Formulation Development

Formulation Development

At CuriRx, we design and perform formulation studies with attention to every detail from use of excipients that are generally recognized as safe (GRAS), to identification of potential stability problems, to composition of clear and precise compounding/formulation process instructions. Depending on administration route and particular physicochemical properties of a drug substance, formulation development may address other concerns, such as compatibility with container/closure systems, compatibility with dosing apparatus which may include the use of Teflon-coated tubing or silanized containers to ensure adequate dose delivery or delivery systems like gel caps, nebulizer, diluents bags, temperature stability of a product under the conditions of pharmaceutical processing, and other relevant concerns. We structure development programs for our clients that integrate process development and scale-up, thereby removing the need for costly reformulation at later stages. With a full range of formulation and analytical development capabilities, we can accelerate your molecule through development to market.

CuriRx has the expertise to work on the most challenging drug formulation issues, including solubility concerns, unstable compounds, innovative delivery options, low dose formulations and high potency compounds. We meet very aggressive timelines by working closely with your toxicologist.  Your drug formulation will achieve the concentration requirements without inducing additional adverse toxic effects.  CuriRx's experts have prepared single formulations which are suitable for multiple routes of administration, can be carried forward into later toxicology studies and can even transition into clinical studies.

CuriRx’s clinical pharmaceutical formulation development will be suitable for manufacture, and for delivering your drug to the patient.

CuriRx's experience in developing clinical drug formulations ranges from simple, early phase dosage forms to more complicated, later phase formulations