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Emmanuel Lollis Eunji Youn Jaehoon Jeong Jordan Angie

Materials that Expand, Swell, or Change Shapes in the Stomach CE 404 Product Design Project 3: Request for Proposal. Emmanuel Lollis Eunji Youn Jaehoon Jeong Jordan Angie. Physical and Chemical Forces Imposed by the Human Body. Pressure Potential mastication Gastric motility Enzymes

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Emmanuel Lollis Eunji Youn Jaehoon Jeong Jordan Angie

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  1. Materials that Expand, Swell, or Change Shapes in the StomachCE 404 Product Design Project 3: Request for Proposal Emmanuel Lollis EunjiYoun JaehoonJeong Jordan Angie

  2. Physical and Chemical Forces Imposed by the Human Body • Pressure • Potential mastication • Gastric motility • Enzymes • Salivary amylase (breaks down starch) • Lysozyme (breaks down bacterial cell walls) • Pepsin (denatures proteins) • Gastric lipase (breaks down fats) • Solvents • Gastric acid (pH of 2) • Mucus infused with bicarbonate (pH of 7)

  3. Specifications • The request for proposal outlined some specifications

  4. Customer Needs

  5. High-level Concepts: Gas-generating devices • Digestible capsule breaks down • Barrier breaks • Gas-forming reaction commences • Drug-infused degradable porous polymer matrix delivers drug over time • Once the porous polymer matrix fully degrades, a hole is exposed through which gas can pass, allowing the device to deflate How it would work Limitations • Device will prematurely expand if crushed

  6. High-level Concepts: Shape-Memory Polymer Technology • Digestible capsule breaks down • Strands of shape-memory polymer material straighten out when exposed to low pH • Drug-infused degradable porous polymer matrix delivers drug over time, decreasing in size until it is gone • Buckyball-like structure physically breaks apart due to gastric contractions How it would work Limitations • Device may prematurely break down if covered by neutral mucus in the stomach • Consumer cannot drink any basic drinks while the pill is dispensing drug • The device might cause discomfort when passing through the pyloric sphincter

  7. High-level Concepts: Electronic Capsule • Digestible capsule breaks down • pH sensor triggers the inflation of the biocompatible balloon • Drug-delivery door opens and closes at pre-programed intervals • Device deflates the biocompatible balloon after delivering the entire payload How it would work Limitations • The inner workings of the electronic capsule are intricate (motor, pump, sensor, processor), which would make it difficult to manufacture

  8. High-level Concepts: Hydrogel • Digestible capsule breaks down • Hydrogel absorbs water in the stomach and quickly expands • Drug-infused degradable porous polymer matrix is exposed to water in the hydrogel. It breaks down, and drug diffuses through the hydrogel. • Hydrogel eventually breaks down into fragments that get smaller and smaller How it would work Limitations • Common hydrogels are not strong enough to withstand the forces imposed by gastric motility

  9. Concept Selection

  10. Final Design Biodegradable controlled release porous polymer matrix surrounded by a superporous hydrogel composite material, all enclosed in a digestible gelatin capsule. Figure (above) - Degradable controlled release porous polymer matrix. Figure (left) – Superporous hydrogel composite material

  11. Processing and Manufacturing • Main Equipment needed • Milling and micronizing equipment • Reaction vessel or mixing tank with stirrer • Moisture chamber for encapsulation • Synthesis of Super-porous Hydrogel • Scale up laboratory synthesis method • Sequential addition of mixture resulting in gelation of cross-linked SPH • Acidification: gastric fluid is used to wash hydrogel for 24 hours • Dry SPH for 5 days • Formulation of degradable porous polymer matrix (PLGA synthesis) • Racial polymerization of lactic acid and glycolic acid • Prepare micro-particles of PLGA using emulsion technique and drug of choice is inserted • Mold matrix into small oval/ circular shape while it is still in an amorphous state

  12. Processing and Manufacturing • Formulation of degradable porous polymer matrix (PLGA synthesis) • Racial polymerization of lactic acid and glycolic acid • Prepare micro-particles of PLGA using emulsion technique and drug of choice is inserted • Mold matrix into small oval/circular shape while it is still in an amorphous state • Inserting hydrogel into hard gelatin capsule • Moisture the dried hydrogel and soften it in moisten chamber • Encapsulation: squeeze softened hydrogel into small gelatin capsule • Quality Control Check • Ensure proper functioning of the drug • Check quality during the process in line and after manufacture

  13. References • Chen, Jun, William E. Belvins, Haesun Park, and Kinam Park. "Gastric Retention Properties of Superporous Hydrogel Composites." Journal of Controlled Release 64.1-3 (1998): 39-51. Web of Science. Web. 10 Nov. 2013. • Rothstein, Sam N., and Steven R. Little. "A “tool Box” for Rational Design of Degradable Controlled Release Formulations." Journal of Materials Chemistry (2011): 21-29. Web of Science. Web. 16 Nov. 2013. • "Biomaterials and Bioanalogous Polymer Systems." Biomaterials and Bioanalogous Polymer Systems. Institute of Macromolecular Chemistry of the Academy of Sciences, n.d. Web. 16 Nov. 2013.

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