UNIT-I y

PILOT PLANT SCALE UP

TECHNIQUES

INDUSTRIAL PHARMACY II
Mahesh Mengade
PES Modern College of Pharmacy (For Ladies)
 INTRODUCTION:

What is pilot plant?

• Pilot plant is a part of the pharmaceutical industry where a lab
scale formula is transformed into a viable product by the
development of liable practical procedure of manufacture.
Pilot plant
R and D Production

• Definition of scale up:

The art of designing of prototype using the data obtained from the
pilot plant model.

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 Objective of pilot plant


• To avoid the scale up problem.

• To produce physically and chemically stable and therapeutic dosage
from.
• Review of the processing equipment.
• Evaluation and validation.
• To identify the critical features of the process.
• To provide master manufacturing formula with instructions for
manufacturing process.
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 Significance of pilot plant:
• 1.Information of batches physical space required for equipment.
• 2.Examination of formulae.
• 3.Appropriate records and reports to support GMP.
• 4.Review of range of relevant processing equipment.
• 5.Production rate can be adjustment.
• 6.Optimize production rate also.
• 7. Idea about physical space required
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 Why perform pilot plant
studies ?
• 1.A pilot plant permit examination of a product and
process on an Intermediate scale previous to large amount
of money are carry out to full scale production.
• 2.It is generally not possible to predict the effects of
many fold increase in scale.
• 3.It is not viable to design a large complex food
processing plant from Laboratory data alone with any
degree of success.
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 A pilot plant can be utilised
for:
• 1.Assessment the result of laboratory studies and making
product and process rectifying and development.
• 2.Manufacture small amount of product for sensory,
chemical, microbiological evaluation, limited market
testing or supply samples to potential customers.
• 3.Regulate suppliable by products of waste stream
requiring treatment before discharge. 4.To supply data
can be used in manufacturing a conclusion on whether or
not to begin a full scale production process. 12/30/2024 6
 General consideration:
• Reporting responsibility
• Personnel requirement
• Space requirement
• Review of the formula
• Raw material
• Equipment
• Production rate
• Process evaluation
• Master manufacturing process
• Product stability and uniformity
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 Reporting responsibility:

• The objective of the reporting responsibility in Pilot plant is to facilitate the

transfer of a product from the laboratory into production.
• The effectiveness of Pilot plant is determined by the ease with which the new
product or process is brought into routine production.
• This could be possible if a good relationship exists between the pilot plant group
with other groups (Research & Development, Processing, Packaging, Engineering,
Quality Assurance, Quality Control, Regulatory and Packaging) of the company.
• The formulator who developed the product can take the product into the
production.
• The formulator continues to provide the support to the other departments even
after the transition into the production has been completed
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 2. Personnel requirements:
The Qualification required for a person to work in pilot plant organization are;
• Good theoretical knowledge on blending
• Pharmaceutical industry experiences.
• Ability to develop good relationships with other personnel.
• Good communication skill (Writing and speaking).
• Practical Experiences in production areas about formulation, process and
equipment.
• Should be able to understand the intent of the formulator and perspective of
production personnel.
• Must have minimum knowledge on Engineering, Electronic and Computer.
• Must have knowledge on Physical, Chemical, Biochemical and Medical attributes of
dosage form.
• Must be aware on the principle of GMP Practices. 12/30/2024 9
The individual responsibilities should be clearly understood by the individuals, which
must be recorded
 3.Space requirements
• a) Administration and information process: Sufficient office and desk space
should be provided for both scientist and technician. The space should be
close to the working area.
• b) Physical testing area: This area should issue permanent bench top for
regularly used physical testing equipment.
• c) Standard equipment floor space: Equipment used should be made
movable where ever possible so that after use it can be stored in the small
store room. Space for cleaning of equipment should be also provided
• d) Storage area: It should have two areas;
 Approved area & Unapproved area
Different areas should supply the storage of in-process material finished bulk
products from the pilot plant and materials from the experimental scale up
batches made in the production. storage area for the packaging material
should also be provided. 12/30/2024 10
 4 Review of the formula:
• The objective of each ingredient and its contribution to
the final product manufactured on small scale equipment
must be thoroughly understood.
• The modification in formulation during the scale up is
possible to be done in phase III trial, so that sufficient
time could be available for generation of meaningful long
term stability data in support of a proposed New Drug
Application (NDA).
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 5.Raw materials:
• One major responsibility of a Pilot plant is the approval
and validation of active and excipient raw materials used
in the Pharmaceutical products.
• This is because the raw materials used during the small
scale formulation trials may not be representative of the
large volume shipment of material due to change in raw
materials properties like particle size, shape, morphology,
bulk density, static charges, rate of solubility, flow
property and colour.
• An alternative supplier must be arranged as stand by
basis which must validate the batches for manufactured
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products.
 6.Equipment
• Equipment should be inexpensive, simplest and systematic
equipment are used. -The size of the equipment should be
such that the experiment trials run should be applicable to
production sized batches. -If the equipment is too small
the process developed will not scale up- if equipment is
too big then the wastage of the expensive active
Ingredients.

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 7.Production rate:
• For determination of production rate, size and type of
equipment required, the immediate and future market
requirement must be considered.
• The selection of process and equipment to produce
batches at a frequency need following considerations that
are;
The time required to clean the equipment between the
batches.
The product loss in the equipment during the manufacture.
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The number of batches that need to be tested before

 8.Process evaluation:
Things that should be critically examined during the Process Evaluation are;
• Order of addition of the components including adjustment of their amount.
• Mixing speed ant time.
• Rate addition of granulating agent, solvents and drug solutions.
• Heating and cooling rates.
• Filter size for liquids.
• Type and nature of filter media used for liquids.
• Screening size for solids.
• Drying temperature and time.
• PAN speed.
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 Preparation of Master
Manufacturing Procedure:
• The Master Manufacturing Procedure includes followings;
The Process or Manufacturing Direction.
Process direction should be precise and explicit.
Must be written in a simple manner which should be easily understood by the operator.
• The Chemical Weight Sheet.
Identification of chemical required.
Quantities of chemical to be added.
Order of chemicals to be added.
The name and Identification number of the ingredient must be mentioned.
• The Sampling Direction.
Time of sampling of finished product.
Manner of sampling of finished products. 12/30/2024 16
 Preparation of Master Manufacturing Procedure:

• The Batch record direction

The batch record directions should include specification for addition rates,
mixing times, mixing speeds, heating and cooling rates and temperature.

• The In-Process Specification.

Must mention a simple and easy access specification for easy understanding of
operators.

• The Finished Product Specification.

The drug in the dose specified.
The self-life of the product.
The capability of the process.
The reliability of the test methods. 12/30/2024 17

The stability kinetics of the product

 GMP Consideration:
The check list of the GMP items that should be a part of the scale-up or
new product or process introduction including following;
• Equipment qualification.
• Process Validation.
• Regulatory schedule preventive maintenance.
• Regular process review and revalidation.
• Relevant writing standard operating procedures.
• The use of competent, technically qualified personnel.
• Adequate provision for training of personnel.
• A well-defined technology transfer system.  Validated cleaning
procedures.  Arrangement of material to avoid cross contamination.
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 PILOT PLANT SCALE UP
CONSIDERATIONS FOR SOLIDS:
• The following points to be carefully consider during scaling up the solid dosage
forms;
• Batch size from intermediate to large scale production.
• Each stage of operation.
• Different types of equipment.
• Use of sophisticated instruments with larger volume load.
• Various sizes of equipment.
Material Handling:
Chemical Weighing:
Tablet blending and Granulation:
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 PILOT PLANTS DESIGN FOR TABLETS:-

• The primary duty of the pilot plant group of workers is to make sure that the newly
formulated tablets advanced by way of product development personnel will prove to
be successfully, economically and continually reproducible on a manufacturing scale.
• The design and creation of the pharmaceutical pilot plant for tablet development
should incorporate functions important to facilitate upkeep and cleanliness.
• If feasible, it must be positioned on the ground floor to expedite the transport and
shipment of substance.
• Each stage taken into consideration cautiously from experimental lab batch length
to intermediate and large scale manufacturing.
• Some process, identical device however one of a kind performance while quantity of
material increased drastically
• May content major procedure trade that utilizes strategies and device that were
either unavailable or improper on lab scale.

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LAYOUT OF PILOT PLANT:

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 PILOT PLANT SCALE UP CONSIDERATIONS FOR
SOLIDS: Material Handling:

The handling of materials is quite different and necessary to

handle carefully in medium and large scale production from the
laboratory scale (Mostly poured by hand or scooped).
• The characteristics of materials like density, size, shape and
static charge must be taken into consideration.
• Any material handling system must deliver the accurate
amount of the ingredient to the destination.
• The cross contamination must be prevented if a system uses
transfer of materials for more than one product step.
• This is accomplished by use of validated cleaning procedure
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for the equipment.

 Tablet
blending and Granulation:

• Powders to be used for encapsulation or to be granulated

must be well blended to ensure good drug distribution.
• Inadequate blending at this stage could result in discrete
portions of the batch being either high or low in potency to
avoid drug content variation.
• Steps should also be taken to ensure that all the ingredients
are free of the lumps and agglomerates can be removed
by doing screening or milling of the ingredients should
be done to avoid flow problems, non-reproducible compression
and encapsulation process, to facilitate content uniformity of
the product.
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• In blending, segregation and mixing operation takes place

which depends on particle size, shape, hardness and density.
 Tablet
Dry Blending and Direct Compression:

Different blenders used in blending are V- blender,

double cone blender, Ribbon blender, Slant cone
blender, Bin blender, Orbiting screw blenders, vertical
and horizontal high intensity mixers.
The factors affect the optimization of blending
operation of directly compressible materials are;
• The order of addition of components to the blender.
• The mixing speed, The mixing time –It affects
compressibility of Finished Material. 12/30/2024 24

• The blender loads Optimum working volume and

 Slugging (Dry Granulation):
• The dry powder cannot be compressed directly
due to poor flow and compression properties.
• The slugging is done by using the Tablet Press of
15 tonnes / Roller compaction.
• After compression, slugs are broken down by
Hammer Mill with suitable particle size
distribution.
• The granulation by dry compaction can also be
achieved by passing powders between two roller
which put pressure of 10 Tonnes per linear inch.
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 Wet Granulation:
The most common reasons given to justify wet granulating are;
• To impart good flow properties to the material,
• To increase the apparent density of the powders,
• To change the particle size distribution,
• Uniform dispersion of active ingredients.
 wet granulation has been carried out using RMG (Rapid Mixer
Granulator) and Fluidized Bed Granulator (FBG)
• The factors that affecting the Fluidized Bed Granulator are;
Process Inlet Air Temperature, Atomization Air Pressure, Air Volume,
Liquid Spray Rate, Nozzle Position, Product and Exhaust Air Temperature,
Filter Porosity. 12/30/2024 26
 Drying:
• The most common conventional method of drying a granulation continues to be
the
circulating hot air oven, which is heated by either steam or electricity.
• The important factors to consider as part of scale-up of an oven drying
operation are airflow, air temperature, and the depth of the granulation
on the trays.
• If the granulation bed is too deep or too dense, the drying process will be
inefficient, and if soluble dyes are involved, migration of the dye to the surface
of the granules.
• Fluidized bed dryers are an attractive alternative to the circulating hot air
ovens.
• The parameters to be considered for drying process by using Tray Dryer for
scale up are
Air flow, Air temperature, Depth of the granulation on the trays, Monitoring of
the drying process by the use of moisture and temperature probes and Drying
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times at specified temperatures and air flow rates for each product.
 Facilities:
To avoid cross contamination in scale up and to facilitate the cleaning of
equipment
effectively, following facilities must be available that are;
• Presence of separate room with availability of more space,
• Must have granulation as unit operation,
• Must have washing and drainage facilities,
• Must have cold, hot water and steam supply system,
• Platform should be with stainless steel or non-dust material system,
• Air condition system is encouraging but if absent, window must be screened,
• Use of a multifunctional processing system.

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 Tablet Compression:
The tablet press performs following functions during the compression are;
• Filling of an empty die cavity with granulation.
• Pre-compression of granulation.
• Compression of granules.
• Ejection of the tablet from the die cavity and take-off of the compressed tablet.
During selection of high speed press criteria that should be considered
are;
• Granulation feed rate.
• Delivery system should not change the particle size distribution.
• System should not cause segregation of coarse and fine particles.

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 Tablet Compression:
• The die feed system must be able to fill the die cavities
adequately in the short period of time that the die is
passing under the feed frame.
• The smaller the tablet, the more difficult it is to get a
uniform to fill high press speeds.
• For high-speed machines, induced die feed systems with a
variety of feed paddles and variable speed capabilities, are
necessary.
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 Tablet Coating:
• Many changes in Sugar coating (Carried in conventional coating pans), due to
new developments in coating technology (Conventional sugar coating pan
changed to perforated pans or fluidized-bed coating columns), changes in
safety and environmental regulations.
• The tablets must be sufficiently hard to withstand the tumbling to which they
are subjected in either the coating pan or the coating column.
• A film coating solution may have been found to work well with a particular
tablet in a small lab coating pan but may be totally unacceptable on a
production scale.
• To facilitate the efficient coating the tablet should not be designed as flat
surface or Sharpe edges.
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 Encapsulation of Hard Gelatin
Capsules:
• The High Speed equipment is used to prepare the capsule by using the
processed powder blend with following particle characteristics like particle
size distribution, bulk density, compressibility to promote good flow property.
• Weight variation in capsules may come due to poor flow characteristics,
improper lubrication and plug sticking to the dosator plunger surface.
• Overlay lubrication may create problems in weight variation, disintegration,
dissolution and Bioavailability.
• The characteristics of granulation and the finished products are greatly
influenced by the type
and size of equipment used for blending, granulating, drying, sizing and
lubrication.
• For better encapsulation, (RH 35 to 65 %) room and appropriate temperature
condition of 15 to 25 °C.
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 PILOT PLANT SCALE UP
CONSIDERATIONS FOR LIQUID ORALS:
• PILOT PLANT SCALE UP CONSIDERATIONS FOR LIQUID ORALS:
The physical form of a drug product that can be incorporated
demonstrates Newtonian or Pseudo plastic flow behavior.
• It conforms to its container at room temperature.
• Liquid dosage forms may be dispersed systems or solutions.
• In dispersed systems there are two or more phases, where one
phase is distributed in another.
• A solution refers to two or more substances mixed homogeneously.
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 Steps of liquid manufacturing
process
• Planning of material requirements.
• Liquid preparation.
• Filling and Packing.
• Quality assurance.
Critical aspects of liquid manufacturing
• Physical Plant.
• Heating, ventilation and air controlling system.
The effect of long processing times at suboptimal temperatures should
be considered in terms of consequences on the physical or chemical stability
of ingredients as well as product.
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 solutions
The parameters to be considered are for scale up of solutions are;

Impeller diameter.

Tank size (diameter).

Number of impellers.

Impeller type.

Mixing capability of impeller.

Rotational speed of the impeller.

Height of the filled volume in the tank.

Number of baffles.

Transfer system.

Clearance between Impeller Blades and wall of the mixing tank.

Filtration equipment (should remove desired materials but should not remove active or
adjuvant ingredients). 12/30/2024 35
Passivation of Stainless Steel (Pre-reacting the SS with acetic acid or nitric acid solution to
remove. the surface alkalinity of the Stainless Steel).
 Suspension:
The parameters to be considered are for scale up of suspension are;
• Versator (To avoid air entrapment).
• Wetting of suspending agent.
• Addition and dispersion of suspending agents.
• Selection of the equipment according to batch size.
• Time and temperature required for hydration of the suspending agent.
• Mixing speeds (High speed should not be used as it leads to air
entrapment).
• Mesh size (Must be able to remove the foreign particulates and sieve
selected based on production batch size trials).
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 Emulsion:
The parameters to be considered are for scale up of emulsion are;
• Homogenizing equipment.
• Temperature.
• Mixing equipment.
• Phase densities.
• In-process or final product filters.
• Phase volumes.
• Screens, pumps and filling equipment.
• Phase viscosities.
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 PILOT PLANT SCALE UP CONSIDERATIONS FOR SEMI SOLIDS:

The following parameters are to be considered during the scale up of semisolid products;
• Mixing speed.  Mixing equipment (Could be able to move semisolid mass from outside
walls to the center and from bottom to top of the kettle).
• Motors (Drive mixing system with appropriate handling system at its most viscous
stage).
• Heating and cooling process.
• Component homogenization.
• Product transfer.  Addition of active ingredients.  Working temperature range.
• Shear during handling and transfer from manufacturing to holding tank to filling lines.
• Transfer pumps (Easily must move viscous material without applying excessive shear
and free of entrapped air).
Following parameters must be consider during choosing the size and type of pump,
• Pumping rate, Pumping pressure required should be considered. 12/30/2024 38

• Product compatibility with the pump surface and Product viscosity.

SUPAC (SCALE UP AND POSTAPPROVAL
CHANGES)GUIDELINES:
• SUPAC represents the changes recommended by the US FDA at
the time of scale up or approval of NDA / ANDA.
• In the process of developing a new drug product, the batch
sizes used in the earliest human studies are small and the
size of the batches is gradually increased (Scale-up).
• The scale-up process and the changes made after approval in
the composition, manufacturing process, manufacturing
equipment, and change of site have become known as Scale-
Up and Post approval Changes, or SUPAC.
12/30/2024 39
 The SUPAC Guidelines define
• The level of changes – Minor, Moderate and Major Changes.
• Test – Application test, in vitro dissolution and in vivo
• Filing – Annual report, changes being effected supplement and Prior Approval
Supplement.

The level of changes may impact on formulation and quality performance in following levels;
• Level 1: unlikely to have detectable Impact.
• Level 2: could have significant impact.
• Level 3: likely to have significant impact.

These guidelines provide recommendations for post approval changes in;

A> The components or composition change,
B> The site of manufacture change,
C>The scale-up of manufacture change
D>The manufacturing (process and equipment) change. 12/30/2024 40
 SUPAC Guidelines
A) The components or composition changes:

This section focuses on changes in excipients in the drug product.

a) SUPAC-MR - Excipient critical or non-critical to the Modified drug

release.
Changes in non-release and release controlling excipients.
b)SUPAC-SS - Changes in preservative in semisolid formulations.
c)SUPAC-IR Changes for immediate-release solid oral dosage
forms.
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 B) The site changes of manufacture:

Changes in location of the site of manufacture, packaging

operations and/or analytical testing laboratory.
• Do not include any scale-up changes, changes in
manufacturing (including process and/or equipment), or
changes in components or composition.
• Current Good Manufacturing Practice (CGMP) inspection.

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 B) The site changes of manufacture:
level of changes
• Level I Changes - Classification-Single facility where the same equipment, standard
operating procedures (SOP's), environmental conditions (e.g., Temperature and
humidity) and controls, and personnel common.
Test Documentation - Application/ compendia requirements in chemistry, dissolution and
in vivo Bioequivalence - None.
Filing Documentation- Annual report.
• Level II Changes - Classification–Same continuous campus, Common personnel, No
other changes.
Test Documentation– Application/ compendial requirements o Notification of Location of
new site
Updated batch records
SUPAC – MR - Multi-point dissolution profiles(15,30,45,60 and 120 min)USP buffer media
12/30/2024 43
at pH 4.5-7.5 forextended release). Three different Media (e.g., Water, 0.1N HCl, and USP
buffer media at pH 4.5 and 6.8for delayed release)until 80% of Drug Released.
 B) The site changes of manufacture:
level of changes

Level III Changes - Classification– Different campus, Different personnel.

Test Documentation –Application/compendial requirements.
• Notification of Location of new site.
• Updated batch record.
• SUPAC - IR: Multi-point dissolution profile in the application/compendial medium.
• SUPAC - MR: Multi-point dissolution profiles (15, 30, 45, 60 and 120 min) USP
buffer media at pH 4.5-7.5 for extended release). Three different Media (e.g.,
Water, 0.1N HCl, and USP buffer media at pH 4.5 and 6.8 for delayed release)
until 80 % of Drug Released.
Filing Documentation- Annual report prior approval of supplement.
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 C) Changes in Batch Size (Scale-Up/Scale-
Down):

Post-approval changes in the size of a batch from the pivotal/pilot scale

bio batch material to larger or smaller production batches call for
submission of additional information in the application.
Scale-down below 100,000 dosage units is not covered by this guidance.
• Level I Changes - Classification- Change in batch size, up to and
including a factor of 10 times the size of the pilot/bio batch.
Test Documentation – Updated batch records application/compendial
requirements stability.
Filing Documentation- Annual report (long term stability data).
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 C) Changes in Batch Size
• Level II Changes - Classification- Changes in batch size beyond a factor of ten
times the size of the pilot or bio batch, No other changes.
Test Documentation – Chemistry Documentation Application/ compendial release
requirements. Notification of change and submission of updated batch records.
Stability testing: One batch with three months accelerated stability data and one
batch on long-term stability.
Dissolution Documentation-Case B testing.
In Vivo Bioequivalence - None.
Filing Documentation- Changes being effected supplement; annual report (long-
term stability data).
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 D) Manufacturing Changes
Manufacturing changes may affect both equipment used in the manufacturing process and the
process itself.
• i)Equipment –
Level I Changes: Classification- Alternate equipment of the same design and principles as automated
equipment.
Test Documentation – Updated batch records, Application/compendial requirements and stability.
Filing Documentation- Prior approval supplement with justification for change; annual report (long-
term stability data).
Level II Changes: Classification- Change to equipment of different design and principle.
Test Documentation – Updated batch records, Application/compendial requirements and stability. o
SUPAC – IR - Multi-point dissolution profiles in multiple media. o SUPAC – MR - Multi-point dissolution
profiles in multiple media. Filing Documentation- Annual report and changes being Effected
Supplement.
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 D) Manufacturing Changes
ii)Process –
Level I Changes: Classification- Alternate equipment of the same design and principles as automated
equipment.
Test Documentation – Updated batch records, Application/compendial requirements and stability.
Filing Documentation- Annual report.
Level II Changes: Classification- This category includes process changes including changes such as
mixing times and operating speeds outside of application/ validation ranges.
Test Documentation – Updated batch records, Application/compendial requirements and stability. o
SUPAC - IR - Multi-point dissolution profile. o SUPAC- MR - Multi-point dissolution profiles in multiple
media.
SUPAC – SS - In vitro release test Documentation.
Filing Documentation- Changes being effected supplement; annual report (long term stability data)

12/30/2024 48
 D) Manufacturing Changes
Level III Changes: Classification- Changes in the type of
process used (e.g. wet granulation to direct compression).
Test Documentation – Updated batch records,
Application/compendial requirements, stability, bio-study and
IVIVC. o SUPAC - IR - Multi-point dissolution profile.
SUPAC- MR - Multi-point dissolution profiles in multiple media.
Filing Documentation- Prior approval supplement with
justification; annual report (long-term stability data).
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 INTRODUCTION TO PLATFORM
TECHNOLOGY
Platform technologies are considered a valuable tool to
improve efficiency and quality in drug product
development.
The basic idea is that a platform, in combination with a
risk-based approach, is the most systematic method to
leverage prior knowledge for a given new molecule. Further
more, such a platform enables a continuous improvement
by adding data for every new molecule developed by this
approach, increasing the robustness of the platform.
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 Designing of platform
technology
• The first step is to identify future market application that the
technology can address.
• Then determine the core building blocks that can be carried out
over to the new application.
• After identifying the core platform technologies, determine what
has to change beyond the platform to expand into new application.
• Where possible, product platform should be designed in a modular
manner to take full advantages of platform benefits.
• Specify and design the platform performance such that it meets
the known future application needs.
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Application of platform technology
1. Medical devices
Medical devices platform development is very much applicable to
medical .Medical device companies face many of the same challenges of new
product development as other industries however the medical device
industry is for the challenged with regulatory hurdles as part of new product
development. Future product line extensions benefit from modular platform
that have already gone through regulatory evaluation such as product safety
testing. Platform provide next-generation product development acceleration
and reduced development time risk and cost modular platform that are
shared across multiple product lines may also benefit from economy of scale
Web Platforms.
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 Application of platform
technology
2. Drug Delivery System
Drug delivery system many companies like CIPLA, DRL,Pfizer etc. has
made a strategic investment in common platform technologies such as
sustained release and combination product and in key platform to
enhance drug delivery system capabilities. These technologies in hence
the drug safety and its efficacy by targeted therapy approach. In some
instances, the convenience of patient in an important factor. The
strategy aim is to formulate differentiated product that overcome
the key challenges of conventional drug delivery systems and add
value to current product.
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 Application of platform
technology
• A. Nanotechnology
• B. Microsphere
• C. Liposome
• D. Hot melt Extrusion
• E. Sustained Release Formulation
• F. Sprinkles

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