Preventing Crystallization with the Crystal16 for Successful Parenteral Formulations - poster
Floor Aalders
Technobis Crystallization Systems, Pyrietstraat 2, 1812SC Alkmaar, The Netherlands
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Many drug substances are formulated as parenteral formulations and administrated directly into the systemic circulation in animals and humans. In order to improve their stability and solubility, many parenteral formulations are formulated using a co-solvent. Ampule or vial dosage forms are often co-solvent concentrated formulations. These concentrates are finally diluted before administrated to the patient. Nevertheless, there are many cases known where dilution of drug formulations has the potential to generate conditions where drug concentrations are supersaturated. Under these circumstances, drug precipitation/crystallization is likely to take place. Drug precipitation after parenteral administration may cause mechanical or chemical irritation at the injection site, and potentially even more serious systemic effects. With the use of the Crystal16, solubility measurements may be performed to help avoid vulnerable formulations and foresee mechanical and chemical irritation at injection site. In the phase diagram of lorazepam was showed how high concentrations of the drug and low ratios of glucose lead to a stable solution in which crystallization does not occur.