INJECTABLE MICROCAPSULE FOR ESTROGEN REPLACEMENT THERAPY

Information

• Research Project
• 6127632

• ApplicationId

  6127632

• Core Project Number

  R44AG013775

• Full Project Number

  3R44AG013775-03S1

• Serial Number

  13775

• FOA Number

• Sub Project Id

• Project Start Date

  9/30/1995 - 29 years ago

• Project End Date

  8/31/1999 - 25 years ago

• Program Officer Name

• Budget Start Date

  8/1/1999 - 25 years ago

• Budget End Date

  8/31/1999 - 25 years ago

• Fiscal Year

  1999

• Support Year

  3

• Suffix

  S1

• Award Notice Date

  7/21/1999 - 25 years ago

Organizations

• BIOTEK, INC.

DESCRIPTION: (Adapted from the Applicant's Abstract): The objective of the program is to develop a 90-day injectable microcapsule form of estradiol to be used for estrogen replacement therapy in postmenopausal women. During Phase I, BIOTEK used the new spray-core microfluidized bed process to prepare estradiol loaded microcapsules and demonstrated sustained 90-day delivery from such capsules in rabbits and in rats. During Phase II, microcapsule development will be completed; all preclinical studies required by the FDA will be conducted; manufacturing specifications, processes and controls will be documented, IND application will be filed with the FDA; microcapsules for clinical studies will be manufactured and a clinical study of safety and pharmacokinetics will be conducted.

IC Name

• Activity

  R44

• Administering IC

  AG

• Application Type

  3

• Direct Cost Amount

• Indirect Cost Amount

• Total Cost

• Sub Project Total Cost

• ARRA Funded

• CFDA Code

  866

• Ed Inst. Type

• Funding ICs

• Funding Mechanism

• Study Section

  ZRG7

• Study Section Name

• Organization Name

  BIOTEK, INC.

• Organization Department

• Organization DUNS

• Organization City

  WOBURN

• Organization State

  MA

• Organization Country

  UNITED STATES

• Organization Zip Code

  01801

• Organization District

  UNITED STATES