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DUROS (DUROS)

✓ Approved

Johnson & Johnson Services, Inc. · therapeutic agent

What is DUROS?

DUROS is a therapeutic agent developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications via injectable (others) or intracavitary injection.

Drug Profile

Brand NamesDUROS
CompanyJohnson & Johnson Services, Inc.
RouteInjectable (Others), Intracavitary Injection
StatusApproved

Therapeutic Indications

DUROS is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresOral appliance application✓ Approved

Related Research Articles

PubMedJornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia2017-01-25

Hard metal lung disease: a case series.

Mizutani Rafael Futoshi RF, Terra-Filho Mário M, Lima Evelise E, Freitas Carolina Salim Gonçalves CS et al.

To describe diagnostic and treatment aspects of hard metal lung disease (HMLD) and to review the current literature on the topic. This was a retrospective study based on the medical records of patients treated at the Occupational Respiratory Diseases Clinic of the Instituto do Coração, in the city of São Paulo, Brazil, between 2010 and 2013. Of 320 patients treated during the study period, 5 (1.56%) were diagnosed with HMLD. All of those 5 patients were male (mean age, 42.0 ± 13.6 years; mean duration of exposure to hard metals, 11.4 ± 8.0 years). Occupational histories were taken, after which the patients underwent clinical evaluation, chest HRCT, pulmonary function tests, bronchoscopy, BAL, and lung biopsy. Restrictive lung disease was found in all subjects. The most common chest HRCT finding was ground glass opacities (in 80%). In 4 patients, BALF revealed multinucleated giant cells. In 3 patients, lung biopsy revealed giant cell interstitial pneumonia. One patient was diagnosed with desquamative interstitial pneumonia associated with cellular bronchiolitis, and another was diagnosed with a hypersensitivity pneumonitis pattern. All patients were withdrawn from exposure and treated with corticosteroid. Clinical improvement occurred in 2 patients, whereas the disease progressed in 3. Although HMLD is a rare entity, it should always be included in the differential diagnosis of respiratory dysfunction in workers with a high occupational risk of exposure to hard metal particles. A relevant history (clinical and occupational) accompanied by chest HRCT and BAL findings suggestive of the disease might be sufficient for the diagnosis. Descrever aspectos relacionados ao diagnóstico e tratamento de pacientes com doença pulmonar por metal duro (DPMD) e realizar uma revisão da literatura. Estudo retrospectivo dos prontuários médicos de pacientes atendidos no Serviço de Doenças Respiratórias Ocupacionais do Instituto do Coração, localizado na cidade de São Paulo, entre 2010 e 2013. Entre 320 pacientes atendidos no período do estudo, 5 (1,56%) foram diagnosticados com DPMD. Todos os pacientes eram do sexo masculino, com média de idade de 42,0 ± 13,6 anos e média de tempo de exposição a metal duro de 11,4 ± 8,0 anos. Os pacientes foram submetidos a avaliação clinica, história ocupacional, TCAR de tórax, prova de função pulmonar, broncoscopia com LBA e biópsia pulmonar. Todos apresentaram distúrbio ventilatório restritivo. O achado de imagem à TCAR de tórax mais frequente foi de opacidades em vidro fosco (em 80%). Em 4 pacientes, o LBA revelou presença de células gigantes multinucleadas. Em 3, foi diagnosticada pneumonia intersticial por células gigantes na biópsia pulmonar. Houve o diagnóstico de pneumonia intersticial descamativa associada à bronquiolite celular em 1 paciente e de pneumonite de hipersensibilidade em 1. Todos foram afastados da exposição e tratados com corticoide. Houve melhora em 2 pacientes e progressão da doença em 3. Apesar de ser uma entidade rara, a DPMD deve ser sempre considerada em trabalhadores com risco ocupacional elevado de exposição a metais duros. A história clínica e ocupacional associada a achados em TCAR de tórax e LBA sugestivos da doença podem ser suficientes para o diagnóstico.

PubMedZhongguo yi xue ke xue yuan xue bao. Acta Academiae Medicinae Sinicae2011-09-13

[Subcutaneous implanted system for the treatment of type 2 diabetes].

Li Yan Y, Guo Hui H

Type 2 diabetes is a complex metabolic disorder characterized by hyperglycemia arising from a combination of insufficient insulin secretion and resistance to insulin action. Insulin has become an important agent in treating this disease, but long-term administration of insulin not only brings pain and inconvenience to the patients but also causes local adipose tissue atrophy and scleroma. Therefore, novel delivery method has become a hot topic, mainly including improving delivery systems, developing new recombinant insulin, and changing the route of administration. This article introduces DUROS (an implanted delivery system), a new route of drug administration.

PubMedThe AAPS journal2010-05-22

Critical variables associated with nonbiodegradable osmotically controlled implants.

Wright Jeremy C JC

Osmotically controlled implants yield precise zero-order drug delivery kinetics and are utilized in a number of applications. The implants deliver drugs for extended periods (weeks to years) and exhibit good in vivo/in vitro correlation. This paper reviews critical variables associated with these implants, with a focus on release rate testing. The extended-duration kinetics can be problematic when attempting to test for >70% cumulative delivery. An innovative scheme based on the scientific principles of operation of the system is described to ensure > 70% delivery at the target rate and duration for the DUROS Viadur (leuprolide acetate) implant.

PubMedJournal of diabetes science and technology2008-05-01

DUROS technology delivers peptides and proteins at consistent rate continuously for 3 to 12 months.

Rohloff Catherine M CM, Alessi Thomas R TR, Yang Bing B, Dahms Janice J et al.

DUROS((R)) delivery technology consists of sterile, nonbiodegradable, single-use devices for continuous, subcutaneous administration of therapeutic molecules at steady rates. DUROS delivery technology is capable of delivering a wide range of therapeutic molecules for durations ranging from 3 to 12 months. Administration of therapy via DUROS devices may facilitate patient compliance with treatment since the DUROS device does not require self-injections. Consistent delivery of drug levels within a targeted therapeutic window achievable with DUROS delivery technology avoids exposure to high initial drug concentrations that can result from bolus injections and that may be associated with certain adverse drug effects. Several approaches have been taken to assess the suitability of DUROS devices for delivery of the therapeutic molecules leuprolide acetate, glucagon-like peptide-1 (GLP-1), and omega interferon (omega IFN). Testing includes determining protein stability and measuring in vitro protein release rates. Three peptides or proteins were formulated into either a solution (leuprolide) or Intarcia's proprietary DUROS suspension formulation (GLP-1, omega IFN) and filled into DUROS devices. The devices demonstrated reliable start-up and continuous steady drug delivery in in vitro studies. Stability of the molecules was maintained for 3 years at 37 degrees C (leuprolide), 2 years at 30 degrees C (omega IFN), or 6 months at 37 degrees C (GLP-1). Patients in clinical studies of a 1-year DUROS device found the device to be comfortable and convenient. Multiple studies demonstrated that peptides or proteins remain stable in DUROS devices and that delivery at a steady rate can be achieved over a wide range of delivery rates.

PubMedInternational journal of toxicology2002-01-19

Chronic (60-week) toxicity study of DUROS leuprolide implants in dogs.

Cukierski M J MJ, Johnson P A PA, Beck J C JC

The toxicity and pharmacodynamics of leuprolide acetate delivered from subcutaneously implanted DUROS leuprolide implants were examined in sexually mature male beagle dogs. The DUROS leuprolide implant is a sterile, nonpyrogenic, nonerodible, single-use, implantable, osmotically driven, drug delivery system for the palliative treatment of advanced prostate cancer. It contains 65 mg of leuprolide and is designed to deliver leuprolide continuously at a nominal rate of 120 microg per day for at least 12 months. Serum drug and testosterone concentrations were compared to values from dogs receiving monthly intramuscular injections of Lupron Depot 3.75 mg or no treatment (sham-operated). The local tissue response induced by subcutaneously implanted DUROS leuprolide implants was also evaluated. Beagles were implanted with a DUROS leuprolide implant for 52 weeks followed by removal and implantation of a new DUROS leuprolide implant for an additional 8 weeks. No mortality or morbidity occurred in this study. No treatment-related changes occurred in mean body weights, blood chemistry, or hematology during the study. Treatment-related atrophy of the testes, epididymides, and prostate gland, consistent with the known pharmacological effects of the drug, was observed in all dogs receiving the DUROS leuprolide implant or the Lupron Depot. Histological examination of these organs showed no distinguishable difference between dogs treated with the DUROS leuprolide implant or Lupron Depot. Weekly serum samples from dogs with DUROS leuprolide implants indicated continuous leuprolide delivery over 60 weeks, while some samples from the Lupron Depot group fell below measurable concentrations. Analysis of serum samples collected every 28 days just before Lupron Depot injection showed that 80% of these samples had leuprolide concentrations below the limit of quantitation (0.1 ng/ml). Serum testosterone concentrations were below castrate levels (<50 ng/dl) by 4 weeks after implantation of DUROS leuprolide implant and remained so for the duration of the study. Lupron Depot 3.75 mg also effectively lowered serum testosterone concentrations, but required reinjection every 28 days. All local tissue reactions to the DUROS leuprolide implant at implant sites were classified as mild following macroscopic examination. Microscopic site scores were mild to moderate. The DUROS leuprolide implant was shown to be safe, to provide continuous leuprolide delivery, and to effectively lower serum testosterone concentrations below castrate levels.

PubMedJournal of controlled release : official journal of the Controlled Release Society2001-07-14

An in vivo/in vitro comparison with a leuprolide osmotic implant for the treatment of prostate cancer.

Wright J C JC, Tao Leonard S S, Stevenson C L CL, Beck J C JC et al.

An osmotically driven implantable system was designed and characterized for the delivery of leuprolide over a year-long duration. Leuprolide has been used in the treatment of prostate cancer since the 1980s. The DUROS implant consists of a titanium alloy cylinder, measures 4 mm in diameter by 45 mm in length and holds approximately 150 microl of formulation. Stability studies indicated that leuprolide was stable, as a solution formulation in DMSO, for several years at 37 degrees C. In vitro release rate testing, at weekly intervals, showed zero-order delivery for 1 year. DUROS implants demonstrated release rates that were reproducible and similar to one another after storage at 25 degrees C for 18 months prior to testing. In vivo studies, with implants placed subcutaneously, revealed delivery rates comparable to those observed under in vitro conditions. Leuprolide stability was also comparable between in vivo and in vitro conditions. Steady leuprolide serum levels produced by the implant resulted in the desired pharmacodynamic efficacy endpoint of testosterone suppression, both in canines and in humans. The good agreement between in vivo/in vitro delivery rates was as expected for a delivery system based on the principles of osmosis.

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