37 Matching Annotations
  1. Mar 2021
    1. The SOMA’s small form factor prevents obstruction in the lower GI tract and allows for easy ingestion. It is smaller in volume than the U.S. Food and Drug Administration (FDA)–approved daily dosed osmotic-controlled release oral delivery system (OROS) (Ø 9 mm × 15 mm), a nondegradable drug delivery capsule with obstruction rates of 1 in 29 million

      This paper discusses that OROS controlled-release devices showed a low occurance of any significant GI events. When used correctly, extended-release products provide substantial therapeutic and convenience benefits without additional risk. Their small size allows for easy ingestion without significant difficulties

    2. We employed geometric models of tortoise shells as initial guesses for the shape

      Specifically, this paper shows that the exact geometry of highly domed terrestrial species is close to optimal for self-righting, and the shell's shape is the predominant factor of their ability to flip back. This study illustrates how evolution solved a far-from-trivial geometrical problem

    3. Preclinical technologies for gastrointestinal (GI)–based biomacromolecule delivery, including permeation enhancers, nanoparticles, and mucus-adhering devices, enhance uptake but can generally only safely achieve bioavailabilities on the order of 1%

      The conclusion from these sources is that most of the technologies in clinical trials are small scale and not groundbreaking. Even the more clinically advanced oral drugs examples of oral bioavailability appear to produce oral bioavailability values of only 1–2% and are, therefore, only currently suitable for a limited range of drugs.

    4. Although the idea of delivering biologic drugs to the GI tract via injection has been previously hypothesized and tested via endoscopic procedures

      demonstrated proof‐of‐concept experiments in swine that microneedle‐based delivery has the capacity for improved bioavailability of a biologically active macromolecule. Moreover, the paper shows that microneedle‐containing devices can be passed and excreted from the GI tract safely. These findings strongly support the success of implementation of microneedle technology for use in the GI tract.

    5. Routine procedures in which gastroenterologists use 5-mm 25-gauge Carr-Locke needles for GI injection provide strong clinical evidence for this action’s safety

      No perforations (injuries) caused by the examination during 1210 upper endoscopies that were performed as part of this trial conducted by gastroenterologists (doctors that study the GI tract) Carr-Locke needle: https://www.steris.com/-/media/us-endoscopy-images/endoscope-devices/carr-locke_injection_needle_300.ashx

    6. Moreover, by delivering into the stomach tissue rather than the small intestine, the dose delivery time is likely to be more predictable given the recognized variability in gastric emptying

      This paper describes an ultrasound method of assessing gastric emptying (food emptying from the stomach and entering the small intestine) time based on measurements of the gastric antrum (the small, lower part of the stomach), which is visible in almost all subjects before and after meals. A total of 54 subjects were examined. The emptying time was determined in all subjects by measuring the changes in the cross-sectional area of the gastric antrum. The results of this study showed a large variation in gastric emptying time.

    7. torque

      A twisting force that tends to cause rocation

    8. Additionally, gastric tissue regenerates quickly, and the fluidity of the mucous barrier seals temporary defects in the lining

      The gastrointestinal lining produces a wide variety of peptides which may contribute to protection from injury as well as repair after injury occurs. Restitution, the initial phase of mucosal repair, is accomplished by rapid moving of the epithelium to reestablish surface epithelial continuity (i.e. seal any injuries)

    9. Orally bioavailable biologic dosage forms may allow health care providers to prescribe these effective medications more quickly, yet the development of such systems poses challenges

      This study shows that orally administered devices could enable the systemic uptake of drugs by engineering around the physiological barriers present in the gastrointestinal (GI) tract. These designs must significantly increase drug bioavailability, deliver a correct dose and remain safe when taken frequently. This paper discusses how these physical methods stand to provide a solid set of alternatives to the classic hypodermic needle administration of drugs.

    10. Motivated by patient and health care professional preference for oral delivery, research on ingestible biomacromolecule formulations began in 1922, the same year as the first insulin injection

      When surveyed, 208 women who were more than 2 years post-breast cancer diagnosis were surveyed about their preferences for daily oral tablets or monthly intramuscular injections. Sixty-three percent of these women preferred oral tablets. This preference has not changed overtime. In 1923, there was an experiment to see if insulin could be delivered orally via an alcoholic solution. It was found that a dose of insulin by mouth required double the dose of insulin administered through injection. That meant it would be much more expensive than the existing method. The oral dose was also much harder to control and unpredictable. Overall, it was determined that alcohol was not a sufficient medium to provide an oral dose of insulin.

    11. gastric mucosa

      The mucus layer that is present on the lining of the organs in the GI tract

    12. Inspired by the self-orienting leopard tortoise (Stigmochelys pardalis)

      Constructing Evidence and Designing Solutions (SEP6): Using the shape and behavior of the toroise, the engineers were able to design their device to function in their desired way

    13. 0.1- to 2-mm-thick intestinal walls
    14. stomach’s 4- to 6-mm-thick wall
    15. Orally administered therapeutic proteins

      Drugs that are orally administered must have various coatings to avoid being broken down within the gut. Although this does pose challenges, it is still promising to study and eventually utalize orally administered drugs for local GI targets.

  2. Feb 2021
    1. health care providers delay insulin initiation an average of 7.7 years and instead prescribe less effective oral medications

      This study evaluated the management of people with type 2 diabetes prescribed two or more oral medications, and/or insulin. It was seen that on average, the median time to insulin for patients prescribed multiple oral agents was 7.7 years. This showed that many people with type 2 diabetes received inadequate monitoring and had poor blood sugar control during the beginning of their treatments.

    2. in vitro

      in a test tube, culture dish, or elsewhere outside a living organism

    3. weeble-wobble toy
    4. peristaltic motion

      Involuntary movements of the longitudinal and circular muscles, primarily in the digestive tract but occasionally in other hollow tubes of the body, that occur in progressive wavelike contractions

    5. mono-monostatic body

      An object which has only one unstable point of balance.

    6. active pharmaceutical ingredient (API)

      Any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes a functional ingredient in the drug product

    7. lumen

      The open space within a tube-shaped body part

    8. actuation

      The action of causing a machine or device to operate.

    9. cellular tight junctions

      Connections between cells that prevent the passage of molecules and ions through the space between membranes of touching cells

    10. protease

      An enzyme (a biological catalyst) which breaks down proteins and peptides

    11. bioavailability

      The ability of a drug or other substance to be absorbed and used by the body

    12. milliposts

      millimeter scale pillars

    13. subcutaneous

      Situated or applied under the skin

    14. plasma

      Plasma is a yellowish liquid component of blood that holds the blood cells of whole blood in suspension. It is the liquid part of the blood that carries cells and proteins throughout the body.

    15. insulin

      A hormone produced in the pancreas which regulates the amount of sugar in the blood. The lack of insulin causes a form of diabetes.

    16. in vivo

      In a living organism

    17. perforation

      A hole made by puncturing or piercing

    18. autonomously

      Acting independently; the ability to act without instruction

    19. permeation

      becoming widely spread

    20. parenteral

      Occuring or administered elsewhere in the body other than the mouth

    21. gastrointestinal (GI) tract

      The GI tract is a series of hollow organs that form a long tube from the mouth to the anus. The organs within the tract include the mouth, esophagus, stomach, small intestine, large intestine, and anus.

    22. Biomacromolecules

      Biomacromolecules are the building blocks of life. The different macromolecules are: Proteins, Lipids, Carbohydrates, and Nucleic Acids. Each of these macromolecules are responsible for different biological functions within the body and the cells