This document discusses tablet coating. It begins by providing a brief history of tablet coating and then discusses the reasons for coating tablets, including changing appearance, taste masking, and protecting ingredients from environmental conditions. It describes the three basic components of tablet coating: tablet properties, the coating process, and coating compositions. Under coating process, it discusses coating equipment types like conventional coating pans and fluidized bed coaters. It also covers coating parameters and types of coatings like sugar coating and film coating.
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
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/
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.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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/
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.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.
Tablet coating engineering is one of the prominent topics in pharmaceutical field.
This slide will help pharmacy student to become familiar with coating technology
A Review on TABLET COATING & A DETAILED STUDY OF ENTERIC COATING OF TABLETVishal Shelke
A Review on TABLET COATING & A DETAILED STUDY OF ENTERIC COATING OF TABLET
by Mr. Vishal Shelke
Sub :- Final Year B.Pharm Project (50 Marks)
B.Pharm Sem VIII
College :- Rajarambapu College of Pharmacy, Kasegaon
Shivaji University Kolhapur.
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!
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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.
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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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- 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
2. The first coated pills were used by Rhazes (850-923). Sugar coating of
pills was extensively developed by Frenchmen. Then a dramatic
change was observed in coating when Abbot laboratories marketed first
film coated tablet. Dr. Dale Wurster develop air suspension coating
technique in 1950s.
Reasons for Coating
Different dosage forms may need different kind of coating formulation,
technique and process. Therefore a formulation development scientist
has to understand the critical aspects associated with each case.
Different dosage forms which can be coated are : tablets, capsules,
pellets, granules, particles and powder. All the above mentioned
dosage forms may need coating for different reasons such as :
1. Change in appearance: To impart colour for easy identification during
manufacture, dispensing, in use by patient and brand image building.
2. To eliminate dust generation: To reduce handling problems and to
reduce dust induced toxicity.
3. Taste masking: Mask the bitter or unpleasant taste.
4. Odour masking: Mask the unpleasant odour of active ingredients like
vitamins, antibiotics etc.
3. 5. Isolation of incompatible materials: Some of the
ingredients may be incompatible to each other, and these
can be separated by putting a barrier coating in between
them.
6. Protection from environmental conditions : Some of the
ingredients may not be stable in the presence of moisture,
light, oxygen etc. The product stability can be improved by
coating.
7. Change in release characteristics: Drug release profile
from the dosage form can be tailored by coating
techniques for example – delayed release (by enteric
coating), extended release (by semi permeable membrane
coating or mixing of pellets which are coated to various
degree or with different coating materials).
8. To improve appearance: often where the core tablet is of
poor colour or shows mottling.
4. Three basic components are critical in Tablet coating.
1.Tablet properties
2.Coating process
1. Coating Equipment
2. Parameters of the coating process
3. Facility and ancillary equipment
4. Automation in coating process.
3.Coating compositions
1. Tablet Properties
Tablets that are to be coated must possess the proper physical
characteristics. In the coating process, the tablets roll in a
coating pan or cascade in the air stream as the coating solution
is applied. The tablets must not chip or break.. Also the tablets
are exposed to elevated temperature and humidity during the
coating. The tablet surface which are brittle gets soften in the
presence of heat or effected by coating solutions tends to
become rough in the early phase of the coating process are
unacceptable for coating, especially for film coating which
deposits thin layer of coating, while sugar coating can fill the
surface imperfection but upto some extent because of their high
solid contents. The tablets must be robust enough to withstand
these conditions.
5. The following must be considered while designing tablets which are to be
coated.
1. Tablet Hardness: tablet breakage is typically seen when the hardness is
inadequate a rule of thumb is the tablets to be coated should have
hardness not less than 8 kp (11.2 scu, 80 N)
2. Tablet Friability: Friability is more important as that of hardness. This
test accurately reflects the stresses that the tablets will when tumbling in a
coating pan. The maximum recommended friability for tablets to be coated
is 0.5% however for best results the aim should be 0.1%. If the friability is
above this limit the tablets may cap, laminate or abrades during coating
process.
3. Tablet core shape: Tablets may be compressed in variety of shape that
include; Round/oblong flat, round/oblong shallow concave, round/oblong
standard concave, round/oblong deep concave.
The flat faced tablets have overall best surface hardness buit tend to be
brittle at the edges, these tablets are not good for coating because of
twinning problem.
The deep concave type good mixing and no twinning problem but they offer
the lowest level of surface hardness, so these are also not suitable
because of high attrition at crown.
6. The best compromise between surface hardness, mixing and twinning is
offered by the normal or shallow concave shapes and these are
recommended for coating.
Generally the flat faced, shallow concave or capsule shaped tablets show
greatest erosion at the edges while deep concave show erosion at the
crown.
4. Tablet porosity: increased tablet porosity can be beneficial in increasing
the force of adhesion between the tablet surface and the applied coat. It
should be kept in mind increase porosity comes at the sacrifice of tablet
hardness.
5. Tablet core ingredients: The ingredients both active and inactive can
have significant effect on the interaction between the substrate and coating.
The most important is the degree of adhesion. The active ingredient is often
present in significant amount in the tablet formulation, this will overwhelm
the influence on adhesion by other ingredients. If the active content is low
and it has negative impact on film adhesion, this may be neutralized by
selection of proper excipient.
Lubricants are added to tablet formulations to minimize both die wall friction
and punch adhesion, lubricants results in decrease of tablet hardness and
coating adhesion, specially when metal (magnesium) stearates are used in
7. Superdisintegrants are valuable materials in tablet formulation due to their
ability to reduce disintegration time and increase dissolution rate.
However if used indiscriminately, they can exert negative effects on
other aspects of tablet quality. High levels of superdisintegrant may
result in orange peel effect though the hardness and friability will be
well in the limit.
Coating Process:
Tablet coating is the application of coating composition to a moving bed of
the tablets with concurrent use of heated air to facilitate evaporation of
the solvent.
Equipment: The process and equipment must provide;
1. Distribution of the liquid coating formulation over the whole of the
available tablet surface (ladling, Spraying).
2. Continuous mixing of the tablet load in order to achieve an evenly
coated product (rotation).
3. Continuous drying to solidify the film quickly (hot air).
4. Removal of solvent vapour (plus dust generated, plus used drying air
and atomizing air).
8. Equipment:
Three types of coating equipments are used.
Standard (conventional) coating pan
Perforated coating pan
Fluidized bed (air suspension) coater
1. Standard (conventional) coating pan
The standard pan is 8 – 60 inches in diameter and is rotated on its
horizontal axis by a motor. Heated air is directed into the pan and onto the
tablet bed surface through a duct and
exhausted out by means of another duct
positioned over the tablet be in front of
the pan. Coating solution is applied either
through ladling or spraying.
9. Pellegrini pan
Pellegrini system has baffled pan and a diffuser that distributes the
drying air over the tablet bed surface.
10. Immersion sword pan
In this system the drying air is introduced through a perforated metal sword
device that is immersed in the tablet bed. The drying air flows upward from
the sword through the tablet bed thus providing efficient drying of the wetted
tablets.
11. Immersion Tube pan
In this system a tube is immersed in the tablet bed. The tube delivers the
heated air, a spray nozzle is built in the tip of the tube to deliver the
coating composition. The coating solution and dry air introduced at the
same time.
12. Perforated pan system
This system make use of perforated or partially perforated drum (pan) that
rotates on its horizontal axis in an enclosed housing. This type of coating
system are more efficient in drying as compared to the conventional system.
With such system mark decrease in coating time can be achieved. The
current systems available include;
1. Manesty Accela Cota
2. Freund Hi-Caoter
3. Driacoater
4. Glatt Coater
13.
14.
15.
16. Fluidized bed (air suspension) coater
This system uses columnar chamber through which high volume heated
air is supplied from the bottom to fluidize the tablet bed, providing the
medium for drying and the energy for mixing. These are most efficient
drying and mixing equipment. These are not commonly used for tablets
on large scale high attrition the tablets chip, breaks, abrades out. This
system is commonly applied for particulate coating (microencapsultion
and pellet coating).
The coating solution is either applied from the bottom (Wurster) or from
the top of the chamber on to the tablet bed.
17.
18. Spraying Application Systems (spray gun):
Two systems are used to apply atomized spray of coating composition onto
the tablets.
1. High pressure air less system
2. Low pressure air atomized system
1. High pressure air less system
In this system the liquid is pumped at high pressure (250-3000 psig) through a
small orifice (0.009-0.20 inch) in the fluid nozzle. The degree of atomization
and the spray rate are controlled by the fluid pressure, orifice size, and
viscosity of the liquid.
The disadvantage of the system is that,
Because of the small orifice the suspension may block it therefore the
coating suspension may be finely milled or filtered.
the airless system doesn't provide independent control of suspension
application rate, degree of atomization and spray fan width.
2. Low pressure air atomized system
In this system liquid is pumped through larger orifice (0.020 – 0.06 inch) at
relatively low pressure (5-50 psig). Low pressure of about 10-100 psig at the
atomizer tip contact the liquid and disperse it in finely divided spray. In this
system atomization can be controlled independently of the operating pressure,
also fan width can be controlled.
19.
20.
21.
22. Coating Parameters
During coating the tablets move through an application zone in which a
portion of the tablets receive some coating. Most of the time tablets are in
drying mode moving away from the application zone and recycled
repeatedly through the application zone. In the coating operation
(continuous) an equilibrium is maintained between coating composition
application rate and the rate of evaporation of the solvent. Deviation from
this equilibrium results in serious coating problems. These two parameters
can be adjusted by;
Spray Gun position: 6-18 inches from the bed, 450 angle to the tablet
bed. Not overlapping fan width nor to far.
Effect of pan load: under loading the pan will result in situation where
the tablet does not cover fully the exhaust plenum, and the majority of the
drying air stream will bypass the tablet bed and drying efficiency will be
low.
Air volume and temperature: Drying is controlled by the quantity and
temperature of the drying hot air, and the quantity of exhaust air. It is
important to balance the inlet and exhaust air flow rates such that there is
slight negative pressure in the chamber. Also the temperature difference
between the inlet and exhaust must be with in 20-30oC. It is important to
monitor the following three temperatures.
1. Inlet Air temperature
2. Tablet Bed temperature (most critical)
3. Exhaust air temperature
23. 4. Coating composition: coating composition contains the ingredients that
are to be applied on the surface of tablet and the solvents , which act as
carrier for the ingredients. These solvents are not required in the final
product and must be removed. A balance must be established between the
coating composition flow rate and the three drying variables (drying air
temperature/quantity and exhaust air quantity).
24.
25. Types of coating
1.Sugar coating
2.Film Coating
1. Conventional film coating
2. Enteric film coating
Film coating on the basis of solvent system
1.Organic coating
2.Aqueous coating
Sugar coating
This involves several steps, the duration of which ranges from few hours to
few days. The quality of coating depends upon the skill of the operator
specially in ladling type of solution application. The sugar coating results in
elegant highly glossed finished tablets. Following steps are involved in sugar
coating.
1. Sealing
2. Subcoating
3. Syruping (smoothing)
4.Finishing
5.Polishing
26.
27. 1. Seal coating (sealing)
To prevent moisture penetration into the tablet core a seal coat is applied.
This is specially required in pan-ladling process, to avoid overwetting of the
tablet bed. Without seal coat the tablets will absorb sufficient moisture to be
softened or disintegrate , effecting the physical appearance. Shellac is the
most commonly applied sealant agent, but it offers the problem of increase
the disintegration and dissolution time on aging because of polymerization
of shellac. Zein is also used as sealant, it has no problem as associated
with the shellac. The process description is
Pan Speed 10 rpm
Supply air temperature 30oC
3 application of 800 ml of sealant solution is applied and the tablets are
allowed to dry for 15-20 minutes between the application. If the tablets
become tacky at any time apply sufficient talc to avoid sticking.
2. Sub Coating
This is applied to round the edges and build up the tablet size. Sugar
coating results in the increase of tablet weight by 50-100%. Usually
gelatin/acacia solution is used along subcoating powder. The process
description is
28. Pan speed 10 rpm
Turn heart and inlet air off. Use exhaust air only
apply 3-9 coats. Use 1-2 liters for first coat and then reduced the quantity
accordingly to obtain the required weight and round edges.
Allow the tablets to dry at least for 20 minutes after each application. Dust
with subcoating powder at the end.
After the last coat, jog the pan for at least 2-4 hours to ensure complete
dryness.
3. Syrup (smoothing/color) coating
The purpose of this step is to cover and fill the imperfection in the tablet
surface caused by subcoating, this is the most technical step as it requires
the most skill. This step usually involves three basic phases.
1. Grossing syrup (a syrup with subcoating powder dispersed in it):
Process outline is
Remove excess dust from the pan. Turn on the exhaust air.
Adjust the temperature to achieve the exhaust air temperature of 45-48oC.
Pan Speed 15 rpm
Apply 5-15 coats of grossing syrup.
2. Heavy syrup: This solution contain color, maintaining the above
parameters apply several coats.
29. 3. Regular syrup: The process steps are
Turn off the heat, reduce the inlet and outlet air.
apply few coats of regular colored syrup to achieve final smoothness, size
and color development.
4. Finishing
With the heat and inlet air supply off , reduced exhaust air and pan speed
of 12 rpm apply 3-4 coats of regular colored syrup rapidly.
shut off the exhaust air and apply last coat of regular syrup without
colorant. This will give depth to the color and will enhance the elegance of
the coat.
stop the pan while the tablets are damp and swiftly shift to jog the pan for
15-30 minutes, leave the tablets overnight to dry completely.
5. Polishing:
this is the final step, the tablets can be polished in standard coating pan or
canvas line polishing pan. The steps involved are
Pan speed 12 rpm
inlet air, outlet air turned off
apply 3-4 coats warm polishing solution (waxes), approximately 300 ml
per application.
Apply the subsequent coat when the solvent is evaporated out.
Sometimes powder wax are also applied.
30. Film Coating
To reduce sugar coating process time and to reduce the requirement for
operator skill, film coating was developed.
Film coating is a technique in which a thin layer/coat of a polymer is
deposited over the tablets/particulate. Depending on the coating polymer the
types of coating are
1.Normal film coating
2.Enteric film coating
3.Aqueous moisture barrier coating (AMB)
On the basis of solvent use the types are
1.Organic Coating
2.Aqueous Coating
Materials used in film coating
A typical film coating formulation is made up of
1. Polymer (film former)
2. Plasticizer
3. Colouring/opacifying agent
4. Solvent
5. Others (surfactants, flavors, sweetening agent, active ingredients and
preservatives.)
31. An ideal coating material should have the following properties;
Solubility in solvent of choice for coating preparation
Solubility required for the intended use
Capacity to produce an elegant looking product
Stability in the presence of heat, light, moisture, air and substrate being
coated
Odorless, colorless and tasteless
compatibility with other ingredients
Non toxic or no pharmacologic activity
Ease of application
Resistant to cracking
No bridging or filling formation
Ease of printing on high speed machines
Polymers/Film formers
The function of the polymer is to provide main structure and basic physical
and chemical properties to the coating.
Polymer viscosity is very important specially in aqueous coating we need to
minimize the water concentration, it is to shorten the process time and to
minimize product exposure to the moisture (moisture sensitive product). But
the coating composition with viscosity above 500 cps are difficult to atomize
and will not produce smooth product. Therefore polymers with low viscosity
are preferred.
32. Nonenteric polymers
The commonly used polymers are
1. Hydroxypropyl methylcellulose (HPMC)
Commercially it is available in different viscosity grades This polymer is
widely used in air suspension and pan spray coating. The properties are
1. Soluble in GI fluid, organic and aqueous solvent system
2. Noninterference with tablet disintegration and drug availability
3. Flexibility
4. Chip resistant
5. No odor or taste
6. Stability in presence of light, heat, air and reasonable amount of moisture
7. Incorporation of colour and other additives with out difficulty
If it is used alone then it may results in bridging and filling, so it may be used
in combination or proper plasticizer may be used.
2. Methyl hydroxyethylcellulose
This polymer has also different viscosity grades, it has similar properties as
that of HPMC but it is soluble in few organic solvents, which has restricted
its use.
33. 3. Ethylcellulose
Depending on the ethoxy substitution different viscosity grades are available
commercially. This material is water and GI fluid insoluble, therefore can not
be used alone for coating. It is used in combination with water soluble
polymer e.g. HPMC. These combination are a used for sustained release
coating. The properties include
1. Soluble in wide variety of organic solvents
2. Non toxic
3. Tasteless, odorless and colorless
4. stable at environmental conditions
Unplasticized ethyl cellulose coats are brittle.
4. Hydroxypropylcellulose
1.It is soluble in water below 40oC, GI fluid and organic solvents
2. it is very tacky and yield very flexible film, it can not be used alone
3. it is good for sub coat but not for color or gloss coat
5. Povidone (PVP)
1.It is available in four viscosity grades i.e. K-15, K-30, K-60 and K-90, the
average molecular weights are 10,000, 40,000, 160,000 and 360,000
respectively.
2.It is soluble in water, GI fluid and variety of organic solvents.
34. 3. Povidone films are clear, hard and glossy
4. Povidone is soluble in both acidic and intestinal media, it can be cross
linked with other materials to produce enteric coating material.
5. povidone is used in coating composition to increase the dispersion of
color.
3. Sodium Carboxymethylcellulose
1. It is available in low, medium ,high and extra high viscosity grades
2. It can easily be dispersed in water to form colloidal solution, but is
insoluble in most organic solvents.
3. the film formed is brittle but adheres well to tablets.
7. Acrylate polymers
Acrylate polymers are marketed under the trademark of Eudragrit.
Eudragrit E(dimethylaminoethyl methacrylate and other neutral
methacrylic acid esters) is the only polymer of this group which is freely
soluble in gastric fluid (acidic media).
8. Polyethylene Glycols
35. Enteric Polymers
Enteric coating polymers are those substances which resists the gastric pH
(acidic) and get dissolves in intestinal fluid (alkaline). The reasons for enteric
coating are
To protect acid labile drugs from gastric fluid e.g. enzymes and certain
antibiotics
To prevent gastric distress or nausea e.g. sodium salicylate
To deliver drug to intestine for local action
To deliver drugs that are optimally absorbed in the small intestine
To provide a delayed release component for repeat action tablets.
An ideal enteric coating polymer should have the following properties
1. Resistance to gastric fluids (acidic pH)
2. Ready susceptibility to or permeability to intestinal fluid (alkaline pH)
Compatibility with other ingredients
Non toxic or no pharmacologic activity
Ease of application
Formation of continuous film
stability alone and in coating solution. The film should not change with
aging
Ease of printing on high speed machines
36. 1. Cellulose Acetate Phthalate (CAP)
CAP is widely used but it has major disadvantage that it dissolves above
pH 6, thus delaying the drug release as the ideal material may dissolve
around pH 5.
It is also hygroscopic and relatively permeable to gastric fluid. The film
formed is brittle thus required plasticizer. It is available under the trademark
of Aquateric from FMC corporation.
2. Acrylate polymers.
Two commercially available acrylates are
Eudragrit L (soluble at pH 6), Eudragrit S (soluble at pH 7)
3. HPMC Phthalate
Three grades are available
HPMCP 55 (HP 50), HPMCP 50 (HP 55) and HPMCP 55S (HP 55S)
These polymers dissolves at lower pH (at 5-5.5) than CAP and acrylates.
Thus resulting in higher bioavailability of some specific drugs.
4. Polyvinyl Acetate Phthalate (PVAP)
It is similar to HP 55 in stability and pH dependant solubility.
37. Plasticizer
The function of plasticizer is to modify the basic mechanical properties of
the polymer. Plasticizers have high affinity for the polymer they are also
called nonvolatile solvents.
There are two techniques to modify the plasticity of the film former;
1.Internal plasticizing
2.External plasticizing
In the former technique chemical modification is brought in the polymer
which alters the physical properties of the polymer i.e. elastic modulus. In
later technique other substances are used as plasticizer in the formulation.
When the plasticizer is used in correct concentration it imparts flexibility by
relieving the molecular rigidity. Commonly 10% of polymer concentration is
used. Examples include
1.Castor Oil
2.PEG 200 and 400
3.Propylene glycol
4.Glycerin
5.Polysorbates (tweens)
6.Sorbitan esters (spans)
38. Coloring and opacifying agent
The function of these ingredients is to enhance the product quality. They
provide
1.Product identification
2.Protect the core from light and moisture
3.They increase the solid concentration with any impact on viscosity thus
reducing the drying time. They are either soluble or form fine suspension
in the solvent system. For uniform distribution the particle size must be <
10 microns. The most common colorants used are FD&C or D&C
certified, these are either dyes or lakes of dyes. Examples include iron
oxide, anthrocyanins, caramel, carotenoids, chlorophyll, indigo, flavones,
turmeric acid and carminic acid.
Opacifiers are used to give more pastel color and increase film coverage.
These can provide white coat or mask the color of the tablet core. These
are mostly inorganic material. The substances employed are
1.Titanium dioxide (Most Common)
2.Talc
3.Aluminum silicate
4.Magnesium carbonate
5.Calcium sulfate
6.Aluminum hydroxide
39. Solvents
The function of the solvent is to dissolve or disperse the polymers and other
additives and transfer them to the surface of substrate (core) the ideal
characteristics are
1.It should either dissolve or disperse the polymer system and other ingredients.
2.Small concentration of polymer (2-10%) should not high viscous solution
3.It should be colorless, tasteless, odorless, inexpensive, inert and noninflammable.
4.Should have rapid drying rate
5.Should not have environmental impact.
The most widely solvents used either alone are in combination are water, ethanol,
methanol, isopropyl alcohol, chloroform , acetone , methyl ethyl ketone and
methylene chloride.
40. Blistering
Definition: It is local detachment of film from the substrate forming blister.
Reason: Entrapment of gases in or underneath the film due to overheating either
during spraying or at the end of the coating run.
Sr. No
CAUSE REMEDY
1.
Effect of temperature on the strength,
elasticity and adhesion of the film.
Use mild drying
condition.
Problems and remedies for tablet coating
41. Chipping
Definition: It is defect where the film becomes chipped and dented, usually at the
edges of the tablet.
Reason: Decrease in fluidizing air or speed of rotation of the drum in pan coating.
Sr. No
CAUSE REMEDY
1.
High degree of attrition
associated with the coating
process.
Increase hardness of the film by
increasing the molecular weight grade
of polymer.
42. Cratering
Definition: It is defect of film coating whereby volcanic-like craters appears
exposing the tablet surface.
Reason: The coating solution penetrates the surface of the tablet, often at the
crown where the surface is more porous, causing localized disintegration of the
core and disruption of the coating.
Sr. No. CAUSES REMEDIES
1.
Inefficient drying.
Use efficient and optimum drying conditions.
2.
Higher rate of
application of coating
solution.
Increase viscosity of coating solution to
decrease spray application rate.
43. Sticking and Picking
Definition: It is defect where isolated areas of film are pulled away from the surface
when the tablet sticks together or to the coating pan and then detached from one
another or from the pan and piece of film get remained to the pan or the other tablet
exposing the core.
Reason: Conditions similar to cratering that produces an overly wet tablet bed where
adjacent tablets can stick together and then break apart.
Sr.No
CAUSE REMEDY
1.
Inefficient
drying.
Use optimum and efficient drying conditions or
increase the inlet air temperature.
2.
Higher rate of
application of
coating solution
Decrease the rate of application of coating solution by
increasing viscosity of coating solution.
44. Pitting
Definition: It is defect whereby pits occur in the surface of a tablet core without any
visible disruption of the film coating.
Reason: Temperature of the tablet core is greater than the melting point of the
materials used in the tablet formulation.
Sr. No CAUSE REMEDY
1.
Inappropriate
drying (inlet air )
temperature
Dispensing with preheating procedures at the
initiation of coating and modifying the drying (inlet
air) temperature such that the temperature of the tablet
core is not greater than the melting point of the batch
of additives used.
45. Blooming/Hazing/Dull Film
Definition: It is defect where coating becomes dull immediately or after prolonged
storage at high temperatures.
Reason: It is due to collection on the surface of low molecular weight ingredients
included in the coating formulation. In most circumstances the ingredient will be
plasticizer.
Sr. No.
CAUSE REMEDY
1.
High concentration and low
molecular weight of
plasticizer.
Decrease plasticizer concentration and
increase molecular weight of
plasticizer.
2.
High processing temperature,
especially when using
cellulosic polymer
Appropriate drying temperature
46. Blushing
Definition: It is defect best described as whitish specks or haziness in the film.
Reason: It is thought to be due to precipitated polymer exacerbated by the use of
high coating temperature at or above the thermal gelation temperature of the
polymers.
Sr.
No.
CAUSES REMEDIES
1. High coating temperature Decrease the drying air temperature
2.
Use of sorbitol in formulation which
causes largest fall in the thermal
gelation temperature of the Hydroxy
Propyl Cellulose, Hydroxy Propyl
Methyl Cellulose, Methyl Cellulose
and Cellulose ethers.
Avoid use of sorbitol with Hydroxy
Propyl Cellulose, Hydroxy Propyl
Methyl Cellulose, Methyl Cellulose
and Cellulose ethers.
47. Colour variation
Definition: A defect which involves variation in colour of the film.
Reason: Alteration of the frequency and duration of appearance of tablets in the
spray zone or the size/shape of the spray zone.
Sr. No.
CAUSE REMEDY
1.
Improper mixing, uneven
spray pattern, insufficient
coating, migration of
soluble dyes-plasticizers
and other additives during
drying.
Go for geometric mixing, reformulation with
different plasticizers and additives or use
mild drying conditions.
48. Orange peel/Roughness
Definition: It is surface defect resulting in the film being rough and nonglossy.
Appearance is similar to that of an orange.
Reason: Inadequate spreading of the coating solution before drying.
Sr. No.
CAUSES REMEDIES
1. Rapid Drying Use mild drying conditions
2. High solution viscosity
Use additional solvents to decrease
viscosity of solution.
3
Indiscriminate use of
superdisintegrant
Correct quantity, decrease flow rate
49. Cracking/Splitting
Definition: It is defect in which the film either cracks across the crown of the tablet
(cracking) or splits around the edges of the tablet (Splitting)
Reason: Internal stress in the film exceeds tensile strength of the film.
Sr. No. CAUSE REMEDY
1.
Use of higher molecular
weight polymers or
polymeric blends.
Use lower molecular weight polymers or
polymeric blends. Also adjust plasticizer
type and concentration.
50. Bridging and Filling
Definition: Bridging is defect in which the bisects or monogram is obscured. During
drying the film may shrinks and pull away from the corners of intagliation or bisects.
In filling the bisects or monogram is filled with coating solution.
Sr. No. CAUSE REMEDY
1.
Improper or inadequate
polymers selection.
Proper plasticizer type and concentration.
2.
Applying to much solution
to form thick films
Proper solution application.
3.
To rapid solution
application causes
deposition of liquid in
narrow monogram or
bisects results in filling
Reduce the flow rate of coating
composition.