Ben Venue has the experienced personnel and facilities to assist in the development of small volume parenteral dosage forms, whether liquid, lyophilized or vacuum-dried. We can develop and fully document the production process for all three methods.

We have also developed sterile suspensions, as well as liquid injectables in aqueous and non-aqueous solvent systems, emulsions, liposomes, and microspheres across most therapeutic classes.

Our Development Department Can:

• Develop and validate analytical techniques for measuring concentrations of active ingredients and excipients
• Establish formulation procedures, precautions and controls that support a wide variety of formulation approaches
• Establish formulation procedures for sterile liquids, whether aseptically filled or terminally sterilized
• Perform stability studies according to ICH guidelines in temperature-controlled storage areas to establish product shelf life
• Match drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency
• Establish validation procedures for manufacturing processes
• Evaluate container/closure systems to select those best suited as determined by product compatibility, lyophilization potential, reconstitution allowance, and batch size
• Provide for orderly scale-up to full production volume to assure that the product can be manufactured efficiently

Many dosage forms have been developed and produced for both domestic and international markets. As a result, our analytical services include the testing specified in international pharmacopeias.