AI+A11Y 11MAY2024 HYDERBAD GAAD 2024 - HelloA11Y (11 May 2024)
Melt extrusion, a novel technology for granulation
1. MELT EXTRUSION
Presented By:
Saurabh Patel
Meiki Yu
Sachi Joshi
Tejasvi Vankayala
Professor: Abu T. Serajuddin Spring 2010
2. INTRODUCTION
Industrial application of the extrusion process dates back to 1930’s.
Most widely applied processing technologies in the plastic, rubber and food
industry.
Currently it accounts for nearly 50% plastic production, including plastic bags,
sheets, pipes etc.
It is used in the array of Pharmaceutical field for the manufacture of granules,
pellets, tablets, suppositories, implants, stents, transdermal systems and
ophthalmic inserts etc.
3. OVERVIEW
Process of converting a raw material into a product of uniform shape
and density by forcing it through a die under controlled conditions.
Continuous process, capable of consistent product flow at relatively
high throughput rates.
An extruder consists of two distinct parts:
The conveying system which transports the material and imparts a
degree of distributive and dispersive mixing
The die system which forms the material into the required shape.
4. TYPES
Two types of system:
1. Molten system under temperature control. Here heat is
applied to the material to control its viscosity and enable
it’s flow through the die.
2. A semisolid viscous system Semisolid systems are
multiphase concentrated dispersions containing a high
proportion of solid mixed with liquid phase.
5. MELT EXTRUSION: THE PROCESS AND
EQUIPMENT
To convert a homogeneous mixture of APIs, polymeric
excipients, and other additives such as plasticizers, fillers,
dyes, and surfactant into product under high t`emperature and
high-shear environment
The extruded product is of uniform shape and density
8. DESIGNS
Schematic diagram of the screw Twin-screw design:
of single-screw extruder -co-rotating twin-screw (top)
-counter-rotating twin-screw (bottom)
9. ADVANTAGES AND LIMITATIONS OF TWIN-
SCREWS
Advantages of twin-screw extruder
Easier material feeding
high kneading
dispersing capacities`
Less tendency to over-heat and short transit time
Disadvantages of twin-screw extruder:
Air-entrapment
high-pressure generation
low maximum screw speeds and output
10. PROCESSING PARAMETERS
Barrel temperature
Feed rate and screw speed
Motor load and melt pressure
Other minor parameters:
Shear rate
Elasticity
Flow of material over hot metal surfaces
Change in viscosity with temperature
11. ADVANTAGES
Neither solvents nor water are used in this process
Fewer processing steps
Simple, continuous, and efficient process
Uniform dispersion of fine particles
Improved bioavailability
Small equipment and low production costs
12. ADVANTAGES (CONTD...)
High efficiency in mixing
Easy control of process parameters
No cross-contamination
Low production time
Improved drug solubility and taste masking
Suitable for some of the thermo labile materials
13. LIMITATIONS
The drug substance should meet specific requirements
Potential air entrapment
Not suitable for all thermo labile materials
Requires addition of plasticizer
Various process parameters are involved
Requires polymer screening
14. APPLICATIONS OF MELT EXTRUSION
In the manufacture of dosage forms and formulations
Granules and Pellets
Tablets
Implants
Transdermal systems
Ophthalmic inserts
Topical films
Effervescent tablets
15. APPLICATIONS(CONTD…)
Improves the dissolution rate and bioavailability of the drug
Controlling and modifying the release of the drug
Development of solid dispersions especially of poorly water
soluble drugs
Production of enteric capsules
Preparation of rapid-release granules(APAP)
16. KALETRA (RITONAVIR/LOPINAVIR)
Capsules Melt extruded tablets
Required higher doses Low doses
To be refrigerated Need not be refrigerated
To be taken with food Need not be taken with food
17. CONCLUSION
An efficient way for manufacturing a wide range of drug
delivery systems - ranging from oral to topical and parenterals
Limitations:
Drug and matrix degradation due to high temperatures and
high shear pressures used during the process
Approaches to overcome limitations:
Formulation approaches like use of low melting carriers and
compatible plasticizers
18. Equipment design and engineering approaches like change in
extruder or screw design
By applying proper formulation techniques and novel
manufacturing processes, it is possible to produce amorphous
solid dispersions of thermally labile active ingredients using
fusion methods