This department is offering a grant to develop a predictive in vitro method for studying aerodynamic particle size distribution in orally inhaled drug products (OIDPs). The project aims to select realistic mouth-throat (MT) models to improve predictability over pharmaceutical induction port assemblies for APSD characterization. Through evaluating pre-screened MT models under various flow rate conditions, this research seeks to establish optimal MT models that provide enhanced in vitro-in vivo correlation. The grant will support the selection of representative OIDP products, APSD characterization using cascade impactors, and assessment of in vitro-in vivo correlation to enhance pharmaceutical development in the early stages of OIDP development.
Opportunity ID: 253193
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-022 |
| Funding Opportunity Title: | Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | Jun 03, 2014 |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Small businesses Private institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Individuals Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Special district governments City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | For orally inhaled drug products (OIDPs), mouth-throat (MT) region behaves as a physiological filter that prevents significant fraction of inhaled drug from reaching the lungs. Hence, use of the models representing morphological features of MT region could help predict the drug loss in the MT region, and hence provide better predictability of lung deposition. Such realistic MT models, coupled with cascade impactors, could be used for characterization of aerodynamic particle size distribution (APSD), and can therefore be used as a pharmaceutical development tool for OIDPs. However, there are some challenges in adopting these modified cascade impactor methods. Although, several MT models have been proposed in the literature, with different geometries that produce different deposition patterns, there is lack of availability of the standardized MT model(s). Moreover, it has been demonstrated that coupling these MT models with realistic inhalation maneuvers in an impactor assembly can further improve in vivo predictability of these methods. However, there are no standardized inhalation maneuvers available for APSD characterization of different OIDPs. In addition, very limited information is available on the validity of the proposed MT models in terms of their in vivo predictability. Therefore, in order to build a predictive in vitro method for characterization of APSD, it is important to address the issues discussed above with aim of identifying optimal MT models that produce acceptable in vitro-in vivo correlation. ObjectivesThe goal of this project is to investigate if realistic physical MT models provide better predictability over pharmaceutical induction port assembly, for APSD characterization of OIDPs. Because there are different MT models proposed in the literature, in vivo predictability of several pre-screened MT models will be evaluated under different flow rate conditions, to select the optimal model(s). Upon successful completion, this research will provide a more realistic APSD characterization method that can be used as a pharmaceutical development tool in the early stages of OIDP development. Detailed DescriptionA predictive in vitro method will be developed to study the aerodynamic particle size distribution of the aerosolized drug particles. The study will consist of four phases. Phase 1: Selection of realistic MT models based on reported in vivo predictability and production/reproduction feasibility.Phase 2: Selection of representative OIDPs on the market for in vitro APSD evaluation using selected MT models. Phase 3: APSD characterization of the selected OIPDs products using cascade impactors USP apparatus 1 and 6 assembled with the selected throat models as well as USP induction port, under different flow rate conditions. Phase 4: Assessment of in vitro-in vivo correlation for each MT models and selection of optimal model/models. |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Made change to Eligible Recipients. | Apr 01, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-022 |
| Funding Opportunity Title: | Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | Jun 03, 2014 |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Small businesses Private institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Individuals Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Special district governments City or township governments |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | For orally inhaled drug products (OIDPs), mouth-throat (MT) region behaves as a physiological filter that prevents significant fraction of inhaled drug from reaching the lungs. Hence, use of the models representing morphological features of MT region could help predict the drug loss in the MT region, and hence provide better predictability of lung deposition. Such realistic MT models, coupled with cascade impactors, could be used for characterization of aerodynamic particle size distribution (APSD), and can therefore be used as a pharmaceutical development tool for OIDPs. However, there are some challenges in adopting these modified cascade impactor methods. Although, several MT models have been proposed in the literature, with different geometries that produce different deposition patterns, there is lack of availability of the standardized MT model(s). Moreover, it has been demonstrated that coupling these MT models with realistic inhalation maneuvers in an impactor assembly can further improve in vivo predictability of these methods. However, there are no standardized inhalation maneuvers available for APSD characterization of different OIDPs. In addition, very limited information is available on the validity of the proposed MT models in terms of their in vivo predictability. Therefore, in order to build a predictive in vitro method for characterization of APSD, it is important to address the issues discussed above with aim of identifying optimal MT models that produce acceptable in vitro-in vivo correlation. ObjectivesThe goal of this project is to investigate if realistic physical MT models provide better predictability over pharmaceutical induction port assembly, for APSD characterization of OIDPs. Because there are different MT models proposed in the literature, in vivo predictability of several pre-screened MT models will be evaluated under different flow rate conditions, to select the optimal model(s). Upon successful completion, this research will provide a more realistic APSD characterization method that can be used as a pharmaceutical development tool in the early stages of OIDP development. Detailed DescriptionA predictive in vitro method will be developed to study the aerodynamic particle size distribution of the aerosolized drug particles. The study will consist of four phases. Phase 1: Selection of realistic MT models based on reported in vivo predictability and production/reproduction feasibility.Phase 2: Selection of representative OIDPs on the market for in vitro APSD evaluation using selected MT models. Phase 3: APSD characterization of the selected OIPDs products using cascade impactors USP apparatus 1 and 6 assembled with the selected throat models as well as USP induction port, under different flow rate conditions. Phase 4: Assessment of in vitro-in vivo correlation for each MT models and selection of optimal model/models. |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-022 |
| Funding Opportunity Title: | Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 03, 2014 |
| Archive Date: | Jul 03, 2014 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $450,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | For orally inhaled drug products (OIDPs), mouth-throat (MT) region behaves as a physiological filter that prevents significant fraction of inhaled drug from reaching the lungs. Hence, use of the models representing morphological features of MT region could help predict the drug loss in the MT region, and hence provide better predictability of lung deposition. Such realistic MT models, coupled with cascade impactors, could be used for characterization of aerodynamic particle size distribution (APSD), and can therefore be used as a pharmaceutical development tool for OIDPs. However, there are some challenges in adopting these modified cascade impactor methods. Although, several MT models have been proposed in the literature, with different geometries that produce different deposition patterns, there is lack of availability of the standardized MT model(s). Moreover, it has been demonstrated that coupling these MT models with realistic inhalation maneuvers in an impactor assembly can further improve in vivo predictability of these methods. However, there are no standardized inhalation maneuvers available for APSD characterization of different OIDPs. In addition, very limited information is available on the validity of the proposed MT models in terms of their in vivo predictability.
Therefore, in order to build a predictive in vitro method for characterization of APSD, it is important to address the issues discussed above with aim of identifying optimal MT models that produce acceptable in vitro-in vivo correlation. Objectives The goal of this project is to investigate if realistic physical MT models provide better predictability over pharmaceutical induction port assembly, for APSD characterization of OIDPs. Because there are different MT models proposed in the literature, in vivo predictability of several pre-screened MT models will be evaluated under different flow rate conditions, to select the optimal model(s). Upon successful completion, this research will provide a more realistic APSD characterization method that can be used as a pharmaceutical development tool in the early stages of OIDP development. Detailed Description A predictive in vitro method will be developed to study the aerodynamic particle size distribution of the aerosolized drug particles. The study will consist of four phases. Phase 1: Selection of realistic MT models based on reported in vivo predictability and production/reproduction feasibility. Phase 2: Selection of representative OIDPs on the market for in vitro APSD evaluation using selected MT models. Phase 3: APSD characterization of the selected OIPDs products using cascade impactors USP apparatus 1 and 6 assembled with the selected throat models as well as USP induction port, under different flow rate conditions. Phase 4: Assessment of in vitro-in vivo correlation for each MT models and selection of optimal model/models. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Specialist Phone 301-827-7175 Email: gladys.bohler@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | ADOBE-FORMS-C | RFA-FD-14-022 | PKG00194668 | May 01, 2014 | Jun 03, 2014 | View |
Package 1
Mandatory forms
253193 RR_SF424_2_0-2.0.pdf
253193 PHS398_ResearchPlan_2_0-2.0.pdf
253193 PHS398_CoverPageSupplement_2_0-2.0.pdf
253193 RR_Budget_1_3-1.3.pdf
253193 RR_KeyPersonExpanded_2_0-2.0.pdf
253193 RR_OtherProjectInfo_1_3-1.3.pdf
253193 PerformanceSite_2_0-2.0.pdf
Optional forms
253193 PlannedReport-1.0.pdf
253193 PHS398_CumulativeInclusionReport-1.0.pdf
253193 RR_SubawardBudget30_1_3-1.3.pdf
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