The report provides a detailed analysis essential for establishing a segesterone production plant. It encompasses all critical aspects necessary for segesterone production, including the cost of segesterone production, segesterone plant cost, segesterone production costs, and the overall segesterone production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a segesterone production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Segesterone is a strong fourth-generation progestin that is used as a long-acting reversible contraceptive in the FDA-approved Annovera vaginal ring. It is combined with ethinyl estradiol and provides one year of highly effective protection through 21-day continuous use followed by 7-day removal. It is employed for ovulation suppression, suitable for women of reproductive potential up to a BMI of 29 kg/m².
Its individual formulations, like vaginal rings and subdermal implants, provide progestin-only contraception. Its transdermal gel combinations with estradiol or testosterone are utilised for female and male hormonal contraception, respectively. Also, it treats endometriosis symptoms via non-oral delivery, avoiding liver metabolism.
The market for segesterone is influenced by rising demand for long-acting reversible contraceptives. The rise in women's reproductive health issues like endometriosis, increasing PCOS and hormonal disorder and the expansion of fertility clinics contribute to the market. The growth in reproductive technologies, women's health awareness, and innovations in sustained-release non-oral progestins boosts its market.
The industrial segesterone procurement is influenced by its cost-effectiveness, along with proven efficacy and safety profiles against other choices. Other factors like GMP-certified supplier reliability with USDMF and CEP records, packaging and storage requirements for ring stability, and regulatory compliance for reproductive health products impact its sourcing costs.
Raw Material for Segesterone Production
According to the segesterone production plant project report, the key raw materials used in the production of segesterone include 3-pyrrolidino-16α,17α-epoxy-16β-methyl-19-nor-3,5-pregnadiene-20-one | benzene |acetic anhydride | p-toluenesulfonic acid.
Production Process of Segesterone
The extensive segesterone production cost report consists of the following major industrial production process:
- From Pyrrolidino-epoxy-norsteroid: The synthesis of segesterone acetate starts from 3-pyrrolidino-16α,17α-epoxy-16β-methyl-19-nor-3,5-pregnadiene-20-one. First, the starting material is heated with acetic anhydride in benzene in the presence of p-toluenesulfonic acid. This promotes epoxide opening, elimination to generate the 16-methylene group, and acetylation at the 17α-position to form the corresponding 3-pyrrolidino-16-methylene-17α-acetoxy intermediate. After that, this intermediate is treated with aqueous sodium acetate in acetic acid and methanol under reflux. This affects the removal of the pyrrolidino enamine and restoration of the Δ4-3-keto steroid system to get segesterone acetate.
Segesterone (in acetate form) has the molecular formula of C23H30O4 with a molecular weight of 370.49 g/mol. It is a white to yellowish powder which is slightly soluble in n-hexane. It is soluble in ethyl acetate, with a melting point of around 173-177 degree Celsius. It has an XLogP3 value of 2.9, which makes it moderately lipophilic. It has no H-bond donors, 4 acceptors, with a topological polar surface area of 60.4 Ų. It shows 95% of serum protein binding (negligible to SHBG). All these physical and chemical properties makes it useful as a fourth-generation progestin.