Co-crystal Development - Psych
We get on an ambitious project to screen for an IP non infringing solid form based on citric acid co-crystal. The parent molecule is not acidic, nor basic, even do not present any other stable polymorphs. The breakthrough came when our researchers discovered an innovative co-crystal form using citric acid, which is not only great in solubility, but also patent protected.
The intensive period of formulation development surprisingly focused on suppression of bioavailability to ensure safety and bioequivalence study passing.
We than moved swiftly to market the product, with Zentiva launching the co-crystal in 2019, a testament to our rapid development cycle. Proud when saying 6 years ahead original patent of parent molecule expired.
The intensive period of formulation development surprisingly focused on suppression of bioavailability to ensure safety and bioequivalence study passing.
We than moved swiftly to market the product, with Zentiva launching the co-crystal in 2019, a testament to our rapid development cycle. Proud when saying 6 years ahead original patent of parent molecule expired.
pH – Independent Absorption
The Project exemplifies our commitment to adding value at every stage of drug development, from the synthesis of active pharmaceutical ingredients to the final stages of drug product development and manufacturing. This effort adopts an integrated approach, where chemical development, solid-state development, and formulation development are closely coordinated.
High variability of clinical efficacy is caused by absorption dependency on pH, when about 30% of patients, present limited absorption of due to higher pH in their stomach. This can occure naturally as achlohydria or be caused by co-administration of another drugs.
Our newly developed anhydrous form of the parent molecule is a crucial condition of formulation with stable bioavailability, which remains consistent regardless of pH changes
High variability of clinical efficacy is caused by absorption dependency on pH, when about 30% of patients, present limited absorption of due to higher pH in their stomach. This can occure naturally as achlohydria or be caused by co-administration of another drugs.
Our newly developed anhydrous form of the parent molecule is a crucial condition of formulation with stable bioavailability, which remains consistent regardless of pH changes
Alternative Synthetic Route Omitting Impurities
We were keen of potential risks coming from secondary amine group presented in the parent structure. It is one of conditions leading to nitrosamine impurities, which is the emerging topic of couple past years.
Understanding the importance of delivering products of the highest quality and purity to our customers, and we have taken on this task with determination.
From the very inception of development, we have designed processes and applied approaches to ensure that the final product can be claimed as Nitrosamine-Free.
Understanding the importance of delivering products of the highest quality and purity to our customers, and we have taken on this task with determination.
From the very inception of development, we have designed processes and applied approaches to ensure that the final product can be claimed as Nitrosamine-Free.