Flow of Pharmaceutics & Pharmaceutical

Technology Subjects at FOP, QIUP

Subject Name Description
Pharmaceutics- Liquid and Semi Solid Dosage Forms
1
Pharmaceutics-2 Sterile Preparations

Pharmaceutics-3 Solid Dosage Forms

Industrial Product Development, Quality

Assurance/GMP , Pharmaceutical
Pharmacy Management, Industrial Pharmacy

Pharmaceutics-4 Extemporaneous
Preparations
Pharmaceutics-5 Advanced/Novel drug delivery
system 1
 PHARMACEUTICS –V
ADVANCED DRUG DELIVERY SYSTEMS
(BPH 3205)
Assoc .Prof. Dr. Mahibub Mahamadsa Kanakal
[Link]@[Link]

2
 INTRODUCTION:
NOVEL DRUG DELIVERY SYSTEMS

Assoc .Prof. Dr. Mahibub Mahamadsa Kanakal

[Link]@[Link]

3
 Lesson Outcomes
After this lecture, and further reading as required, students will
be able to :
 Recognise the Ideal properties of active pharmaceutical
ingredient (API) to formulate into NDDS
 Recognise Advantages, disadvantages and applications of
NDDS
 Recognise Carrier design according to pathology and
pharmacology of diseases such as cancer, diabetes and
infections
 Drug delivery based on Circadian rhythm
4
NOVEL DRUG DELIVERY SYSTEMS

5
 DRUG DELIVERY
• 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. 6
 DRUG DELIVERY
• 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.
• Protein and peptide drugs have to be delivered by
injection. 7
 DRUG DELIVERY

• 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.
8
 NEED OF NOVEL DRUG
DELIVERY METHODS
• The conventional dosage forms provide drug release
immediately and it causes fluctuation of drug level in
blood depending upon dosage form.
• Conventional drug delivery systems cannot target to
required site of action specifically.
• Therefore, to maintain the drug concentration within
therapeutically effective range and to delivery
specific site of action need novel drug delivery
system. Ex: Targeted drug delivery systems 9
 Novel Drug Delivery
Systems
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”. 10
 Novel Drug Delivery
Systems
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”. 11
 Novel Drug Delivery
Systems
• 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.
• 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
12
which are far better than conventional dosage forms.
 BENEFITS OF NDDS

• 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.
• Drastic reduction on Side effects.
• Reduction in dose size
• Localized action
• Potent drugs are better managed by NDDS 13
 FACTORS INFLUENCING NOVEL
DRUG DELIVERY SYSTEMS
• Physicochemical properties of a drug
• Route of administration
• Acute / Chronic therapy
• Target sites
• The Patient
• The disease state/level
14
 CATEGORIES OF NDDS

TARGETED DRUG DELIVERY SYSTEM

CONTROLLED DRUG DELIVERY SYSTEM

MODULATED DRUG DELIVERY SYSTEM

15
 Sustained Release/ Controlled
Release
• 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).
• Sometimes SR is called as controlled release, but all
16
controlled release are not sustained release.
 Classification of NDDS with
Reference
[Link] Diffusion Types (In which rate to release
of release control
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 the17
drug).
 Classification of NDDS with
Reference
to release control
[Link] 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. 18
 Classification of NDDS with
Reference
to release
[Link] & Diffusion Controlled Release Systemcontrol
(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).
[Link] penetration/Osmotic Pressure Controlled
NDDS (in which drug may be osmotically active or drug
may be combined with osmotically active salts like NaCl). 19
 Classification of NDDS with
Reference
to change
5. Chemically controlled NDDS (systems releasetheircontrol
chemical
nature/structure when exposed to biological fluids)
[Link] (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).
[Link] 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
20
using spray dryer technique).
 LIST OF DRUG CARRIERS IN NDDS

 Nanosomes  Microparticle
 Liposomes  Microemulsion
 Niosomes  Nanosuspension
 Nanoparticle  Micelles
 Nanosphere
 Microsphere 21
 Targeted Drug Delivery System

• 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.
22
 Targeted Drug Delivery System

• 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.

23
 MODIFIED DRUG DELIVERY
SYSTEMS
 Extended release(ER) is such a dosage form that allows
reduction in dosing frequency from that of conventional dosage
form.

 Controlled release (CR) dosage forms release drug at a constant

rate and provide plasma conc. That remain constant with time.

 Targeted release describes drug release directed towards

concentrating a drug in a body region, tissue, or site for
absorption or for drug action.
24
MODIFIED DRUG DELIVERY
SYSTEMS

25
NOVEL DRUG DELIVERY
SYSTEMS

26
 Gastro retentive drug
delivery systems
General Methods to Achieve Gastroretention: A controlled drug
delivery system with prolonged residence time in the stomach

27
 Intrauterine
For several years release of hormones

28
 NANOTECHNOLOGY
 There is a tremendous impact of nanotechnology in every
field/sphere of life and has a dramatic influence on medicine.
 They are of submicron size i.e. < 1 µm.
 Application of nanotechnology for diagnosis, treatment,
monitoring and control of biological systems is termed as
nanomedicine.
 Unique advantage of nanoparticulates is by their use as
pharmaceutical delivery systems and imaging agents.
 Several varieties of nanoparticles include, polymeric
nanoparticles, metallic nanoparticles, liposomes, niosomes,
micelles, quantom dots, dendrimers, carbon nano tubes etc. 29
NANOTECHNOLOGY-NANO
CARRIERS

Carbon Nanotube Quantum dots

Carbon 60 Niosomes
30
 NANOTECHNOLOGY-
LIPOSOMES
– Artificial spherical vesicles with one or more phospholipid bilayers
enclosing similar number of [Link]
– Like subcellar particles, 25-5000nm
Hydrophilic

Hydrophobic

31
 MICELLES
Def: Micelle is an aggregate of amphipathic molecules in
water, with the nonpolar portions in the interior and the
polar portions at the exterior surface, exposed to water.

32
Def: They are highly branched
macromolecules with a central
core, branch cells and surface
groups.

33
 Transdermal Drug Delivery
Systems
Def: Transdermal drug delivery systems are those which
can deliver the drugs through the skin portal to systemic
circulation at a predetermined rate and maintain clinically
effective concentrations over a prolonged period of time.

34
 PULMONARY ROUTE
Nasal route of drug delivery
dates back to human
civilization e.g. Sniffing
tobacco, hallucinogens etc.
MDI

Ophthalmic route
Ocusert Nasal route 35
 REFERENCES

• Chen Q eta al (2024) Novel Drug Delivery Systems: An

Important Direction for Drug Innovation Research and
Development, Pharmaceutics ,Volume 16 issue 5 Page
No : 674.

• Jain NK. Controlled and Novel Drug Delivery. CBS

Publisher & Distributors P Ltd: India; 2014.

36
THANK
YOU
37