Opportunity Information: Apply for RFA FD 13 014
Apply for RFA FD 13 014
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Development of in vivo predictive dissolution method for orally inhaled drug products" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on May 7, 2013 and posted on May 7, 2013.
- Applicants must submit their applications by Jul 2, 2013 Applications are due July 1, 2013, and must be receivedby 500PM local time of applicant organization. July 2, 2013 is the termination date of this FOA.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $60,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- The number of recipients for this funding is limited to 7 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses County governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments State governments Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education Small businesses.
- Eligible Agencies of the Federal Government U.S. Territory or Possession Native Tribal Organizations (other than Federally recognized tribal governments) Faith based or Community based Organizations Regional Organizations Non domestic (non U.S.) Entities (Foreign Institutions)
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Opportunity Summary:
This FDA grant opportunity focuses on a long-standing gap in how orally inhaled drug products (OIDPs), such as dry powder inhalers (DPIs) and metered dose inhalers (MDIs), are evaluated for performance. The core issue is that clinical performance is not determined only by where particles land in the lung (regional deposition). It also depends heavily on how fast and how completely those deposited particles dissolve in the lung environment. Dissolution in the lung influences two critical outcomes at once: the amount of drug that becomes available locally at the site of action (which relates to efficacy for locally acting products), and the rate and extent of drug absorption into systemic circulation (which ties to pharmacokinetics and safety). The FDA notes that while multiple in vitro dissolution approaches have been proposed for inhalation products, none has successfully incorporated all the key biological and physicochemical realities of the lung in a way that has been demonstrated to predict in vivo dissolution.
The opportunity is motivated by specific, well-recognized challenges unique to the lungs. Unlike typical oral dissolution testing, inhaled particles encounter only a very small volume of lung lining fluid, and that fluid contains endogenous surfactants that can change wetting and dissolution behavior. Realistic testing must also reflect how much drug mass is deposited per unit surface area in different regions of the lung, as well as how particles interact with each other after deposition (including inter-particulate cohesive or adhesive effects that can slow or alter dissolution). Because existing methods do not capture these variables together, the FDA is seeking work that can create a more physiologically relevant, predictive dissolution method for inhaled aerosols.
A key scientific backdrop for the project is an FDA Office of Generic Drugs (OGD) research effort begun in 2011 examining pharmacokinetics for locally acting inhaled products, specifically looking at how sensitive pharmacokinetic (PK) measures are to changes in aerodynamic particle size distribution (APSD) across three formulations of fluticasone propionate (FP) DPI. Since observed PK differences among formulations can arise from multiple sources, including differences in dissolution rate, the FDA is signaling the need to directly study dissolution for these formulations and integrate dissolution information into models that connect lung deposition patterns to PK outcomes. In other words, the dissolution method is meant to become a missing link between in vitro aerosol characterization and in vivo drug behavior.
The objective of the grant is to develop an in vitro dissolution method for OIDPs that can predict in vivo dissolution for drugs delivered by inhalation. The FDA frames the payoff as improved understanding of which formulation attributes drive dissolution, stronger in vitro-in vivo relationships for inhaled drugs, and better tools for connecting formulation design to local lung availability and systemic exposure. Ultimately, the deliverable is positioned as a Quality by Design (QbD)-enabling tool that could support formulation development and optimization and also strengthen product quality control approaches for OIDPs.
The technical work is organized into three phases. Phase 1 centers on developing or modifying existing dissolution methods so they better reflect in vivo lung conditions, explicitly incorporating constraints like limited lung lining fluid volume, realistic deposited mass per lung surface area, and other in vivo-relevant factors (including the presence of surfactants and particle interaction effects). Phase 2 involves selecting a set of OIDPs for the dissolution study that spans a broad range of active pharmaceutical ingredient (API) physicochemical properties, such as solubility, particle size, crystallinity, lipophilicity, and cohesive/adhesive behavior. The selected products should include both solution and suspension MDIs as well as DPIs, and the FDA will provide OGD research fluticasone propionate formulations for use in the work. Phase 3 is the model-building step: developing a mathematical framework that links the in vitro dissolution outputs to pharmacokinetic measures, with the aim of making dissolution data meaningfully predictive of in vivo behavior.
From an administrative standpoint, this was issued as a discretionary funding opportunity by the Food and Drug Administration under a Cooperative Agreement mechanism, categorized under Health Science and Technology and other research and development (CFDA 93.103). The posting date was May 7, 2013, with applications due by July 1, 2013 (5:00 PM local time), and the funding announcement terminating July 2, 2013; the archive date is August 1, 2013. The estimated total funding listed is $60,000, while the award floor and ceiling are both stated as $200,000 (suggesting the announcement text contains internal inconsistencies, or that the totals reflect different budgeting assumptions). The opportunity anticipated up to 7 awards and did not require cost sharing or matching. Eligibility is broad and includes various U.S. governmental entities, tribal organizations, higher education institutions (public and private), nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and also allows for non-U.S. entities (foreign institutions), among other categories described in the eligibility section.
Frequently Asked Questions (FAQs)
What is the main purpose of this FDA grant opportunity?
The grant is focused on developing an in vitro dissolution method for orally inhaled drug products (OIDPs) that can predict in vivo dissolution for drugs delivered by inhalation. The goal is to close a long-standing gap where existing in vitro approaches have not been shown to reliably reflect what happens in the lung after aerosol particles deposit.
Which product types are included under orally inhaled drug products (OIDPs) in this announcement?
The opportunity specifically references dry powder inhalers (DPIs) and metered dose inhalers (MDIs). It also notes that the product set for study should include both solution and suspension MDIs, as well as DPIs.
Why is dissolution in the lung important for evaluating inhaled drug performance?
The FDA frames clinical performance as depending on more than regional deposition (where particles land). It also depends on how quickly and how completely deposited particles dissolve in the lung environment. Lung dissolution influences (1) local availability at the site of action (important for locally acting products and efficacy) and (2) the rate and extent of systemic absorption (which affects pharmacokinetics and safety).
What gap or problem is this funding opportunity trying to address?
Multiple in vitro dissolution approaches for inhalation products have been proposed, but the FDA notes that none has successfully incorporated all key biological and physicochemical realities of the lung in a way that has been demonstrated to predict in vivo dissolution.
How is lung dissolution testing different from typical oral dissolution testing?
The announcement highlights several lung-specific challenges that make direct translation from oral dissolution testing inappropriate, including: very small volumes of lung lining fluid, the presence of endogenous surfactants that can change wetting and dissolution behavior, the need to reflect realistic deposited drug mass per unit surface area in different lung regions, and the impact of particle-particle interactions after deposition (including cohesive or adhesive effects) that can slow or alter dissolution.
What lung factors should a proposed in vitro dissolution method incorporate?
Based on the description, the method is expected to incorporate constraints and conditions such as limited lung lining fluid volume, endogenous surfactants, realistic deposited mass per lung surface area (including differences across lung regions), and inter-particulate interactions (cohesive/adhesive effects) that can influence dissolution.
What is the overall objective/deliverable expected from the funded work?
The stated objective is an in vitro dissolution method for OIDPs that is meaningfully predictive of in vivo dissolution. The FDA positions the deliverable as enabling improved understanding of formulation attributes that drive dissolution, stronger in vitro-in vivo relationships for inhaled drugs, and a Quality by Design (QbD)-enabling tool that can support formulation development, optimization, and product quality control approaches for OIDPs.
How does this opportunity connect in vitro aerosol characterization to in vivo behavior?
The opportunity describes dissolution testing as a missing link between in vitro aerosol characterization and in vivo drug behavior. It calls for integrating dissolution information into mathematical models that connect lung deposition patterns to pharmacokinetic (PK) outcomes.
What is the FDA scientific background mentioned for this project?
The announcement references an FDA Office of Generic Drugs (OGD) research effort that began in 2011 examining pharmacokinetics for locally acting inhaled products. That work examined how sensitive PK measures are to changes in aerodynamic particle size distribution (APSD) across three formulations of fluticasone propionate (FP) DPI, and it notes that PK differences among formulations can arise from multiple sources, including dissolution rate.
What role does aerodynamic particle size distribution (APSD) play in the motivation for this grant?
APSD is mentioned in the context of the FDA OGD research exploring PK sensitivity to APSD changes across multiple fluticasone propionate DPI formulations. Because observed PK differences can be influenced by dissolution rate (among other factors), the grant emphasizes directly studying dissolution and linking dissolution outputs to PK measures.
Does the opportunity specify any particular drug or formulations for use in the research?
Yes. The announcement states that the FDA will provide OGD research fluticasone propionate (FP) formulations for use in the work. It also calls for selecting additional OIDPs spanning a broad range of API physicochemical properties.
What kinds of API physicochemical properties should be represented in the selected OIDPs?
The product set selected for study is expected to span a broad range of API properties, including solubility, particle size, crystallinity, lipophilicity, and cohesive/adhesive behavior.
How is the technical work organized (phases)?
The opportunity describes three phases: (1) develop or modify dissolution methods to better reflect in vivo lung conditions (including limited fluid volume, realistic deposited mass per area, surfactants, and particle interaction effects); (2) select a set of OIDPs covering a wide range of API physicochemical properties and including solution and suspension MDIs plus DPIs (with FDA-provided FP formulations included); and (3) build a mathematical framework linking in vitro dissolution outputs to PK measures to make dissolution data predictive of in vivo behavior.
What is Phase 1 focused on?
Phase 1 focuses on developing or modifying existing dissolution methods so they better reflect in vivo lung conditions. The FDA explicitly calls out incorporating constraints like limited lung lining fluid volume, realistic deposited mass per lung surface area, and other in vivo-relevant factors such as surfactants and particle interaction effects.
What is Phase 2 focused on?
Phase 2 focuses on selecting OIDPs for dissolution study that represent a broad range of API physicochemical properties. The set should include both solution and suspension MDIs and DPIs, and it will include FDA-provided OGD research fluticasone propionate formulations.
What is Phase 3 focused on?
Phase 3 focuses on model development: creating a mathematical framework that links in vitro dissolution outputs to pharmacokinetic measures, aiming to make in vitro dissolution results meaningfully predictive of in vivo behavior.
What kind of funding mechanism is used for this opportunity?
The announcement describes the opportunity as discretionary funding by the Food and Drug Administration under a Cooperative Agreement mechanism.
How is the opportunity categorized (program area / CFDA number)?
It is categorized under Health Science and Technology and other research and development, with CFDA listed as 93.103.
What are the key dates listed in the announcement?
The posting date is May 7, 2013. Applications were due July 1, 2013 at 5:00 PM local time. The funding announcement termination date is July 2, 2013. The archive date is August 1, 2013.
How much funding is available and how many awards were anticipated?
The announcement lists an estimated total funding of $60,000 and anticipated up to 7 awards. It also states an award floor of $200,000 and an award ceiling of $200,000, which appears internally inconsistent with the estimated total funding number as presented.
Is there any inconsistency in the stated funding amounts?
Yes. The opportunity lists estimated total funding as $60,000, while also listing both the award floor and award ceiling as $200,000. The description suggests these figures may reflect internal inconsistencies in the announcement text or different budgeting assumptions.
Is cost sharing or matching required?
No. The announcement states that cost sharing or matching was not required.
Who is eligible to apply for this grant?
Eligibility is described as broad and includes various U.S. governmental entities, tribal organizations, higher education institutions (public and private), nonprofit organizations (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and non-U.S. entities (foreign institutions), among other categories described in the eligibility section.
Are foreign (non-U.S.) institutions eligible?
Yes. The eligibility description indicates that non-U.S. entities (foreign institutions) are allowed.
What is the intended impact on product development and quality control for OIDPs?
The FDA positions the work as QbD-enabling, meaning it should help connect formulation attributes to dissolution behavior and, in turn, to local lung availability and systemic exposure. The intended impact includes supporting formulation development and optimization and strengthening product quality control approaches for orally inhaled drug products.
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