Ben Venue has the experienced personnel and facilities to assist in the development of small volume parenteral dosage forms, whether liquid or lyophilized. We can develop and fully document the process for lyophilization or vacuum-drying necessary to manufacture these dosage forms.

Our Development Department:

• Applies and validates analytical techniques for measuring concentrations of active ingredients and excipients.
• Establishes formulation guidelines, precautions and controls that provide for versatility in manufacture using lyophilization or vacuum-drying processes.
• Establishes formulation guidelines for sterile liquids, whether aseptically filled or terminally sterilized.
• Performs stability studies in temperature-controlled storage areas to establish product shelf life.
• Matches drug, excipient and solvent systems with various filtration media to attain maximum compatibility and efficiency.
• Establishes validation procedures for manufacturing processes.
• Evaluates container/closure systems to select those best suited as determined by product compatibility, lyophilization potential, reconstitution allowance, and batch size.
• Provides 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 foreign markets. Ben Venue has manufactured lyophilized or vacuum-dried products including steroids, hypertensive and other cardiovascular agents, ophthalmic preparations, diagnostic agents and numerous antineoplastic entities. We have also developed sterile suspensions as well as liquid injectables in aqueous and nonaqueous solvent systems.

Development and validation of HPLC methodology can be done on an individual contract basis or as part of a total development project for new products.