DUROS® Technology Delivers Peptides and Proteins at Consistent Rate Continuously for 3 to 12 Months

Rohloff, Catherine M.; Alessi, Thomas R.; Yang, Bing; Dahms, J. K.; Carr, John P.; Lautenbach, Scott D.

doi:10.1177/193229680800200316

Cited by 38 publications

(27 citation statements)

References 11 publications

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“…Leuprolide release was observed for 1 year at constant rate at 37°C in unstirred phosphate-buffered saline 117 . Similar in vitro release profiles have been observed with sufentanil from the DUROS Chronogesic system 121 and interferon from the OMEGA DUROS system 115 . Nevertheless, most impressive character of these implants is the IVIVC of release data, which simplifies the process of implant development.…”

Section: Miscellaneous Modes Of Protein Deliverysupporting

confidence: 76%

“…Osmotically controlled, mechanical devices, “nonbiodegradable” implants have been designed for extended delivery at a constant rate. These systems have been shown to be biocompatible and effective to provide constant therapeutic concentrations in a number of animal and human trials 115-120 . Some of the osmotically-driven implants include Duros® (DURECT), ALZET® (veterinary medicine, research application) and Viadur® (leuprolide acetate, marketed formulation) 120 .…”

Section: Miscellaneous Modes Of Protein Deliverymentioning

confidence: 99%

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Long-term delivery of protein therapeutics

Vaishya

Khurana

Patel

et al. 2014

Expert Opinion on Drug Delivery

162

104

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Introduction Proteins are effective biotherapetics with applications in diverse ailments. Despite being specific and potent, their full clinical potential has not yet been realized. This can be attributed to short half-lives, complex structures, poor in vivo stability, low permeability frequent parenteral administrations and poor adherence to treatment in chronic diseases. A sustained release system, providing controlled release of proteins, may overcome many of these limitations. Areas covered This review focuses on recent development in approaches, especially polymer-based formulations, which can provide therapeutic levels of proteins over extended periods. Advances in particulate, gel based formulations and novel approaches for extended protein delivery are discussed. Emphasis is placed on dosage form, method of preparation, mechanism of release and stability of biotherapeutics. Expert opinion Substantial advancements have been made in the field of extended protein delivery via various polymer-based formulations over last decade despite the unique delivery-related challenges posed by protein biologics. A number of injectable sustained-release formulations have reached market. However, therapeutic application of proteins is still hampered by delivery related issues. A large number of protein molecules are under clinical trials and hence there is an urgent need to develop new methods to deliver these highly potent biologics.

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Section: Miscellaneous Modes Of Protein Deliverysupporting

confidence: 76%

Section: Miscellaneous Modes Of Protein Deliverymentioning

confidence: 99%

Long-term delivery of protein therapeutics

Vaishya

Khurana

Patel

et al. 2014

Expert Opinion on Drug Delivery

162

104

View full text Add to dashboard Cite

show abstract

“…However, an obvious drawback of IFN-ω is that it requires daily subcutaneous administration, which might influence patients’ compliance and impair its effectiveness. A proprietary delivery system (Omega DUROS® device) that is implanted subcutaneously and provides continuous drug delivery for 48 weeks is suggested to overcome this drawback [131]. In addition to the anti-HCV activities of IFN-α and IFN-ω, a limited study showed that IFN-κ has cell-associated antiviral effects against the HCV replicon [49].…”

Section: Hepatitismentioning

confidence: 99%

Type I Interferons: Distinct Biological Activities and Current Applications for Viral Infection

Gong

Zhao

et al. 2018

Cell Physiol Biochem

139

111

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The interferons (IFNs) are a primary defense against pathogens because of the strong antiviral activities they induce. IFNs can be classified into three groups: type I, type II and type III, according to their genetic, structural, and functional characteristics and their receptors on the cell surface. The type I IFNs are the largest group and include IFN-α, IFN-β, IFN-ε, IFN-ω, IFN-κ, IFN-δ, IFN-τ and IFN-ζ. The use of IFNs for the treatment of viral infectious diseases on their antiviral activity may become an important therapeutic option, for example, IFN-α is well known for the successful treatment of hepatitis B and C virus infections, and interest is increasing in the antiviral efficacy of other novel IFN classes and their potential applications. Therefore, in this review, we summarize the recent progress in the study of the biological activities of all the type I IFN classes and their potential applications in the treatment of infections with immunodeficiency virus, hepatitis viruses, and influenza viruses.

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“…ITCA 650 is a miniature osmotic pump system that is designed to deliver zero-order, continuous SC release of exenatide at a precise predetermined rate for up to 12 months with a single placement (9,10). The sterile product with dimensions similar to a small match stick is inserted SC in the abdominal region with a placement tool using aseptic technique during a short office procedure that can be performed by a physician, physician's assistant, or other licensed practitioner (9).…”

mentioning

confidence: 99%

Randomized Trial of Continuous Subcutaneous Delivery of Exenatide by ITCA 650 Versus Twice-Daily Exenatide Injections in Metformin-Treated Type 2 Diabetes

et al. 2013

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OBJECTIVETo evaluate ITCA 650, a continuous subcutaneous miniature osmotic pump delivery system of exenatide versus twice-daily exenatide injections (Ex-BID) in subjects with type 2 diabetes.RESEARCH DESIGN AND METHODSWe conducted a randomized, two-stage, 24-week, open-label, phase 2 study in type 2 diabetes inadequately controlled with metformin. Stage I: 155 subjects were randomized to 20 or 40 μg/day of ITCA 650 or Ex-BID 5→10 μg. Stage II: 131 subjects were rerandomized to 20, 40, 60, or 80 μg/day of ITCA 650. Change from baseline for HbA1c, weight, and fasting plasma glucose were evaluated at weeks 12 and 24.RESULTSHbA1c was significantly lower in all groups after 12 and 24 weeks. Stage I: mean change in HbA1c from a mean baseline of 7.9–8.0% was −0.98, −0.95, and −0.72% for the 20 and 40 μg/day ITCA 650 and Ex-BID groups, respectively, with 63, 65, and 50% of subjects achieving HbA1c levels ≤7% (P < 0.05). Stage II: significant (P < 0.05) reductions in HbA1c (∼1.4% from baseline) were achieved with 60 and 80 μg/day ITCA 650, and 86 and 78% of subjects achieved HbA1c ≤7% at 24 weeks; respectively. Weight was reduced by 2.8–3.7 kg (P < 0.05) at 24 weeks in all except the 20→20 μg/day group. ITCA 650 was well tolerated; nausea was lower and transient with 20 μg/day relative to Ex-BID; and 60 μg/day had the best profile of tolerability and HbA1c lowering.CONCLUSIONSITCA 650 significantly reduced HbA1c and weight and was well tolerated. The 20→60 μg/day regimen was considered the best dose for further examination in phase 3.

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DUROS® Technology Delivers Peptides and Proteins at Consistent Rate Continuously for 3 to 12 Months

Abstract: 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.

Cited by 38 publications

References 11 publications

Long-term delivery of protein therapeutics

Long-term delivery of protein therapeutics

Type I Interferons: Distinct Biological Activities and Current Applications for Viral Infection

Randomized Trial of Continuous Subcutaneous Delivery of Exenatide by ITCA 650 Versus Twice-Daily Exenatide Injections in Metformin-Treated Type 2 Diabetes

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