Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Glass as a packaging material in pharmaceutical packagingShweta Shelke
This presentation gives a brief idea about the types of glasses used in pharmaceutical industry and its intended use. Different tests used for assuring its quality for intended use.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Size reduction is a process of reducing large solid unit masses, coarse particles or fine particles.
Size reduction may be achieved by two methods:
1] Precipitation
2] Mechanical process
1] Precipitation method: Substance is dissolve in appropriate solvent.
2] Mechanical process: Mechanical force is introduce by using different equipments like ball mill, colloid mill etc.
The ball miller machine is a tumbling mill that uses steel milling balls as the grinding media, applied in either primary grinding or secondary grinding applications.
Introduction
Objectives
Methods of size reduction
Advantages of size reduction
Disadvantages of size reduction
Mechanism of size reduction
Laws governing to the size reduction
Principle of Size Reduction, Construction, working and uses of following-
Hammer mill
Ball mill
Fluid Energy Mill
Edge Runner Mill
End Runner Mill
SIZE REDUCTION AND FACTORS AFFECTING SIZE REDUCTION IN PHARMACEUTICAL INDUSTRYAkankshaPatel55
In the realm of pharmacy, size truly matters! Particle size reduction, often referred to as comminution, plays a crucial role in transforming raw materials into effective and readily absorbable medications. It's like shrinking giants - turning bulky substances into microscopic warriors ready to combat ailments.
Why is size reduction so important? Imagine trying to swallow a whole apple compared to taking a bite. The smaller the pieces, the greater the surface area exposed, and the faster and more efficiently something dissolves or reacts. In the world of medicine, this translates to:
Enhanced drug bioavailability: Smaller particles dissolve quicker and more readily in the digestive system, leading to faster absorption and action of the medication. Think of it as opening wider doors for the drug to enter the bloodstream and reach its target.
Improved drug stability: Smaller particles tend to be more stable and less prone to degradation, ensuring the medication's potency and effectiveness over time.
Uniformity and mixing: Precise size control allows for consistent drug distribution within a dosage form, guaranteeing accurate and reliable dosing.
Tailored drug delivery: Size reduction facilitates the development of specialized drug delivery systems, like inhalers or sublingual tablets, where minute particles are crucial for targeted action.
How is size reduction achieved? A variety of techniques are employed, each with its own advantages and best suited for specific materials:
Milling: Mechanical grinding using ball mills, hammer mills, or jet mills physically breaks down larger particles into smaller ones.
Micronization: Specialized techniques like air jet milling or fluidized bed milling achieve ultra-fine particle sizes in the micron range (1-10 micrometers).
Cryo-milling: Grinding at cryogenic temperatures minimizes heat generation, preserving sensitive drug compounds.
Size reduction isn't just about brute force. Choosing the right technique and particle size depends on various factors, including the drug's physical and chemical properties, desired release profile, and dosage form. It's a delicate dance between effectiveness, stability, and manufacturability.
The impact of size reduction extends far beyond individual medications. It enables the development of innovative drug delivery systems, like controlled-release tablets or transdermal patches, that improve patient compliance and treatment outcomes. It also plays a vital role in research and development, allowing scientists to study drug interactions and optimize formulations at the microscopic level.
So, the next time you pop a pill, remember the invisible giants behind it - the power of size reduction silently working its magic to deliver healing and hope.
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.
Size reduction, process of size reduction, size reduction a topic of pharmac...RajkumarKumawat11
Size reduction, process of size reduction, size reduction a topic of pharmaceutics, cutter mill, roller mill, hammer mill, ball mill, fluid energy mill, the disintegrator, mills used in pharmaceutical process
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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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.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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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!
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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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
3. Definition:-
Spheronization or marumerization, is a rapid and flexible
process where pharmaceutical products are made into small
spheres, or spheroids of diameter ranging from about 0.5mm to
1mm where as in marumerizatin 0.6mm t0 1.2mm.
3
4. Advantages:-
1. Optimum flow and handling characteristics:-
• The flow characteristics of spheres makes them suitable
for transportation by most systems found in the
pharmaceutical industry, including vacuum transfer.
2. More reproducible packing into small container:-
• The packing into small containers, such as hard gelatine
capsules, or larger packages is much more convenient than
other drug form such as powders or granules.
• Eliminate quality problems with variable dosage due to
packing problems with powder.
4
5. 3. Minimum surface area/volume ratio:-
•Spheres provide the lowest surface area to volume
ratio and thus pharmaceutical compounds can be coated
with minimum of coating material. Important for effective
release of some drugs.
4. Optimum shape for coating and for controlled
release:-
•Coating can provide controlled, targeted release at
different location within the body.
•spheres are dense material that can easily be coated
within a minimum of coating material.
5
6. 5.Easy mixing of non-compatible products:-
spherical particles are easily mixed.
6.Elimination of dust:-
Contamination is reduced.
The amount of fines and dust will be reduced
during transport and handling.
7.Improve hardness and friability:-
Spheronization increases the hardness and reduces
friability of granules.
6
7. Spheronization process
Dry mixing of ingredients – to achieve a homogeneous powder
dispersion;
Wet massing – to produce a sufficiently plastic wet mass.
Extrusion – to form rod shaped particles of uniform diameter .
Spheronization – to round off these rods into spherical particles .
Drying - to achieve the desired final moisture content.
Screening -to achieve the desired narrow size distribution.
7
9. Extrusion
It produces rod shaped particles of uniform diameter from the
wet mass.
Wet mass is forced through the dies and shaped into small
cylindrical particles with uniform diameter .
The extrudate particles breaks at similar lengths under then
own weight.
Extrudate must have enough plasticity to deform ,but extrudate
particles do not adhere to other particles when collected.
Based on their feed mechanism extruders divided into 3 types
1.screw feed extruder(axial and radial)
2.Gravity feed extruder (cylinder roll, gear roll and radial)
3.Piston feed extruder
9
10. 2. Screen or basket extruder:-
Lower density extrudate.
Relatively high throughput.
3. Gear extruder:-
produces relatively high density.
Gears are robust and long lasting.
10
1.Screw feed extruder:-
•Commonly used in industrial
application.
•High pressure and heat can degrade
pharmaceutical product.
11. Type of extruder used in pharmaceutical industry:-
Equipment Description Main uses
Extruder 20 Bench top screen
extruder
Laboratory experimental/small
scale production(25-30kg/hr)
Extruder 35 Production screen
extruder
Lab /production , low cost
.high out put (2kg/min) of less
dense extrudate.
Extruder 40 Production gear
extruder
Quality extrudate output 40-
100kg/hr
Extruder 100 Production gear
extruder
Quality extrudate output
100-500kg/hr
11
12. 1.Extruder 20:-
Designed for pharmaceutical
process development work
in lab.
Few dead spaces where
material can collect.
Minimum effective load
requirement is about 30g
Can be easily dismantled for
easy cleaning.
12
14. The mini screw extruder:-
For small quantity of material.
Smallest batch size can be extruded
is about 5g.
Material loaded into it manually.
Die hole size is 0.7mm to 2mm.
Minimum wastage of valuable
product.
Can be quickly dismantled for easy
cleaning.
14
15. The primary extrusion process variables are :
1) The feed rate of the wet mass
2) The diameter of the die
3) The length of the die
4) The water content of the wet mass
15
16. THE SPHERONIZATION PROCESS:-
Basic configuration:-
Machine consists of a rotating friction disk,
designed to increase friction with the
product, which spins at high speed at the
bottom of cylindrical bowl.
16
17. The ongoing action of particles colliding with the wall and being
thrown back to the inside of the plate creates a “rope-like”
movement of product along the bowl wall.
When particle have obtained the desired spherical shape,
discharge valve of the chamber is opened and the granules are
discharged by the centrifugal force.
17
18. The rounding of the extrudate into spheres is dependent on
frictional forces generated by particle- particle and particle
–equipment collisions.
The bottom disc has a grooved surface to increase these
forces. Two geometric patterns are generally used.
1) A cross –hatched pattern with grooves running at right
angles to one another .
2) A radial pattern with grooves running radially from the
centre of the disc.
18
19. The transition from rods to spheres during spheronization
occurs in various stages
cylinder
cylinder with rounded ends
dumbbell
eclipsed
spheres
19
20. Rotor granulation
In the fruend granulator ,the powder mix is added to the
bowl and wetted with granulating liquid from a spray.
The baseplate rotates at high speed and centrifugal force,
keeps the moist mass at edges of the rotor.
The velocity difference between the rotor and the static
walls, combined with the upward flow of air around the
rotor plate ,cause the mass to move in a toroidal
motion,resulting in the formation of spheres.
20
22. Standard features of marumerizer
Perfect cGMP design,smooth covering.
Explosion free design.
Automatic cleaning of entire system.
Completely integrated full opening side discharge.
Advance process for easy and automated granulation.
jacketed/insulated bowl.
Integration with mill is possible.
Video monitoring the process.
Technical specifications for marumerizer:
22
Model Marumeri
zer-380
Marumeri
zer-500
Marumeri
zer-700
Marumeri
zer-900
Marumeri
zer-700(T)
Marumeri
zer-900(T)
Batch
cap./kgs.
0.5-3.2 3-10 5-20 15-50 10-40 30-100
24. Table summarizing the different types of caleva
spheronizers for pharmaceutical production and
development :
Equipment Description Main use
Micro spheronizer --------- Laboratory:small
quantity
Spheronizer-120 Bench top Laboratory/experimental
Spheronizer-250 Lab scale bench top Low cost high output
Spheronizer-380 ------ Quality spheroids output
Spheronizer-500 ------- Quality spheroids output
24
25. Example of spheronizers:-
Spheronizer 250:-
25
Spheronizes380
spheronizer500
26. Key spheronization factors:-
1.Disc speed and load.
2.Disc groove geometry.
3.Disc diameter and speed.
4.Product parameters.
5.Retention time.
1.Disc speed & load:-
There is an optimum disc speed and load for each disc
diameter.
Momentum too low:-
Extrudate not densified sufficiently.
No spheres formed.
26
27. Momentum too high:-
Too much force on the granules.
Compression of particles within the granules.
Minimum porosity.
Granules fracturing.
The spheronizer drum charge volume:-
The optimum charging volume depends upon the machine size
and the product characteristics.
Ex-machine with a 380nm diameter disc, charged with a volume
of 4 liters. Depending on the density of the spheres and
smoothness of the granules.
27
28. 2.Disc groove geometry:-
Square cross hatched design is most commonly used.
3.Product parameter:-
The particles must be plastic enough to allow deformation
during collisions, but also must be strong enough to
withstand collision with the disc, other particles & the
spheronizer wall without breaking up.
4.Retention time:-
Typical spheronization retention time necessary to
obtained spheres is from 2 to 6 min .
28
29. Machine parameters
The basic machine consist of a round disc with rotating
drive shaft ,spinning at the bottom of a cylindrical bowl.
This is most often cross hatched ,several sizes available.
These discs are designed to increase the friction with the
product.
1)Friction plate pattern
2)Friction plate speed
3)Retention time
4)The charge volume
29
30. 1)Friction plate pattern:-
• The most common groove pattern used for spheroniser discs is
the “waffle-iron” or cross hatch design ,where the friction plate
is like a chessboard of chopped off pyramids.
• Discs with a radial design are also used.
2)Friction plate speed:-
• The typical rotation speed of a 700 mm diameter disc ranges
from 400 to 500 rpm.
• The optimum speed depends on the characteristics of the
product and the particle size.
30
31. 3)Retention time:-
Typical retention time to obtain spheres range from 2 to 6
minutes.
The edges of cylindrical granules are the most fragile part and
they will generate dust during handling .
Spheronization with short retention time can help to reduce
dust significantly.
4)The charge volume:-
The optimum level depends upon the machine size and the
product characteristics.
Increasing the load per batch increases the hardness of the
spheres and smooths the granule surface.
31
32. Product parameters
The rheology of the product can be changed by varying
the formulation or physically.
Binders can be used to increase the strength of the
granules and reduce the amount of fines generated
during the process.
Lubricants will increase the plasticity.
Water can also be used as lubricant.
The optimum moisture content for spheronization is
slightly less than for extrusion.
32
33. 1)Auxillary equipment:-
These can help to improve the efficiency and ease of the
process.
2)Water jacket:-
Warm water useful to drive off moisture that would cause
product sticking on the chamber wall.
Cooling the wall will avoid temperature rises in heat
sensitive products.
The average temperature rise is generally rather
small(normally about 4 c).
33
34. 3)Air introduction:-
It prevents dust from getting between the rotating plate
and the wall of the chamber .
It also help to remove moisture from the granule’s surface.
4)Non- stick coatings :-
The chamber wall and the spheronization plate can be
coated with non-stick materials if this is necessary for
ease of use with sticky materials or cleaning.
34
35. Reference
The design and manufacture of medicines (edited by
Michael.E Aulton),3rd edition.Aulton’s(pharmaceutics)
page no:419-422.
Inventi rapid:pharma tech journal ;review on extrusion
and spheronization (publication date 20-10-2012).
A literature review .,Chris Vervaet,Lieven Baert and Jean
Paul Remon.Interntional journal of pharmaceutics volume
116(28th march 1995).
www.umangpharmaceuticals.com.
35