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Integral BioSystems
Clinical Dosage Form and Pharmacy

Clinical Dose Form development is the translation from Drug Product that contains stable, soluble drug in excipients to the drug-containing biocompatible vehicle, also called the End Use Infusion Solution. While the Drug Product solution may contain a high concentration of soluble or lyophilized drug in a small vial, the final infusion solution may have to be prepared by adding the drug concentrate or reconstitute to a intravenous infusion fluid, such as isotonic saline, or water, or lactated Ringers, etc. For drugs that precipitate at physiological pH, a regimen of infusion flow rate and optimum concentration must be developed, to minimize risks of phlebitis. Lastly, the infusion solution must be stable to ICH guidelines, to 24 hours at room temperature. Finally, the infusion solution must be ideally, photo-stable for 24 hours, so that the drug therapy can occur under ambient light conditions. This piece of formulation dosage form development is by far, the most critical.

Integral BioSystems has expertise that can translate your Drug Product to the forms suitable for administration in the clinic. This can be as simple as a simple reconstitution procedure, or a series of dilutions compliant to USP <797>, to prepare the clinical doses at the desired concentrations. We can assist you with consulting, or actual hands-on help, with the preparation of the clinical pharmacy protocol.

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