The document discusses various granulation techniques used in pharmaceutical manufacturing. It begins with an introduction to granules and granulation. It then covers different granulation methods including dry granulation, wet granulation and advanced techniques like fluid bed granulation, extrusion-spheronization, steam granulation and melt granulation. The document provides details on the process, equipment used, advantages and disadvantages of each method. It aims to explain why granulation is important and the various ways it can be achieved.
$ 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
$ 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.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
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.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
Evaluation of the physical & mechanical properties of high drug load formulations (Metformin, APAP, and Aspirin) - Wet Granulation vs. Foam technique
About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is usually taken orally, but can be administered sublingually, buccally, rectally or intravaginally. The tablet is just one of the many forms that an oral drug can take such as syrups, elixirs, suspensions, and emulsions. Medicinal tablets were originally made in the shape of a disk of whatever color their components determined, but are now made in many shapes and colors to help distinguish different medicines. Tablets are often stamped with symbols, letters, and numbers, which enable them to be identified. Sizes of tablets to be swallowed range from a few millimeters to about a centimeter. Some tablets are in the shape of capsules, and are called "caplets". Other products are manufactured in the form of tablets which are designed to dissolve or disintegrate; e.g. cleaning and deodorizing products.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
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Prix Galien International 2024 Forum ProgramLevi Shapiro
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
1. A
seminar
on
GRANULATION
Presented by, Under the guidance of,
Mr. NAMDEO SHINDE Dr. N. H. ALOORKAR
M. PHARM. (sem. I) M.PHARM., Ph. D.
SATARA COLLEGE OF PHARMACY,
SATARA.
1/27/2013 1
4. Why we prepare granules when
we have powders….?
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 4
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.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 5
6. To avoid powder segregation. Contd...
-Segregation may result in weight variation.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 6
7. Contd...
To enhance the flow of powders.
(Higher flowability gives better filling of the dies or containers)
To produce uniform mixtures.
(Mixtures of various particles tend to segregate in
transport or handling because of differences in particle
size, shape and density)
SATARA COLLEGE OF PHARMACY,
SATARA. 1/27/2013 7
8. Dust free formulations.
(Decrease dust generation and reduce
employee exposure to drug product)
To eliminate poor content uniformity.
SATARA COLLEGE OF PHARMACY,
SATARA. 1/27/2013 8
9. Methods of granulation
DIRECT COMPRESSION
COMPRESSION GRANULATION
WET GRANULATION
SATARA COLLEGE OF PHARMACY,
SATARA. 1/27/2013 9
10. 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
SATARA COLLEGE OF PHARMACY,
SATARA. 1/27/2013 10
11. Steps in Dry Granulation
Compaction of powder
Milling
Screening
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 11
12. Contd…
How can
we do it………?
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 12
13. Contd…
By two ways
ROLLER
SLUGGING COMPACTION
Large tablet produced Powder is squeezed
in heavy duty tablet between two rollers to
press. produce sheet of material
e.g. Chilsonator
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 13
14. Contd…
Equipments
Has two parts,
Machine for compressing dry powder to
form compacts.
Mill for breaking these intermediates to
granule.
e.g. CHILSONATER
HAMMER MILL
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 14
15. Advantages Disadvantages
Less No uniform
equipments & color
space distribution
Eliminate
Process create
need of binder
more dust
solution
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 15
16. COMPRESSION granulation
It mainly involves three steps -
Milling of drug and excipients
Mixing of drug and
excipients
Tablet compression
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 16
17. Contd…
CAPPING
LAMINATION
EQUIPMENTS
ARE
EXPENSIVE
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 17
18. wet granulation
In this, powdered medicament and
other excipients are moistened with
granulating agent.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 18
19. Contd…
Steps in wet granulation
• Mixing of the drug(s) and excipients
1
• Mixing of binder solution with powder mix. to form
2 wet mass
• Coarse screening of wet mass using a suitable sieve .
3 (6-12 # screens)
4 • Drying of moist granules.
• Screening of dry granules through a suitable sieve
5 (14-20 # screen).
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 19
20. 1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 20
22. Contd…
TIME
LABOR EQUIPMENTS
Limitation
of wet
granulation
LOSS OF
ENERGY MATERIAL
SPACE
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 22
23. Methods
Contd…
Single pot granulation
High shear mixture granulation
Fluid bed granulation
Extrusion- Spheronization
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 23
24. 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
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 24
28. Contd..
ADVANTAGES DISADVANTAGES
Increase in
Short processing time. temperature may cause
chemical degradation of
Lesser amount of liquid thermolabile material.
binders required compared
with FBG. Over wetting of
granules can lead to large
Highly cohesive material size lumps formation.
can be granulated.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 28
29. Fluid bed granulation
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.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 29
30. Contd…
-Homogeneous granules.
---Gentle product handling.
--Uniform spraying of all
particles in the fluid bed.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 30
31. Contd…
Advantages Disadvantages
1.It reduces dust 1. The Fluid Bed cleaning is
formation during labor-intensive and time
processing consuming.
2. It reduces product loss
2. Difficulty of assuring
3. It improves worker reproducibility.
safety.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 31
32. Extrusion-Spheronization
1.Dry mixing of materials to achieve homogeneous
dispersion.
2. Wet granulation of the resulted mixture to form wet
mass.
3. Extrusion of wet mass to form rod shaped particles.
4. Rounding off (in spheronizer)
5. Drying
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 32
33. Extrusion-Spheronization
Different steps involved in the Extrusion- Spheronization process
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 33
36. Steam Granulation
This process is a modification of conventional
wet granulation.
Here steam is used as a binder instead of water.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 36
37. Contd…
Advantages
1.Uniformly distribution the powder particles.
2. Higher dissolution rate of granules because of larger
surface area generated.
3. Time efficient.
4. Maintain sterility.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 37
38. Contd…
Disadvantages
1. Requires special equipment for steam generation and
transportation.
2. Requires high energy inputs.
3. Thermolabile materials are poor candidates.
4. More safety measure required.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 38
39. Melt Granulation
Here granulation is achieved by the addition of meltable
binder.
Binder is in solid state at room temperature but melts in
the temperature range of 50 – 80˚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.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 39
40. Contd…
water soluble binders-
e.g. Polyethylene Glycol (PEG)
2000, 4000, 6000, 8000
(40-60 0C)
water insoluble binders-
e.g.. Stearic acid (46-59 0C),
Cetyl or stearyl alcohol(56-60 0C)
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 40
41. Contd…
Advantages Disadvantages
-Heat sensitive materials are
-Time and cost effective poor candidates
- Lower-melting-point binder
-Controlling and may melt/ soften during
modifying the release of handling and storage
drugs
-Higher-melting-point binders
require high melting temp.
-Water sensitive drugs are and can contribute instability
good candidates problems for heat-labile
materials.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 41
42. MOISTURE ACTIVATED DRY GRANULATION
In MADG, moisture is used to activate granule formation, without the
need to apply heat to dry the granules.
STAGES
MOISTURE DISTRIBUTION/
AGGLOMERATION
ABSORPTION
-Moisture absorbents like
-Drug is blended with diluents microcrystalline cellulose or
and powder silicon dioxide, are added while
mixing.
-A small amount of water (1-4%)
Is sprayed -Moisture redistribution within
the mixture.
-Agglomerate formation
(size 150–500μm) Entire mixture becomes
relatively dry.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 42
43. Contd…
Advantages:
1.Applicable to more than 90% of the granulation need for
pharmaceutical, food and nutritional industry.
2. Time efficient.
3. Suitable for continuous processing
4. Less energy involved during processing.
Disadvantages:
1. Moisture sensitive and high moisture absorbing API are
poor candidates.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 43
44. Moist Granulation Technique (MGT)
A small amount granulating fluid is added to activate dry
binder and to facilitate agglomeration.
Moisture absorbing material like Microcrystalline
Cellulose (MCC) is added to absorb any excess moisture.
Drying step is not necessary.
Applicable for developing a controlled release
formulation.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 44
45. Thermal Adhesion Granulation Process (TAGP)
-It is applicable for preparing direct tableting formulations.
-Mixture of API and excipients are heated to a temp. 30-130ºC .
in closed system until granulation.
It provides granules with-
- Good flow properties.
- Binding capacity to form tablets of low friability.
- Adequate hardness.
1/27/2013 SATARA COLLEGE OF 45
PHARMACY, SATARA.
46. TIME
EFFICIENT
COST
NO EFFECTIVE
OVERWETTING
FOAM
GRANULATION
IR, CR
UNIFORM
FORMULATION
BINDER
DISTRIBUTION
WATER SENSITIVE
DRUGS
1/27/2013 SATARA COLLEGE OF 46
PHARMACY, SATARA.
47. Freeze granulation Technology
Developed and adopted by ,
Swedish Ceramic Institute (SCI).
-By spraying a powder suspension into liquid nitrogen, the drops
(granules) are instantaneously frozen. In a subsequent freeze-
drying the granules are dried by sublimation of the ice without
any segregation effects.
-Finally it produces spherical, free flowing granules.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 47
49. TOPO Technology
HERMES PHARMA has developed unique technology for
carrying out single pot granulation.
Requires very small quantity of liquid to start the chain
reaction
Pure water or water-ethanol mixtures are used.
Technology produces granules for tablets which contain at
least one solid crystalline, organic acid and one alkaline or
alkaline earth metal carbonate that reacts with the organic
acid in aqueous solution to form carbon dioxide.
As a result, there are no solvent residues in the finished
products, granules have excellent hardness and stability.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 49
50. Continuous Flow Technology
The technology does not need any liquid to start the chain
reaction.
Granulation is carried out in an inclined drum into which
powder is fed at one end and granulate is removed at the
other.
The process produces granule with surface protected by
inactive component that do not harm to sensitive API.
CF technology can produce up to 12 tons of granules every
day.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 50
51. Contd…
Key Benefits-
Sensitive APIs are protected .
Granules and effervescents become less sensitive to
humidity and high temperature.
Granules form extremely stable products.
No solvent residues in the final products.
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 51
52. GRANULATION CHARACTERIZATION:
Sr. No. Parameters Method
1 Particle Morphology Optical microscopy
2 Particle Size Distribution Sieve analysis, laser light scattering
3 Nature Powder X-Ray Diffraction
4 Surface Area Gas adsorption
5 Granule Porosity Mercury intrusion methods
6 Granule Strength Development of a Formulation
7 Granule Flowability and Density Hopper Method, Density Apparatus
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 52
55. REFERENCES
1) Stahl H, A review article on latest process advancements and
innovations in Granulation technology.
2) Yadav V. B., Yadav A. V., Liquisolid granulation technique for tablet
manufacturing: an overview in Journal of Pharmacy Research.
3)Malcolm Summers, Michael Aulton, a review on Granulation.
4) Niro pharma system on current issues and troubleshooting fluid bed
granulation,may1998.
5)Harald Stahl,Senior pharmaceutical technologist, GEA Pharma
Systems, Germany
7)Detlev Haack . Hermes Arzneimittel GmbH – Division Hermes
Pharma, Grosshesselohe (Germany).
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56. THANK
YOU….
1/27/2013 SATARA COLLEGE OF PHARMACY, SATARA. 56