A joint venture of research work focused on novel technology for granulation. Instructor: Dr. Abu T. M. Serajuddin, St. John’s University.

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

6. THE MELT EXTRUDER

7. MELT EXTRUSION
Schematic diagram of a single-screw compounding extruder

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

19. Melt Extrusion