2. • A platform is a group of technologies that are used
as a base upon which other applications, processes
or technologies are developed.
• Platform technologies are considered a valuable tool
to improve efficiency and quality in drug product
development.
3. • Nanotechnology has been adapted by companies such as
cipla to develop targeted therapies for diseases like
cancer.
• It involves employing nanosize particles to deliver drugs
to specific types of cells such as cancer cells.
• The particles are engineered so that they are attracted to
diseased cells which allow direct treatment of those cells.
• nanotech-based products such as paclitaxel, fenofibrate
and sirolimus, amongst others.
• The aim is to prevent unwanted toxicity due to wide
distribution, improve patient compliance and thus provide
favourable clinical outcomes
• Nanoparticulate drug delivery systems show a promising
approach to obtain desirable drug-like properties by
altering the biopharmaceutics and pharmacokinetics
properties of the molecule
4.
5.
6. • Microsphere technology is used to develop
for targeted delivery
• this technology is used for a site-specific action, to
eliminate inconvenience of repeated injections and to
decrease toxic side-effects.
• microsphere injection formulations for Leuprolide
and Triptorelin
7. • Microparticles are a type of drug delivery systems
where the particle size ranges from one micron (one
thousandth of a mm) to few mm.
• micro particulate technology offer numerous
advantages compared to conventional dosage forms,
which include improved efficacy, reduced toxicity,
improved patient compliance and convenience
• Microparticulate technology can be used to entrap
solids, liquids or gases into polymeric matrix or shell.
• Generally microparticulate drug delivery systems can
be divided into microcapsules and microspheres
8. • Microcapsule is defined as a system in which drug
containing core is completely surrounded by a
polymer shell. The core can be solid, liquid or gas;
the shell is a continuous, porous or non-porous
polymeric layer. Microcapsules are classified into
three basic categories as mono cored, poly cored and
matrix type.
• Microsphere is a system in which the drug substance
is either homogenously dissolved or dispersed in a
polymeric matrix. Microspheres show different
release properties compared to true microcapsules.
9. Advantages
1. Taste and odor masking. Eg: Fish oils, sulfa drugs.
2. Protection of drugs from environment.
3. Particle size reduction for enhancing solubility of the poorly soluble
drug.
4. Sustained or controlled drug delivery Eg: KCl, Ibuprofen.
5. Targeted release of encapsulated material.
6. Live cell encapsulation. Eg: Resealed erythrocytes
7. Conversion of liquid to free flowing solids.
8. Delay of volatilization.
9. Separation of incompatible components Eg: Excipients, buffers and
other drugs.
10. Improvement of flow of powder.
11. Safe handling of toxic substances.
12. Aid in dispersion of water insoluble substance in aqueous media
10. Disadvantages
• The costs of the materials and processing
• Reproducibility is less.
• Process conditions like change in temperature, pH,
solvent addition, and evaporation/agitation may
influence the stability of core particles to be
encapsulated.
• The environmental impact of the degradation
products of the polymer matrix produced in response
to heat,
• hydrolysis, oxidation, solar radiation or biological
agents.
11. • Liposomes offer excellent opportunity to selectively
target drugs; which is expected to optimize the
pharmacokinetical parameters, the pharmacological
effect and to reduce the toxicity of the drugs.
• liposomal and Amphotericin B,
12. • When phospholipids are dispersed in water, they spontaneously form closed
structure with internal aqueous environment bounded by phospholipid
bilayer membranes, this vesicular system is called as liposome.
• Liposomes were discovered about 40 years ago by A.D. Bangham which
has become the versatile tool in biology, biochemistry and medicine today.
Advantages
• Liposomes are biocompatible, completely biodegradable, nontoxic and non
immunogenic.
• Suitable for delivery of hydrophobic, amphipathic and hydrophilic drugs.
• Protect the encapsulated drug from external environment.
• Reduced toxicity
Disadvantages
• Production cost is high
• Short half life
• Leakage and fusion of encapsulated drug molecules
13. • Hot melt extrusion produce solid molecular
dispersions with considerable advantages over
solvent-based processes such as spray drying and co-
precipitation.
• This technology is used to provide sustained,
modified and targeted drug delivery. This technology
can be applied for tablets, implants and topical
delivery systems such as topical liposomal
formulations and transdermal patches
14. • Osmotic-controlled Release Oral Delivery System
(OROS) technology is used to deliver once-daily
tablets. This advanced technology uses osmotic
pressure to deliver the drug in several therapeutic
areas.
• It can lead to improved safety profile, stable drug
concentrations, uniform drug effects and reduced
dosing frequency
15. • The osmotic controlled release oral delivery system is an
advanced control release oral drug delivery system in the
form of a rigid tablet with a semipermeable outer
membrane and one or more small laserdrilled holes in it.
• These systems consist of a drug core containing osmogen
that is coated with a semipermeable membrane.
• This coating has one or more delivery ports through
which a solution or suspension of the drug is released
over time.
• Drugs that possess short half life and high potent drugs
are suitable candidates to prolong the treatment.
• Osmotic agents are employed to protect the concentration
gradient across the membrane.
• They also creates a driving force for the uptake of water
and help in maintaining drug consistency in the hydrated
formulation.
16. 1. They typically give a zero order release summary after an
initial lag.
2. Deliveries may be belated or pulsed if preferred.
3. Drug discharge is free of gastric pH and hydro dynamic
state.
4. They are well unspoken and characterized.
5. The release mechanisms are not dependent on drug.
6. A high quantity of in-vitro and in-vivo correlation (ivivc)is
obtained in osmotic systems.
7. Superior release rates are promising with osmotic systems
compared with predictable diffused controlled drug
delivery systems.
8. The release from osmotic systems is modestly affectedby
the presence of food in gastro intestinal tract
17. Disadvantages
• Special equipment is necessary for making an orifice
in the system.
• It may cause irritation or ulcer due to release of
soaked solution of drug.
• Dose dumping.
• Retrieval therapy is not possible in the case of
unpredicted adverse events
• If the coating process is not well controlled there is a
danger of film defects, which outcome in dose
discarding.
18. • OROS technology enables the use of an effective starting dose
and eliminates the need for dose titration. This allows
symptom control much earlier than immediate-release tablets.
• Another technology adapted to develop sustained release
tablets is the Mutiple-Unit Pellet System (MUPS) technology.
The tablet is made of multiple particulates that disintegrate
into individual pellets, thus providing sustained drug release.
19. • orally disintegrating tablets which disintegrate
rapidly when placed upon the tongue and ensure
faster onset of action. This technology is adapted to
several molecules to provide for line extensions to aid
patient convenience and compliance
• Inhalation Technology
Inhalation products for chronic respiratory diseases
such as asthma,
20. • Oral granule formulation called 'Sprinkles' especially
for paediatric patients have been developed. They can
be sprinkled over a child’s food making the drug
palatable. This formulation addresses the issue of
compliance, a key challenge in paediatric therapy.
This technology has been used to develop anti-HIV
therapy for children
21. • Stempeutics - a leading stem cell company developing
stem cell based medicinal products, with facilities in
Bengaluru and Manipal (India) as well as in Kuala
Lumpur (Malaysia).
22. • Cipla is geared to embark upon the global opportunity
for Biosimilars, particularly the monoclonal antibodies.
They have acquired 40% stake in MabPharm, an Indian
biotech company and 25% stake in BioMab, a biotech
company in Hong Kong.
• A state-of-the art facility in Goa, India is dedicated to
manufacture monoclonal antibodies. The aim is to
provide these biologics-based medicines at affordable
prices and thus improve access to medicine.
• 1 - Rotahaler is a trademark used in India only. Outside
India it is known as DPhaler.
• 2 - Imported from 3M Pharmaceutic
