Calcipotriol (Calcipotriene)

Calcipotriol (Calcipotriene)   is a vitamin D derivative indicated for the treatment of Plaque psoriasis and Scalp psoriasis. It is presented on the market in cream, ointment and solution formulations and marketed under the trade name Dovonex or Daivonex. It is marketed by the originator Leo Pharma and other pharmaceutical companies worldwide.

There is also a combination of Calcipotriol (Calcipotriene) with Betamethasone Dipropionate indicated for  Psoriasis vulgaris 
The precise mechanism of Calcipotriol (Calcipotriene) in remitting psoriasis is not well-understood. However, it has been shown to have comparable affinity with calcitriol (Vit D) for the Vitamin D receptor, while being less than 1% as active as the calcitriol in regulating calcium metabolism. The mechanism of action of calcipotriene, a synthetic analog of vitamin D3, is similar to the natural 1,25-(OH)2-D3 (calcitriol) occurring in the human body. Calcitriol (i.e., active vitamin D3) is the metabolite of cholecalciferol (i.e., inactive vitamin D3). Calcipotriene binds to vitamin D receptors on epidermal cells and tissue cells. Activation of this ligand-receptor complex results in inhibition of cell proliferation and induction of cell differentiation in psoriatic skin. Calcipotriene is also similar to calcitriol in its ability to suppress thymocyte proliferation, T-helper function, and lymphocyte proliferation.

General data on Calcipotriol (Calcipotriene) Active Pharmaceutical Ingredient

Calcipotriol (Calcipotriene) Molecular Formula: C27H40O3
Calcipotriol (Calcipotriene) Molecular Weight:412.6
Calcipotriol (Calcipotriene) CAS Registry: 112828-00-9;112965-21-6
Calcipotriol (Calcipotriene)  ATC:D05AX02

TAPI's Calcipotriol (Calcipotriene) Pharmaceutical Ingredient

TAPI's Calcipotriol (Calcipotriene) Active Pharmaceutical Ingredient is produced in Assia Industries Limited –Teva Tech site in Beer Sheva, Israel.

Teva's API division is specialized in Vitamin D derivatives, like Calcipotriol (Calcipotriene) and we offer Custom Synthesis services for Vitamin D Derivatives.

Our Vitamin D derivatives plant, in Teva-Tech is equipped with state of the art production equipment and it can produce on small to large scales of these active pharmaceutical ingredients.

TAPI's Calciportiol has unique features that might be advantage for final dosage development. TAPI has filed several patent applications for This product.  Please, see table below for issued patents and pending applications.

TAPI's Active Patent Applications

Patent type	Description	App./publication/patent #	Status (date)
Process	Crystallization process	US 7,351,869	Granted 1-Apr-08
		WO 04046097	Published 03/06/2004
	Process for purification	US 2003/0166226	Published 4/9/2003
		WO 03/060094	Published 24/7/2003
	Epimerization of Analogues of Vitamin D	US 7,205,420	Published 18/3/2004
		WO 03/106412	Published 24/12/2003

TAPI provide full service on Calcipotriol ( Calcipotriene) and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Calcipotriol (Calcipotriene). Contact us today for further inquiries and samples availability information for TAPI's Calcipotriol. 

Pharmacopeias

Ph. Eur. 5.5 (Calcipotriol (Calcipotriene), Anhydrous; Calcipotriol (Calcipotriene)um Anhydricum). A white or almost white, crystalline powder. It is sensitive to heat and light. Depending on temperature and time, a reversible isomerisation to pre-Calcipotriol (Calcipotriene) takes place in solution. Practically insoluble in water; freely soluble in alcohol; slightly soluble in dichloromethane. Store in airtight containers at a temperature of -20° or below. Protect from light.

Ph. Eur. 5.5 (Calcipotriol (Calcipotriene) Monohydrate; Calcipotriol (Calcipotriene)um Monohydricum). A white or almost white, crystalline powder. It is sensitive to light. Depending on temperature and time, a reversible isomerisation to pre-Calcipotriol (Calcipotriene) takes place in solution. Practically insoluble in water; freely soluble in alcohol; slightly soluble in dichloromethane. Store in airtight containers. Protect from light.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients