Dosage Form Development

After identification of the optimal strategy to improve drug solubility / dissolution and bioavailability, the next stage is to develop a finished dosage form suitable for administration in clinical trials. 

Formulation prototyping studies are designed and performed with attention to every detail, from use of excipients and processes that are accepted by US and European regulatory authorities, to identification and prevention of potential stability and processing problems that may be encountered during technology transfer for scale up clinical manufacture.

Using specially designed small scale formulation processing equipment, we can manufacture a variety of prototype formulations for oral, parenteral and pulmonary administration routes, including:

• Procesed powder in bottle
• Tablets and capsules (powder and liquid hard fill, enteric coating for modified / delayed / targeted release)
• Pellets, granules and mini-tablets (including enteric coated)
• Oral fast dissolving thin films
• Oral and parenteral liquids (solubilised liquids, suspensions (including aqueous nanosuspensions), powders for reconstitution,  lyophilisation)
• Mucoadhesive thin films (sublingual and buccal)
• Powder blends in capsules for dry powder inhalation 

Formulation prototype development projects start with the development of a strategic formulation plan and is the result of a thorough analysis of the previously generated preformulation data report, the intended manufacturing process, any patient compliance issues and the strategic goals of the company.  This plan is produced through close communication with the client's study team and our experienced formulation scientists andin-house Qualified Person (QP).

Current projects include:

• Development of an emergency use direct injection IV bolus formulation of a poorly water soluble / hydrolytic antiarrhythmic agent (currently in Phase II)
• Preparation of an extemporaneous oral suspension (currently in Phase I)
• Manufacture of an amorphous solid dispersion, powder in capsule formulation for a low solubility API (currently in Phase IIa)
• Reformulation of a modified release tablet dosage form of an acid labile API to provide faster onset of action (commercial reformulation)
• Preparation of a redispersable drug nanoparticulate for LCM (Phase II)
• Development of a liposomal injectable formulation to improve systemic half life (currently in Phase I)