WO2008120965A1 - Composition pharmaceutique comprenant une combinaison d'un agent antiarthritique, d'un agent chondroprotecteur et d'un agent anti-inflamatoire - Google Patents

Composition pharmaceutique comprenant une combinaison d'un agent antiarthritique, d'un agent chondroprotecteur et d'un agent anti-inflamatoire Download PDF

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Publication number
WO2008120965A1
WO2008120965A1 PCT/MX2008/000010 MX2008000010W WO2008120965A1 WO 2008120965 A1 WO2008120965 A1 WO 2008120965A1 MX 2008000010 W MX2008000010 W MX 2008000010W WO 2008120965 A1 WO2008120965 A1 WO 2008120965A1
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WO
WIPO (PCT)
Prior art keywords
agent
osteoarthritis
pharmaceutical composition
formulation
glucosamine
Prior art date
Application number
PCT/MX2008/000010
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English (en)
Spanish (es)
Inventor
Leopoldo de Jesús ESPINOSA ABDALA
María Elena GARCÍA ARMENTA
Josefina Santos Murillo
Victor Guillermo Alvarez Ochoa
Original Assignee
Espinosa Abdala Leopoldo De Jesus
Garcia Armenta Maria Elena
Josefina Santos Murillo
Victor Guillermo Alvarez Ochoa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Espinosa Abdala Leopoldo De Jesus, Garcia Armenta Maria Elena, Josefina Santos Murillo, Victor Guillermo Alvarez Ochoa filed Critical Espinosa Abdala Leopoldo De Jesus
Priority to ARP080101371A priority Critical patent/AR065916A1/es
Publication of WO2008120965A1 publication Critical patent/WO2008120965A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism

Definitions

  • the present invention is applied in the pharmaceutical industry and describes a pharmaceutical composition composed of the synergistic combination of an antiarthritic agent, such as: Chondroitin, - a chondroprotective agent, such as: Glucosamine and an anti-inflammatory agent, this being: Meloxicam, which are formulated in a single dosage unit, which is indicated for the prevention and / or treatment of osteoarthritis, rheumatoid arthritis, osteoarthritis and other related rheumatic diseases.
  • an antiarthritic agent such as: Chondroitin
  • a chondroprotective agent such as: Glucosamine
  • an anti-inflammatory agent such as: Meloxicam
  • osteoarthritis is a disease that too often suffers a large part of the population of the western world, however, its distribution is universal, there are differences that are based on various factors such as: geographical area, patterns Genetic, environmental development and lifestyle.
  • osteoarthritis is the most important cause of functional disability in regards to processes related to the musculoskeletal system and the second cause of permanent disability after cardiovascular diseases .
  • People suffering from osteoarthritis are affected in their economic situation and in their lifestyle, since the expenses invested in treatment are very high and most likely the consequence of this disease is the loss of employment and salary, due to the disability caused by this disease.
  • the effects related to lifestyle in people suffering from osteoarthritis are: Limitation in work performance, depression, despair, anxiety and loss of interest and motivation to perform the activities of daily living.
  • Osteoarthritis is the most common type of arthritis and affects men and women of adulthood, especially the elderly, being frequent in men before they reach 45 years of age, while after 45 years , the disease is more common in women. • However, osteoarthritis is not typical of people with advanced age, as there are young people who suffer from this disease, which is caused by an injury or a blow to a joint. There are other causes that cause the appearance of osteoarthritis, among these may be: excess weight, muscle weakness; nerve damage that supplies the joint area; synovial disease and even hereditary factors. Osteoarthritis is a disease of the joints that primarily affects cartilage. In osteoarthritis, the joints are damaged due to deterioration of the cartilage, which is a firm tissue, elastic and slippery that covers the extreme parts of the bones.
  • the cartilage provides a smooth and slippery surface that facilitates the mobility of the joints and allows the bones to have movement by sliding from one over the other, in addition to having the function of acting as a cushion between the bones , absorbing the tension produced by daily physical activities.
  • the surface of the cartilage that is present between the joints wears and breaks, causing the bones to move and cause friction against one another, causing symptoms such as pain, inflammation, deformity and difficulty use the joint, resulting in the loss of physical movement.
  • synovial fluid which lubricates the joint and is mainly composed of a substance called hyaluronic acid. People who suffer from osteoarthritis may have more hyaluronic acid between the joints than normal, however, this could be diluted, causing this to decrease their protective function.
  • Osteoarthritis is a disease that affects only the joints, without causing any damage to other internal organs. When the body detects the damage that osteoarthritis causes in the cartilage, it responds by producing new cartilage; However, the construction of the new cartilage does not maintain the rate of production with respect to how quickly it is destroyed, triggering the development of the final stage of osteoarthritis.
  • Rheumatoid Arthritis This is a chronic disease of common prevalence and worldwide distribution that most commonly affects people between 25 and 55 years of age, with women being the most affected than men. It is characterized by severely affecting survival, functional capacity and quality of life of the individual suffering from it, as well as the ability to maintain a satisfactory job. Rheumatoid arthritis commonly affects the joints of both sides of the body equally, with the wrists, fingers, knees, feet and ankles being the most frequently affected parts of the body.
  • RA Rheumatoid arthritis
  • the way in which this disease manifests itself is through the immune system, which in normal conditions fights foreign substances, such as viruses or bacteria, but in the case of this disease classified as autoimmune, the immunological system takes the healthy tissue confusing it with foreign substances, causing the body to attack itself.
  • Rheumatoid arthritis causes pain, stiffness, swelling and loss of function in the joints, and can also cause inflammation in other organs.
  • the manifestation and severity of rheumatoid arthritis can vary considerably, and can be caused by: infection, inheritance (genes), activity hormonal, among others, being these factors that can contribute to its development.
  • Mortality due to direct causes or complications derived from rheumatoid arthritis continues to be double what was observed in the control population, without changing this trend in the last four decades.
  • Osteoarthritis is the most frequent of joint diseases and its prevalence increases with age. It is estimated that the radiological signs of osteoarthritis are rare before 40 years of age (2%), appear in 30% of people aged between 45 and 65 years and in 68% of people over 65 years of age. age. Typical joint disorders of osteoarthritis begin in the second decade of life, affecting 90% of people over 40 years.
  • Osteoarthritis affects the neck, lumbar region, knees, hips and finger joints. Approximately 70% of people over 70 show radiological evidence of the disease, but only half of them develop symptoms. Osteoarthritis can also affect joints that have been previously damaged by excessive and prolonged use, infection or a previous rheumatic disease. Patients with osteoarthritis suffer pain and functional impairment.
  • NSAIDs non-steroidal anti-inflammatory drugs
  • the pharmaceutical composition object of the present invention is composed of the synergistic combination of an antiarthritic agent, a chondroprotective agent and an anti-inflammatory agent, which produce a satisfactory therapeutic effect when administered together in a single oral dosage unit unlike when they are administered independently, generating benefits such as They are: lower concentrations of the active ingredients formulated, lower doses administered, faster action, greater efficacy of the therapeutic effect and lower adverse effects.
  • Chondroitin is an antiarthritic with specific therapeutic activity. It is formed by chains of repeated molecules called glycosaminoglycans (GAG), mainly composed of the combination of various sulfated and non-sulfated residues of glucoronic acid and n-acetyl-galactosamine, necessary for the formation of proteoglycans (which provides elasticity to the cartilage), which are large macromolecules composed of a protein core to which multiple chains of glycosaminoglycans and oligosaccharides adhere that are found in the articular cartilage, which has a very important structural function, since it retains water and various nutrients useful for the formation of a healthy joint matrix, in addition to allowing the passage of other molecules through it, this property being very important, since the cartilage receives no blood supply.
  • GAG glycosaminoglycans
  • Chondroitin is currently obtained and manufactured from natural sources such as: shark and / or beef cartilage, as well as bovine trachea cartilage, and can also be obtained through synthetic processes It is used to improve symptoms and prevent progressive damage during the degenerative process that manifests itself in patients suffering from osteoarthritis. For many years, research experts stated that Chondroitin administered orally did not cause the desired effect, since the molecules that compose it are too large that doubted that they could be absorbed through the digestive tract.
  • glutamine which is the precursor of the generation of glycosaminoglycans and constitutes up to 50% of the composition of hyaluronic acid, which is the natural lubricant found in synovial fluid, which has the function of being a lubricant and buffer, to restore and maintain healthy functioning of joints and / or joints.
  • Glucosamine inhibits some cartilage-destroying enzymes, such as collagenases and phospholipase A2 and the formation of other substances that damage tissues, such as: macrophage superoxide radicals.
  • Glucosamine also fulfills several functions as a component of cartilage, among which are the following:
  • proteoglycans It is an essential part of proteoglycans and is essential for the production of glycosaminoglycans, which are cartilage proteins that accumulate water. • It acts as a stimulant on chondrocytes that are cells that synthesize and secrete the organic components of the extracellular matrix, such as: collagen, hyaluronic acid, proteoglycans and glycoproteins Glucosamine is the factor that determines the amount of proteoglycans that chondrocytes can synthesize.
  • Glucosamine sulfate provides significant amounts of sulfur, which is an essential nutrient of the joints. In fact, individuals suffering from arthritis generally have deficiencies of said nutrient.
  • Glucosamine in the arrest or retardation of joint degeneration seems to be directly due to its ability to act as an essential substrate and stimulate the synthesis of glycosaminoglycans and the structure of hyaluronic acid necessary for the formation of proteoglycans found in the structural matrix of the joints.
  • Glucosamine is the fundamental block necessary for the biosynthesis of several types of compounds, among which are included: glycolipids, glycoproteins, glycosaminoglycans (which were previously called: mucopolysaccharides), hyaluronate and proteoglycans.
  • glycolipids glycoproteins
  • glycosaminoglycans glycosaminoglycans (which were previously called: mucopolysaccharides), hyaluronate and proteoglycans.
  • mucopolysaccharides glycosaminoglycans
  • proteoglycans As a component of these macromolecules, glucosamine plays an essential role in the synthesis of cell membranes, connective tissue, joint surfaces, tendons, ligaments, synovial fluid, skin, nails, blood vessels, heart valves and bone matrix.
  • Glucosamine is a very water-soluble small molecule, which is very easily absorbed by intestinal cells through active transport; and when administered orally as glucosamine sulfate, about 90% of its absorption is carried out rapidly in the gastrointestinal tract. Glucosamine is eliminated in the urine for 48 hours after oral administration in a proportion of about 5% of the administered dose. The main amount of Glucosamine administered orally is metabolized in joint tissues and is removed as CO2 in the expired air.
  • Glucosamine is rapidly incorporated into articular cartilage, this being the tissue in which the highest concentrations of this compound are found. Glucosamine treatment is considered to normalize substrate biosynthesis. required to restore joint functional capabilities. Glucosamine shows no effects on the cardiocirculatory system, on respiratory function and on the central or vegetative nervous system.
  • a successful treatment for osteoarthritis should effectively control the pain and slow or reverse the progression of the disease.
  • Biochemical and pharmacological data together with studies in animals and humans show that Glucosamine can satisfy both criteria.
  • Meloxicam is a non-steroidal anti-inflammatory that performs anti-inflammatory, analgesic and antipyretic functions. It is an enolcarboxyamide derivative that belongs to the enolic acid group (related to oxicans: piroxicam, tenoxicam, sudoxicam). It performs a potent inhibitory activity on cyclooxygenase-2 (COX-2), with a selectivity 75 times higher for COX-2 compared with COX-I, acting as an inhibitor in the synthesis of prostaglandins that have the function of being responsible mediators of inflammatory processes.
  • COX-2 cyclooxygenase-2
  • the selective and specific blockade performed on cyclooxygenase-2 gives Meloxicam a double therapeutic benefit by achieving, on the one hand, a remarkable anti-inflammatory and analgesic activity in patients suffering from rheumatic diseases
  • osteoarthritis rheumatoid arthritis, osteoarthritis, osteoarthritis
  • it has excellent tolerance with minimal gastrointestinal or ulcerogenic adverse effects, unlike those patients who are treated with other non-steroidal anti-inflammatory agents, such as indomethacin, naproxen or acetylsalicylic acid.
  • non-steroidal anti-inflammatory agents such as indomethacin, naproxen or acetylsalicylic acid.
  • the effective intracellular access of Meloxicam is determined by its lipophilic and amphiphilic properties.
  • the low water solubility of Meloxicam at an acidic pH and its amphiphilic protonation behavior are responsible for tissue kinetics which prevents the concentrations of this active substance in certain tissues from rising.
  • Meloxicam has a good digestive absorption and optimal bioavailability (89%), after having been administered a single dose by mouth. Some of the main pharmacokinetic characteristics are: its prolonged absorption, its sustained serum concentrations and its long elimination half-life (20 hours), which allows a single daily dose to be administered. Once its absorption in the digestive tract, Meloxicam easily diffuses into the blood and inflamed tissues, having a high adherence with plasma proteins (> 99%) and its metabolites are excreted both in the urine and feces .
  • Meloxicam is indicated for the treatment of diseases such as: osteoarthritis, rheumatoid arthritis, gouty arthritis, muscular and traumatic conditions, as well as in inflammatory processes of soft tissues, airways and gynecological conditions.
  • the antiarthritic agent used in the pharmaceutical composition object of the present invention is the active ingredient Sulfate of Chondroitin, which is present in the formulation in a concentration range from 1.0 gr. up to 1.5 gr., preferably a concentration of approximately 1.1 gr. to 1.3 gr. per dose unit.
  • the chondroprotective agent that is formulated in the pharmaceutical composition object of the present invention is the active ingredient Glucosamine, which is present in a concentration range from 1.2 gr. up to 1.7 gr., preferably a concentration of approximately 1.4 gr. to 1.6 gr. per dose unit.
  • the anti-inflammatory agent contained in the pharmaceutical composition object of the present invention is the active ingredient Meloxicam, being present in the formulation in a concentration range from 6.5 mg. up to 17 mg, with a concentration of approximately 7.0 mg being preferably used, at 16.0 mg. per dose unit.
  • the pharmaceutical composition protected by the present invention is formulated to be administered orally in a single powder dosage unit for solution with single dose sachets, in which the drug is contained.
  • Said pharmaceutical composition has been developed with the purpose of providing a pharmaceutical alternative for the treatment of diseases such as: osteoarthritis, rheumatoid arthritis, osteoarthritis and other related rheumatic diseases, which offers significant advantages such as: lower concentrations of active principles contained in the formulation, the effective control of pain suffered by patients suffering from such diseases, in addition to slowing or reversing their progression.
  • diseases such as: osteoarthritis, rheumatoid arthritis, osteoarthritis and other related rheumatic diseases, which offers significant advantages such as: lower concentrations of active principles contained in the formulation, the effective control of pain suffered by patients suffering from such diseases, in addition to slowing or reversing their progression.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne une composition pharmaceutique qui comprend une combinaison synergique composée par : un agent antiarthritique, tel que le principe actif sulfate de chondroïtine; un agent chondroprotecteur, tel que le principe actif glucosamine; et un agent anti-inflammatoire, tel que le principe actif meloxicam. Lesdits agents sont formulés en une seule unité de dosage destinée à être administrée par voie orale sous forme de poudre pour une solution contenue dans des enveloppes monodoses. Lesdits agents sont destinés à être utilisés pour le traitement de maladies, notamment : ostéoarthrite, polyarthrite rhumatoïde, arthrose et toute autre maladie rhumatismale associée.
PCT/MX2008/000010 2007-04-02 2008-01-29 Composition pharmaceutique comprenant une combinaison d'un agent antiarthritique, d'un agent chondroprotecteur et d'un agent anti-inflamatoire WO2008120965A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
ARP080101371A AR065916A1 (es) 2007-04-02 2008-04-01 Composicion farmaceutica que comprende la combinacion de un agente antiartritico, un agente condroprotector y un agente antiinflamatorio

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
MXMX/A/2007003947 2007-04-02
MX2007003947A MX2007003947A (es) 2007-04-02 2007-04-02 Composicion farmaceutica que comprende la combinacion de un agente antiartritico, un agente condroprotector y un agente antiinflamatorio.

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WO2008120965A1 true WO2008120965A1 (fr) 2008-10-09

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AR (1) AR065916A1 (fr)
CL (1) CL2008000963A1 (fr)
MX (1) MX2007003947A (fr)
WO (1) WO2008120965A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8765717B2 (en) * 2008-07-03 2014-07-01 Monte Verde S.A. Meloxicam and glucosamine formulation and uses thereof
WO2022250523A1 (fr) * 2021-05-26 2022-12-01 Garcia Perez, Miguel Angel Produits, kits pharmaceutiques et leurs utilisations, comprenant un précurseur direct dans la formation de glycosaminoglycanes et un anti-inflammatoire non stéroïdien en tant que compositions indépendantes

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040229038A1 (en) * 2003-03-03 2004-11-18 Elan Pharma International Ltd. Nanoparticulate meloxicam formulations
US20050101563A1 (en) * 2001-08-14 2005-05-12 Pharmacia Corporation Method and compositions for the treatment and prevention of pain and inflammation
RU2260432C1 (ru) * 2004-10-12 2005-09-20 Открытое Акционерное Общество "Нижегородский Химико-Фармацевтический Завод" (Оао "Нижфарм") Средство для лечения болезней суставов

Patent Citations (3)

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US20050101563A1 (en) * 2001-08-14 2005-05-12 Pharmacia Corporation Method and compositions for the treatment and prevention of pain and inflammation
US20040229038A1 (en) * 2003-03-03 2004-11-18 Elan Pharma International Ltd. Nanoparticulate meloxicam formulations
RU2260432C1 (ru) * 2004-10-12 2005-09-20 Открытое Акционерное Общество "Нижегородский Химико-Фармацевтический Завод" (Оао "Нижфарм") Средство для лечения болезней суставов

Non-Patent Citations (1)

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Title
JINHWA CHANG ET AL.: "Osteochondrodysplasia in three Scottish Fold cats.", JOURNAL OF VETERINARY SCIENCE., vol. 8, no. 3, September 2007 (2007-09-01), pages 307 - 309, XP055354490 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8765717B2 (en) * 2008-07-03 2014-07-01 Monte Verde S.A. Meloxicam and glucosamine formulation and uses thereof
WO2022250523A1 (fr) * 2021-05-26 2022-12-01 Garcia Perez, Miguel Angel Produits, kits pharmaceutiques et leurs utilisations, comprenant un précurseur direct dans la formation de glycosaminoglycanes et un anti-inflammatoire non stéroïdien en tant que compositions indépendantes

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Publication number Publication date
MX2007003947A (es) 2009-02-25
AR065916A1 (es) 2009-07-08
CL2008000963A1 (es) 2008-09-12

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