SOURCES SOUGHT
B -- Approach to the Understanding and Predicting
- Notice Date
- 5/19/2009
- Notice Type
- Sources Sought
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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
- HHS-FDA-SS-09-1055924
- Archive Date
- 6/10/2009
- 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
- Description: Approach to the Understanding and Predicting Excipient Properties and Functionality This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) for approach to the Understanding and Predicting Excipient Properties and Functionality. This information is being sought for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA). No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future a official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. No telephone inquiries will be accepted. FDA may consider soliciting services for a base year and one option year firm fixed price contract. Objectives: 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. Draft 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. Due to their significance in direct compression, they are available in numerous grades. For example, MCC is available with a wide range of particle sizes, densities, and moisture contents. Lactose is also available in many different grades and it comes in anhydrous, monohydrate, and spray-dried forms. DCP is available in many different grades and it comes in anhydrous and dihydrate forms. The dihydrate form is known to dehydrate during product storage; the released water can facilitate the chemical decomposition of the API and also have an adverse effect on the properties of the finished dosage form. Super disintegrants such as sodium starch glycollate, croscarmellose sodium and crospovidone or traditional disintegrants such as starch and pregelatinized starch are commonly used in most direct compression formulations. These come in fewer grades than the filler/binders; however, the different disintegrants have different disintegration mechanisms, which need to be understood when formulating in tablet or capsule formulations. With lubricants MgSt is the most commonly used disintegrant, and one of the most problematic excipients that merits intensive study. The product (tablet) performance criteria will include: intra- and inter-tablet content uniformity, mechanical durability (breakage and attrition resistance), and disintegration. In addition to providing data, procedures, and recommendations useful to the FDA and industrial formulators for the proposed excipients, these activities will also serve as a template for future work expanding the range of excipients and manufacturing pathways. The proposed research will involve the following main deliverables for each excipient: Review the literature (including journal articles, handbooks, standards, trade articles, and interviews with industrial representatives) to: •Provide a work plan to coordinate timelines and the following deliverables: •Identify material parameters that are critical to achieving the targeted final dosage form functional properties and provide a summary report to the FDA. •Compile reported measurements of these material parameters including information related to how the measurement was made (e.g., measurement method, equipment model, measurement uncertainties, etc.) and provide a summary report to FDA. •Identify how property variability impacts processing behavior and final dosage form variability and provide a summary report to FDA. •Compile common test methods and standards for measuring significant material properties. The most reliable “best of class’ methods will be identified and documented and provide a summary report to FDA. •Compile a list of models, including assumptions, limitations, and accuracy, that relate the excipient properties to manufacturing parameters and the final dosage form properties and provide a summary report to FDA. •A comprehensive report detailing the overall findings will be delivered. In addition, NIPTE will hold an interactive workshop to present the results of our report findings with scientists from the FDA, industry, and academia invited to attend. We may anticipate a labor hour type contract with a base year and one year option. Viable parties shall provide the following: Part A. Capabilities and Technical Experience – Provide a capability statement describing how your company can provide us with an approach to the Understanding and Predicting Excipient Properties and Functionality listed in the Draft Scope of Work. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm’s status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest for the proposed excipients. Part D. Cost Estimate - Provide a cost estimate for the services (i.e. hourly rates, hours/days) and the number of hours in the approach to the Understanding and Predicting Excipient Properties and Functionality. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation on Subcontracting. Responses shall be: -identified with the Sources Sought number ; -no more than five (10) pages in length; -not submit marketing materials; -submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/HHS-FDA-SS-09-1055924/listing.html)
- Record
- SN01822225-W 20090521/090520001142-8bb11e2e98d5c2d7f5b37be789190795 (fbodaily.com)
- Source
-
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