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Provisional Patent Applications is claimed: These priority applications are all incorporated here by reference in their entirety to provide continuity of disclosure. Examples of suitable fluids include foods or biologically active compounds, for example pharmaceutical compositions, body fluids, for example blood, or other types of compositions, for bvg diagnostic and analytical reagents or compositions. The present invention also relates to a pharmaceutical package or other fluid filled vessel having a coated hgv cylindrical interior surface.
The present invention also relates more generally to medical devices, including devices other than packages or vessels, for example catheters.
Such pharmaceutical packages or other vessels are used in large numbers for these purposes, and must be relatively economical to manufacture and yet highly reliable in storage and use. During this shelf life, it can be important to isolate the material filling the pharmaceutical package or other vessel from the external environment.
Also, it can be important to isolate the material filling the pharmaceutical package or other vessel from the vessel wall containing it, to avoid leaching material from the pharmaceutical package or other vessel wall, barrier coating bfw layer, or other functional coatings or layers into the prefilled contents or vice versa.
The relatively strong, impermeable and inert surface of borosilicate glass has performed adequately for most drug products. However, the recent advent of costly, complex and sensitive biologies as well as such advanced delivery systems as auto injectors has exposed the physical and chemical shortcomings of glass pharmaceutical packages or other vessels, including possible contamination from metals, flaking, delamination, and breakage, among other problems.
Moreover, glass contains several components which can leach out during storage and cause damage to the stored material. The heterogeneous bgc of borosilicate glass creates a non-uniform surface chemistry at the molecular level.
Under such high temperatures alkali ions migrate to the local surface and form oxides. The presence of ions extracted from borosilicate glass devices may be involved in degradation, aggregation and denaturation of some biologies. Many proteins gbv other biologies must be lyophilized freeze driedbecause they are not sufficiently stable in solution in glass vials or syringes.
Silicone oil has been implicated in the precipitation of protein solutions such as insulin and some other biologies. Additionally, the silicone oil coating or layer is often non-uniform, resulting in syringe failures in the market. Glass-forming processes do not yield the tight dimensional tolerances required for some of the newer auto-injectors and delivery systems.
Plastic allows small molecule gases to permeate into or out of the device. The permeability of plastics to gases can be significantly greater than that of glass and, in many cases as with oxygen-sensitive drugs such as epinephrineplastics previously have been unacceptable for that reason. Plastics allow water vapor to pass through devices to a greater degree than glass. This can be detrimental to the shelf life of a solid lyophilized drug. Alternatively, a liquid product may lose water in an arid environment.
Plastic pharmaceutical packages or other vessels contain organic compounds that can leach out or be extracted into the drug product. Thus, there is a desire for plastic pharmaceutical packages or other vessels, in particular plastic syringes, with gas and solute barrier properties which approach the properties of bgww.
There also can be a need for glass vessels with surfaces that do not tend to delaminate or dissolve or leach constituents when in contact bggv the vessel contents.
Prefilled syringes are commonly prepared and sold so the syringe does not need to be filled before use, and can be disposed of after use. The syringe can be prefilled with saline solution, a dye for injection, or a pharmaceutically active preparation, for some examples. The prefilled syringe can be wrapped in a sterile package before use.
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To use the prefilled syringe, any packaging and cap are removed, optionally a hypodermic needle or another delivery conduit can be attached to the distal end of the barrel, the delivery conduit or syringe can be moved to a use position such as by inserting the hypodermic needle into a patient’s blood vessel or into apparatus to be rinsed with the contents of the syringeand the plunger tip, piston, stopper, or seal can be advanced in the barrel to inject the contents of the barrel.
The movable part is prevented from moving easily and smoothly by frictional resistance. A common need for syringes, auto-injector cartridges, and similar devices is lubrication or a lubricity coating or layer to reduce frictional resistance and adhesion between the barrel and the movable part, allowing it to slide in the barrel more easily when dispensing a pharmaceutical composition or other material from the device.
The frictional resistance has two main aspects-breakout force and plunger sliding force. A “barrel” refers either to a medical syringe barrel or to a medical cartridge barrel, both more generally known as a medical barrel. The breakout force tends to increase with storage of a syringe, after the prefilled syringe plunger has pushed away the intervening lubricant or adhered to the medical barrel due to decomposition of the lubricant between the plunger and the medical barrel.
The breakout force is the force needed to overcome “sticktion,” an industry term for the adhesion between the plunger and medical barrel that needs to be overcome to break out the plunger and allow it to begin moving. PDMS-based lubricant systems are known to present with a measurable extractable profile in pre-filled syringes, which provides the potential for adverse interaction with the drug formulation and results in the bolus injection of silicone oil.
Non-uniformity of silicone oil occurs because it is not covalently bound to the surface and flows. The lubricity coating or layer has one of the following atomic ratios, measured by X-ray photoelectron spectroscopy XPSSiO x C y or SiN x C ywhere w is 1x in this formula is from about 0.
The lubricity coating or layer also can be far thinner and more uniform than PDMS, reducing the amount of lubricant used. A medical barrel is provided comprising a wall having a generally cylindrical inner surface defining at least a portion of a lumen. The generally cylindrical inner surface has a diameter in the range from 4 to 15 mm. An inner electrode is provided having an outer surface including a portion located within the lumen and coaxial with and radially spaced from 1.
The inner electrode has an internal passage having at least one outlet. An outer electrode is also provided. The barrier coating or layer has a mean thickness. The magnetic field is applied under conditions effective to reduce the standard deviation of the mean thickness of the gas barrier coating on the generally cylindrical inner surface. The apparatus includes a medical barrel holder, a feeder, and one or more magnetic field generators.
The apparatus comprises a barrel holder, an inner electrode, an outer electrode, a feeder, and one or more magnetic field generators. The inner electrode is coaxial with and radially spaced from 1. In the option shown, a plunger tip, piston, stopper, or seal and plunger push rod are installed.
The plasma generation, material feed, and exhaust systems are omitted to better show the construction of the electronic bottle. The magnets 61 have the north pole oriented inward and the alternating magnets 62 have the north pole oriented outward. In one embodiment all eight have the same field strength, providing only radial confinement. In another embodiment the ring magnets on each end of the stack have a higher field strength, providing axial confinement too.
The following reference characters are used in the drawing figures:. The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality unless indicated otherwise.
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Whenever a parameter range is indicated, it is intended to disclose the parameter values given as limits of the range and all values of the parameter falling within said range.
A volatile organosilicon precursor, defined as such a precursor that can be supplied as a vapor in a PECVD apparatus, can be an optional organosilicon precursor. Optionally, the organosilicon precursor can be selected from the group consisting of a linear siloxane, a monocyclic siloxane, a polycyclic siloxane, a polysilsesquioxane, an alkyl trimethoxysilane, a linear silazane, a monocyclic silazane, a polycyclic silazane, a polysilsesquiazane, and a combination of any two or more of these precursors.
The standard volume of a charge or other fixed amount of gas is the volume the fixed amount of the gas would occupy at a standard temperature and pressure without regard to the actual temperature and pressure of delivery. Standard volumes can be measured using different units of volume, and still be within the scope of the present disclosure and claims. For example, the same fixed amount of gas could be expressed as the number of standard cubic centimeters, the number of standard cubic meters, or the number of standard cubic feet.
Standard volumes can also be defined using a22 standard temperatures and pressures, and still be within the scope of the present disclosure and claims. But whatever standard is used bhw a given case, when comparing relative amounts of two or more different gases without specifying particular parameters, the same units of volume, standard temperature, and standard pressure are to be used relative to each gas, unless otherwise indicated.
For example, in the working examples the flow rates are expressed as standard cubic centimeters per minute, abbreviated as seem. As with the other parameters, other units of time can be used, such as seconds bvv hours, but consistent parameters are to be used when comparing the flow rates of two or more gases, unless otherwise indicated.
The substrate can be the inside wall of a vessel having a lumen. Though the invention is not necessarily limited to pharmaceutical packages or other vessels of a particular volume, pharmaceutical packages or other vessels are contemplated in which the lumen can have a void volume from bvw.
These dimensions are exemplary and do not represent limits. The substrate surface can be part or all of the inner or generally cylindrical interior surface 16 of a vessel having at least one opening and an inner or generally cylindrical interior surface One or two openings, like the openings of a common type of blister package well, vial or sample tube one opening or a common type of syringe or medical barrel two openings are preferred.
If the vessel has two openings, they can be the same size or different sizes. If there is more than one opening, one opening can be used for the gas inlet for a PECVD coating method according to the present invention, while the other openings are either capped or open.
A vessel according to the present invention can be a sample tube, for example for collecting or storing biological fluids like blood or urine, a syringe or a part thereof, for example a medical barrel for storing ggv delivering a biologically active bgg or composition, for example a medicament or pharmaceutical composition, a vial for storing biological materials or biologically active compounds or compositions, a pipe, for example a catheter for transporting biological materials or biologically active compounds or compositions, or a cuvette for holding fluids, for example for holding biological materials or biologically active compounds bwg compositions.
For example, a vessel for blood collection can have an inner or generally cylindrical interior surface defining a lumen and an exterior surface, the passivation layer or pH protective coating or layer can be on the inner or generally cylindrical interior surface 16, and the vessel can contain a compound or composition in its lumen, for example citrate or a citrate containing composition.
Generally, the interior surface of the vessel can be cylindrically shaped, like, for example in a sample tube or a medical barrel. Sample tubes and syringes or their parts for example medical barrels are contemplated.
Hydrophobicity can be w2 a function of both the untreated substrate and the coating or layer. The same applies with appropriate alterations for other contexts wherein the term “hydrophobic” is used.
The term “hydrophilic” means the opposite, i. The present hydrophobic coatings or layers are primarily defined by their hydrophobicity and the process conditions providing hydrophobicity. Suitable hydrophobic coatings or layers and their application, properties, and use are described in U. Dual functional passivation layers or pH protective coatings or hgv that also have the properties of hydrophobic coatings or layers can be provided for any embodiment of the present invention.
The value of x stated alone is applicable to the empirical composition SiO x throughout this specification, except as a different usage is clearly indicated.
The values of x and y used throughout this w2 should be understood 2a ratios of an empirical formula for example for a coating or layerrather than as a limit on the number or type of atoms in a molecule. For example, a bvg composition Si 4 0 4 C 8 aa2 be described by the following empirical formula, arrived at by dividing each subscript in the molecular formula by 4, the largest common factor: The values of hgw and y are also not limited to integers.
For example, if three measurements of a coating at different points are 17 nm, 31 nm, and 34 nm, the thickness range of that coating is nm. A single surface can include a generally cylindrical portion and another portion bfv is not generally cylindrical, such as the surfaces of a side wall and end wall of a syringe defining its lumen. This method vgw standard wetting tension solutions called dyne solutions to determine the solution that comes nearest to wetting a plastic film surface for exactly two seconds.
This is the film’s wetting tension. In this contemplated embodiment, the relevant static frictional resistance in the context of the present invention is the breakout force as defined herein, and the relevant kinetic frictional resistance in the context of the present invention is the plunger sliding force as defined herein. The breakout force can be of particular relevance for evaluation of the coating or layer effect on a prefilled syringe, i.
It can advantageously be determined using the ISO A synonym for “plunger sliding force” often used in the art is “plunger force” or “pushing force”.
These two forces can be expressed in N, lbs or kg and all three units are used herein. These units correlate as follows: Its use can be analogous to use in the context of a syringe and its plunger tip, piston, stopper, or seal, s2 the measurement of these forces for a vessel and its closure are contemplated to be analogous to the measurement of these forces for a syringe, except that at least in most cases no liquid is ejected from a vessel when advancing the closure to a seated position.