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Pharmaceutical containers with low adsorption/absorption of active ingredients, and a method of testing materials for adsorption/absorption of active ingredientsRelated Patent Categories: Stock Material Or Miscellaneous Articles, Hollow Or Container Type Article (e.g., Tube, Vase, Etc.), Polymer Or Resin Containing (i.e., Natural Or Synthetic), Contains Vapor Or Gas Barrier, Polymer Derived From Vinyl Chloride Or Vinylidene Chloride, Or Polymer Containing A Vinyl Alcohol UnitPharmaceutical containers with low adsorption/absorption of active ingredients, and a method of testing materials for adsorption/absorption of active ingredients description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20050287325, Pharmaceutical containers with low adsorption/absorption of active ingredients, and a method of testing materials for adsorption/absorption of active ingredients. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This application claims the benefit of U.S. Provisional Patent Application No. 60/483,367 filed Jun. 27, 2003. The present invention relates to suitable materials for use in storage-stable containers for aqueous pharmaceutical compositions, such as prostaglandin formulations, and to containers comprising such materials. The present invention also relates to a method for determining if a material is suitable for use in storage-stable containers for aqueous pharmaceutical compositions. BACKGROUND [0002] Pharmaceutical compositions comprising one or more active ingredients must possess certain levels of stability and purity in order to be suitable for safe and efficacious administration to patients. The pharmaceutical composition may also contain other components, e.g. excipients, such as flavoring agents and preservatives. Such compositions are considered stable if the concentration of active ingredient(s) can be maintained at the level specified on the label for the maximum anticipated shelf-life under given environmental conditions. A pharmaceutical composition is considered unstable when the potency of the active ingredient(s) is lost. [0003] The potency of a drug product may decline over time during storage due to various reasons, such as degradation of the active ingredient(s), reaction of the active ingredient(s) with excipients or container materials, leaching of the active ingredient(s) through the container wall, and absorption/adsorption of the active ingredient(s) into/to the container wall. Similarly, the purity of a medicinal preparation may also change during storage due to leaching of chemicals into the drug preparation from the container materials, from the labels on the containers, or from the environment where the packaged medicinal product is stored. Thus, the containers used for packaging medicinal preparations can significantly affect the stability and purity of the preparations contained therein. Preservatives, for example, may also permeate the container wall and as a result, their preservative value is diminished. The solvent of the composition may also permeate the container wall, which will increase the concentration of the active ingredient and of the other components of the composition. [0004] One example of a group of one or more active ingredients is prostaglandins. Prostaglandins are relatively unstable medical agents and are used for treatment of various conditions, including glaucoma, which is an eye disorder afflicting various mammals, including primates and humans, and is characterized in that it increases intraocular pressure (ocular hypertension). Prostaglandins such as, but not limited to, latanoprost, are susceptible to adsorption/absorption by plastic packaging components, and this adsorption/absorption decreases the potency of the compositions upon storage. [0005] Containers commonly used for medicinal products include glass containers, polypropylene containers, and polyethylene containers. (See e.g. U.S. Pat. No. 6,235,781). However, since glass containers are rigid and not squeezable, they are not very suitable for medicinal preparations which are conveniently dispensed on a drop-by-drop basis. Typical user-friendly containers, dispensers, or bottles for medicinal preparations are formed from e.g. polyethylene, polypropylene, or polyethylene terephthalates (PET), which in most instances provide a suitable combination with a pharmaceutical preparation, resulting in a packaged medicinal product that is user-friendly for dispensing of the pharmaceutical preparation on a drop-by-drop basis. [0006] The ophthalmic products XALATAN.RTM. (comprising approximately 50 .mu.g/ml latanoprost) and XALCOM.RTM. (comprising approximately 50 .mu.g/ml latanoprost and 5 mg/ml timolol) are packaged in bottles. The bottle is typically made of clear low-density polyethylene with a clear low-density polyethylene dropper tip, a high-density polyethylene screw cap, and a clear low-density polyethylene overcap. Unopened bottles are stored at a recommended temperature of approximately 2-8.degree. C. Upon storage at the recommended temperature, the concentrations of latanoprost and latanoprost/timolol, respectively, are stably maintained in the products. [0007] Plastic containers have some drawbacks since the active agent, depending on the choice of plastic material employed for the container, can be absorbed and/or adsorbed by the container material. This absorption/adsorption decreases the potency of the formulations during the storage. In order to reduce or prevent the absorption and/or adsorption of e.g. certain prostaglandins, the plastic containers comprising the pharmaceutical compositions are commonly kept in refrigerators until opened, and once opened, they can be kept in room temperature and used within a limited period of time, typically 1-2 months. The requirement that the ophthalmic preparation is to be kept refrigerated reduces the availability of the treatment in countries where such storage conditions are less available or reliable. Furthermore, even where available, refrigeration of the preparation increases the cost of the treatment to the patient, and thus, further reduces its availability to those in need. [0008] Despite these advances, there is still an unmet need for a method for storing such preparation over periods of time without refrigeration. There is also a need for a packaged medicinal product and method for packaging pharmaceutical compositions, which can increase the stability of the pharmaceutical composition or prevent the loss of an ingredient of the composition. [0009] Furthermore, there is a need for a rapid and convenient method of testing candidate materials for their absorption/adsorption properties with respect to one or more active ingredients to be contained in vessels made by the material. SUMMARY OF THE INVENTION [0010] The present invention relates to a container comprising, [0011] a) one or more polyolefins exhibiting less than 20% sorption of one or more active ingredients as determined by a suitably acceptable method; and [0012] b) a composition comprising said one or more active ingredients. [0013] In another embodiment of the invention, the container according to the invention, wherein the suitably acceptable method comprises the steps of: [0014] a) providing a sample of said container having a surface area of S; [0015] b) immersing said sample in a volume V of said composition, such that the surface area to volume ratio S/V is in the range of from about 1 to about 100 cm.sup.-1; and [0016] c) subjecting said sample immersed in said composition to a temperature T that is above room temperature, for a period of time P that is less than two weeks. [0017] In another embodiment, the container according to the invention, wherein said P is 10 days. [0018] In yet another embodiment, the container according to the invention, wherein said T is 56.degree. C. [0019] In yet another embodiment, the container according to the invention, wherein said one or more polyolefins comprise either ethylene monomers, propylene monomers, or both. [0020] In yet another embodiment, the container according to the invention, wherein said one or more polyolefins are selected from the group consisting of low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), and blends thereof. [0021] In yet another embodiment, the container according to the invention, wherein said one or more polyolefins are selected from the group consisting of homopolymers of low-density polyethylene (LDPE), homopolymers of high-density polyethylene (HDPE), and homopolymers of polypropylene(PP). Continue reading about Pharmaceutical containers with low adsorption/absorption of active ingredients, and a method of testing materials for adsorption/absorption of active ingredients... 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