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  • Ciclosporin, cyclosporine or cyclosporin, is an immunosuppressant drug widely used post-allogeneic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It has been studied in transplants of skin, heart, kidney, lung, pancreas, bone marrow and small intestine. Ciclosporin is a cyclic nonribosomal peptide of 11 amino acids (an undecapeptide) produced by the fungus Tolypocladium inflatum Gams, initially isolated from a Norwegian soil sample.
  • Cyclosporine  is a potent immunosuppressant medication that is considered a disease modifying antirheumatic drug (DMARD) because it not only decreases the pain and swelling of arthritis but it may also prevent joint damage and reduce the risk of long term disability.


  • Ciclosporin is thought to bind to the cytosolic protein cyclophilin (immunophilin) of immunocompetent lymphocytes, especially T-lymphocytes. This complex of ciclosporin and cyclophylin inhibits calcineurin, which under normal circumstances is responsible for activating the transcription of interleukin-2. It also inhibits lymphokine production and interleukin release and therefore leads to a reduced function of effector T-cells. It does not affect cytostatic activity. It has also an effect on mitochondria. Ciclosporin A prevents the mitochondrial PT pore from opening and inhibits thus cytochrome c release, a potent apoptotic stimulation factor. However, this is not the primary mode of action for clinical use but rather an important effect for research on apoptosis.


  • The production of a nanosuspension is the transformation of a macrosized powder into a mostly aqueous nanosized suspension. Therefore the first step is the wetting of the dry powder with a solution of the stabiliser of the suspension. Nanosuspensions can be prepared with concenentrations of up to 40% (w/w). High pressure homogenisation is a high energy process and stresses the coumpound. In order to minimise the stress for the drug, as well as to minimise the friction of the homogenisation material (e.g. valve, valve seat) some prehomogenisation steps are performed.

  • A macrosuspension containing 4% (w/w) of cyclosporine and 0.5% of Poloxamer 188 as stabiliser was produced. The temperature of the nanosuspension during the production was varied in order to investigate the influences on the quality and the stability of the resulting nanosuspensions.


  • Industrial interests focussed on high sales drugs (e. g. cyclosporine) to be formulated with SLN. Pharmatec (Milan/Italy) developed a cyclosporine SLN formulation for oral administration as competitive product to Sandimmun Neoral.

  • Cyclosporine has been a key drug in the prevention of rejection in patients undergoing transplants for 20 years, and to date is approved for use in kidney, heart and liver transplant patients. Chiron's application for Pulminiq is aiming to get approval for the use of the drug, alongside standard immunosuppressive therapy, to improve survival and cut rejection in lung transplant patients.


  • The biotechnology arm of an Enterprises in Kolkata, plans to market Cyclosporin, used in kidney transplantation, in the U.S. global generic drug market. To this effect the company also plans a joint venture with an U.S. based company at Puerto Rico. Initially this company will supply the bulk drug to the JV to produce the drug locally. The demand for Cyclosporin in the U.S. market is estimated at $450 million.

  • Eons' generic cyclosporine is expected to produce a significant impact on the market for the softgel capsule, which currently exceeds $300 million annually. Transplant recipients must take daily doses of the drug to prevent organ rejection, at an annual cost of more than $6000 for the brand.

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