Solid Dispersion Formulation Development for compound E2

National Institute of Diabetes and Digestive Kidney Diseases (NIDDK intends to procure on a sole source basis with Patheon Development Services of 62925 NE 18th St., Bend, OR 97701. The National Institutes of Health (NIH), National Library of Medicine (NLM), NIDDK's Laboratory of Endocrinology and Receptor Biology is looking to develop an oral pill or capsule formulation by manipulating the physicochemical properties of the API compound to improve solubility and bioavailability. The ultimate project goal is to complete preclinical animal testing and submit sufficient data in a package to the Food and Drug Administration for an Investigational New Drug application. Previous work identified suspension vehicles with adequate solubility for IP administration, however for future clinical development, determining the feasibility of an oral solid dosage form is desired. Due to its crystallinity and low solubility, formulation as an amorphous solid dispersion may provide more rapid dissolution and super saturation at intestinal pH, thereby increasing API absorption following oral delivery. The prospective contractor will select a range of polymeric excipients for use in preparing compound in solid dispersions. Lead solid dispersion formulations which offer increased in vitro kinetic solubility and desirable physical properties will be manufactured at increased drug loading. Selected dispersions will also be tested in an accelerated stability study to examine chemical and physical stability of amorphous drug form. The best-performing solid dispersions will be manufactured at larger scale for use in animal PK studies. These dispersions will also be tested in a study of the effect of humidity on material stability. A prototype immediate release tablet formulation will be developed, and sufficient tablets will be provided to NIDDK or its designate for non-human in vivo studies. At each stage of the project, results will be provided and the selection of formulations to advance will be made in consultation with the lab, along with a "go-no go" decision to proceed to the next stage via execution of the next option. It is essential to improve the bioavailability and solubility. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b) (1). The North American Industry Classification System Code is 325412 and the business size standard is 750. Only one award will be made as a result of this solicitation. This will be awarded as a firm-fixed price type contract. The period of performance shall be five (5) months from date of award. This is not a solicitation for competitive quotations. However, if any interested party believed they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NIDDK to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NIDDK Acquisitions Branch on or before 10:00 AM EST on Tuesday, August 27, 2015. Electronic submissions will be accepted or they can be mailed to the DK Acquisitions Branch to the address stated above. All questions must be in writing and can be faxed to 301-480-4226 or emailed to April Merriwether, Contract Specialist, merriwetheran@mail.nih.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractor must be registered and have valid certification in the System for Award Management (SAM) [formerly CCR] http://www.sam.gov . No collect calls will be accepted. Please reference solicitation number NIHLM2015617 on all correspondences. Confidentiality - No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).