Supercritical carbon dioxide for drying and sterilizing parenteral dosage forms

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43CA139643-01
Agency Tracking Number: CA139643
Amount: $100,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Solicitation Year: 2009
Award Year: 2009
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
DUNS: 622968837
HUBZone Owned: Y
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 () -
Business Contact
Phone: (785) 841-7120
Research Institution
DESCRIPTION (provided by applicant): The long range goal of this project is to develop methods of using supercritical carbon dioxide (scCO2) to achieve terminal sterilization that meets or exceeds the USP standard of 10-6 microbial survival probability and that produces a dry drug product in a single process. The objective of this application is to identify at least one set of conditions in which the act of drying drugs by the scCO2 process known as lyophobic precipitation (LP) can also sterilize the drug product in its dispensing container as well as the chamber in which the process is conducted. The rationale behind this project is that recent observations that scCO2 can be used to effect terminal sterilization of food and medical products without damaging the product will be adaptable to the LP drying process. Many drugs, including many anticancer agents, must be administered by non-oral routes (intravenous or intraperitoneal) and therefore must be sterile for injection. For stability reasons such drugs often must be dry as well as sterile. Current technology requires a two-step process of filter-sterilization followed by lyophilization under aseptic conditions to achieve safe, stable dosage forms. To accomplish the objectives of this application two specific aims will be pursued: (1) determine the level of sterilization of drug substance and container under normal LP conditions and using tested and untested added sterilizing agents, and (2) determine the level of sterilization of the chamber under normal LP conditions and using tested and untested added sterilizing agents. The strategy to accomplish the specific aims is to measure the level of killing of standard sterility-testing biological indicators added to containers of model drug under conditions that mimic the conditions that will eventually be used commercially. Similarly, challenge doses of biological indicators will be placed in the LP chamber to determine effectiveness of sterilization of the process with and without added sterilizing agents. The expectation is that at the conclusion of this Phase I SBIR period of support, precise conditions necessary to achieve a sterilization activity level of 10-6 for drug substance contained in a dispensing container and the chamber in which the lyophobic precipitation occurs will be identified. This information will guide a Phase II application to determine the effect of treatment conditions determined in this study on the chemical stability of existing oncology drugs that possess various reactive groups (e.g., alcohols, amines, thiols, carboxylic acids, etc.) that may prove susceptible to damage. PUBLIC HEALTH RELEVANCE: This project proposes a new technique to safely dry and terminally sterilize drugs in their dispensing containers. If successful, this approach will lead to simpler processing of injectable drugs that would increase safety and lower production costs.

* Information listed above is at the time of submission. *

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