. Patients rated their satisfaction on a scale from 1 (very satisfied) to 5 (very dissatisfied). Adverse events were monitored throughout.
RESULTS
Fifteen patients were included (mean age = 54.5 years, SD = 8.6 years). Mean baseline total testosterone concentration was 241.6 ng/dL (SD = 88.8 ng/dL; mean = 8.4 nmol/L, SD = 3.1 nmol/L). Mean testosterone serum concentrations fluctuated during the first 2 weeks (range = 300-1,000 ng/dL, 10.4-34.7 nmol/L) but remained higher than or equal to 300 ng/dL (10.4 nmol/L) through day 113. Concentrations of free testosterone, dihydrotestosterone, and estradiol mirrored that of total testosterone. Male functioning (IIEF score), depression (CES-D total score), and androgen-deficiency symptoms (qADAM total score) improved from baseline. Most patients were "very satisfied" (40.0%) or "quite satisfied" (26.7%) with treatment. Testosterone pellets were well tolerated. Pellet extrusion and polycythemia occurred in one patient each.
CLINICAL IMPLICATIONS
Implantation of high doses (900 mg) of testosterone pellets are generally well tolerated and could provide clinical benefit for some patients.
STRENGTHS AND LIMITATIONS
This study provides standardized data for the implantation of 12 testosterone pellets. However, the open-label uncontrolled design of this study and its small and ethnically non-diverse patient population limit the interpretation of these data, particularly the patient-reported outcomes.
CONCLUSION
Implantation of 12 testosterone pellets (900 mg) was well tolerated and provided adequate and sustained serum testosterone concentrations. Additional randomized controlled trials are needed to confirm efficacy and safety findings. McMahon CG, Shusterman N, Cohen B. Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency. J Sex Med 2017;14:883-890.
Topics: Adolescent; Adult; Aged; Dihydrotestosterone; Drug Implants; Estradiol; Humans; Hypogonadism; Male; Middle Aged; Patient Reported Outcome Measures; Patient Satisfaction; Penile Erection; Prospective Studies; Surveys and Questionnaires; Testosterone; Treatment Outcome; Young Adult
PubMed: 28673432
DOI: 10.1016/j.jsxm.2017.04.734 -
Journal of Controlled Release :... Nov 2023Different types of ibuprofen-loaded, poly (D,L lactic-co-glycolic acid) (PLGA)-based implants were prepared by 3D printing (Droplet Deposition Modeling). The theoretical...
Different types of ibuprofen-loaded, poly (D,L lactic-co-glycolic acid) (PLGA)-based implants were prepared by 3D printing (Droplet Deposition Modeling). The theoretical filling density of the mesh-shaped implants was varied from 10 to 100%. Drug release was measured in agarose gels and in well agitated phosphate buffer pH 7.4. The key properties of the implants (and dynamic changes thereof upon exposure to the release media) were monitored using gravimetric measurements, optical microscopy, Differential Scanning Calorimetry, Gel Permeation Chromatography, and Scanning Electron Microscopy. Interestingly, drug release was similar for implants with 10 and 30% filling density, irrespective of the experimental set-up. In contrast, implants with 100% filling density showed slower release kinetics, and the shape of the release curve was altered in agarose gels. These observations could be explained by the existence (or absence) of a continuous aqueous phase between the polymeric filaments and the "orchestrating role" of substantial system swelling for the control of drug release. At lower filling densities, it is sufficient for the drug to be released from a single filament. In contrast, at high filling densities, the ensemble of filaments acts as a much larger (more or less homogeneous) polymeric matrix, and the average diffusion pathway to be overcome by the drug is much longer. Agarose gel (mimicking living tissue) hinders substantial PLGA swelling and delays the onset of the final rapid drug release phase. This improved mechanistic understanding of the control of drug release from PLGA-based 3D printed implants can help to facilitate the optimization of this type of advanced drug delivery systems.
Topics: Polylactic Acid-Polyglycolic Acid Copolymer; Drug Liberation; Polyglycolic Acid; Sepharose; Lactic Acid; Gels; Printing, Three-Dimensional; Drug Implants
PubMed: 37714435
DOI: 10.1016/j.jconrel.2023.09.020 -
Magnetic Resonance in Medicine Jan 2015Metallic particles have shaped the use of magnetic resonance imaging (MRI) for molecular and cellular imaging. Although these particles have generally been developed for... (Review)
Review
Metallic particles have shaped the use of magnetic resonance imaging (MRI) for molecular and cellular imaging. Although these particles have generally been developed for extracellular residence, either as blood pool contrast agents or targeted contrast agents, the coopted use of these particles for intracellular labeling has grown over the last 20 years. Coincident with this growth has been the development of metal oxide particles specifically intended for intracellular residence, and innovations in the nature of the metallic core. One promising nanoparticle construct for MRI-based cell tracking is polymer encapsulated metal oxide nanoparticles. Rather than a polymer coated metal oxide nanocrystal of the core: shell type, polymer encapsulated metal oxide nanoparticles cluster many nanocrystals within a polymer matrix. This nanoparticle composite more efficiently packages inorganic nanocrystals, affording the ability to label cells with more inorganic material. Further, for magnetic nanocrystals, the clustering of multiple magnetic nanocrystals within a single nanoparticle enhances r2 and r2* relaxivity. Methods for fabricating polymer encapsulated metal oxide nanoparticles are facile, yielding both varied compositions and synthetic approaches. This review presents a brief history into the use of metal oxide particles for MRI-based cell tracking and details the development and use of biodegradable, polymer encapsulated, metal oxide nanoparticles and microparticles for MRI-based cell tracking.
Topics: Absorbable Implants; Animals; Cell Tracking; Contrast Media; Drug Implants; Humans; Image Enhancement; Magnetic Resonance Imaging; Metal Nanoparticles; Polymers; Reproducibility of Results; Sensitivity and Specificity
PubMed: 24753150
DOI: 10.1002/mrm.25263 -
Contraception May 2016Establish a current cross-sectional national picture of intrauterine device (IUD) and implant provision by US family physicians and ascertain individual, clinical site...
OBJECTIVE
Establish a current cross-sectional national picture of intrauterine device (IUD) and implant provision by US family physicians and ascertain individual, clinical site and scope of practice level associations with provision.
STUDY DESIGN
Secondary analysis of data from 2329 family physicians recertifying with the American Board of Family Medicine in 2014.
RESULTS
Overall, 19.7% of respondents regularly inserted IUDs, and 11.3% regularly inserted and/or removed implants. Family physicians provided these services in a wide range of clinical settings. In bivariate analysis, almost all of the individual, clinical site and scope of practice characteristics we examined were associated with provision of both methods. In multivariate analysis, the scope of practice characteristics showed the strongest association with both IUD and implant provision. For IUDs, this included providing prenatal care with [adjusted odds ratio (aOR) 3.26, 95% confidence interval (95% CI)=1.93-5.49] or without (aOR=3.38, 95% CI=1.88-6.06) delivery, performance of endometrial biopsies (aOR=16.51, 95% CI=11.97-22.79) and implant insertion and removal (aOR=8.78, 95% CI=5.79-13.33). For implants, it was providing prenatal care and delivery (aOR=1.77, 95% CI=1.15-2.74), office skin procedures (aOR=3.07, 95% CI=1.47-6.42), endometrial biopsies (aOR=3.67, 95% CI=2.41-5.59) and IUD insertion (aOR=8.58, 95% CI=5.70-12.91).
CONCLUSIONS
While a minority of family physicians regularly provided IUDs and/or implants, those who provided did so in a broad range of outpatient settings. Individual and clinical site characteristics were not largely predictive of provision. This connotes potential for family physicians to increase IUD and implant access in a variety of settings. Provision of both methods was strongly associated with scope of practice variables including performance of certain office procedures as well as prenatal and/or obstetrical care.
IMPLICATIONS
These data provide a baseline from which to analyze change in IUD and implant provision in family medicine, identify gaps in care and ascertain potential leverage points for interventions to increase long-acting reversible contraceptive provision by family physicians. Interventions may be more successful if they first focus on sites and/or family physicians who already provide prenatal care, obstetrical care, skin procedures and/or endometrial biopsies.
Topics: Attitude of Health Personnel; Chi-Square Distribution; Cross-Sectional Studies; Drug Implants; Female; Health Care Surveys; Humans; Intrauterine Devices; Male; Multivariate Analysis; Physicians, Family; Practice Patterns, Physicians'; United States
PubMed: 26776938
DOI: 10.1016/j.contraception.2016.01.004 -
Drug and Alcohol Dependence Aug 2018Long-acting opioid pharmacotherapy (OPT) is presumed to offer benefits over more conventional OPT formulations. This paper analyzes the views and experiences of people...
BACKGROUND
Long-acting opioid pharmacotherapy (OPT) is presumed to offer benefits over more conventional OPT formulations. This paper analyzes the views and experiences of people who use or have used heroin in order to explore two novel systems for delivering long-acting OPT: implants and depot injections. New materialism theorizing is used to interpret and frame the findings.
METHODS
Qualitative data were generated via seven focus groups conducted during 2017 in London, UK. Participants (n = 44; 28 men and 16 women; ages 33-66 years) had all received OPT. Focus group discussions covered real and potential OPT delivery systems. All participant data relating to implants and depot injections were coded using MAXQDA software and analysed inductively via Iterative Categorisation.
FINDINGS
Participants discussed implants and depot injections in terms of interacting physical, psychological and social factors: dose stability; OPT administration; stopping treatment; co-presence of an antagonist; breaking rituals and habits; reduced choice and control; feeling normal; information needs; getting on with everyday life; and social interaction. Participants identified both benefits and concerns, and variable needs and preferences, with respect to each delivery system.
CONCLUSIONS
Implants and depot injections are not 'fixed' medications that can be administered to people to achieve pre-determined treatment aims. Rather, they are complex 'assemblages' with uncertain outcomes. Furthermore, they are themselves part of wider interactive 'assemblages'. Drug developers and treatment providers need to understand this complexity in order to target long-acting OPT at people most likely to benefit from it, and to reduce any unintended negative consequences.
Topics: Adult; Aged; Analgesics, Opioid; Delayed-Action Preparations; Drug Implants; Drug Users; Female; Focus Groups; Health Knowledge, Attitudes, Practice; Heroin Dependence; Humans; Male; Middle Aged; Narcotic Antagonists; Opioid-Related Disorders; Qualitative Research
PubMed: 29857327
DOI: 10.1016/j.drugalcdep.2018.03.057 -
Acta Pharmaceutica (Zagreb, Croatia) Mar 2019The aim of this work was to evaluate gellan gum as binder in pellet formulations, with theophylline as the model drug, in comparison with polyvinylpyrrolidone (PVP). A...
The aim of this work was to evaluate gellan gum as binder in pellet formulations, with theophylline as the model drug, in comparison with polyvinylpyrrolidone (PVP). A full 32 factorial design was realized, with binder and diluent factors at three levels each. Pellets were produced by the extrusion/spheronization technique, and dried in a fluid-ized bed. Physical tests and dissolution tests were conducted. The results showed that the binder factor was not significant for pellet size and granulometry distribution. Rather, trends of a different response of gellan gum were identified, in comparison with PVP, in aspect ratio and dissolution tests: more round pellets were obtained in formulations with gellan gum, and more variable dissolution resulted when this polysaccharide was present. Therefore, if the usage of this compound in immediate release pellet formulations is verified, this justifies the interest in the development of sustained release systems using gellan gum.
Topics: Chemistry, Pharmaceutical; Drug Compounding; Drug Implants; Excipients; Particle Size; Polymethacrylic Acids; Polysaccharides, Bacterial; Polyvinyls; Pyrrolidines; Solubility; Theophylline
PubMed: 31259713
DOI: 10.2478/acph-2019-0007 -
Canadian Medical Association Journal Jun 1977
Topics: Alcoholism; Disulfiram; Drug Implants; Humans; Substance-Related Disorders
PubMed: 861891
DOI: No ID Found -
Heart (British Cardiac Society) Jan 2006The cost effectiveness of drug eluting stents is being called into question. But is this fair in the light of all the available clinical data?
The cost effectiveness of drug eluting stents is being called into question. But is this fair in the light of all the available clinical data?
Topics: Coronary Restenosis; Cost-Benefit Analysis; Drug Implants; Evidence-Based Medicine; Humans; Myocardial Revascularization; Quality-Adjusted Life Years; Reoperation; Stents
PubMed: 15939723
DOI: 10.1136/hrt.2005.066316 -
Acta Biomaterialia May 2019Macroporous scaffolds made of a SiO-CaO-PO mesoporous bioactive glass (MBG) and ɛ-polycaprolactone (PCL) have been prepared by robocasting. These scaffolds showed an...
Macroporous scaffolds made of a SiO-CaO-PO mesoporous bioactive glass (MBG) and ɛ-polycaprolactone (PCL) have been prepared by robocasting. These scaffolds showed an excellent in vitro biocompatibility in contact with osteoblast like cells (Saos 2) and osteoclasts derived from RAW 264.7 macrophages. In vivo studies were carried out by implantation into cavitary defects drilled in osteoporotic sheep. The scaffolds evidenced excellent bone regeneration properties, promoting new bone formation at both the peripheral and the inner parts of the scaffolds, thick trabeculae, high vascularization and high presence of osteoblasts and osteoclasts. In order to evaluate the effects of the local release of an antiosteoporotic drug, 1% (%wt) of zoledronic acid was incorporated to the scaffolds. The scaffolds loaded with zoledronic acid induced apoptosis in Saos 2 cells, impeded osteoclast differentiation in a time dependent manner and inhibited bone healing, promoting an intense inflammatory response in osteoporotic sheep. STATEMENT OF SIGNIFICANCE: In addition to an increase in bone fragility and susceptibility to fracture, osteoporosis also hinders the clinical success of endosseous implants and grafting materials for the treatment of bone defects. For the first time, macroporous scaffolds made of mesoporous bioactive glass and ε-caprolactone have been evaluated in a sheep model that mimics the osteoporosis conditions in humans. These implants fostered bone regeneration, promoting new bone formation at both the peripheral and the inner parts of the scaffolds, showing thick trabeculae and a high vascularization degree. Our results indicate that macroporous structures containing highly bioactive mesoporous glasses could be excellent candidates for the regenerative treatment of bone defects in osteoporotic patients.
Topics: Animals; Bone Regeneration; Disease Models, Animal; Drug Implants; Female; Glass; Humans; Mice; Osteoblasts; Osteoclasts; Osteogenesis; Osteoporosis; Polyesters; Porosity; RAW 264.7 Cells; Sheep; Zoledronic Acid
PubMed: 30965142
DOI: 10.1016/j.actbio.2019.04.019