Cerbios has developed and is developing and manufacturing Drug Substances used in respiratory inhalation therapies that are inherently HPAPI.

Given the strict requirements for inhalators, our strategic commitment ensures a high level of technical and regulatory standards to position the company amongst the leading suppliers of therapeutical APIs for respiratory disease.

Tiotropium Bromide is a long-acting muscarinic antagonist (LAMA) of muscarinic receptors, formulated as a powder or solution for inhalation. Approved therapeutic use is for chronic obstructive pulmonary disease (COPD) and asthma. Cerbios’ API has specific characteristics (PSD, flowability) which make it appropriate to be used for both formulations (powder capsules and solution). Cerbios has developed both Tiotropium Bromide monohydrate as well as the anhydrous form.

* Products covered by valid patents in any country are not offered or supplied to these countries for commercial purposes. Where valid patents are in place, only use for research and development is allowed, if permitted by the relevant laws.

USE

Tiotropium Bromide is mainly used for the long-term treatment of reversible bronchospasms associated with COPD, including chronic bronchitis and emphysema.

It is also recommended for maintenance monotherapy in patients with moderate to severe COPD who have persistent symptoms which have not been relieved by  selective short-acting inhaled β2-adrenergic agonist therapy. 

TIOTROPIUM BROMIDE ANHYDROUS
PROPERTIES

CAS Number :
Formula :
Molecular Weight :

136310-93-5
C19H22BrNO4S2
472.42 g/mol

REGULATORY

FDA :
CEP :
China DFM :
Korea DMF :
EU:

028820
Under preparation
Under preparation
20180287631 (*)
DCP or MR or EFSA

(*) Application ongoing

TIOTROPIUM BROMIDE MONOHYDRATE
PROPERTIES

CAS Number :
Formula :
Molecular Weight :

139404-48-1
C19H24BrNO5S2
490.4 g/mol

REGULATORY

FDA :
CEP :

Under preparation
Under preparation

Family

  • Long-acting muscarinic antagonist

Therapeutic area

  • Anti-asthma and COPD

Synonims

  • 3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane, 7-[(2-hydroxy-2,2-di-2-thienylacetyl)oxy]-9, 9-dimethyl-, bromide (1:1), (1α,2β,4β,5α,7β)-
  • 3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane, 7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-, bromide, (1α,2β,4β,5α,7β)-
  • (1α,2β,4β,5α,7β)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-di-methyl-3-oxa-9-azoniatricyclo[3.3.1.0]nonane bromide