This seminar presentation summarized various granulation techniques used in pharmaceutical manufacturing. It began with an introduction defining granulation and its purposes in improving powder flow, uniformity, and eliminating dust. The main granulation methods discussed were wet, dry and direct compression granulation. Advanced techniques like steam, melt, and foam granulation were also covered. The presentation concluded that granulation technology allows for efficient production of drug delivery systems and can improve drug dissolution and bioavailability through formation of solid solutions.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
$ CONTENTS $
#Introduction
#Objective of granulation
#Essential properties of granules
#Mechanism of bond formation
#Mechanism of granule formation
#Method of granulation
#Modern equipments in granulation technology
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
$ CONTENTS $
#Introduction
#Objective of granulation
#Essential properties of granules
#Mechanism of bond formation
#Mechanism of granule formation
#Method of granulation
#Modern equipments in granulation technology
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
Granulation, the process of particle enlargement agglomeration technique, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules.
Granulation process can be divided into two types: wet granulation that utilize a liquid in the process and dry granulation that requires no liquid.
the recent progress in the granulation techniques and technologies such as pneumatic dry granulation, reverse wet granulation, steam granulation, moisture-activated dry granulation, thermal adhesion granulation, freeze granulation.
Granules- A multi particle entities in which primary powder particles are made to adhere to form a large particle.
Granulation- A process of collecting particles together by creating bonds between them. Bonds are formed by compression or by using binding agent.
Granulation improve the flow of powdered materials by forming sphere like or regularly shaped aggregates called granules.
Pharmaceutical granulation process is used for tablet and sometimes capsule dosage forms;
However, in some applications the process is used to produce spherical granules for the modified release indications or to prepare granules as sprinkles to be used by pediatric patients.
It is the topic of Industrial pharmacy 2 from semester 7 of Bachelor of pharmacy.
It involved all information regarding Pharmaceuticals production scale up technique .role of managers, Engineer and scientists are explained properly .
ROLE OF MANAGER
1. Ensure a safe work environment for all pilot plant operations and compliance with all health and safety policies and procedures.
2.Provide technical leadership and operational oversight of Pilot Plant facility.
3.Partner with Process Development to optimize and implement new processes and technology at the pilot scale.
4.Train engineers and associates in the functional tasks necessary to successfully perform their duties.
5.Schedule activities of pilot plant personnel and ensure the tasks are completed in a timely manner.
6.Provide personnel career development, coaching, and feedback including performance management discussions with each direct report.
7.Train and oversee compliance with Quality Assurance policies and procedures that relate to the Pilot Plant.
8.Write and review standard operating procedures, batch records, process deviations reports, CAPAs, and change control requests.
Manage raw material receipt and release system.
9.Manage plant supplies and raw materials inventory.
Role of engineers:
1.Plant engineers oversee the electrical mechanical systems of a manufacturing plant, from installation to troubleshooting.
2. They are called upon to improve the plant's efficiency, upgrade to new technologies, repair equipment, increase production, and reduce manufacturing issues .
3.Try to process on a model of proposed plant before committing large sum of money on a production unit.
4.Examination of the formula to determine its ability to withstand batch scale & process modification.
5.Evaluation & Validation for process and equipment.
6.To identify the critical features of the process.
Guidelines for production & process controls.
7.To provide master manufacturing formula with instructions for manufacturing procedure.
8.To avoid the scale up problems.
Process of solid ,liquid dosage forms and their guidelines followed along with proper equipment study is provided and the major controls to maintain scale up consideration were mentioned.
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Seminar on granulation by purnima
1. A
SEMINAR
ON
GRANULATION
PRESENTED BY-
T N PURNIMA
14T21R0083
B.Pharm IV year
UNDER THE GUIDANCE OF-
Mr. Shireesh Kiran M.Pharm
Assistant professor
Department of Pharmaceutics
CMR COLLEGE OF PHARMACY
3. INTRODUCTION
Granulation-Granulation is the process in which the powder particles
are made to adhere to form large particles called granules.
Pharmaceutical granules typically have a size range between 0.2-4mm ,
depending on their subsequent use.
Granulation Technology
5. To avoid powder segregation.
To enhance the flow of powder.
To produce uniform mixtures.
To produce dust free formulations.
To eliminate poor content uniformity.
To improve compaction characteristics of mix.
7. “Direct compression is a dry process where the powdered material is
compressed directly into tablets without modifying the physical nature of the
tablet formulation”.
8. Advantages Disadvantages
• Less time consuming. •Cannot be utilized for drugs that exhibit
poor flow properties.
• Required less labour, equipments, and
space area , hence it is economical.
•Large dose drugs which are not self
compressible are not suitable for direct
compression as large amounts of diluents
is required.
• Few processing steps. • Stratification occurs which results in poor
drug contents uniformity of formed
tablets.
• High stability and faster dissolution. •Dry nature of this technique results in the
development of static charge. This results
in poor drug content uniformity.
9. When To Choose DRY method?
Drug dose is too high.
Do not compress well after wet granulation.
Heat sensitive drugs.
Moisture sensitive drugs.
e.g. Aspirin , Vitamins
10.
11. Dry granulation can be done in two ways –
• By slugging
• Roller compaction
e.g:- CHILSONATOR
HAMMER MILL
ADVANTAGES DISADVANTAGES
Less equipments & space It is an expensive process
Suitable for moist and heat
sensitive drugs
Process create more dust
13. In this, powdered medicament and other excipients are
moistened with granulating agent.
14. ADVANTAGES DISADVANTAGES
• Suitable for high dose drugs which have
poor flow ability.
• Required large space
• Suitable for bulky and dust producing
powders.
• Not suitable for hydrolysable,
thermolabile and moisture sensitive
drugs
• Useful in the preparation of controlled
release dosage forms.
• Equipments employed are expensive
• Dissolution rate of insoluble drugs can
be enhanced.
• Wetting and drying steps make this
technique time consuming
16. Single pot granulation
The granulation is done in a normal high shear
processor and dried in same equipment.
• e.g. Single Pot Processor /
One-Pot Processor
19. ADVANTAGES DISADVANTAGES
•Mixing, massing and granulation are
all performed within in the same
equipment.
•Less wetting and more rapid drying
•Improved coefficient of weight
variation
•Improved content uniformity
•Relatively easy to clean
•Relatively high cost
•High noise level
•Adding material directly is not
convenient
•Non movable
20. Fluidization is the operation by which fine solids are
transformed into a fluid like state through contact with
a gas.
Granulating and drying can be completed in one step
inside the machine.
Fluidbed granulation
21. ADVANTAGES DISADVANTAGES
1.It reduces dust formation during
processing
1. The Fluid Bed cleaning is labor-
intensive and time consuming.
.
2. It reduces product loss 2. It is expensive
3. It improves worker safety 3. It produces low density granules.
24. This process is a modification of conventional wet granulation.
Here steam is used as a binder instead of water.
Steam, at its pure form is transparent gas, and provides a
higher diffusion rate into the powder and a more favorable
thermal balance during the drying step.
25. ADVANTAGES DISADVANTAGES
1.Uniformly distribution the powder
particles.
1. Requires special equipment for
steam generation and
transportation.
2. Higher dissolution rate of
granules because of larger surface
area is generated.
2. Requires high energy inputs.
3. Time efficient. 3. Not suitable for Thermolabile
materials
4. Maintain stability. 4. More safety measure required.
26. This granulation method is also know as theromplastic granulation.
Here granulation is achieved by the addition of meltable binder.
e.g:- Water soluble binders
Polyethylene Glycol (PEG - 2000 to 8000)
[40-60 0C]
Water insoluble binders
Stearic acid [46-59 0C]
Stearyl alcohol [56-60 0C]
Binder is in solid state at room temperature but melts in the temperature range of
50 – 90˚C.
Melted binder then acts like a binding liquid.
There is no need of drying phase since dried granules are obtained by cooling it to
room temperature.
27.
28. Foam granulation technique involves addition of liquid binders
as aqueous foam. The advantages of foamed binder addition
conventional binder addition method includes-
• No spray nozzle is used
• Time efficient drying
• Cost effective
• Uniform distribution of binder
• No over wetting
• Applicable for water sensitive formulation
• Applicable for controlled release formulaion
29.
30. CONCLUSION
Today Granulation Technology represents an efficient pathway
for manufacture of various drug delivery systems.
Advanced Granulation Techniques is applicable to improve
the dissolution characteristics of a poorly water soluble drug
by improving the dissolution rate and bioavailability of the
drug by forming a solid solution.
Granulation techniques are economic and less time consuming.
31. Lachman L., Lieberman H.A., and Kanig J.L. The theory and
practice of industrial pharmacy. Third edition; Varghese
publishing house, Bombay; 1991.
Lieberman H.A. and Lachman L. Pharmaceutical dosage
forms: tablet. Vol 1; Marcel Dekker, INC. New York; 1980.
Lieberman H.A. and Lachman L. Pharmaceutical dosage
forms: tablet. Vol 2; Marcel Dekker, INC. New York; 1980.
http://www.pharmpedia.com/Tablet:Formulation_of_tablets/Bi
nders .
https://en.wikipedia.org/wiki/Granulation_(process).
REFERENCES