摘要:
Formulations and methods are provided for improving the stability upon exposure to aqueous media of polypeptides present in non-aqueous suspension vehicles. In particular aspects of the invention, formulations are provided that comprise a complex of a metal ion and a polypeptide suspended in a non-aqueous, biocompatible suspension vehicle. Aggregation of individual polypeptide molecules is reduced when aqueous media is introduced to such formulations, serving to stabilize the polypeptide.
摘要:
Formulations and methods are provided for improving the stability upon exposure to aqueous media of polypeptides present in non-aqueous suspension vehicles. In particular aspects of the invention, formulations are provided that comprise a complex of a metal ion and a polypeptide suspended in a non-aqueous, biocompatible suspension vehicle. Aggregation of individual polypeptide molecules is reduced when aqueous media is introduced to such formulations, serving to stabilize the polypeptide.
摘要:
A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.
摘要:
An implantable device includes a reservoir containing a suspension of an interferon in an amount sufficient to provide continuous delivery of the interferon at a therapeutically effective rate of 1 ng/day to 600 μg/day to maintain and achieve therapeutic blood or plasma levels of the interferon throughout a substantial period of the administration period.
摘要:
A particle formulation includes an erythropoietin receptor agonist, a buffer, and a sugar, wherein the buffer and sugar stabilize the erythropoietin receptor agonist against aggregation.
摘要:
The present invention is related to materials and methods for forming polymeric delivery vehicles that reduces risk of oxidative degradation of a carried drug and the resulting compositions.
摘要:
An osmotic pump system includes a capsule having at least one delivery port, a membrane plug retained at an open end of the capsule remote from the delivery port, the membrane plug providing a fluid-permeable barrier between an interior and an exterior of the capsule, and a removable imbibition rate reducer attachable to the capsule. The imbibition rate reducer comprises one or more flow controllers selected from the group consisting of an orifice having a selected size smaller than a surface area of the membrane plug and a membrane having a selected thickness, surface area, radial compression, and permeability. The imbibition rate reducer allows customizable delivery of medicaments.
摘要:
The present invention provides a suspension vehicle and suspension formulations deliverable from an implantable delivery device. In particular, the suspension vehicle of the present invention allows the formulation of beneficial agent suspensions that are stable over time at ambient and physiological temperatures. In addition, the beneficial agent suspensions formed using the suspension vehicle of the present invention allow controlled delivery of beneficial agent from an implanted delivery device over sustained periods of time, even when such delivery occurs at low flow rates, through a small-diameter delivery channel. Also included in the present invention are implantable delivery devices.
摘要:
A suspension formulation of interferon includes a non-aqueous, single-phase vehicle including at least one polymer and at least one solvent, the vehicle exhibiting viscous fluid characteristics, and an interferon contained in a particle formulation dispersed in the vehicle. The particle formulation includes a stabilizing component comprising one or more stabilizers selected from the group consisting of carbohydrates, antioxidants, and amino acids. The suspension formulation is characterized in that less than 10% of the interferon degrades over 3 months under an accelerated storage condition.
摘要:
The present invention includes materials and methods for providing vehicles useful for providing drug formulations that address the potential drawbacks of known nonaqueous formulations. In particular, the present invention includes nonaqueous vehicles that are formed using a combination of polymer and solvent that results in a vehicle that is miscible in water. The nonaqueous vehicles facilitate the formulation of drug formulations that are stable over time, even when stored at, or exposed to, elevated temperatures. Moreover, the miscible vehicles of the present invention allow the preparation of drug formulations that work to reduce the occurrence of partial or complete occlusions of the delivery conduits included in delivery devices used to administer the drug formulations.