Formulation and Process Development Articles

Most biologicals and some small-molecule drugs are best administered through injections. Although this delivery route has its advantages, economic considerations, side effects, and practical concerns could dissuade some patients from maintaining full compliance with a parenteral-drug regime.

PharmTech» Otonomy has developed a formulation platform that enables local delivery of drugs into the ear to treat middle- and inner-ear conditions such as Meniere's disease*, certain forms of hearing loss, and infection. The diseases have traditionally been treated by surgical means. I understand the company had an unusual beginning. Can you tell me about that?

Manufacture of sterile parenteral drug products involves a series of unit operations (1) and aseptic processing conducted under strict requirements with respect to product quality. The manufacturing process is designed and validated to address such requirements and to ensure supply of safe and efficacious products.

This article is part of PharmTech's supplement "Injectable Drug Delivery."

The formulation process for parenteral, or injectable, solutions often follows the overly simplified method of combining water for injection (WFI), active pharmaceutical ingredient (API) and excipients in a formulation vessel (FV) located within a formulation room and mixing until dissolved.

This article is part of PharmTech's supplement "Injectable Drug Delivery."

This article is part of PharmTech's supplement "Injectable Drug Delivery."

This article is part of PharmTech's supplement "Injectable Drug Delivery."

Nature has provided us a wide variety of materials to help improve and sustain the health of all living things either directly or indirectly. In recent years there have been important developments in different dosage forms for existing and newly designed drugs and natural products, and semi-synthetic as well as synthetic excipients often need to be used for a variety of purposes.

Purpose: This study intended to prepare a stable hydroxycamptothecin (HCPT) emulsion to characterize the formulation properties and to evaluate the tissue distribution pattern in comparison with the commercially available HCPT injections. Methods: The content of HCPT in the emulsion was measured by HPLC.