New drug delivery technology for “Cystic Fibrosis” (Ivacaftor)

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  • New drug delivery technology for Cystic Fibrosis

  • Contents

    Drug delivery system

    Cystic fibrosis

    Ivacaftor

    Traditional dosage form of IVACAFTOR

    Proposed dosage form

    Advantages of the proposed dosage form

    Side-effect reduction of proposed dosage form

    Conclusion

  • Drug delivery system

    Refers to the technology which is utilized to present the

    drug to the desired body site for drug release &

    absorption.

  • Cystic fibrosis

    A progressive & genetic disease that causes persistent lung

    infections and limits the ability to breathe over time. It

    may also affects the pancreas, liver, kidneys, and intestine.

  • Drugs used to treat cystic fibrosis

  • Ivacaftor

    Formula : C24H28N2O3

    Molecular Weight : 392.490 g/mol

    Generic name : Ivacaftor.

    Brand name : Kalydeco.

    Drug approved : Jan 31,2012.

    Cystic fibrosis usage approved : May 17,2017.

  • Traditional dosage form of IVACAFTOR

    Tablet

    Film-coated

    Oral Granules.

  • Proposed dosage form

    Buccal Tablet.

    A topical route of administration by which drugs are

    applied in the cheek at canine fossa through the diffusion

    of oral mucosa which enters directly into the bloodstream.

  • Advantages of the proposed dosage form

    1. Better Bio-availability : Traditional dosage forms of

    Ivacaftor has 99% protein binding. So bio-availability is

    almost lowest.

    2. Rapid onset of action : Tmax is around 3-5 hours. So it

    takes more time to show its therapeutic effect.

    3. Avoid first-pass metabolism : By liver due to direct entry

    into the bloodstream.

  • Side-effect reduction of proposed dosage form

    1. Soar throat : Pain or irritation of the throat caused by

    inflammation & trauma. (Local)

    2. Sneezing : Uncontrollable expulsion of air through the

    nose & mouth. (Local)

    3. Runny nose : Production of extra mucus by the nose.

    (Local)

  • Side-effect reduction of traditional dosage form

    4. Nasal congestion : Blockage of the nasal passages

    usually due to inflamed blood vessels. (Local)

    5. Loss of appetite.

  • Conclusion

    Ivacaftor was sold for $339M in USA during the year of

    2014 for other indications. As its usage for cystic fibrosis is

    approved by US-FDA recently, it has huge opportunity to

    do well in this disease condition too. Also if we can

    successfully formulate the buccal form of Ivacaftor, then

    it will boost the usages & sales of Ivacaftor further

    more.

  • References

    1. https://en.wikipedia.org/wiki/Cystic_fibrosis

    2. https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/

    3. http://www.deltagene.eu/cftr

    4. https://en.wikipedia.org/wiki/Ivacaftor

    5. https://en.wikipedia.org/wiki/First_pass_effect

    6. https://www.drugs.com/kalydeco.html

    7. https://www.drugs.com/sfx/kalydeco-side-effects.html

    8. https://www.drugs.com/dosage/kalydeco.html