Formulation Development

Formulation development is the development of a customized dosage form for a specific administration route. WLI has accumulated years of experience in development of vehicles for administration of pharmaceuticals, and vehicles for storage, which may be different from the administrable vehicle. Formulation studies are designed and performed 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 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 or delivery systems like gel caps, temperature stability of a solid form under the conditions of pharmaceutical processing, and other relevant concerns.

The types of formulation development studies conducted by WLI vary and reflect the range of administration routes employed in clinical practice. Most of our work focuses on oral and intravenous (IV) routes of administration. We do perform formulation development work with clients interested in topical, transdermal, ophthalmic, intra-articular, subcutaneous, and other routes of delivery. Moreover, we welcome projects that involve specialty dosage forms and proprietary administration devices, and we have experience with such studies. An example of such devices are systems based on iontopheresis.

WLI performs formulation development work with a variety of drug substances, including small molecules, peptides, proteins, oligonucleotides, and cytotoxic materials.

To read an article on formulation development, click here.