new drug delivery technology for “cystic fibrosis” (ivacaftor)
TRANSCRIPT
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New drug delivery technology for “Cystic Fibrosis”
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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
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Drug delivery system
Refers to the technology which is utilized to present the
drug to the desired body site for drug release &
absorption.
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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.
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Drugs used to treat cystic fibrosis
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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.
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Traditional dosage form of “IVACAFTOR”
Tablet
Film-coated
Oral Granules.
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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.
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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 it’s therapeutic effect.
3. Avoid first-pass metabolism : By liver due to direct entry
into the bloodstream.
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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)
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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.
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Conclusion
• “Ivacaftor” was sold for $339M in USA during the year of
2014 for other indications. As it’s 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.
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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