Calcitriol

Chemical division

Formula

CERBIOS - PHARMA SA
CAS number: 32222-06-3

 

Synonyms

1α,25-Dihydroxyvitamin D3
1α,25-Dihydroxycholecalciferol
(1α,3β,5Z,7E)-9,10-Seco-cholesta-5,7,10(19)-triene-1,3,25-triol

 

Background and use

Vitamin D3 is a prohormone produced in skin through ultraviolet irradiation of 7-dehydrocholesterol. It is biologically inert and must be metabolized to 25-hydroxyvitamin D3 in the liver and then to 1α,25-dihydroxyvitamin D3 (=Calcitriol) in the kidney in order to exert his function. The hormonal form of vitamin D3, i.e. Calcitriol, acts through a nuclear receptor to carry out its many functions: calcium absorptions, phosphate absorption in the intestine, calcium mobilization in bone and calcium reabsorption in the kidney. Therefore “classical” pharmacological uses of Calcitriol include: treatment of calcium malabsorption, ricket, osteoporosis, renal osteodistrophy and osteomalacia. One important finding during the 90’s was the discovery that Vitamin D metabolites and specially Calcitriol exert other functions in the body beside the classical calcium mobilizing activity, i.e. they show cell differenciating and immunomodulating activity. Therefore the possible use of Calcitriol for treating hyperparatyroidism, psoriasis, some autoimmune diseases and certain types of cancer: however because of the danger of hypercalcemia, the dosage has to be strictly controlled.

 

    • High Potency Active Ingredients (HPAI)
    • Drug
      Substance
    • Patent
    • DMF
    • CEP
    • Calcitriol
    • •
    • •
    • •
    • •

 

Regulatory compliance

Cerbios-Pharma’s calcitriol is complying to the European as well as to the US Pharmacopoeia. EDMF and US-DMF are available, active and updated. An application for the Certificate of Suitability of the European Pharmacopoeia at the European Directorate for the Quality of Medicines (EDQM) was filed recently.

Intellectual property

A process for the production of Calcitriol is patent protected (EP 735 510; US 5 698 714; AU 676 982; IL 118 837)

Packaging information

The API is packed in 2, 20, 50 or 100mL brown, type 1 glass bottles with rubber closure and aluminium crimp cap.