Formulation Development and Analytical Services at Formulationbio
for the pharmaceutical Industry
Formulation development is of paramount importance for new drug development as it can determine patentability, lifecycle and, ultimately, the success of a pharmaceutical product. Fully aware of the challenges that may arise from this process, Formulationbio recently announces that it now provides a comprehensive range of formulation development and analytical services for the pharmaceutical industry.
“Pharmaceutical formulation development is an indispensable step that makes the new drug substance being discovered gradually develop into a commercial drug product,” commented a senior scientist from Formulationbio. The scientist responsible for drug formulation must determine the most appropriate administration route to achieving effective drug delivery, and then optimize the formulation’s characteristics while taking into consideration the drug product’s bioavailability and processing requirements.
According to statistics, only 10% of new drug products in preclinical formulation development successfully reach the market. Therefore, Formulationbio provides the following four services to assist pharmaceutical companies conduct their drug formulation projects.
Preformulation To guarantee the dosage forms are stable and safe and has good bioavailability, preformulation is needed, which investigates the physical and chemical properties of a drug substance when used alone or combined with excipients. Formulationbio can provide tailored preformulation analysis services, covering Crystallinity Determination, Amorphous Content Determination, Hygroscopicity Evaluation, Particle Size Analysis, Moisture Content Determination, Solubility Analysis, LogP/LogD/pKa Analysis, Stability Analysis, API-Excipient Compatibility, etc.
Formulation A large suite of formulation development services are offered at Formulationbio, that covers: Solids Dosage Forms Development (such as tablets, capsules, granules, pellets and powders), Semi-solids Dosage Forms Development (such as ointments, gels, suppositories, creams), and Liquids Dosage Forms Development (such as solutions, drops, nasal sprays, injections).
Drug Analysis To ensure the drug meets the regulatory requirements, drug analysis is necessary during which process physical, chemical, or biological methods are used to test and analyze different dosage forms of drugs. Formulationbio provides the following drug analytical services: Disintegration Test, Dissolution Test, Tablet Hardness Test, Tablet Fragility Test, Elemental Impurities Analysis, Residual Solvents Test, Dosage Units Uniformity Test, Bioavailability/Bioequivalence Detection, Microbial Limits Test, Particulate Matter Test, Extractables & Leachables Test, etc.
Custom Pharmaceutical Excipients (formulationbio.com/custom-pharmaceutical-excipients.html)
In cases where traditional excipients are unable to meet market demand, some novel excipients need to be manufactured to meet the special needs of pharmaceutical market. Formulationbio provides customized services of multi-functional excipients or co-processing excipients, either through modification of a known excipient as a derivative or via the creation of a new chemical entity without base structure.
For more related information, please visit: formulationbio.com/services.html.
About Formulationbio Staffed with a group of pharmaceutical experts, including Chemists, Biochemists, Engineers, and highly qualified operators, Formulationbio not only supplies a wide range of excipients, but also works closely with the pharmaceutical industry as a contract service organization, offering outstanding expertise to handle complex pharmaceutical formulation.