Small Molecule Services

Formulation Support Services

Safety, efficacy, quality and stability, truly the goals of formulation. Primera’s experienced and dedicated staff will work closely with you to ensure your formulation has these critical qualities.

Understanding the dynamic nature of formulation development is key. Primera understands that our clients need close communication as well as flexibility when working with varying formulations to determine the lead candidate. We will work closely with you and ensure that we will be flexible and expedient with the changing requirements.

Trust Primera to Assist and Guide Your Formulation Decisions with our Analytical Support

At Primera, we have expanded our service capabilities into preformulation and formulation development areas to support both non-clinical and clinical studies for all types of dosage forms.

Our Team

Our capabilities include assisting our clients in pre-formulation, formulation screening, physiochemical testing, API-excipient compatibility assessments, and predictive accelerated stability studies.

Capabilities

Solubility

pH Solubility Profile
Solubility in Organic Solvents
Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF)
Solubility in Fed State Simulated Intestinal Fluid (FeSSIF)
Simulated Gastric Fluid (SGF)

Stability

Solution Stability
Solid State Stability
Photostability

Inherent Properties

pKa, Log p/Log D
Intrinsic Dissolution

Predictive Accelerated Stability

Primera will work with you to design a predictive accelerated stability study to assist with your understanding of your formulations and their stability.

API-Excipient Compatibility

Screening of excipient and API compatibility is encouraged by (ICH) Q8 and Quality by Design (QbD) principles.
Primera will work with you for an understanding of the interactions between the API and the formulation components.
Changes in the physical, chemical and therapeutic properties of the API will be studied.

Particle Size Distribution

Primera will utilize particle size instrumentation such as the Mastersizer 3000 and Zetasizer Nano to assist you with your formulation development.

Polymorph Studies

Primera will use X-Ray Diffraction to help characterize the API and drug product through-out the drug development process.

Differential Scanning Calorimetry (DSC)

DSC is a common thermal platform that is utilized for testing excipient incompatibilities. Primera has this technology and can utilize this to assist you in your determination of the optimal API-Excipient combination.

Small Molecule Services

Formulation Support Services

Trust Primera to Assist and Guide Your Formulation Decisions with our Analytical Support

Our Team

Capabilities

Dedication. Quality. Experience.

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