Polypharma antiresorptive drug dossiers

Polypharma Technologies & Sciences GmbH (Polypharma) can provide support for development of antiresorptive drugs used to depress osteoclasts and diminish resorption of bone in the treatment of osteoporosis and osteonecrosis bone diseases.

These antiresorptive drug dossiers can be used to empower potential producers across the Middle East and North Africa (MENA) region who are seeking fast track market-ready antiresorptive drugs in oral solid dose and other forms for in Osteoporosis, Rheumatology, Metabolic, Diabetic and Nutrition applications.

Antiresorptive medicines

Antiresorptive is the term used to describe a medicine that prevents bone breakdown and reduces vulnerability to future fractures. These drugs not only slow any further deterioration of the skeleton, but also allow for some repair and restoration of bone mass and strength. Use of antiresorptive therapy may be supplemented by anabolic therapy to help build new bone and further reduce fracture risk.

Antiresorptive and anabolic drugs can be applied both to prevention and treatment of osteoporotic fractures, and also to other bone diseases.

The main types of antiresorptive agents are bisphosphonates, selective estrogen receptor modulators (SERMs), and the monoclonal antibody denosumab.

Polypharma antiresorptive drug dossiers

Polypharma’s extensive portfolio of generic human medicines available as pre-prepared dossiers includes a number of significant antiresorptive drugs in its Rheumatology and Metabolic categories. These include:

• Alendronic acid: Polypharma can offer a fully developed EU-CTD dossier for Alendronic acid, a leading bisphosphonate that has been marketed in branded form as Fosamax, Binosto, and that is also known as alendronate sodium, and alendronate. Taken in tablet or liquid form, the drug has been shown to strengthen bone in those vulnerable to osteoporosis.
• Risedronate sodium: Also from the bisphosphonate class, Risonedrate (branded name Actonel) is also available from Polypharma in fully developed EU-CTD dossier format, covering tablet administration. Risonedrate sodium is highly indicated in osteoporosis treatment and is also a leading therapy for patients suffering from Paget’s disease.
• Zoledronic acid: Zoledronic acid (also called Zometa).is a further bisphosphonate that attaches itself to bone cells to slow bone change. Administered in liquid form by intravenous drip or cannula, it is particularly indicated in prevent bone problems in myeloma and advanced cancer patients, to reduce chances of recurrence of breast cancer post-surgery, preventing bone loss for people having aromatase inhibitors, and lowering levels of calcium in the blood in hypercalcemia.
• Calcitonin: Alternatively known as CT and thyrocalcitonin, Calcitonin is a hormone produced in humans by the parafollicular cells (C-cells) of the thyroid gland and helps to regulate blood levels of calcium and phosphates, opposing the action of parathyroid hormone. Calcitonin also acts to inhibits the activity of the osteoclast cells responsible for breaking down bone. It can also decrease the resorption of calcium in the kidneys, again leading to lower blood calcium levels.
• Vitamin D₃: Vitamin D₃ (cholecalciferol-D3), is a fat-soluble vitamin that helps the body absorb calcium and phosphorus. It is commonly used to treat and prevent bone disorders such as rickets and osteomalacia). When combined calcium, Vitamin D₃ can also be used in osteoporosis therapy.

The above list refers only to those antiresorptives already subject of fully-developed drug dossiers. Polypharma is also able to develop other antiresorptive dossiers on request and after having carried out a specific feasibility study on the substance.

Resources

Click on Polypharma human medicine dossiers for further information.
Click on Generic drug dossier development  for further information.