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The NIPTE-FDA Excipients Knowledge Base hosted at pharmaHUB. Ann Christine Catlin Meeting at the FDA August 15, 2011. A Publicly Available Database. Excipients Database. Where to Host the Database ?.

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slide1

The NIPTE-FDA Excipients Knowledge Base

hosted at pharmaHUB

Ann Christine Catlin

Meeting at the FDA

August 15, 2011

slide3

Where to Host the Database ?

pharmaHUB: a cyber infrastructure developed at Purdue University to support collaboration among researchers, educational outreach, and the sharing of data, tools and resources for the pharmaceutical engineering community.

slide4

What is a HUB ?

nanoHUB: an environment for scientific collaboration

slide5

Building a Scientific Community

185,000 users worldwide

>5,000,000 hits/month

20% of all .edu domains116 classes at 76 institutions in 2009

333 International Educational Institutions

8,200 users ran 345,000 analyses

slide6

HUBzero-powered Research Communities

hubzero.org

  • Feb 2007: 1 hub
  • Feb 2008: 5 hubs
  • Feb 2009: 8 hubs
  • Feb 2010: 21 hubs
  • Feb 2011: 30 hubs
  • All with their own funding streams, projects, developers
slide7

A HUB for Pharmaceutical Engineering

  • EVO seed funding from NSF, online since December 2007
  • pharmaHUB mission …
    • Educational materials and experiences for training pharmaceutical engineers & scientists
    • Modeling, computational, and decision support tools for drug product & process design
    • Science and engineering research in pharmaceutical manufacturing
  • More than 20,000 unique visitors in 2009-2010… with 4900 core users, 551 organizations, 105 resources and 30 simulation tools
  • Ongoing funding: $1.9M NSF award 2009-2013 to address complete product cycle development
slide8

Community Shared Resources

Teaching Videos,

Online Presentations, Courses & Tutorials, Homework Problems,

Publications,

Workshops,

Images & Documents,

Analysis & Modeling Tools,

Grid Computing

Data,

Databases.

and more ….

Search Tags,

Found by Google,

Recommendations,

“See Also”,

Usage Statistics,

Goggle Analytics,

Wishlists,

Collaborative Groups,

and more …

slide9

pharmaHUB Tools

Visualization of Molecular Crystals

Particle-surface Adhesion

Tablet Dissolution model

Hopper Flow Discharge (Discrete Element Model)

Rotating Drum (DEM)

High Shear Mixer (DEM)

Excipient Spectra Analyzer

Continuous Particle Blending (Compartment Model)

Roller compactor: Steady State & Dynamic models

Cake filtration model

Guideline ontology & SWOOP ontology browser

Multipurpose operation production planner (MOPP)

Lyophilization Calculator

slide11

Analysis Tools (30 now available)

Visualization of Molecular Crystals

Particle-surface Adhesion

Tablet Dissolution model

Hopper Flow Discharge (Discrete Element Model)

Rotating Drum (DEM)

High Shear Mixer (DEM)

Excipient Spectra Analyzer

Continuous Particle Blending (Compartment Model)

Roller compactor: Steady State & Dynamic models

Cake filtration model

Guideline ontology & SWOOP ontology browser

Multipurpose operation production planner (MOPP)

Lyophilization Calculator

slide12

Courses, Modules, and Lectures

Statistical Model Building and Design of Experiments

Computational Methods for Molecular Crystals

Visualization of Molecular Crystals

Discrete Element Method (DEM)

Characterization of Nanopharmaceutical Materials

Colloids and Surfactants

Liquid Mixing Fundamentals

Sterilization and Disinfection

Mixing Equipment and Processes

API Process Unit Operations Development and Design

Pharmaceutical Bulk Drug Production

Application of ChE Principles to Drug Delivery

Particle and Flow Characterization

Introduction to Rheology of Complex Fluids

Pharmaceutical concepts into introductory ChE courses

slide14

What are the Benefits of a HUB ?

  • Purdue-supported hardware and grid-computing services
  • Constant support by the HUBzero Tech Team… with yearly upgrades and new technologies
  • Stable and well-funded cyber infrastructure
  • Worldwide contributions
  • Developments from other hubs
  • Services to build and support Databases with worldwide access
slide15

Excipients Knowledge Base

the database and beyond…

Establish a knowledge-based system that maintains values of fundamental pharmaceutical excipient material properties and also contains models, best practices and methods for using this data in the systematic design of pharmaceutical products and processes.

slide16

Excipients Database Schema

Excipients

-MCC

Products

-PH 101

Lot #

-P109821003

Properties

-Particle Size

Equipment

-Malvern

Test Method

-Light Scattering

slide17

Excipients Database Structure

Analysis Tools

make decisions and solve problems

Web

Interface

Derivations & Plots of Measurements

histograms, yield loci, powder flow function,

frequency & cumulative distributions

Measurements

raw data, chemical and test descriptions

Catalogs

excipients, vendors, products, lots,

test methods, equipment, properties

slide18

Excipient Knowledge Base at the HUB

  • Independent data collection from global research community
  • Contribution through user-friendly web-forms and spreadsheets
  • Data pulls from other sources (like the FDA)
  • Cross-check for measurements obtained with different methods
  • Community validation, ratings, reviews
  • Interactive browse, search, sort, filter, graph, comparison, analysis and download
  • Features like … works on iPhones!
  • Statistics for who uses the database and how (Google analytics)
slide19

Excipient Knowledge Base at the HUB

  • Community interaction
    • groups
    • discussions
    • wiki
    • Q&A
    • wishlists
  • Community-contributed data, algorithms, computational tools, visualization tools, and knowledge
  • (L. T, Principal Scientist at Merck “I am an expert in text mining and we have technology to extract relationships in text. I am now assembling the excipient ontologies that exist .... Perhaps that data could be interesting for your database. Let me know … “)
slide20

Knowledge for predicating the properties

of the final product … the tablet

  • Look up and compare chemical and physical properties critical to manufacturing, stability, and performance of drug products
  • Plot NIR spectra to explore property variations between vendors, between lots and even within lots
  • Use range searches on Hausner ratio and Carr index to identify flowability
  • Generate the shear cell powder flow function to determine if a powder is cohesive or free-flowing to help with sizing of hoppers
  • Evaluate tensile strength of compacts based on moisture content
  • Explore particle size, size variation and particle shape to understand cohesion, compressibility and shear strength
slide21

Excipients Knowledge Base R&D Group

Attribution …

Sumudinie Fernando

Sudheera Fernando

Linas Mockus

Ting Wang

Kristine Alston

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