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1
2
 Drug delivery is the method or process of
administering pharmaceutical compound
to achieve a therapeutic effect in humans
or animals.
 Most common methods of delivery include
the preferred non-invasive peroral (through
the mouth), topical (skin), transmucosal
(nasal, buccal, sublingual, vaginal, ocular
and rectal) and inhalation routes.
3
 Many medications such as peptide and
protein, antibody, vaccine and gene
based drugs, in general may not be
administered using these routes because
they might be susceptible to enzymatic
degradation or can not be absorbed into
the systemic circulation efficiently due to
molecular size and charge issues to be
therapeutically effective.
 Protein and peptide drugs have to be
delivered by injection.
4
 The conventional dosage forms provide
drug release immediately and it causes
fluctuation of drug level in blood
depending upon dosage form.
 Therefore to maintain the drug
concentration within therapeutically
effective range need novel drug delivery
system.
5
 “Novel Drug delivery System (NDDS) refers
to the approaches, formulations,
technologies, and systems for transporting a
pharmaceutical compound in the body as
needed to safely achieve its desired
therapeutic effects. It may involve scientific
site-targeting within the body, or it might
involve facilitating systemic
pharmacokinetics; in any case, it is typically
concerned with both quantity and duration
of drug presence”.
6
 Novel Drug delivery is often approached via a
drug's chemical formulation, but it may also
involve medical devices or drug-device
combination products. Drug delivery is a
concept heavily integrated with dosage form
and route of administration.
 NDDS is advanced drug delivery system which
improves drug potency, control drug release to
give a sustained therapeutic effect, provide
greater safety, finally it is to target a drug
specifically to a desired tissue.
7
 NDDS is a system for delivery of drug other
than conventional drug delivery system.
 NDDS is a combination of advance
technique and new dosage forms which
are far better than conventional dosage
forms.
8
 Optimum dose at the right time and right
location.
 Efficient use of expensive drugs, excipients
and reduction in production cost.
 Beneficial to patients, better therapy,
improved comfort and standard of living.
9
10
11
 Targeted Drug Delivery System
 Controlled Drug Delivery System
 Modulated Drug Delivery System
 SR – Release of initial dose & further prolonged
release of drug. Also called extended release,
delayed release, prolonged release. SR means
slow release of a drug substance from a
dosage form to maintain therapeutic response
for extended period (8-12hrs). Time depends on
dosage form. e.g., Aspirin SR Tablet,
Zuclopenthixol Depot Injection etc.
 CR – Release of drug in controlled release for
long periods. In this the rate or speed at which
the drug is released is controlled. e.g., Adalat
CR (Nifidipine).
12
 Sometimes SR is called as controlled
release but all controlled release are not
sustained release.
13
 The drug is delivered in such a way that
drug is only active in the target area of the
body (cancerous tissues) in which drug is
released over a period of time in a
controlled manner. e.g., Colon targeted
drugs.
 Delivery of drugs to their site of action is one
of the major problem facing the
pharmaceutical industries.
14
 Physicochemical properties of a drug
 Route of administration
 Acute / Chronic therapy
 Target sites
 The Patient
 The disease state/level
15
1. Matrix Diffusion Types (In which rate of release is
controlled by diffusion of dissolved drug in the matrix).
› Rigid Matrix Diffusion (in which insoluble plastic
materials like PVP & fatty acids are used.
› Swellable Matrix Diffusion (in which Hydrophilic gums
like guar gum, tragacanth, HPMC, CMC, Xanthan
Gum & Polyacrilamides are used). These are also
called Glassy Hydrogels and popular for
sustaining/control the release of highly water soluble
drugs.
› Reservoir System (in which polymer content in
coating, thickness of coating & hardness of micro-
capsules control the release of the drug).
16
2. Dissolution Matrix Type (in which drug is
homogeneously dispersed throughout in a rate
controlling medium waxes like bees wax, carnuba
wax, hydrogenated castor oil, which control the
drug dissolution by controlling the rate of
dissolution).
› Encapsulation (in which dissolution is controlled
by dissolution controlling coating system like use
of cellulose, Polyethylene Glycols,
polymethylacrylates, and waxes. Dissolution rate
also depend upon coating material stability and
thickness of coating film.
17
3. Dissolution & Diffusion Controlled Release
System (in which drug is encapsulated in
partially soluble membrane, pores are
created due to soluble parts of coating
film which permits entry of aqueous
medium into core and drug dissolution
starts by diffusion of dissolved drug out of
system. Mixture of water soluble PVP and
water insoluble ethyl cellulose is used for
this purpose).
18
4. Water penetration/Osmotic Pressure
Controlled NDDS (in which drug may
be osmotically active or drug may be
combined with osmotically active salts
like NaCl).
5. Chemically controlled NDDS (in which
systems change their chemical
nature/structure when exposed to
biological fluids)
19
6. Hydrogels (in which three dimensional
structures of hydrophilic polymers having
chemical and physical cross links provide a
network structure to hydrogels. These are
insoluble due to network structure and provide
desirable protection of liable drugs, proteins
and peptides).
7. Ion Exchange Resins Controlled Release
Systems (in these systems, ionisable drug is
absorbed on ion-exchange resins granules
then granules are coated with water
permeable polymers using spray dryer
technique).
20
 Nanosomes
 Liposomes
 Niosomes
 Nanoparticle
 Nanosphere
 Microsphere
 Microparticle
 Microemulsion
 Nanosuspension
 Micelles
21
22
23
 Reservoir System (Microcapsule)
 Matrix System (Microspheres)
24
 Decreased dosing frequency.
 Reduced rate of rise of drug
concentration in blood.
 Sustained and consistent blood level
within the therapeutic window.
 Enhanced bioavailability.
 To achieve a targeted drug release.
 Reduced side effects.
 Improved patient compliance.
25
Systemic application
From injection site to target
Systemic application
From injection site to target
Within 15 seconds after intravenous injection, the nanoparticles have
traversed the vasculature and arrived in the organ containing the lesion.
They have travelled as far as one meter ( = one million µm).
The capillary vessel located in the organ contains nanoparticles that are
only 100 µm distant from the lesion cells. This last 100 µm offers the
grand challenges that presently hinder success in Nanomedicine: there
are several barriers to be surmounted during this 100 µm.
 Virosomes act both as carrier and asadjuvant with
multifunctions during the induction of an immune
response.
 Thecarrier function comprises the positive effects of
embedding the antigen into ahigher structure, the
virosome particle.
 The adjuvant function relates to the immune stimulating
properties of the virosomes and their components on the
immune system.
 It also suceedsin stimulating specific immunity without
causing non-specificinflammation.
31
32
33
THANK YOU
FOR
PATIENCE
34

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Novel drug delivery

  • 1. 1
  • 2. 2
  • 3.  Drug delivery is the method or process of administering pharmaceutical compound to achieve a therapeutic effect in humans or animals.  Most common methods of delivery include the preferred non-invasive peroral (through the mouth), topical (skin), transmucosal (nasal, buccal, sublingual, vaginal, ocular and rectal) and inhalation routes. 3
  • 4.  Many medications such as peptide and protein, antibody, vaccine and gene based drugs, in general may not be administered using these routes because they might be susceptible to enzymatic degradation or can not be absorbed into the systemic circulation efficiently due to molecular size and charge issues to be therapeutically effective.  Protein and peptide drugs have to be delivered by injection. 4
  • 5.  The conventional dosage forms provide drug release immediately and it causes fluctuation of drug level in blood depending upon dosage form.  Therefore to maintain the drug concentration within therapeutically effective range need novel drug delivery system. 5
  • 6.  “Novel Drug delivery System (NDDS) refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects. It may involve scientific site-targeting within the body, or it might involve facilitating systemic pharmacokinetics; in any case, it is typically concerned with both quantity and duration of drug presence”. 6
  • 7.  Novel Drug delivery is often approached via a drug's chemical formulation, but it may also involve medical devices or drug-device combination products. Drug delivery is a concept heavily integrated with dosage form and route of administration.  NDDS is advanced drug delivery system which improves drug potency, control drug release to give a sustained therapeutic effect, provide greater safety, finally it is to target a drug specifically to a desired tissue. 7
  • 8.  NDDS is a system for delivery of drug other than conventional drug delivery system.  NDDS is a combination of advance technique and new dosage forms which are far better than conventional dosage forms. 8
  • 9.  Optimum dose at the right time and right location.  Efficient use of expensive drugs, excipients and reduction in production cost.  Beneficial to patients, better therapy, improved comfort and standard of living. 9
  • 10. 10
  • 11. 11  Targeted Drug Delivery System  Controlled Drug Delivery System  Modulated Drug Delivery System
  • 12.  SR – Release of initial dose & further prolonged release of drug. Also called extended release, delayed release, prolonged release. SR means slow release of a drug substance from a dosage form to maintain therapeutic response for extended period (8-12hrs). Time depends on dosage form. e.g., Aspirin SR Tablet, Zuclopenthixol Depot Injection etc.  CR – Release of drug in controlled release for long periods. In this the rate or speed at which the drug is released is controlled. e.g., Adalat CR (Nifidipine). 12
  • 13.  Sometimes SR is called as controlled release but all controlled release are not sustained release. 13
  • 14.  The drug is delivered in such a way that drug is only active in the target area of the body (cancerous tissues) in which drug is released over a period of time in a controlled manner. e.g., Colon targeted drugs.  Delivery of drugs to their site of action is one of the major problem facing the pharmaceutical industries. 14
  • 15.  Physicochemical properties of a drug  Route of administration  Acute / Chronic therapy  Target sites  The Patient  The disease state/level 15
  • 16. 1. Matrix Diffusion Types (In which rate of release is controlled by diffusion of dissolved drug in the matrix). › Rigid Matrix Diffusion (in which insoluble plastic materials like PVP & fatty acids are used. › Swellable Matrix Diffusion (in which Hydrophilic gums like guar gum, tragacanth, HPMC, CMC, Xanthan Gum & Polyacrilamides are used). These are also called Glassy Hydrogels and popular for sustaining/control the release of highly water soluble drugs. › Reservoir System (in which polymer content in coating, thickness of coating & hardness of micro- capsules control the release of the drug). 16
  • 17. 2. Dissolution Matrix Type (in which drug is homogeneously dispersed throughout in a rate controlling medium waxes like bees wax, carnuba wax, hydrogenated castor oil, which control the drug dissolution by controlling the rate of dissolution). › Encapsulation (in which dissolution is controlled by dissolution controlling coating system like use of cellulose, Polyethylene Glycols, polymethylacrylates, and waxes. Dissolution rate also depend upon coating material stability and thickness of coating film. 17
  • 18. 3. Dissolution & Diffusion Controlled Release System (in which drug is encapsulated in partially soluble membrane, pores are created due to soluble parts of coating film which permits entry of aqueous medium into core and drug dissolution starts by diffusion of dissolved drug out of system. Mixture of water soluble PVP and water insoluble ethyl cellulose is used for this purpose). 18
  • 19. 4. Water penetration/Osmotic Pressure Controlled NDDS (in which drug may be osmotically active or drug may be combined with osmotically active salts like NaCl). 5. Chemically controlled NDDS (in which systems change their chemical nature/structure when exposed to biological fluids) 19
  • 20. 6. Hydrogels (in which three dimensional structures of hydrophilic polymers having chemical and physical cross links provide a network structure to hydrogels. These are insoluble due to network structure and provide desirable protection of liable drugs, proteins and peptides). 7. Ion Exchange Resins Controlled Release Systems (in these systems, ionisable drug is absorbed on ion-exchange resins granules then granules are coated with water permeable polymers using spray dryer technique). 20
  • 21.  Nanosomes  Liposomes  Niosomes  Nanoparticle  Nanosphere  Microsphere  Microparticle  Microemulsion  Nanosuspension  Micelles 21
  • 22. 22
  • 23. 23
  • 24.  Reservoir System (Microcapsule)  Matrix System (Microspheres) 24
  • 25.  Decreased dosing frequency.  Reduced rate of rise of drug concentration in blood.  Sustained and consistent blood level within the therapeutic window.  Enhanced bioavailability.  To achieve a targeted drug release.  Reduced side effects.  Improved patient compliance. 25
  • 27. Systemic application From injection site to target Within 15 seconds after intravenous injection, the nanoparticles have traversed the vasculature and arrived in the organ containing the lesion. They have travelled as far as one meter ( = one million µm). The capillary vessel located in the organ contains nanoparticles that are only 100 µm distant from the lesion cells. This last 100 µm offers the grand challenges that presently hinder success in Nanomedicine: there are several barriers to be surmounted during this 100 µm.
  • 28.
  • 29.  Virosomes act both as carrier and asadjuvant with multifunctions during the induction of an immune response.  Thecarrier function comprises the positive effects of embedding the antigen into ahigher structure, the virosome particle.  The adjuvant function relates to the immune stimulating properties of the virosomes and their components on the immune system.  It also suceedsin stimulating specific immunity without causing non-specificinflammation.
  • 30.
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  • 33. 33