Form.....Formation.....Formulation.....The 3 "Fs"
Pharmaceutical formulation is the process in which different chemical substances, including the Active Pharmaceutical Ingredient (API), are combined to produce a medicinal product. The API may be administered in a number of different formulations such as tablet, capsule, ointment, cream, injection, liquid, etc.
Crystallics formulation expertise is focused on preclinical and early human (phase I and II) formulations to allow you to quickly take your compound into these settings to establish the safety and efficacy profile of your API.
Formulation studies consider such factors as particle size, polymorphism, solubility and dissolution rate, as all of these can influence bioavailability and hence the safety and efficacy of a drug. By having expertise in-house across solid state chemistry, preformulation and formulation design, Crystallics is able to tailor the formulation to the drug’s physical and chemical characteristics. Indeed, a highly hygroscopic or deliquescent salt formulation of your API may be very soluble and can be used to demonstrate safety with high exposure levels in animals in toxicity studies as per regulatory requirements, but such a formulation would never be used as final commercial formulation.
Crystallics develops preclinical and phase I and II formulations for NCE drugs, OTC products, generic products, and 505(b)(2) product candidates.
Crystallics' research programs are undertaken in close cooperation with the customer. Customer focus is at the core of our organization and we strive for timely and effective communication throughout the entire project. Our projects are tailored to meet the needs of the customer and the API and we provide comprehensive and clear reports including concise recommendations ensuring successful drug development.