Formulation Development

Formulation Development:

We are proud to offer outstanding expertise in all areas of formulation development. Our clients can turn to us for formulation projects for solid, topical and parenteral (including liquid, powdered and lyophilized) dosage forms. Additionally, our scientists have the cutting edge knowledge to develop and optimize more exotic controlled and sustained release, microemulsion, microsphere, liposome and targeted delivery dosage forms to give your product the state-of-the art efficiency and effectiveness required in today’s competitive market. Our formulation experts have an excellent “track record” of successful formulation development, including trouble shooting difficult problems other scientists may be unable to handle.

Solid dosage form development:

Appropriate excipients, drug excipient(s) ratios and process steps are established for the preparation of immediate controlled and sustained release tablets and capsule dosage forms. Analytical methods for content uniformity, weight variation, disintegration dissolution and stability testing, cleaning procedures and other methods to characterize the dosage form and fully developed and validated so clinical production and technology transfer for scale-up to commercial production can occur rapidly and efficiently.

Parenteral dosage form development:

Appropriate excipients, drug excipient(s) ratios, solvents and compounding procedures are established for the preparation of liquid and lyophilized dosage forms. Container/closure filter and process equipment compatibility studies can be performed. Studies are performed to evaluate the acceptability of moist heat terminal sterilization. Analytical methods for the characterization of the dosage form, lyophilization cycles, and cleaning methods are developed and fully validated. All aspects of the parenteral dosage form process are comprehensively developed and optimized so clinical production and technology transfer for scale up to commercial production can occur rapidly and efficiently.