A method of preparing dry powder vaccines that contain aluminum salts

Life Sciences : Therapeutics

Available for licensing

Inventors

  • Zhengrong Cui, Ph.D. , Coillege of Pharmacy
  • Robert Williams III, Ph.D. , College of Pharmacy
  • Xinran Li , Pharmaceutics

Background/unmet need

Aluminum salts such as aluminum hydroxide and aluminum phosphate have been used as adjuvants in human vaccines for decades. Aluminum salt-containing vaccines, including hepatitis A and B, pneumococcal, anthrax, rabies and DPT vaccines are formulated as liquid suspensions that are required to be kept at 2° to 8° Celsius during transport and storage. These vaccines must be kept as liquid suspensions because exposure to freezing temperatures leads to irreversible coagulation that damages the potency of vaccines.

This poses a major problem because, by some studies, as many as 75 to 100 percent of vaccine shipments are exposed to freezing temperatures at varying points along the distribution chain, resulting in costly waste of vaccine supplies. Thus, there is a need for methods to eliminate the issue of temperature sensitivity of aluminum-adjuvanted vaccines in order to decrease waste and improve availability to patients.

Invention Description

Inventors from The University of Texas at Austin have developed a new method to dry vaccines that contain aluminum salts as adjuvants. The dried vaccine powder can be readily reconstituted without significant loss of potency. The dry powder vaccine is not sensitive to freezing temperatures and may be stored in a wide range of temperatures, including room temperature.

The researchers have conducted proof-of-concept studies using vaccines including human hepatitis B vaccine and animal tetanus toxoid vaccine. The potency of the reconstituted vaccines had been tested in animal models. The researchers are currently working to apply the method to other aluminum-adjuvanted and non-adjuvanted vaccines to further show its broad applicability.

Benefits/Advantages

  • The method can be applied to any aluminum-adjuvanted vaccine.
  • A low percentage of excipient(s) is needed during the drying process.
  • The dried powder vaccine can withstand a wide range of temperatures, including freezing conditions.
  • The dry vaccine powder can be reconstituted easily--"melts" in diluent quickly, without agitation.
  • The dry vaccine powder may be potentially administered by routes other than parenteral injection.

Features

  • Fast rate of drying prevents coagulation of vaccines adjuvanted with aluminum salts.
  • The stability and potency of vaccines are maintained upon reconstitution of the dry powder.
  • Vaccine powder is not sensitive to freezing temperatures during shipment and storage.

Development Stage

Beta product/commercial prototype

IP Status

  • 2 U.S. patents application filed