World-class Pharmaceutical Product Development
With Discovery and Pre-Formulation studies complete, your API is ready to move into formulation development, and Pion has innovative pharmaceutical formulators and expertise to help you characterize the drugs that you take into further testing.
Formulation Development Services
Pion offers extensive support in clinical research and pharmaceutical formulation. We study and interpret essential data, such as dissolution rates, precipitation risks, and solubility behaviors of a formulated drug product. Using modern analytical techniques, we help researchers predict potential in vivo performance issues and achieve better success rates.
Dual Stage Dissolution
Pion has developed a two-stage dissolution assay that simulates the transfer of a drug from stomach to intestine. This can reveal the influence of changing pH conditions on a drug’s behavior.
Biorelevant Dissolution
Pion can characterise dissolution and solubility behaviour in biorelevant media simulating different zones and compositions within the human body.
SDI Final Form Integrity
Surface dissolution imaging can accelerate your formulation development by revealing the disintegration characteristics of drug dosage forms.
Compendial Dissolution
Our analysts run Compendial Dissolution tests for you on Pion equipment or serve as consultative partners.
MacroFLUX
With Pion’s MacroFLUX™ device, you can reliably test and rank the absorption potential of formulations in-vitro to greatly enhance in-vivo prediction.
BioFLUX
Pion’s BioFLUX™ accurately assesses the absorption potential of finished dosage forms under biorelevant conditions, greatly enhancing IVIVC modelling.
Particle Sizing
Pion’s laser obscuration time and image analysis techniques can characterize particle size without the need to know the optical properties of the sample.
Subcutaneous Formulation
Pion can investigate the bioavailability of subcutaneous or intraocular formulations in vitro, using our novel Scissor instrument.
What is Formulation Development?
Formulation development is a critical phase in product development. During this multi-step process, the active drug is characterized and combined with other chemical substances to produce a final, marketable pharmaceutical product.
Formulation development involves a variety of activities. It covers analytical assay development and characterization, particle sizing, and dosage form development. In addition, researchers assess the drug’s disintegration characteristics and measure its absorption potential.
Pharmaceutical formulation can influence the life cycle, patentability, and overall success of the drug. Many companies outsource pharmaceutical analysis to save time and ensure no issues or procedures are overlooked.
Experts in Pharmaceutical Formulation
Unrivalled Technology
We use modern facilities and scientific equipment to deliver world-class formulation development services.
Dedicated Team
We are at the forefront of analysis, field service, and pharmaceutical laboratory instrumentation. Our formulation development specialists have the skills and training to help you develop compliant and optimal dosage forms.
Exceptional Quality
Our U.S. center of excellence for production is ISO 9001:2015 certified, meaning all our products and services meet customer needs through a quality management system.
Scientific Instruments
We provide novel in-vitro tools that promote quicker, more informed decision-making.
Resource Library
Latest citations of Pion instruments and services in industry white papers, webinars, videos, and case studies.