SOLICITATION NOTICE
B -- Approach to the Understanding and Predicting Excipient Properties and Functionality
- Notice Date
- 6/25/2009
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-SOL-1055924
- Point of Contact
- Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
- E-Mail Address
-
Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) intends to solicit a contract for the project, “Approach to the Understanding and Predicting Excipient Properties and Functionality”. The ultimate goal of this project is to establish an information system that is used to maintain values of fundamental pharmaceutical excipient material properties, and which contains models, best practices, and methods for using this data in the systematic design of pharmaceutical products and processes. This system will be publicly accessible in order to improve the efficacy, quality, and efficiency of manufacturer’s products, and improve the science for establishing industry guidances. Physical property databases for various material classes are common in other fields of engineering; for example, there are many databases of material properties on the NIST website. These standardized and reliable material properties are indispensable to an engineer who is designing an industrial product and process. Currently, there are no such databases for the physical properties of pharmaceutical excipients. Scope of Work: The proposed work is the first part of a larger program to identify, measure, and provide useful models for predicting excipient properties that affect the performance of solid dosage formulations. The current proposal focuses on materials from three excipient classes used in virtually all immediate release direct compression tablet manufacturing. They include a binder/diluent such as microcrystalline cellulose (MCC), lactose and dibasic calcium phosphate, a disintegrant such as Na starch glycolate or pregelatinized starch and a lubricant such as magnesium stearate (MgSt). These three excipients are the most commonly used filler/binders used in direct compression formulations, and they span the range from very ductile to very brittle materials. The anticipated contract type is a labor hour for two years, one (1) Base Year and one (1) Option Year. This will be a full and open competition solicitation. This contract will be awarded on a best value basis. The designated North American Industry Classification System (NAICS) code is 611310. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal contract. The website is http://www.ccr.gov. This announcement is not an RFQ. Interested parties shall submit an email to request the solicitation at Tara.Hobson@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-SOL-1055924/listing.html)
- Record
- SN01856405-W 20090627/090625235436-4f024ab3c66709cf671e7ea127b581c0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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