Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-11-20
2003-10-14
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S600000, C424S657000, C424S659000, C424S660000, C426S590000, C426S599000, C426S648000, C426S658000
Reexamination Certificate
active
06632449
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions containing boron which are useful for a variety of purposes, including enhancing bone health, alleviating arthritis, pain, and inflammation, and promoting other beneficial health effects. The invention is further directed to methods of preparing such compositions, methods of administering the compositions, and kits containing the compositions.
BACKGROUND OF THE INVENTION
Osteoarthritis is a widespread, degenerative disease of the joints, cartilage, and other articular components. Osteoarthritis affects all ethnic groups worldwide. In addition to humans, osteoarthritis affects nearly all mammals, for example, horses and cows, as well as domestic cats and dogs. Many treatments for osteoarthritis have been proposed, all resulting in varying degrees of success.
One osteoarthritis treatment which has been recently proposed is oral administration of chondroprotective agents such as glucosamine and/or chondroitin. See e.g., Henderson, U.S. Pat. No. 5,364,845, assigned to Nutramax Laboratories, issued Nov. 15, 1994. Indeed, various commercial products are available in the marketplace, including nutritional supplements containing such agents and powders which may be formulated into beverage compositions immediately prior to use.
Typically, administration of such agents is designed to enhance proteoglycan through an increased concentration of glycosaminoglycans. Enhanced proteoglycan provides the framework for collagen and other joint components, as well as imparting flexibility, resiliency, and resistance to compression. Thus, these agents may be administered according to various methods to enhance the articular compositions or, at a minimum, inhibit the process of degradation.
However, readily available compositions are not designed to combat all factors leading to the degradation of joints and bones. Thus, it is important to discover new compositions which more broadly meet the needs of the osteoarthritic, or pre-osteoarthritic (e.g., athletic) subject. Most recently, scientists have been studying the link between boron and the prevention or treatment of arthritis. Newnham suggests that dietary boron is related to the incidence of arthritis. See Newnham, “The Role of Boron in Human Nutrition,”
Journal of Applied Nutrition,
Vol. 46, No. 3 (1994). Newnham has studied various geographies and soil conditions, and has indicated a relationship between a higher incidence of arthritis and low boron levels in soils and foods grown in such conditions. Accordingly, boron would be a useful mineral for inclusion in products which are useful for the treatment of arthritis and related conditions, either alone or in combination with other chondroprotective agents such as glucosamine and chondroitin.
In addition to these benefits, it has been shown that boron may be useful for the treatment of cancers such as prostate cancer, as well as neurological function.
Unfortunately, however, the actual formulation of boron in commercial food and beverage products, particularly beverage products, can be problematic. Indeed, the present inventor has discovered that boron can present solubility issues which make such formulation difficult, particularly with respect to low solubility in aqueous beverages. Low solubility, typically observed through precipitation of the boron in aqueous solution, leads to unpalatable or undesirable formulations in terms of appearance. Additionally, and even more problematic, this low solubility decreases the likelihood that the boron will be appropriately dosed (for example, due to settling of the boron in a beverage container, resulting in non-consumption or low consumption of the boron) and further decreases the likelihood that the boron will be solubilized and thus bioavailable to the mammal in need of treatment.
As a particular example, the present inventor has found that formulation of boron in fruit or vegetable juice matrices can be particularly difficult absent the teachings of the present invention. For example, it has been discovered that the combination of boron form and pH of the composition, when not chosen properly within the guidance of the present invention, can lead to complexation of the boron with the pectin found in such fruit or vegetable juices. Such complexes can be insoluble, leading to the foregoing issues related to unfavorable formulation, mineral delivery, and bioavailability. Moreover, improper selection of boron compound together with pH of the composition can cause unfavorable complexation with other ingredients or otherwise present solubility issues.
The present inventor has discovered that the pH and form of boron which is utilized, particularly wherein intended for use in an aqueous beverage form, should be chosen within the teachings of the present invention. In particular, the present inventor has surprisingly discovered that the pH of the composition should be at least about 2 pH units less than the pKa of the boron compound chosen for use. Proper selection of boron compounds and pH within the teachings of the present invention can therefore result in a composition which is useful for the variety of health benefits delivered by boron, including treatment for arthritis or other joint dysfunction.
The inventor has further discovered defined methods of making compositions containing a boron compound. For example, it has been surprisingly discovered that appropriate pH adjustment of a composition containing a boron compound, prior to addition of pectin (e.g., fruit or vegetable juice), carbohydrates, or other ingredients which may cause complexation or other issues, is largely important to successful formulation of the composition. These findings are indeed surprising and have not been addressed in the literature. These and other embodiments of the present invention are defined herein, which surprisingly can provide compositions containing boron which aid in dosage, compliance, and bioavailability.
SUMMARY OF THE INVENTION
In one embodiment of the invention, compositions are provided which comprise:
a) a boron compound; and
b) at least about 10% water, by weight of the composition; wherein the pH of the composition is at least about 2 pH units less than the pKa of the boron compound.
Methods of preparing the foregoing compositions are also provided. In particular, a preferred method of preparing a beverage composition is provided, comprising the steps of:
a) providing an aqueous solution comprising the boron compound, wherein the pH of the aqueous solution is at least about 2 pH units less than the pKa of the boron compound and wherein the aqueous solution is substantially free of pectin and carbohydrate; and
b) combining the aqueous solution with one or more additional beverage components.
Further disclosed are methods of using (including administering) the compositions, as well as kits comprising the compositions.
DETAILED DESCRIPTION OF THE INVENTION
Publications and patents are referred to throughout this disclosure. All references cited herein are hereby incorporated by reference.
All percentages and ratios are calculated by weight unless otherwise indicated. All percentages and ratios are calculated based on the total composition unless otherwise indicated.
All component or composition levels are in reference to the active level of that component or composition, and are exclusive of impurities, for example, residual solvents or by-products, which may be present in commercially available sources.
Referred to herein are trade names for components including various ingredients utilized in the present invention. The inventors herein do not intend to be limited by materials under a certain trade name. Equivalent materials (e.g., those obtained from a different source under a different name or reference number) to those referenced by trade name may be substituted and utilized in the methods herein.
In the description of the invention various embodiments and/or individual features are disclosed. As will be apparent to the ordinarily skilled practitioner, all combinations of such
Chuey S. Robert
Oh Simon J.
Page Thurman K.
Roof Carl J.
The Procter & Gamble Co.
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