Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
1999-04-20
2001-12-25
Low, Christopher S. F. (Department: 1653)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S008100, C514S054000, C514S062000, C514S801000, C530S356000
Reexamination Certificate
active
06333304
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the use of exogenous therapeutic compositions containing glucosamine, hydrolyzed collagen and a bioflavanol for the repair of animal connective tissue, and to therapeutic techniques employing exogenous glucosamine, hydrolyzed collagen and a bioflavanol.
BACKGROUND OF THE INVENTION
Cartilage is the connective tissue which cushions moveable joints. Joint cartilage damage is commonly referred to by a number of terms which are used interchangeably here, including arthritis, arthroses and osteoarthritis. Osteoarthritis is a syndrome characterized by pathologic change of synovial joints accompanied by clinical signs of pain and disability. Unfortunately, most animals have sustained damage to joint cartilage by middle age. Although the causes of degenerative processes are generally unknown, as a general matter, cartilage damage can be classified as one of two forms of osteoarthritis. Primary osteoarthritis occurs when normal forces act on abnormal cartilage causing degeneration. An example is the aging process, where daily physical activity and cellular metabolism create wear and tear on the articular cartilage leading to an arthritic condition. Secondary osteoarthritis occurs when abnormal forces act on normal cartilage causing degeneration. An example is traumatic injury such as tearing the anterior cruciate ligament which may cause enough damage to the joint capsule to lead to arthritis. The result of primary and secondary osteoarthritis is the same—a painful condition in which the animal typically is caught up in a cycle in which the body cannot efficiently repair itself at a rate faster than the rate of degeneration.
Referring now to
FIG. 1
, it can be seen that a normal joint 10 constitutes the interface between opposing compact bones
1
and
11
. Normal joint
10
includes a fibrous joint capsule
3
which defines a joint cavity
5
. Joint cavity
5
is lined with a synovial membrane
4
and is filled with synovial fluid
9
. Articular cartridge
6
cushions the contact of bones
1
and
11
in normal joint
10
.
Referring now to
FIG. 2
, it can be seen that an arthritic joint
12
exhibits deterioration of articular cartilage
6
′ as evidenced by worn, irregular and insufficient thicknesses of articular cartilage
6
′. The cushioning of the contact between bones
1
′ and
11
′ is thereby diminished, which leads to pain and inflammation in the area. The volume of synovial fluid
9
′ may also be decreased, further diminishing the cushioning ability of arthritic joint
12
.
Many factors affect or exacerbate the extent of cartilage deterioration. For example, some animals are predisposed genetically to joint disease and degeneration of joint tissue at an early age. In addition, an animal's genetic makeup can influence the thickness and durability of cartilage which will affect an animal's predisposition to arthritis. Other animals experience abnormal wear and tear on joints as a result of poor conformation and/or excess mechanical stress on musculoskeletal systems. Also, aggressive exercise schedules during youth (as may occur with race horses or athletes) may accelerate the manifestation of joint deterioration problems in later years.
In any case, once the cartilage of a joint is damaged, an inflammatory response ensues. Inflammation itself may be painful, causing the animal to make musculoskeletal adjustments that can exacerbate the joint damage. In addition, inflammation can reduce circulation to the damaged area, preventing needed nutrients and building materials from reaching the damaged area. The body's attempt to repair the damage can even worsen the injury. Degradative enzymes and histamine released at the site of tissue injuries can cause or worsen an arthritic condition. In addition, it is known that as neutrophils invade the area, free radicals (molecules with an electron shortage) are released into the environment causing oxidative damage. Free radicals released in the joint produce further cellular damage before they can be captured by other electrons from surrounding tissues, for example, from cellular membranes, in order to stabilize themselves, which results in a devastating chain reaction causing further tissue damage and inflammation. If cellular membrane damage becomes extensive, cells may die. Free radicals have also been shown to irreversibly break down cartilage matrix proteoglycans.
Initial attempts at dealing with arthroses involved treatment with non-steriodal anti-inflammatory agents such as aspirin. However, as anatomical and physiological knowledge about cartilage, connective tissue and joints has grown, preferred treatments include dietary supplements for use in rebuilding the damaged connective tissue. In the last two decades, popular treatments have focused on one or another substances, reflecting in part, the growing knowledge about cartilage structure and physiology.
It is now known that cartilage fibers and matrix are initially formed by cells called chondroblasts. After cartilage formation is complete, the mature chondrocytes remain in the matrix to produce cartilage as needed to maintain the cartilage. Hyaluronic acid is an acidic mucopolysaccharide present in the extracellular substance of connective tissue which attracts and holds moisture within the connective tissue and complexes to other amino sugars to form the ground substances of the cartilage matrix.
Glucosamine, an amino sugar, is a major constituent of hyaluronic acid and is preferentially taken up by chondrocytes and used in the synthesis of hyaluronic acid. By increasing the amount of hyaluronic acid, glucosamine supplementation leads to the rehydration of cartilage, resulting in increased lubrication and shock absorbing capability. Glucosamine supplementation also leads to an increase in proteoglycans in the extracellular matrix of articular cartilage, thereby increasing the overall amount and the structural integrity of the cartilage.
Glucosamine is also used by chondrocytes to produce glycosaminoglycans, which lead to the production of proteoglycans that hold and hydrate connective tissue. With glucosamine supplementation, chondrocytes may be able to replenish the cartilage matrix and synovial fluid when cartilage is damaged. This is accomplished, in part, because glucosamine increases production of chondroitin sulfate, a glycosaminoglycan which is a component of joint tissue. In addition, chondroitin sulfate inhibits degradative enzymes. However, due in part to the high molecular weight of chondroitin sulfate, chondroitin sulfate is believed to be broken down in the digestive tract for “re-assembly” into chondroitin sulfate in the joint tissue where needed. The breakdown into smaller pieces is significant because one of these smaller pieces is galactosamine which has been shown to decrease or inhibit chondroitin sulfate synthesis, in comparison to a control group in studies.
Studies have been performed to ascertain the effectiveness of glucosamine as a treatment for arthroses in people, dogs and horses. A common view among veterinarians and medical doctors is that the chondroprotective effect of glucosamine is well supported, with results variable but generally positive, and glucosamine considered generally safe for use in joint disease treatment. Surveys of responses indicated that animals and people treated with glucosamine commonly experience some benefit after two or more weeks of treatment. In humans, substantial benefit was experienced after eight or more weeks of treatment. A survey of veterinarians who utilized a glucosamine product to treat dogs with arthritis concluded the product was helpful for improving mobility and alleviating pain. A study of 25 horses diagnosed with degenerative joint disease showed improvement in horses treated with an oral glucosamine formulation.
However, there appears to be substantial variability in positive response of glucosamine treatments compared to placebo treatment. Three glucosamine treatment studies are summarized below in Table
Bath Teresa K.
Lynch Neal
Hogan & Hartson LLP
Low Christopher S. F.
Mohamed Abdel A.
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