Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1999-05-19
2002-06-04
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S449000, C424S450000, C514S046000, C514S507000, C514S411000, C514S568000, C514S630000
Reexamination Certificate
active
06399093
ABSTRACT:
FIELD OF THE INVENTION
A method and topical composition for the treatment of musculoskeletal disorders.
BACKGROUND OF THE INVENTION
The musculoskeletal system consists of bones, muscles and joints. Ten percent of medical visits to physicians are for disorders of the musculoskeletal system. Musculoskeletal disorder include: sprains, strains, tendinitis, tenosynovitis, fibromyalgia, osteoarthritis, rheumatoid arthritis, gout, pseudogout (calcium pyrophosphate deposition disease), polymyalgia rheumatica, bursitis, acute and chronic back pain and osteoporosis, which interfere with the normal performance of activities of daily living. Injuries include sprains, strains and tears of ligaments, tendons, muscles and cartilage damage. Pain is the most common symptom and is frequently caused by injury or inflammation. Besides pain, other symptoms such as stiffness, tenderness, weakness and swelling or deformity of affected parts are manifestations of musculoskeletal disorders. Sports injuries are a significant cause of musculoskeletal disorders resulting in pain, strain, sprains, stiffness and leg cramps.
Occupational injuries however, have become this country's most costly form of illnesses. The Bureau of Labor Statistics reported in 1992, that one half of the 2.3 million nonfatal occupational injuries and illnesses which resulted in days away from work involved musculoskeletal disorders. The Occupational Safety and Health Administration (OSHA) estimates in 1999, that more than 647,000 Americans suffer from injuries or illnesses due to work-related musculoskeletal disorders (WMSDs). These disorders account for more than 34% of all workdays lost to injuries and illnesses and cost employers $15 to $20 billion per year in direct workers' compensation costs and another $100 billion on lost productivity, employee turnover, and other indirect expenses. Cumulative trauma disorders (CTDs) frequently involve the upper extremities, such as wrists, shoulders or elbows. Carpal tunnel syndrome of the wrist has become the fastest growing occupational hazard in the United States today.
Arthritis, a musculoskeletal disorder, is the leading cause of disability in the United States. The Centers for Disease Control and Prevention (CDC) stated that arthritis and other rheumatic conditions accounted for about 744,000 hospitalizations and 4 million days of care in 1997. It is estimated that 43 million people are now affected and expected to increase to 60 million people by 2020. Arthritis costs the country about $65 billion a year.
Osteoporosis afflicts 200 million people worldwide and 25 million people in the U.S., of whom 80% are women, yet one man in three will also get osteoporosis. One woman in two over the age of 60 is likely to have an osteoporotic bone fracture. The incidence of hip fracture exceeds that of cancer of the breast, cervix and uterus combined. Sixteen percent of patients suffering hip fractures will die within six months, while 50% will require long-term nursing care. The estimated cost of treatment and care for osteoporosis and related fractures exceeds 10 billion per year in the U.S. alone.
Treatment usually consists of an oral ingestion of an analgesic such as nonsteroidal anti-inflammatory drugs (NSAIDs). Adverse side effects of oral NSAIDs, such as hypersensitivity, gastropathy, renal impairment, liver toxicity and prolonged bleeding merit concern in the very young and elderly. The use of topical analgesic compositions to treat musculoskeletal disorders is an effort to overcome the side effects of oral preparations with the advantage of delivering the analgesic directly to the affected body part.
SUMMARY OF THE INVENTION
This invention relates to a method for the treatment of musculoskeletal disorders in mammals by the application of a topical composition comprising a permeation enhancing amount of one or more penetration enhancers, and one or more bio-affecting agents to provide anti-inflammatory relief and analgesia to the applied body part.
DETAILED DESCRIPTION OF THE INVENTION
The components of the method and composition of the present invention will be discussed separately because no prior art embraces them as a solitary method or composition to reduce inflammation and provide analgesia to the affected body part due to musculoskeletal disorders. The topical composition of the present invention comprises one or more penetration enhancers and one or more bio-affective agents.
Penetration Enhancer
A penetration enhancer or permeation enhancer is an agent used to increase the permeability of the skin to a pharmacologically active agent to increase the rate at which the drug diffuses through the skin and enters the tissues and bloodstream. A chemical skin penetration enhancer increases skin permeability by reversibly altering the physiochemical nature of the stratum corneum to reduce its diffusional resistance. In a review of the technical and patent literature up to 1996, more than 275 different chemical compounds were found to be cited as skin penetration enhancers. Most of the compounds are generally recognized as safe (GRAS) ingredients that would often be considered inert by a formulator. Osborne D W, Henke J J,
Pharmaceutical Technology
, November. 1997, pp 58-86. The compounds cited in the article are incorporated by reference. Examples of penetration enhancers include: alcohols, such as ethanol and isopropanol, polyols, such as n-alkanols, limonene, terpenes, dioxolane, propylene glycol, ethylene glycol, other glycols, and glycerol; sulfoxides, such as dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide; esters, such as isopropyl myristate/palmitate, ethyl acetate, butyl acetate, methyl proprionate, capric/caprylic triglycerides, ketones; amides, such as acetamide oleates such as triolein; various surfactants, such as sodium lauryl sulfate; various alkanoic acids such as caprylic acid; lactam compounds, such as azone; alkanols, such as oleyl alcohol; dialkylamino acetates, and admixtures thereof.
A number of patents disclose the use of penetration enhancers to deliver medications transdermally. Grasela et al, U.S. Pat. No. 5,837,289, discloses the use of at least two separate penetration enhancers in a cream to deliver an extensive list of medications, Catz et al, U.S. Pat. No. 5,238,933, discloses a skin permeation enhancer composition comprising a lower aliphatic ester of a lower aliphatic carboxyl acid in combination with a lower alkanol to administer an active agent. Sharma et al, U.S. Pat. No. 5,229,130, discloses a vegetable oil-based skin permeation enhancer to deliver active agents through the skin. Tsuk, U.S. Pat. No. 4,933,184, discloses a transdermal composition that uses methanol either sequentially or simultaneously to deliver drugs. Havemeyer et al, U.S. Pat. No. 4,342,784, discloses a method of topically administering a gel with DMSO and carboxy polymethylene resin with a neutralizing agent to enable the skin salt to break down the gel to release the DMSO. Rajadhyaksha, U.S. Pat. No. 5,482,965, discloses a transdermal composition containing a dioxane. Samour, U.S. Pat. Nos. 5,620,980, 5,807,957, discloses the use of a dioxolane and urethane to treat hair loss. None of the above cited patents teach or suggest the use of the method or composition outlined in the present invention.
Bio-affecting Agents
The present invention relates to novel compositions for topical application and delivery of bio-affecting agents through the protective outer layer of the skin, into the underlying tissues and into the vascular network of the targeted body part. The term “bio-affecting agent” refers to any chemical substance or formulation which beneficially affects the body. The bio-affecting agents of the preferred composition comprises; analgesics, NSAIDs, anti-inflammatory agents, colchicine, S-adenosyl-methionine, methyl-sulfonyl-methane, antioxidants, anti-infectives, zinc compounds, amino sugars, aloe vera extracts, and other active agents to form a solution, suspension, cream, ointment, gel, film, or spray.
The concentration
Advanced Medical Instruments
Reamer James H.
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