Salmeterol Xinafoate INKE, S.A. Salmeterol Xinafoate Salmeterol Xinafoate (INKE S.A.) EXECUTIVE SUMMARY GENERAL MARKET DATA
!Product Data!Patent Situation World wide!Market Analysis
SPECIFIC DATA – Salmeterol Xinafoate (INKE S.A.)
!Chemical Description!Standard of Quality!Chemical Development Plan
Salmeterol Xinafoate Executive Summary Salmeterol Xinafoate (API): High quality available with industrial batches.
EDMF in CTD FORMAT. Own alternative process patent Experience with similar APIs (e.g. Formoterol Fumarate)
Fast decision making and adaptation to customer requirements.
State of the art manufacturing facilities, complying with cGMP, FDA standards and ISO 9001:2000, provided with the latest technologies and equipment. No customer complaints as a result of high quality standard. Technical and Regulatory support to our customers. Salmeterol Xinafoate GENERAL MARKET DATA Salmeterol Xinafoate General Product Data (I) Drug Name World Status Pharma Status
Aeromax Arial GR-33343G GR-33343X Salmetador salmeterol hydroxynaphthoate Serevent Serevent Accuhaler Serevent Diskhaler Serevent Diskus Serevent Surehaler Serobid SN-408 Ultrabeta
Salmeterol Xinafoate General Product Data (II) Therapy Description Therapy Status
Pharmacology Description
Therapy Code Pharmacology Code
Route of AdministrationRoute of Administration Code Respiratory, inhaled
Indication Indication Status Salmeterol Xinafoate General Product Data (III) Originator Development Stage
Licensee Salmeterol Xinafoate Patent Situation Worldwide (I) Priority Country Priority Date C o u n try N a m e C o u n try S ta tu s Y e a r L a u n c h e d L ice n sin g O p . Salmeterol Xinafoate Patent Situation Worldwide (II) C o u n try N a m e C o u n try S ta tu s Y e a r L a u n c h e d L ic e n s in g O p . Salmeterol Xinafoate Market Analysis Global Market Size
IMS data's covering the period including from April 2004 through end
Salmeterol Xinafoate SPECIFIC DATA Salmeterol Xinafoate (INKE S.A.) Salmeterol Xinafoate Chemical Description
(1RS)-1-[4-Hydroxy-3-(Hydroxymethyl)phenyl]-2-[[6(4-phenylbutoxy)hexyl]amino]ethanol 1-hydroxynaphthalene-2-carboxylate.
The Active Ingredient Salmeterol Xinafoate has one chiral center. It is a racemic mixture of the two enantiomers with the configurations R and S. Salm
Formote et er
ol Fumarate ol Xinafoate General Properties
Slightly soluble in ethanol, isopropyl alcohol and in chloroform. .
Salmeterol Xinafoate melts at about 137-138 ºC. Salmeterol Xinafoate Standard of Quality (I)
Two polymorphic forms of Salmeterol Xinafoate have been described in the literature. The Salmeterol Xinafoate manufactured by INKE S.A. corresponds to the polymorph I, because it is the most thermodynamically stable form at room temperature. Salmeterol Xinafoate Standard of Quality (II) According ICH Q3A and Q3C Guidelines
Isopropyl acetate, Methyl ethyl Ketone, tetrahydrofuran
Remarks: Isopropyl acetate, tetrahydrofuran and methyl ethyl Ketone are defined as “Solvents with low toxic potential” according with ICH Q3C Guideline.
Salmeterol Xinafoate contains not less than 98,0% and not more than 102,0 % of C25H37NO4·C11H8O3 calculated with reference to the anhydrous substance. Remarks: This product meet requirements of EP monograph Nº 022005:1765 Salmeterol Xinafoate Chemical Development Plan Final of Synthesis Development Validation of Analytic Methods Customer File Industrial Batches for DMF DMF in CTD Format Process Validation (2006) Certificate of suitability Eur. Ph. (2006)
PHYTOESTROGEN REVIEW Jillian E Stansbury Estrogen and Estrogen Receptor Basics Estrogens and all steroids play many important physiologic roles in both men and women. Not only do the estrogens (estradiol, estriol, and estrone) help direct basic sexual characteristics, but they also affect the central nervous system in terms of masculinization, feminization, and sexual behavior. I