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Prepared by ; Jenisha
Timbadiya(25)
Topic: Dry powder inhaler
Atmiya institute of pharmacy
• There are many route of administration but oral is
more preferrable ‘cause it’s non-invasive, convenient
& painless so orally inhaled therapy have been
developed.
• Instead of giving dry powder doses like tablets &
capsules orally, inhalation of those dry powder doses
is more better as it not required diffusion, absorption,
metabolism it will directly absorbed in blood through
lung tissue.
• Many advantages of drug delivery by inhalation like
large surface area of lung provides efficient drug
absorption
• Inhalation of dry powder is simple & convenient &
gives quick action of drug can be obtained
• DPIs are devices through which a dry powder formulation
of an active drug is delivered for local or systemic effect
via the pulmonary route
• DPIs are used to treat respiratory diseases such as
asthma, COPD, bronchitis etc.
• For inhalation dry powder particles must be sized less
than 5µm whereas for systemic effects particle size of
less than 2µm is needed for drug deposition in the small
peripheral airways.
 In 1956 MDI was invented for
asthma
 Inhalation of medication since 1950s
 In 1967 DPI started to use
 In 1988 in DPI multidose device
TURBUHALER was introduced
Effective dosing
• Targeted & optimized delivery
• Operable at low inhalation flow rates
• Uniform dose
Effective device
• In process controls for quality
• Good enviornmental production
• Compact, portable, cheap & reusable
Easy to use
• Powder production/powder properties
• Powder formulation
• Dry powder inhaler device.
• Particle size:
generally 2-5µm
for alveoli penetration max size 3 micron & not less than 1 micron for
free flow
Over micronised powder creates problems like improper powder flow
& forms deagegated cloud
• pH
• Surface rotation
• Surface morphology & surface energy is important for free
flowing & formation of segregation cloud
• Crystallinity & polymorphism
• Moisture content & hygroscopicity
• Polydispersity
• Surface area
a) Active p’ceutical
ingredient
• Therapeutic protein,
insulin, drugs to treat
bone disorders, vaccines
• Drugs for asthma &
chronic obstructive
pulmonary disease like β2
adrenergic agonists,
corticosteroids, cromones &
anticholinergic)
• API of micron size
formulated with or without
carrier
b)excepient
• To improve flow properties
& to prevent
agglomeration
• Ex. Lactose, glucose,
mannitol
 Currently, lactose is the only excipient used in
DPIs.
 Lactose is highly crystalline & has the smooth
surfaces & satisfactory flow properties desirable
for a DPI carrier particle.
 One drawback of lactose is that it is a reducing
sugar, which makes it incompatible with drugs
that have primary amine moieties.
 Excipients are not always required, the Pulmicort
, Astrazeneca (Budesonide) Turbuhaler is an
example of an excipient free formulation.
When patient activates the DPI &
inhales
Airflow through the device creates
shear & turbulence
Air introduced into the powderbed &
static powder blend is fluidized then
enters the patient’s airway
The drug particles separate from the
carrier particles & are carried deep
into lungs to excert effects
While the larger carrier particles
impact in oropharynx & are cleared
1)Deposition in
respiratory tract
2)Clearance
mechanism:
Dissolution
Mucocillary
clearance(MCC)
Macrophage
uptake
Translocation
• DPI design must be coordinated with the
formulation of drug
• Performance of drug & reachness of drug
to lungs not only depends on powder
formulation but also on the inhaler device.
• Mouthpiece is critical parameter.
Spinhaler
Rotahaler
Handihale
r
Aerolizer
Single
-unit
dose
device
Turbuhaler
Twisthaler
Easyhaler
Clickhaler
Accuhaler/
Diskus
Multi
dose
reservoi
r
devices
Aerohaler
Diskhaler/
Rotadisk
Multi
unit
dose
device
s
a)Spinhaler:
In it capsule is placed
into a holder located
on top of a propeller.
The walls of capsule
are pierced by two
spears when the
patient primes the
device by sliding a
cam. spinhalerTM
• Insert capsule into
rotahaler
• Twist it to break the
capsule
• Inhale deeply
• Several breath may be
required.
• No coordination of
aerosol required
• After use,empty gelatin
capsule removed &
replaced by another
capsule
• Reservoir systems offer the advantage of
variable dosing, generate less waste, are less
expensive to manufacture & are simpler to use
than unit dose systems.
• Maintaining a highly flowable drug powder in this
system leads to greater drug formulation
challenges.
• This contain a bulk supply of drug from which
individual doses are released with each
acutation.
• The first such inhaler to be develop was
Turbuhaler.
1)loading dose:
• While loading, it must be in
upright position.
• Twist the bottom colored grip
fully to the right side, twist it
back again to left.
• There will be sound of click.
2)inhaling the dose:
• Keep it in horizontal position.
• Inhale for 10 sec.
• There is window for dose
indicator onto device.
• Multi unit dose DPIs utilizes individually
prepared & sealed doses of drug.
• The first develop was aerohaler which
contained six unit dose capsule each
delivering one dose of drug.
• Ex. Aerohaler, Diskhaler
To load:
• Lift up the mouthpiece to
open
• Lift the magazine up slightly
& turn it round in a
clockwise direction until
mark 6 lines up with the on
the base. Push magazine
down again
• Load the capsules into the
magazine. Push the
mouthpiece down until it
clicks
To use:
• To inhale hold it
upright. Push the
button, on side of
inhaler until it clicks, it
pierces the capsule.
• Breath out, put
mouthpiece in mouth,
breath in as deeply as
possible, remove
aerohaler from mouth,
hold breath for 10 sec,
breath out.
• Turn the magazine for
next dose.
• Reload magazine
when all capsules have
Aerohaler
Device drug
1)Rotahaler Albuterol/salbutamol,
beclomethasone
Handihaler Tiotropium
Aerolizer Eformoterol
2)accuhaler/Discus Albuterol/salbutamol,
beclomethasone, c
Clickhaler Albuterol/salbutamol,
beclomethasone
Easyhaler Albuterol/salbutamol,
Beclomethasone
Turbuhaler Budesonide, Formoterol,
Terbutaline
3)Aerohaler Fenoterol, Ipratropium
bromide
Diskhaler/Rotadisk Albuterol/salbutamol,
Beclomethasone,
Albuterol/salbutamol,
beclomethasone
Current DPI producing brands
Gold®
Astra®
Asmanex®
Seretide®
Relenza®
Bochringer Ingelheim®
Symbicort®
Mankind®
• Little or no patient coordination is required
• Convenient & easy to use
• Propellent free design as this is toxic in nature.
• Onset of action without need for absorption, digestion,
circulation of drug because direct absorption from alveoli
to blood for systemic effect
• Quick relief in case of bronchodilation
• Spacer is not required
• Higher lung deposition than pMDI.
• Dependency on patient’s inspiratory flow rate.
• Device resistance & other design issues like
mouthpiece is critical for inhalation.
• Not available world wide.
• More expensive than pMDI.
• Dose uniformity problems.
• Development & mfg are more expensive &
complex.
• Most type are moisture sensitive. Humidity
potentially causes powder clumping & reduced
dispersal of fine particle mass.
• Need to reload capsule each time.
• Apperance & colour
• Microscopic evaluation
• Microbial limits
• water/moisture content
• Assay(drug content determination)
• Particle size analysis
• Drug content per unit dose / dose delivery
• Average fill weight per capsule
• Impurities & degradation products
 Initially inhalation therapy was used only for
pulmonary diseases like asthma.
 But from past few decades it is used in Cystic
fibrosis, Chronic obstructive pulmonary disease
as well as in systemic diseases like Irritable
bowel syndrom, Schizophrenia, Migraine,
Diabetes, Obesity
 Recent progress in non-pulmonary indications
includes:
Staccata® filled by Loxapine – Schizophrenia –
US
Afrezza® - diabetes
Inavir® - influenza - Japan
• www.sciencedirect.com
• www.medscape.com
• Wikipedia.org
• Newman sp – aerosol drug delivery, deposition &
clearance studies
• Mankind.co.in
• J. hickey – p’ceutical inhalation aerosol technology
• Remington – the science & practice of pharmacy
• COPD at your fingerprint by John miles & June robert
dry powder aerosols

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A relative description on Sonoporation.pdf
 

dry powder aerosols

  • 1. Prepared by ; Jenisha Timbadiya(25) Topic: Dry powder inhaler Atmiya institute of pharmacy
  • 2. • There are many route of administration but oral is more preferrable ‘cause it’s non-invasive, convenient & painless so orally inhaled therapy have been developed. • Instead of giving dry powder doses like tablets & capsules orally, inhalation of those dry powder doses is more better as it not required diffusion, absorption, metabolism it will directly absorbed in blood through lung tissue. • Many advantages of drug delivery by inhalation like large surface area of lung provides efficient drug absorption • Inhalation of dry powder is simple & convenient & gives quick action of drug can be obtained
  • 3. • DPIs are devices through which a dry powder formulation of an active drug is delivered for local or systemic effect via the pulmonary route • DPIs are used to treat respiratory diseases such as asthma, COPD, bronchitis etc. • For inhalation dry powder particles must be sized less than 5µm whereas for systemic effects particle size of less than 2µm is needed for drug deposition in the small peripheral airways.
  • 4.  In 1956 MDI was invented for asthma  Inhalation of medication since 1950s  In 1967 DPI started to use  In 1988 in DPI multidose device TURBUHALER was introduced
  • 5. Effective dosing • Targeted & optimized delivery • Operable at low inhalation flow rates • Uniform dose Effective device • In process controls for quality • Good enviornmental production • Compact, portable, cheap & reusable Easy to use
  • 6. • Powder production/powder properties • Powder formulation • Dry powder inhaler device.
  • 7. • Particle size: generally 2-5µm for alveoli penetration max size 3 micron & not less than 1 micron for free flow Over micronised powder creates problems like improper powder flow & forms deagegated cloud • pH • Surface rotation • Surface morphology & surface energy is important for free flowing & formation of segregation cloud • Crystallinity & polymorphism • Moisture content & hygroscopicity • Polydispersity • Surface area
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  • 9. a) Active p’ceutical ingredient • Therapeutic protein, insulin, drugs to treat bone disorders, vaccines • Drugs for asthma & chronic obstructive pulmonary disease like β2 adrenergic agonists, corticosteroids, cromones & anticholinergic) • API of micron size formulated with or without carrier b)excepient • To improve flow properties & to prevent agglomeration • Ex. Lactose, glucose, mannitol
  • 10.  Currently, lactose is the only excipient used in DPIs.  Lactose is highly crystalline & has the smooth surfaces & satisfactory flow properties desirable for a DPI carrier particle.  One drawback of lactose is that it is a reducing sugar, which makes it incompatible with drugs that have primary amine moieties.  Excipients are not always required, the Pulmicort , Astrazeneca (Budesonide) Turbuhaler is an example of an excipient free formulation.
  • 11. When patient activates the DPI & inhales Airflow through the device creates shear & turbulence Air introduced into the powderbed & static powder blend is fluidized then enters the patient’s airway The drug particles separate from the carrier particles & are carried deep into lungs to excert effects While the larger carrier particles impact in oropharynx & are cleared
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  • 14. • DPI design must be coordinated with the formulation of drug • Performance of drug & reachness of drug to lungs not only depends on powder formulation but also on the inhaler device. • Mouthpiece is critical parameter.
  • 16. a)Spinhaler: In it capsule is placed into a holder located on top of a propeller. The walls of capsule are pierced by two spears when the patient primes the device by sliding a cam. spinhalerTM
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  • 18. • Insert capsule into rotahaler • Twist it to break the capsule • Inhale deeply • Several breath may be required. • No coordination of aerosol required • After use,empty gelatin capsule removed & replaced by another capsule
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  • 21. • Reservoir systems offer the advantage of variable dosing, generate less waste, are less expensive to manufacture & are simpler to use than unit dose systems. • Maintaining a highly flowable drug powder in this system leads to greater drug formulation challenges. • This contain a bulk supply of drug from which individual doses are released with each acutation. • The first such inhaler to be develop was Turbuhaler.
  • 22. 1)loading dose: • While loading, it must be in upright position. • Twist the bottom colored grip fully to the right side, twist it back again to left. • There will be sound of click. 2)inhaling the dose: • Keep it in horizontal position. • Inhale for 10 sec. • There is window for dose indicator onto device.
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  • 27. • Multi unit dose DPIs utilizes individually prepared & sealed doses of drug. • The first develop was aerohaler which contained six unit dose capsule each delivering one dose of drug. • Ex. Aerohaler, Diskhaler
  • 28. To load: • Lift up the mouthpiece to open • Lift the magazine up slightly & turn it round in a clockwise direction until mark 6 lines up with the on the base. Push magazine down again • Load the capsules into the magazine. Push the mouthpiece down until it clicks
  • 29. To use: • To inhale hold it upright. Push the button, on side of inhaler until it clicks, it pierces the capsule. • Breath out, put mouthpiece in mouth, breath in as deeply as possible, remove aerohaler from mouth, hold breath for 10 sec, breath out. • Turn the magazine for next dose. • Reload magazine when all capsules have
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  • 33. Device drug 1)Rotahaler Albuterol/salbutamol, beclomethasone Handihaler Tiotropium Aerolizer Eformoterol 2)accuhaler/Discus Albuterol/salbutamol, beclomethasone, c Clickhaler Albuterol/salbutamol, beclomethasone Easyhaler Albuterol/salbutamol, Beclomethasone Turbuhaler Budesonide, Formoterol, Terbutaline 3)Aerohaler Fenoterol, Ipratropium bromide Diskhaler/Rotadisk Albuterol/salbutamol, Beclomethasone, Albuterol/salbutamol, beclomethasone
  • 34. Current DPI producing brands Gold® Astra® Asmanex® Seretide® Relenza® Bochringer Ingelheim® Symbicort® Mankind®
  • 35. • Little or no patient coordination is required • Convenient & easy to use • Propellent free design as this is toxic in nature. • Onset of action without need for absorption, digestion, circulation of drug because direct absorption from alveoli to blood for systemic effect • Quick relief in case of bronchodilation • Spacer is not required • Higher lung deposition than pMDI.
  • 36. • Dependency on patient’s inspiratory flow rate. • Device resistance & other design issues like mouthpiece is critical for inhalation. • Not available world wide. • More expensive than pMDI. • Dose uniformity problems. • Development & mfg are more expensive & complex. • Most type are moisture sensitive. Humidity potentially causes powder clumping & reduced dispersal of fine particle mass. • Need to reload capsule each time.
  • 37. • Apperance & colour • Microscopic evaluation • Microbial limits • water/moisture content • Assay(drug content determination) • Particle size analysis • Drug content per unit dose / dose delivery • Average fill weight per capsule • Impurities & degradation products
  • 38.  Initially inhalation therapy was used only for pulmonary diseases like asthma.  But from past few decades it is used in Cystic fibrosis, Chronic obstructive pulmonary disease as well as in systemic diseases like Irritable bowel syndrom, Schizophrenia, Migraine, Diabetes, Obesity  Recent progress in non-pulmonary indications includes: Staccata® filled by Loxapine – Schizophrenia – US Afrezza® - diabetes Inavir® - influenza - Japan
  • 39. • www.sciencedirect.com • www.medscape.com • Wikipedia.org • Newman sp – aerosol drug delivery, deposition & clearance studies • Mankind.co.in • J. hickey – p’ceutical inhalation aerosol technology • Remington – the science & practice of pharmacy • COPD at your fingerprint by John miles & June robert