Pharmaceutical formulation is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. Development of novel dosage forms such as capsules, tablets, oral solutions, suspensions and syrups has become an important current focus for pre-clinical safety evaluation within the pharmaceutical industry. BOC Sciences has significant experience performing risk assessments and subsequent statistically designed experimentation for understanding the parameters and quality attributes that impact the clinical performance and safety of formulations, manufacturability of dosage forms, and stability in primary packaging.
BOC Sciences provides wide range of services such as, formulation development, scale-up process (up to 50 kg batch size), stability study, CMC document for registration (IND) and cGMP facility for CTM manufacturing (Phase I and Phase II). Pre-formulation studies in combination with analytical methods are critical to identifying the best formulation strategy for a compound. Certain candidates present specific challenges such as poor solubility, low bioavailability and/or permeability and poor physical stability. Formulation development can be helpful in overcoming many of these issues.